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Issuance Registration No. 11-1471057-000120-10 2019 Drug Approval Report July, 2020 Innovative Convergence Product Support Department 1. General Information on Drug Approval/Notification (Overall) in 2019 1 1.1. General Information ················································································ 3 1.2. Approval of New Drugs ········································································· 16 1.3. Approval on Orphan Drugs ··································································· 27 1.4. Item Approval and notification by Major Efficacy Group and Classification Code ················································································· 31 2. Information on Approval of Drugs (Chemical Drugs) ···························· 37 2.1. Information on Approval of New Drugs ············································ 42 2.2. Information on Approval of Orphan Drugs ······································· 54 2.3. Information on Approval of Incrementally Modified Drugs ··········· 57 2.4. Information on Approval of Drugs Requiring Data Submission ······· 66 3. Information on Approval of Biopharmaceuticals ······································· 86 3.1. Information on Approval of Biologics ················································· 91 3.2. Information on Approval of Recombinant Protein Products ········· 95 3.3. Information on Approval of Cell Therapy Products ······················ 103 4. Information on Approval of Herbal Medicinal Preparations ··················· 107 4.1. Information on Approval of Herbal Medicinal Preparations as Prescription Drugs ·················································································· 110 4.2. Approval Status of Herbal Preparations as OTC Drugs ················· 115 4.3. Information on Approval of Drug substances and Herbal substances ····· 116 [Appendix] Information on departments responsible for pharmaceutical petitions, etc. ·················································································· 117 Contents of Tables Table 1. Outline of Drug Approval/ Notification Status (2017-2019)) ······················ 3 Table 2-1. Number of Drug Approval/ Notification by Year (Excluding Herbal Substance) ············································································ 5 Table 2-2. Number of Drug Approval/ Notification by Year (Including Herbal Substance)) ··········································································· 5 Table 2-3. Notification Status of Korean Herbal Substance by Year ··························· 6 Table 3-1. Drug Approval/ Notification Status by Institution in 2019 ······················· 8 Table 3-2. Outline of Drug Approval and Notification in 2019 ··································· 8 Table 4. Details of Drug Approval and Notification by Regional Offices in 2019 ································································································································· 9 Table 5. Information on Drug Manufacture and Import in 2019 ··························· 10 Table 6. Details of Drug Products and Drug Substances Approval/ Notification in 2019 ···················································································································· 10 Table 7. Classification of Chemicals, Biopharmaceuticals and Herbal Medicine from Drug products in 2019 ············································································ 11 Table 8. Classification of New Drugs, Drugs Requiring for Data Submission and Generic drugs in 2019 ························································································ 12 Table 9. Items Approved by the Headquarters in 2019 (Drug products) ·········· 13 Table 10. Overview of Drug Approvals in 2019 ··························································· 13 Table 11. Number of Approvals (Notification) by Drug Type (2012-2019) (Including Revoked and Withdrawn Items) ················································· 14 Table 12. New Drug Approvals in 2019 ········································································· 14 Table 13-1. Approval of Chemical, Biopharmaceuticals and Herbal Medicinal Products as New Drugs (2010-2019) (Including Revoked and Withdrawn Items) ······················································································································· 18 Table 13-2. New Drug Approval Status by Year (2010-2019) (Including Revoked and Withdrawn Items) ·················································· 18 Table 14. Therapeutic Class of New Drug Approval Items by Year (2010-2019) (Including Revoked, Withdrawn and Released Orphan Items) ················ 19 Table 15. 2019 New Drug Approval List (Including New Drugs Removed from Orphan Drug List) ································································································ 21 Table 16. List of New Drugs Developed in Korea (1999-2019) (Including Withdrawn Items) ············································································ 26 Table 17. Orphan Drug Approval Status in 2019 ··························································· 27 Table 18. Approval of New Orphan Drugs by Year (2010-2019) (Including Revoked and Withdrawn Items) ···················································· 27 Table 19. Ingredients of Newly Designated Orphan Drug in 2019 ··························· 28 Table 20. Number of Approved and Notified Items by therapeutic class in 2019 (Including Revoked and Withdrawn Items) ··················································· 31 Table 21. Single Classification number of Top 5 Approval Items (2015-2019) (Including Revoked and Withdrawal Items) ·················································· 33 Table 22. Approval and Notification of Drug products by Major Therapeutic Class in 2019 ······················································································································ 34 Table 23. Approval Status of Pharmaceutical Drugs (Chemical Drugs) by Review Type in 2019 ··········································································································· 39 Table 24. Approval Status of Manufactured/Imported New Drugs (2014~2019) (Chemical Drugs) ··································································································· 42 Table 25. Approval Status of New Drugs by Drug Classification Code (2014~2019) (Chemical Drugs) ··································································································· 43 Table 26. Approval Status of New Drugs in 2019 (Chemical Drugs) ······················· 49 Table 27. Approval Status of Orphan Drug in 2019 (Chemical Drugs) ··················· 54 Table 28. Type of Incrementally Modified Drugs in 2015~2019 ································· 58 Table 29. List of Incrementally Modified Drugs (2009~2019) ······································ 60 Table 30. Approval Status of Drugs Requiring Data Submission in 2019 ··············· 66 Table 31. Approval of Drugs with New Salt or New Isomer that Require Data Submission in 2019 ······························································································· 67 Table 32. Approval Status of Drugs with New Composition that Require Data Submission in 2019 ······························································································· 68 Table 33. Approval Status of Drugs with Changes in strength of active substances that Require Data Submission in 2019 ···························································· 73 Table 34. Approval Status of Drugs with New Route of Administration Requiring Data Submission in 2019 ····················································································· 75 Table 35. Approval Status of Drugs with New Dosage/Administration that Require Data Submission in 2019 ····································································· 75 Table 36. Approval Status of Drugs with New Dosage Form (Same Route of Administration) that Require Data Submission in 2019 ······························ 76 Table 37. Approvals Status of Biopharmaceuticals by Review Type in 2019 ················· 88 Table 38. Approval Status of Biopharmaceuticals in 2019 (Including Drugs for Export Only and Drug Substances) ·························· 89 Table 39. List of Biopharmaceuticals Approved in 2019 ··············································· 93 Table 40. List of Approved Recombinant Protein Products in 2019 ························· 98 Table 41. List of Approved Biosimilars (2012~2019) ···················································· 101 Table 42. List of Approved Cell Therapy Products (2001~2019) ······························ 103 Table 43. Approval of Herbal Medicinal Preparations by Review Type in 2019 109 Table 44. Approval Status of Herbal Medicinal Preparations 2019 ·························· 110 Table 45. Approval Status of Herbal Medicinal Preparations as Prescription Drug in 2019 ···················································································································· 112 Table 46. Approval Status of Herbal Medicinal Preparations as OTC drugs in 2019 ································································································································ 115 Table 47. Approval Status of Herbal Medicinal Preparations in 2019 (Drug Substance and Herbal Substances) ······················································ 116 Table 48. Information on departments responsible for pharmaceutical petitions, etc. (As of June, 2020) ······························································································· 117 Contents of Figures Figure 1-1. Number of Drug Approval and Notification (2010-2019) (Excluding Herbal Substances) ······························································· 6 Figure 1-2. Number of Drug Approval and Notification (2010-2019) (Herbal Substances) ··················································································· 7 Figure 2. Information on Approval of Drugs by Drug Type (2012~2019) ···· 15 Figure 3. Approval Status of New Drugs by Year (2010-2019) (Including Revoked, Withdrawn and Released New Drugs) ··············· 20 Figure 4. Approval of New Orphan Drugs by year (2010-2019) ················ 28 Figure 5. Ratio of Approval Cases (Notification) Classified by Major Efficacy Groups in 2019 ······················································································· 31 Figure 6. Annual Approval (Notification) of Drugs by Drug Therapeutic Class (2011-2019) ····················································································· 32 Figure 7. Approval on Incrementally Modified Drugs by Acceptance Criteria and by Type (2009 ~ 2019) ······························································· 59 1 General Information on Drug Approval/Notification (Overall) in 2019 - 1 - 1. General Information on Drug Approval/Notification (Overall) in 2019 This 2019 Drug Approval Report is to support the systematization and efficiency of establishment/enforcement of related regulations and drug approval /notification; and product development by sharing the information on approval /notification of all drugs in line with the 2018 Drug Approval Report. 1.1. General Information First, according to the approval/notification information on all drugs in 2019 including chemical drugs, biopharmaceuticals and herbal medicinal products, a total of 6,187 items were approved and notified as shown in Table 1. The total number of items increased by about 2.5 times YoY (3,705 items), and especially the number of approved and notified items for manufacturing increased sharply by about 2.6 times (3,675 items). Table 1. Outline of Drug Approval/ Notification Status (2017 ~2019) (Unit: number of items) Drug Drug product Notifi Head Regional Drug substances Herbal Year Total Approval Mfg. Imported (excluding products substances Pres OTC cation quarters Office herbal cribed substances) 19 6,187 ’ 18 2,482 ’ 17 2,524 ’ 3,691 2,496 629 5,558 6,035 152 4,809 71 1,307 (59.7%) (40.3%) (10.2%) (89.8%) (97.5%) (2.5%) (77.7%) (1.2%) (21.1%) excluding herbal excluding herbal excluding herbal substances substances substances (1307) (1307) (1307) 3,684 1,196 622 4,25 4,728 152 (75.5%) (24.5%) (12.7%) (87.3%) (96.9%) (3.1%) excluding herbal substances(%) 98.5% 1,379 1,103 397 2,085 2,360 122 2,046 75 361 (44.4%) (16.0%) (84.0%) (95.1%) (4.9%) (82.4%) (3.0%) (14.6%) excluding herbal excluding herbal substances substances substances (361) (361) (361) 1,378 743 396 1,725 1,999 122 (65.0%) (35.0%) (18.7%) (81.3%) (94.2%) (5.8%) 1,315 1,209 361 2,163 2,360 (52.1%) (47.9%) (14.3%) (85.7%) (93.5%) 164 2,049 55 420 (6.5%) (81.2%) (2.2%) (16.6%) excluding herbal substances substances substances (420) substances(%) 3.5% excluding herbal (420) excluding herbal 96.5% excluding herbal (420) 1,306 798 352 1,752 1,940 164 (62.1%) (37.9%) (16.7%) (83.3%) (92.2%) (7.8%) excluding herbal substances(%) 97.4% 670 (86.1%) (13.9%) 1,514 532 (74.0%) (26.0%) 1.5% (55.6%) excluding herbal 4,139 1,573 476 (76.8%) (23.2%) 2.6% * Excluding drugs for export (80 items), including revoked and withdrawn items and herbal substances - 3 - Among the total items (6,187 items), approved items and notified items accounted for 59.7% (3,691 items) and 40.3% (2,496 items), respectively while 629 items (10.2%) and 5,558 items (89.8%) were approved and/or notified by the headquarters and regional offices, respectively. This shows the number of approved and notified items increased sharply in 2019 compared with 2018. Domestic items for manufacturing/marketing accounted for 97.5% (6,035 items) whereas imported items, 2.5% (152 items) only. The drug products, drug substances, and herbal substances accounted for 77.7% (4,809 items), 1.2% (71 items), and 21.1% (1,307 items) respectively, which shows the number of drug products and herbal substances increased sharply while that of imported items and drug substances was similar to those in the previous year. Drug products (98.5%) were significantly larger than drug substances (1.5%) when excluding herbal substances, and the prescription drugs amounted to 86.1% (4,139 items) and the over-the-counter (OTC) drugs to 13.9% (670 items) respectively. Like 2018, domestic items for manufacturing/marketing took the most among the items approved and notified in 2019. However, there were no significant increase in the number of approved and notified domestic items for manufacturing/marketing (excluding herbal substances in 2018 (1,999 items) compared to 2017 (1,940 items), but increased about 2.4 times in 2019 (4,728 items) compared to the previous year. This is considered to be the effect of the surge in the number of approved (notified) generic drug submitted with the consigned (joint) bioequivalence test data. In case of the notification items (excluding herbal substances), due to introduction of the pre-GMP of OTC drugs from July 1, 2009, the number of notification items (753 items) in 2011 decreased significantly to almost the half as compared to that of 2010 (1,530 items) and later there was no significant change. However it increased by 1.6 times (453 items) in 2019 compared to the previous year due to the surge in the number of generic drugs. - 4 - The number of approval and notification items for herbal substances increased to 1,307 items in 2019 by 3.6 times (946 items) compared to 361 items in 2018 because of an increase in the number of items coming from notification of items made by new drug manufacturers. Table 2-1. Number of Drug Approvals/ Notifications by Year (Excluding Herbal Substance) (Unit: number of items) Category 2010 2011 2012 2013 2014 2015 2016 2017 2018 Approval 614 853 831 1,423 1,811 2,110 2,030 1,306 1,378 (increase % YoY) Notification (increase % YoY) Total (increase % YoY) 38.9% 1,530 753 -50.7% 2,144 -2.5% -25.0% 687 -8.7% 1,606 71.2% -5.4% 787 14.6% 1,518 27.3% 45.6% 1,118 42.1% 2,210 16.6% 904 -19.1% 2,929 32.5% -3.8% -35.7% 815 -9.8% 3,014 2.9% 5.5% 798 -2.1% 2,845 743 -6.9% 2,104 -5.6% -26.0% 2,121 8.1% 2019 3,684 (75.5%) 167.3% 1,196 (24.5%) 61.0% 4,880 130.1% * Excluding drugs for export and herbal substances, including revoked/withdrawn items Table 2-2 Number of Drug Approvals/ Notifications by Year (including Herbal Substance) (Unit: number of items) Category 2010 2011 2012 2013 2014 2015 2016 2017 2018 Approval 618 853 835 1,423 1,811 2,110 2,036 1,315 1,379 (increase % YoY) Notification (increase % YoY) Total (increase % YoY) 38.0% 3,479 7,269 107.8% 4,115 -2.1% 97.4% 3,898 -46.3% 8,122 70.4% -41.7% 973 -75.0% 4,733 47.3% -49.4% 1,296 33.2% 2,396 16.6% 2,813 1,792 4,923 58.4% 3,828 -22.2% -34.1% 1,103 -8.8% 2,524 * Excluding drugs for export and herbal substances, including revoked/withdrawn items - 5 - 4.9% 1,209 117.1% -36.3% -32.5% 3,107 29.7% -3.5% -35.4% 2,482 -1.7% 2019 3,691 (59.7%) 167.7% 2,496 (40.3%) 126.3% 6,187 149.3% Table 2-3. Notification Status of in Herbal Substances by Year (Unit: number of items) Category 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 1,967 6,516 3,211 186 178 1,909 983 420 361 1307 Herbal substances (increase % YoY) All notified items herbal substances 231.3% 3,497 -50.7% 7,269 -94.2% 3,898 -4.3% 973 972.5% -48.5% -57.3% -14.0% 1,296 2,813 1,792 1,209 1,103 262.0% 2,496 * Excluding drugs for export and herbal substances, including revoked/withdrawn items Figure 1-1. Number of Drug Approval and Notification (2010~2019) (Excluding Herbal Substances) - 6 - Figure 1-2. Number of Drug Approval and Notification (2010 ~2019) (Herbal Substances) - 7 - To analyze the approval and notification of medical products of 2019 in detail, it was found the items approved by regional offices was 3,062 items (83.1%) out of total 3,684 approved items, which is about 4.9 times more than the items approved by the Headquarters 622 items (16.9%) (Refer to Table 3-1). This means that the number of approval cases of generic drugs, which is subject to the approval of regional offices, is relatively higher than that of drugs requiring for data submission. In addition, 99.9% of 3,062 drugs approved by regional offices were the manufactured items (3,059 items) (Refer to Table 3-2). Table 3-1. Drug Approval/ Notification Status by Institution in 2019 (Unit: number of items) Type Total Headquarters Regional Office Approval 3,684 (100%) 622 (16.9%) 3,062 (83.1%) Notification 1,196 - 1,196 Herbal Substances 1,307 7 1,300 Total 6,187 (100%) 629 (10.2%) 5,558 (89.8%) * Excluding drugs for export (80 items), including revoked/withdrawn items and herbal substances Table 3-2. Outline of Drug Approval and Notification in 2019 (Unit: number of items) Domestically manufactured (4,728 items) Imported (152 items) Headquarters Approval Prescribed (3,356) (4,054) Drug products (4,706) Notification (498) 99.5% OTC (652) 13.8% 0.5% Prescribed Office (498) Headquarters 67.8% Office (34) (34) Regional Office (7) (7) Notification Regional Office (15) (3) (3) (18) Approval (4) (4) Regional Office (0) Notification Regional Office (14) Drug substances (49) (15) (3) Headquarters (618) Headquarters Regional Office Notification Regional Office 11.8% Notification Regional Office (79) 55.9% OTC (0) Approval (82) (85) Drug products (103) Regional Approval (618) Drug substances (22) Approval Regional (3,059) 85.7% Headquarters (497) 32.2% (14) Approval Headquarters (1) (1) Notification Regional Office (48) (48) * Excluding drugs for export (80 items) and herbal substances(1,307 items), including revoked/withdrawn items - 8 - According to approvals and notifications by regional offices, Gyeongin Regional Office handled the most items (36.0%, 2,003 items) of total items, followed by Seoul and Daejeon Regional Offices, accounting for 24.7% at the same level (1,374 and 1,372 items respectively). Most of the total approvals and notifications (85.4%) were handled in Gyeongin, Seoul and Daejeon Regional Office and most of herbal substances were handled by Seoul Regional Office (69.0%, 897 items) (Refer to Table 4). Table 4. Details of Drug Approval and Notification in Regional Offices in 2019 (Unit: number of items) Item Approval Notification Herbal substances Total 1,312 484 207 2,003 (42.8%) (40.5%) (15.9%) (36.1%) 321 156 897 1,374 (10.5%) (13.0%) (69.0%) (24.7%) 913 406 53 1,372 (29.8%) (34.0%) (4.1%) (24.7%) 323 71 12 406 (10.5%) (5.9%) (0.9%) (7.3%) 72 32 131 235 (2.4%) (2.7%) (10.1%) (4.2%) 121 47 0 168 (4.0%) (3.9%) (0%) (3.0%) 3,062 1,196 1,300 5,558 (100%) (100%) (100%) (100%) Gyeongin Seoul Daejeon Regional Office Gwangju Daegu Busan Total * Excluding drugs for export, including revoked/withdrawn items and herbal substances - 9 - When analyzing the status of manufactured and imported items of approved and notified items, the approval items took the higher proportion. In case of manufacturing items, the approval (60%) were more than the notification items (40%) by 20% and, in case of imported items, the approval items (57%) were more than the notification items (43%) by 14% (Refer to Table 5). Table 5. Information on Drug Manufacture and Import in 2019 (Unit: number of items) Item Total Approved 3,691 Declared Manufactured Imported 3,604 87 (60%) (57%) 2,431 65 (40%) (43%) 6,035 152 (100%) (100%) 2,496 Total 6,187 * Excluding drugs for export (80 items), including revoked/withdrawn items and herbal substances According to the analysis of drug products and drug substances of approved/ notified items, in case of drug products, 76% (3,676 items) was approved items while, in case of the drug substances, (excluding herbal substance), only 11% (8 items) was approved items and the rest 89% (63 items) is notification items (Refer to Table 6). Table 6. Details of Drug Products and Drug Substances Approval/ Notification in 2019 (Unit: number of items) Item Total Approval 3,691 Notification Total Drug products Drug substance (including herbal substances) Drug substance (excluding herbal substances) 3,676 15 8 (76%) (1%) (11%) 1,133 1,363 63 (24%) (99%) (89%) 4,809 1,378 71 (100%) (100%) (100%) 2,496 6,187 * Excluding drugs for export (80 items), including revoked/withdrawn items - 10 - When an alyzing the types of drugs in the drug products (approved/notified), chemical drugs accounted for the most (95.0%, 4,569 items), biopharmaceuticals accounted for 0.6% (27 items), and herbal preparations accounted for 4.4% (213 items) (Refer to Table 7). Table 7. Classification of Chemicals, Biopharmaceuticals and Herbal Medicine from Drug Products in 2019 (Unit: number of items) Type Drug products Total 1) Chemical drugs 4,809 2) Biopharmaceuticals 3) Herbal medicine 4) 4,569 27 213 (95.0%) (0.6%) (4.4%) 1) Excluding drugs for export only (80 items), including revoked/withdrawn items 2) Out of 4,569 items, 572 items were approved by the Headquarters 3) In Table 37 and Table 38, List of approved biopharmaceuticals, all 37 items (including 9 items for export only) were approved by the Headquarters 4) Out of 213 items, 15 items were approved by the Headquarters. Table 44 and Table 45, 2019 approval of herbal medicinal products and herbal substances approval information show 56 items (including 3 drug substance items and 7 herbal substance item) From drug products, following drugs were approved and generic drugs took the most : new drugs including orphan new drugs (0.7%, 35 items); orphan drugs except new drugs (0.2%, 9 items); drugs requiring data submission (4.6%, 220 items); and generic drugs, etc. (94.6%, 4,545 items). Among the drugs requiring data submissions, 13 combination drugs which were developed by changing the active substance type or combination ratio were approved as incrementally modified drugs because an improvement in their efficacy and/or usability improvement were acknowledged (Refer to Table 8). - 11 - Table 8. Classification of New Drugs, Drugs Requiring for Data Submission and Generic drugs in 2019 (Unit: number of items) New drugs Item Types Chemical 4,569 Drug products Biopharmaceuticals 7) 27 Herbal medicinal products Orphan drugs Drugs Requiring data submission Others Herbal medicinal Incrementally Drugs Orphan products (Head (Regional modified requiring based New new Orphan on quarters) Office) drugs for data drugs drug Herbal (IMD) submission Medicine Book 28 0 8 5 2 1 13 4) 183 340 5) 3,997 6) 19 5 10 207 10 8) 198 213 1) Total 4,809 (100%) 33 2) 35 3) 2 (0.7%) 9 (0.2%) 13 220 (4.6%) 340 4,195 4,545 (94.5%) 1) Excluding drugs for export (80 items), including revoked/withdrawn items 2) 35 items were new drugs approved in 2019, except post-approval change in new drugs (Refer to Table 15). 3) It is a new drug ingredients designated as both orphan drug and new drug. 4) Special formulations, generic drugs for narcotic drugs, and items that exempt safety and efficacy review, etc. 5) Standard manufacturing standard items, generic (excluding special formulations and drugs) drugs 6) Cell therapy products and human placenta-derived drugs 7) In Table 37 and Table 38, 2019 list of biopharmaceuticals approved includes 37 items (including 9 items for export only) approved by the Headquarters 8) Out of 213 items, 15 items were approved by the Headquarters. In table 44 and table 45 “Information on Approval of Herbal Medicinal Products 2019”, there are 56 items (including 3 drug substances, 7 herbal substance). - 12 - In addition, from the drug products approved by the Headquarters, most of them were chemical drugs (572 items, 93.2%). In case of chemical drugs and herbal medicine, manufactured products took the most of approval, but in case of biopharmaceuticals (27 items), ratio of imported products (74%) was high (Refer to Table 9). Table 9. Items Approved by the Headquarters in 2019 (Drug products) (Unit: number of items) * Types Total Manufactured Imported Approval by the Headquarters (Drug products) 614 531 83 Chemical 572 (93.2%) 509 63 Biopharmaceuticals 27 (4.4%) 7 20 Herbal medicine 15 (2.4%) 15 0 Excluding drugs for export only, including revoked/withdrawn items From drug products, approval of prescription drugs and OTC were as follows: prescription drugs were 86.1% (4,319 items), which was approved by more than 6 times than OTC drugs (13.9%. 670 items). In addition, the number of approved drug products items was about 3 times higher than the number of notified items (Refer to Table 10). Table 10. Overview of Drug Approvals in 2019 (Unit: number of items) Item Total Prescribed OTC Drug products 4,809 4,139 670 (100%) (86.1%) (13.9%) 3,676 3638 38 (100%) (99.0%) (1.0%) 1,133 501 632 (100%) (44.2%) (55.8%) Approved Declared * Excluding drugs for export only, including revoked and withdrawn items - 13 - According to the annual trends of item approvals and notifications as above, the numbers of the approved and notified items by drug type were similar in the recent 2 years, but the numbers of approved and notified drug products and herbal substances increased rapidly in 2019, which was the largest number of total items approved and notified since 2012. To be specific, 4,139 items of prescription drugs were approved in 2019 and increased by 173.3% compared to 2018 (1,514 items). In addition, OTC drugs approved in 2019 were 670 items, increased by 25.9% compared to 2018 (532 items). However, the number of approvals and notifications of drug substances was similar to 2018 (Refer to Figure 2 and Table 11). Table 11. Number of Approvals (Notification) by Drug Type (2012-2019) (Including Revoked and Withdrawn Items) (Unit: number of items) Items 2012 2013 2014 2015 2016 2017 2018 2019 Prescription drugs 1,002 1,669 2,090 2,289 2,280 1,573 1,514 4,139 (Increase YoY, %) OTC 66.6% 406 (Increase YoY, %) Drug substance 5.2% 110 (Increase YoY, %) Herbal substance 114 3.6% 3,215 (Increase YoY, %) Total 427 186 -94.2% 4,733 2,396 25.2% 726 70.0% 113 - 0.9% 178 - 4.3% 3,107 9.5% -0.4% 626 -13.8% -31.0% 481 -23.2% 99 -12.4% 84 -15.2% 1,909 972.5% -34.5% 983 -48.5% 4,923 - 14 - -1.0% -57.3% 3,828 -3.8% 476 11.8% 55 36.4% 420 -14.0% 2,524 173.4% 532 670 25.9% 75 71 -5.3% 361 1,307 262.0% 2,482 6,187 Figure 2. Information on Approval of Drugs by Drug Type (2012 ~2019) - 15 - 1.2. Approval of New Drugs New drugs newly approved in 2019 are 35 items in total including 28 chemical drugs (4 MF item and 24 imported items) and 7 biopharmaceuticals (7 imported items). For the number of ingredients in those new drugs, 21 new ingredients were approved including 15 ingredients from chemical drugs and 6 ingredients from biopharmaceuticals (Refer to Table 12 and, for the total list of new drugs, Refer to Table 15). It was found that 88.6% of new drugs were imported items showing imported items still took most of new drugs. Table 12. New Drug Approvals in 2019 (unit: number of items) Item Total Chemical drugs Biopharmaceuticals [No. of Ingredients] 1) 35 (100.0%) 28 2) Herbal medice 7 0 Total [21 (100.0%)] [15] [6] [0] 4 (11.4%) 4 0 0 [2 (9.5%)] [2] [0] [0] 31 (88.6%) 24 7 0 [19 (90.5%)] [13] [6] [0] Manufactured Imported 1) Of the 35 items, both orphan drug and new drug were 2 items 2) Chemical drugs newly approved in 2019 were 28 items, and the items designated as new drugs according to the change in approvals were 4 items (Refer to Table 15). To see the current status of new drug item approvals after 2010, the average number of new drug approvals over the past 10 years was 31 items, the approvals of new drugs were slow since 2016 but new drugs were approved more than the average in 2019 (Refer to Table 13 and Figure 3). According to the ratio of imported products from new drugs approved in 2019, the imported items and the manufactured items were 88.6% and 11.4% respectively, which shows the introduction of imported drugs to the domestic market still influences the total number of new drugs. As for the number of ingredients, the - 16 - imported items and the manufactured items took charge of 90.5% and 9.5% respectively, which shows most of new substances introduced to the domestic market are the imported items. New drugs developed in the country have been steadily approved by 1~2 items each year (5 items in 2015), but in 2019, there was neither approval of new drugs developed in the country nor visible development results. - 17 - Table 13-1. Approval of Chemical, Biopharmaceuticals and Herbal Medicinal Products as New Drugs by Year (2010-2019) (Including Revoked and Withdrawn Items) (Unit: number of items) Item 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 49 31 17 23 49 34 25 29 15 35 (26) (22) (14) (15) (27) (19) (10) (18) (12) (21) 1 2 2 1 1 5 1 1 2 0 3 8 3 3 3 6 2 1 2 4 43 17 10 13 38 18 19 16 9 24 0 0 0 0 0 0 0 1 0 0 Manufactured 0 0 0 0 0 0 0 1 0 0 Imported 1 6 4 6 8 10 4 11 4 7 Manufactured 0 0 0 0 0 0 0 0 0 0 Imported 2 0 0 1 0 0 0 0 0 0 No. of approved items 1) (No. of new drub ingredient) Domestically developed drugs 2) Chemical drug Manufactured 3) Imported Domestically developed drugs Biopharmaceuticals Herbal medicine 1) Number of new drugs approved in the year excluding items designated as new drugs due to removal from the orphan drugs designations 2) In the case of domestically developed new drugs, items with several contents were indicated as one item, 3) The number of products manufactured and marketed include that of domestically developed drugs. Table 13-2. New Drug Approval Status by Year (2010~2019) (Including Revoked and Withdrawn Items) (Unit: number of items) Item 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Manufactured 3 8 3 3 3 6 2 2 2 4 (11.7%) (6.1%) (25.8%) (17.6%) (13.0%) (6.1%) (17.6%) (8.0%) (6.9%) (13.3%) (11.4%) Imported 46 23 14 20 46 28 23 27 13 31 (88.3%) (93.9%) (74.2%) (82.4%) (87.0%) (93.9%) (82.4%) (92.0%) (93.1%) (86.7%) (88.6%) No. of items 49 31 17 23 49 34 25 29 15 35 - 18 - According to analysis of drug approvals since 2010 by drug efficacy group, 19 items of nervous system drugs in 2010, 6 items of urinary reproductive organ drugs (3 ingredients), 6 items of anti-cancer drugs (4 ingredients) in 2012, 6 items of diabetes drugs (3 ingredients) in 2013, 16 items of nervous system drugs (5 ingredients) in 2014, nervous system drugs (8 items) and diabetes drugs (8 items) in 2015, 14 items of anti-cancer drugs (7 ingredients) in 2016, 11 items of anti-cancer drugs (5 ingredients)in 2017, 4 items of other chemotherapy drugs (2 ingredients), and 13 anti-cancer drugs (5 ingredients) in 2019 took the largest and the accumulated approvals of new drug item by classification number for the past 10 years were in the order of anti-cancer drugs (72 items), nervous system drugs (56 items), and diabetes drugs (32 items) (Refer to Table 14). Table 14. Therapeutic Class of New Drug Approvals by Year (2010~2019) (Including Revoked, Withdrawn and Released Orphan Items) (unit: number of items) 2019 Item 2010 2011 2012 2013 2014 2015 2016 2017 2018 Post Total Approval -approval change Nervous system 19 0 1 1 16 8 2 0 0 9 0 56 8 3 6 4 7 5 14 11 1 10 3 72 1 3 1 6 11 8 0 0 2 0 0 32 7 1 1 0 2 5 2 3 4 4 0 29 5 3 0 0 1 2 6 9 1 0 0 27 3 1 0 0 4 1 2 1 0 1 0 13 0 6 0 2 0 0 0 0 0 0 0 8 1 1 2 0 3 0 0 0 0 3 0 10 0 1 2 3 1 0 0 8 2 1 0 18 5 12 4 7 4 9 6 3 5 7 1 63 49 31 17 23 49 38 32 35 15 35 4 agents Antineoplastic agents Antidiabetic agents Antiviral agents Cardiovascula r agents Respiratory organ agents Urogenital organ agents Sensory organ agents Allergic agents Others Total - 19 - 39 328 Figure 3. Approval Status of New Drugs by Year (2010 - 2019) (Including Revoked, Withdrawal and Released New Drugs) - 20 - (Refer to Table 15) Table15. 2019 New Drug Approval List (Including New Drugs Removed from Orphan Drug List) Chemical Drugs, No. Mfg./ Import Product Besponsa Inj 1 Import (inotuzmab ozogamicin) Company Pfizer Korea Ltd. Date of Approval 2 Import Pharma (lifitegrast) Korea Co., 3 Import (Emicizumab, Gene recombination) Efficacy/Effectiveness (partially omitted) [421] Treatment of adults with relapsed agents Ophthalmic JW Pharma Miscellaneous 2019-01-17 blood and Corp. body fluid drugs Routine prophylaxis to prevent or reduce bleeding with the VIII Gilead Biktarvy Science 2019-01-18 in A of patients (congenital deficiency) with factor VIII inhibitors of adults HIV-1 without substitution [629] frequency episodes hemophilia factor in Import precursor Treatment of dry eye in adults Treatment 4 B-cell agents [339] ceutical refractory acute lymphoblastic leukemia (ALL) [131] 2019-01-09 Ltd. Hemlibra S.C Inj Code 2019-01-03 Antineoplastic or Shire Xiidra Eye drops Biopharmaceuticals infection resistance known for each component of this drug, which Miscellaneous shows the stale virus figure Chemothera inhibiting effects for more than 3 Korea Ltd. -peutics months without therapy, existing or anti-retroviral failure to anti-retroviral treat therapy (HIV-1 RNA <50 copies/mL) GLANATEC 5 Import Reduction Ophthalmic Kowa Solution Korea 0.4%(Ripasudil Company., Hydrochloride Ltd. [131] 2019-02-21 Ophthalmic agents hydrate) in of patients ocular with pressure open-angle glaucoma and ocular hypertension who are inadequate or unable to use be ta-blockers or prostaglandin analogs Briviact Oral 6 Import Solution (brivaracetam) Briviact 10mg 7 8 Import Import Adjunctive film-coated onset tablets (brivaracetam) Korea UCB Briviact 25mg Co., Ltd. 2019-03-04 [113] film-coated from tablets Briviact 50mg Import and 16 epilepsy (brivaracetam) 9 seizures secondary Antiepileptics adult film-coated tablets - 21 - therapy with for or partialwithout generalisation adolescent years of in patients age with No. Mfg./ Import Product Company Date of Approval Efficacy/Effectiveness (partially omitted) Code (brivaracetam) Briviact 100mg 10 Import film-coated tablets (brivaracetam) [739] 11 Import Tristel Spori Wipes&Foam HP&C Ltd. 2019-03-26 Other public sanitary cares Vocinty 10mg 12 Import Tablets (vonoprazan fumarate) Vocinti 20mg 13 14 Import Import Tablets (vonoprazan Disinfection of medical instruments such For Takeda Pharmaceut ical [232] 2019-03-29 Peptic ulcer company. agents Limited Import in Import erosive patients of the of esophagitis who and repeat recrudescence condition recurrent ulcer and maintenance of recurrence prevention gastric or during of duodenal nonsteroidal fumarate) anti-inflammatory drug therapy Verzenio ⦁ In combination with an aromatase inhibitor as initial 50mg/tablet endocrinebased therapy for Verzenio the treatment of postmenopausal 100mg/tablet women with hormone receptor (abemaciclib) (HR)-positive, human epidermal growth Verzenio 16 endoscopes probes without lumen the healing (abemaciclib) 15 as ultrasound 150mg/tablet (abemaciclib) Eli Lilly and [421] 2019-05-01 Antineoplasti Company c agents factor (HER2)- • receptor negative 2 advanced or metastatic breast cancer. In combination with fulvestrant for the treatment of women with hormone receptor (HR)positive, Verzenio 17 Import human 200mg/tablet growth (abemaciclib) (HER2)-negative factor epidermal receptor 2 advanced or metastatic breast cancer with disease progression following endocrine therapy. 1. Amitiza Soft Cap. 18 Import μ 8 g (lubiprostone) Takeda 19 Import μ 24 g [238] 2019-05-17 company. Purgatives, 2. Treatment of narcotic analgesic clysters (opioid) - induced constipation Limited in adult patients with chronic non-cancerous pain Evenity Inj. Import c h ro n ic adults (lubiprostone) 20 of id io p a th ic constipation in Pharmaceut ical Amitiza Soft Cap. T re a tm e n t [399] Pre-filled Syringe Amgen (Romosozumab, Korea Gene Limited Miscellaneo 2019-05-31 us metabolism recombination) agents - 22 - 1) Treatment of osteoporosis postmenopausal women in at high risk of fracture 2) Osteoporosis in men at high risk of fracture bone mass to increase No. Mfg./ Import Product Company Date of Approval [229] Facenra 21 Import Prefilled Astra Syringe Inj. Zeneca 30mg(Benralizumab) Korea Efficacy/Effectiveness (partially omitted) Code Miscellaneo 2019-06-05 usrespiratory organ agents An add-on in adult maintenance patients treatment with severe eosinophilic asthma inadequately controlled despite current treatment Emgality 120mg/mL Prefilled 22 Import Sysringe [119] Inj(galcanezumab, Gene 23 Import Miscellaneo recombination) Lilly Korea Emgality Ltd. 2019-09-05 us central Prophylaxis of migraine in nervous adults 120mg/mL Prefilled system Pen Inj agents (galcanezumab, Gene recombination ) 2019-10-02 (Conversio Cerdelga cap. 24 Import 84mg (eliglustat tartrate) Sanofi -aventis Korea Co., Ltd. n to [399] orphan/ Miscellaneo new drug ) us *Initial metabolism approval agents date : Long-term treatment of adult patients with Type 1 Gaucher disease (GD1) as CYP2D6 poor metabolizer (PM), intermediate metabolizer (IM) or extensive metabolizer (EM) 2015-11-12 25 Import Cabometyx 20mg 2019-10-11 film coated (release tablets(cabozantini from b) orphan Cabometyx 40mg 26 Import film coated tablets(cabozantini b) 27 Import IPSEN Korea Co., Ltd. 1) cell to new *Initial film coated approval tablets(cabozantini date: b) 2017-09-26 Pharmaceut ical Co., Lonsurf of liver cell carcinoma has been 29 Mfg. treatment who [421] patients treated have treated c agents based and T20 Import Lynparza(Olaparib AstraZenec 2019-10-29 - 23 - that [421] previously and irinotecan- chemotherapy, if with cancer fluoropyrimidine-, biological RAS Ovarian cancer an therapy, wild-type, anti-EGFR therapy 30 with with patients been with anti-VEGF combination tablet of colorectal 2019-10-17 Antineoplasti oxaliplatin- Ltd. growth Treatment metastatic Cheil endothelial of liver cell carcinoma combination tablet T15 in prior therapy 2) The Mfg. (RCC) following sorafenib prior to treatment Lonsurf 28 renal factor(VEGF)-targeted Antineoplasti c agents advanced carcinoma vascular [421] drug ) Cabometyx 60mg of patients and conversion Treatment an No. Mfg./ Import Product Company Date of Approval Code • Efficacy/Effectiveness (partially omitted) Monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated ) 100mg capsule high serous30 ovarian (including fallopian grade cancer tube or primary peritoneal) who are in response (complete response or partial response) • to platinum- based chemotherapy Single maintenance treatment for adult patients with p l a t i n u m - s e n s i t i v e , recurrent, a highly ovarian Pharmaceut Antineoplasti ical Co. c agents fallopian in Lynparza response to or cancer) more than platinum-based therapy Import (olaparib), 50 mg, cancer peritoneal secondary 31 (including tube primary Ltd epithelial cancer (partially or completely) capsules Breast cancer Treatment with negative cancer. had of gBRCA adult patients mutation HER2- metastatic have previously chemotherapy treatment. The who breast patient may undergone adjuvant before atfer or have therapy surgery or chemotherapy under metastatic conditions. This drug is with advanced breast cancer 32 Import coated tablets (Ribociclib succinate) Novartis [421] Korea Co., 2019-10-30 Antineoplasti Ltd. c agents in or metastatic (HR) human epidermal negative • patients who have hormone receptor factor Kisqali 200mg film used positive receptor and and growth 2 (HER2) administered in combination as follows: Combination with aromatase inhibitors as endocrine a primary therapy in p r e m e n o p a u s a l , perimenopausal, postmenopausal or women a kinase inhibitor indicated in combination - 24 - with an No. Mfg./ Import Product Company Date of Approval Efficacy/Effectiveness (partially omitted) Code aromatase inhibitor initial therapy of as endocrine-based for the treatment postmenopausal women with hormone receptor (HR)positive, human growth factor epidermal receptor (HER2)-negative • 2 advanced or metastatic breast cancer If the disease has progressed in postmenopausal initial or woman endocrine as therapy, use with fulvestrant Xofluza(baloxavir 33 Import marboxil) film coated Tablets 40mg Xofluza(baloxavir marboxil) film 34 Import [629] Roche Korea Miscellaneo 2019-11-22 us Chemothera coated Tablets -peutics 20mg [629] 35 Import Pipeltro Tab MSD Korea (doravirine) Ltd Miscellaneo 2019-11-22 us Chemothera -peutics Ongentys 25 mg 36 Mfg. [119] hard capsules (opicapone) SK Chemical Ongentys 50 mg 37 Mfg. Miscellaneo us central 2019-11-26 nervous Co., Ltd. hard capsules system (opicapone) agents Skyrizi Pre-filled Syringe Inj 38 Import (risankizumab, Gene [142] AbbVie Korea Ltd. 2019-12-03 * Import immunogen preparations recombination) 39 Non-specific Eybelis Eye Santen drops 0.002% Pharmaceut (Omidenepag ical Korea Isopropyl) Co., Ltd. [131] 2019-12-03 Ophthalmic agents Treatment of influenza A or B virus infection in patients aged 12 dose of and - 25 - single should be initiated within 48 hours of symptom onset.) In combination antiretroviral for the with medicinal treatment infected with past present or other products, of HIV-1 adults without evidence of other antiretroviral treatment Adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose fluctuations who motor cannot be stabilised on those combinations Treatment severe of moderate to psoriasis in plaque adults who require phototherapy or systemic therapy (including biological therapy) Lowering the of following angle eye pressure diseases: glaucoma and in openocular hypertension Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. above(A XOFLUZA precautions for use) Table 16. List of New Drugs Developed in Korea (1999-2019) No. product name 1 Sunpla Injection Company name SK Chemicals Active ingredient Heptaplatin (Including Withdrawn Items) Efficacy/ Effectiveness 1999.7.15 (stomach cancer) (1993.7.20) Easyf Solution DAEWOONG Recombinant human 0.005% PHARMACEUTICAL epidermal growth factor 3 Milican Injection DONG WHA PHARM. Holmium nitrate- 166 Anticancer drug (liver cancer) 4 Q-ROXIN Tablet JW Pharmaceutical Balrofloxacin Antimicrobial agent (antibiotic) 2 Remarks Anticancer drug Diabetic, foot ulcer treatment 2001.5.30 (1997.3.4) 2001.7.6 (1997.5.28) 2001.12.17 (1993.5.6) 2002.12.27 5 Factive Tablet LG Chemical . Gemifloxacin Mesylate Antimicrobial agent (antibiotic) US FDA approval (2003.4.4) 6 7 8 9 Apitoxin Injection Pseudovaccine Injection Guju Pharmaceutical Dry honey bee poison CJ Healthcare Dried pseudomonas protein Camtobell Injection Chong Kun Dang Pharm. Revanex Tablet Yuhan Corporation 2003.5.28 vaccine (1995.1.26) Belotecan Anticancer drug 2003.10.22 Revaprazan HCl Anti-ulcer agent 2005.9.15 Zydena Tablet DONG-A ST Udenafil 11 LEVOVIR Capsule Bukwang Pharm. Clevudine 12 PELUBI Tablet Daewon Pharmaceutical Felubiprofen MVIX Tablet SK Chemicals 14 Noltec Tablet IL-YANG PHARM. 15 Kanarb Tablets 16 PYRAMAX Tablet 17 18 19 Boryung Pharmaceutical 2003.5.3 (1999.11.29) Pseudomonas preventive 10 13 Arthritis treatment Mirodenafil HCl Ilaprazole Fimasartan potassium trihydrate SHINPOONG Pyronaridine Pharmaceutical Co. tetraphosphate, Artesunate ZEPEED Tablet JW Pharmaceutical Avanafil Supect Capsule IL-YANG PHARM. Radotinib HCl Gemigliptin tartrate Erectile dysfunction treatment agent Hepatitis B treatment agent Osteoarthritis treatment agent Erectile dysfunction treatment agent 2005.11.29 2006.11.13 (2001.06.13) 2007.4.20 2007.7.18 Anti-ulcer agent 2008.10.28 Antihypertensive agent 2010.9.9 Malaria treatment agent 2011.8.17 Erectile dysfunction treatment agent 2011.8.17 Cancer drug (leukemia) 2012.1.5 Diabetes treatment agent 2012.6.27 Zemiglo Tablet LG Chemical 20 Duvie Tablet Chong Kun Dang Pharm. Lobeglitazone sulfate Diabetes treatment agent 2013.7.4 21 Riavax Injection KAEL GEMVAX Tertomoride hydrochloride Anticancer drug 2014.9.15 22 Acelex Capsule CrystalGenomics Inc. Polmacoxib Osteoarthritis treatment agent 2015.2.5 Antimicrobial agent (antibiotic) 2015.3.20 23 ZABOLANTE Tablets DONG WHA PHARM. sesquihydrate Zabo flocasin DAspartate hydrate 24 Sivextro Tablet DONG-A ST Teddyolide phosphate Antimicrobial agent (antibiotic) 2015.4.17 25 Sivextro Injection DONG-A ST Teddyolide phosphate Antimicrobial agent (antibiotic) 2015.4.17 26 Suganon Tablet DONG-A ST Evogliptin tartrate Diabetes treatment agent 2015.10.2 Anticancer drug 2016.5.13 Hepatitis B treatment agent 2017.5.15 27 Olita Tablet 28 BESIVO TABLET 29 Alzavue Inj. FutureChem Co., Ltd Florapronol(18F) 30 K-CAP Tab. CJ Health Care Corp. Tegoprazan ※ Hanmi Pharmaceutical Olmutinib dihydrochloride ILDONG PHARMACEUTICAL CO. monohydrate Bexifovir dipiviris Maleate Excluding Revoked items - 26 - radioactive diagnostic agent for AD GERD treatment agent 2018.2.2 2018.7.5 1.3. Approval on orphan drugs Orphan drugs approved in 2019 were 11 items in total (including 2 orphan new drugs), which were all imported drugs and 8 chemical drug items and 3 biopharmaceutical items were approved. For the number of ingredients, 9 ingredients were approved including 6 ingredients of chemical drugs, 3 ingredients of biopharmaceuticals (Refer to Table 17). Table 17. Orphan Drug Approval Status in 2019 (Unit:: number of items) Total (No. of ingredients) Item Imported Chemical drug Biopharmaceuticals 11 8 3 (9) (6) (3) Orphan 2 New Drug (2) Herbal medicine 0 2 0 0 (2) According to orphan drug approvals since 2010, the number of items approved was similar until 2014, but 49 items were approved in 2015, which is 1.8 times larger than the annual average of approved items for the recent 5 years (27 items). This seems to be an outcome of conducting of prior GMP program evaluation, review of specifications and test methods, and submission of risk management plan for orphan drugs since July 2015 (Refer to Table 18, Figure 4). From 2017, the approval of orphan drugs tends to decrease and 17 items and 11 items were approved in 2018 and 2019 respectively. Table 18. Approval of New Orphan Drugs by year (2010-2019) (Including Revoked and Withdrawn items) (Unit: number of items) Item 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Orphan Drugs 26 26 27 28 28 49 34 18 17 11 - 27 - Figure 4. Approval of New Orphan Drugs by year (2010-2019) * Total 11 items including orphan new drugs in 2019 In addition, a total of 23 ingredients were designated as orphan drugs in 2019 (Refer to Table 19). Table 19. Ingredients of Newly Designated Orphan Drugs in 2019 No. Ingredient (General Name) 1 Mecasermin (Inj.) 2 Romiplostim (Inj.) Disease Growth failure in children due to severe primary IGF-1 deficiency Treatment of severe immunosuppressive aplastic therapy or to anemia which that is refractory immunosuppressive to therapy is not applied Treatment of relapsed or refractory acute myeloid leukemia patients with 3 Gilteritinib (Oral) a FLT3 mutation Treatment of relapsed or refractory acute myeloid leukemia patients with 4 Quizartinib (Oral) positive FLT3-ITD mutation 5 Avelumab (Inj.) Treatment of metastatic Merkel cell carcinoma 1. Patients up to 25years of age with B-cell precursor acute lymphocytic leukemia(ALL) that is refractory or in second or later relapse. 2. 6 Adult patients with relapsed or refractory(r/r) large B-cell lymophoma Tisagenlecleucel(Inj.) after B-cell two or more lines lymophoma(DLBCL) of systemic not therapy otherwise including specified,, high lymphoma and DLBCL arising from follicular lymphoma. - 28 - diffuse grade large B-cell No. Ingredient (General Name) Disease 7 Galcanezumab (Inj.) Prophylaxis of migraine in adults 8 Siponimod (Oral) Secondary advanced multiple sclerosis 1. Locally advanced or metastatic non-small cell lung carcinoma with ROS1 positive 2. 9 Entrectinib (Oral) The treatment of adult and pediatric patients with NTRK fusion- positive locally advanced or metastatic solid tumors, who have a hihg potential severe progressed morbidity following prior during surgical therapies, or as resection,, initial therapy and have when there are no acceptable standard therapies. Neuron 10 cell Ceroid Lipofuscinosis 2(Co., Ltd.N2) caused by tripeptidyl Cerliponase alfa(Inj.) peptidase 1 (TPP1) deficiency The treatment urothelial 11 Erdafitinib (Oral) of adult carcinoma, alterations, who patients whose have with locally tumors disease have progression advanced certain during or or metastatic FGFR genetic following at least one line of prior chemotherapy including within 12 months of neoadjuvant or adjuvant chemotherapy Treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with 12 an NTRK gene fusion having a high likelihood of severe morbidity Larotrectinib (Oral) during surgical resection after prior standard therapy or as initial therapy when there is no adequate treatment option. 13 Deutetrabenazine (Oral) Huntington's chorea Used as a low-intensity pre-treatment therapy in combination with fludarabine for hematopoietic stem cell transplantation in patients with the 14 Treosulfan (Inj.) following diseases where standard pre-treatment therpary is not suitable: lymphoblastic leukemia, myelogenous leukemia, myelodysplastic syndrome, multiple myeloma, lymphoma 15 Isatuximab (Inj.) Combination therapy with myeloma multiple with pomalidomide who previously and dexamethasone received more than in two patients kinds of treatments including lenalidomide and proteasome inhibitors Combination with 16 therapy relapsed or with bendamustine refractory diffuse and large rituximab B-cell in adult lymphoma, patients who are Polatuzumab vedotin (Inj.) unsuitable for hematopoietic stem cell transplantation and have failed one kinds of previous treatments Combination 17 Acalbrutinib (Oral) therapy with Obinutuzumab in patients with chronic lymphocytic leukemia who have not been previously treated over age 65 or under 65 years of age with comorbid conditions Moxetumomab pasudotox Treatment of patients with hairy cell leukemia who have received two (Inj.) or more previous treatments, including purine nucleoside analogy Lutetium(17LU) Treatment oxodotreotide (Inj.) with somatostatin receptor positive 18 of gastrointestinal, pancreatic, 19 - 29 - adult neuroendocrine tumors No. Ingredient (General Name) Disease 20 Inebilizumab (Inj.) Optic neuritis category disease 21 Risdiplam (Oral) Spinal muscular atrophy 22 Enasidenib mesylate (Oral) Treatment of adult patients with recurrent or refractory leukemia with Isocitrate dehydrogenase-2, IDH2 mutation 23 Satralizumab (Inj.) Optic neuritis category disease - 30 - acute myeloid 1.4. Item Approval and Notification by Major Efficacy Group and Classification Code Drug products approved and notified in 2019 by drug efficacy group are as follows: drugs for nervous systems such as dementia drugs (22.2%), drugs for circulatory systems such as hypertension drugs (18.8%), drugs for digestive organs such as stomach ulcer drugs (11.3%), metabolic drugs such as diabetes drugs, (9.1%) and antibiotic preparations (5.6%) in descending order (Refer to Table 20 and Figure 5). Table 20. Number of Approved and Notified Items by therapeutic class in 2019 (Including Revoked and Withdrawn Items) (Unit: number of items) Metabolism Class (390) Antibiotic Chemo Blood and Allergy no. Nervous Circulatory Digestive system system system drugs therapy body fluid (220) Others (110, 120) (210) (230) Others Diabetes (610) (620) (330) (396) Total 1,070 902 545 (22.2%) (18.8%) (11.3%) 226 211 (4.7%) (4.4%) 267 251 230 (5.6%) (5.2%) (4.8%) 207 900 4,809 437 (4.3%) (18.7%) (9.1%) Figure 5. Ratio of Approval Cases (Notification) Classified by Major Efficacy Groups in 2019 - 31 - As for the approvals and notifications by therapeutic class since 2011, metabolic drugs, nervous system drugs, digestive system drugs and circulatory drugs take large part as in the previous year. In 2019, nervous system drugs which took the largest ratio as in the previous year increased by 2% YoY. Most of the nervous system drugs (67.8%) were Antipyretics, analgesic, and anti-inflammatory drugs and miscellaneous central nervous system agents. The drugs which took the second largest ratio were cardiovascular agents, most of which (98.8%) were antihypertensives, hyperlipidemia agents and miscellaneous cardiovascular agents (Refer to Figure 6 and Table 22). Figure 6. Annual Approval (Notification) of Drugs by Drug Therapeutic Class (2011-2019) According to detailed approvals and notifications by drug classification code for sub-therapeutic class, antihypertensives (code 214) and antipyretic, analgesic, and anti-inflammatory agents (code 114) took 10.0% (482 items) and 7.3% (351 items) respectively and they have remained top 5 for recent 5 years. Besides, miscellaneous central nervous system agents (7.8%, 374 items), peptic ulcer agents and hyperlipidemia agents (5.7%, 117 items) ranked high (Refer to Table 21). - 32 - Table 21. Single Classification Number of Top 5 Approval Items (2015~2019) (Including Revoked and Withdrawal Items) 2015 2016 2017 2018 2019 Efficacy Efficacy Efficacy Efficacy Efficacy of classification No. of classification No. of classification No. of classification No. of classification No. items (code number) (code number) items (code number) items (code number) items (code number) items Miscellaneous 1 urogenital and 315 anal organ agents (10.8%) Antihypertensives 366 (214) (13.3%) (259) Antipyretics, 2 Antipyretics, Miscellaneous chemotherapeutics (629) 166 analgesics, and 152 Antihypertensives 482 (8.1%) anti-inflammatory (7.4%) (214) (10.0%) agents (114) Antipyretics, Miscellaneous analgesics, and 261 Hyperlipidemia 227 analgesics, and 146 Antihypertensives 145 central nervous 374 anti-inflammatory (9.0%) agent (218) (8.2%) anti-inflammatory (7.1%) (214) (7.1%) system drugs (7.8%) agents (114) agents (114) (119) Miscellaneous 3 Miscellaneous Peptic ulcer 237 central nervous 177 Antihypertensives 138 central nervous 128 analgesics, and 351 agents (232) (8.1%) system drugs (6.4%) (214) (6.7%) system drugs (6.3%) anti-inflammatory (7.3%) (119) (119) Antipyretics, 4 agents (114) Miscellaneous Antidiabetic agent 180 analgesics, and 173 central nervous 112 hyperlipidemia 117 Peptic ulcer 340 (396) (6.2%) anti-inflammatory (6.3%) system drugs (5.5%) agents (218) (5.7%) agents (232) (7.1%) 102 Hyperlipidemia 261 (5.0%) agent (218) (5.4%) agents (114) 5 Antipyretics, (119) Antihypertensives 175 Peptic ulcer 153 (214) (6.0%) agents (232) (5.5%) No. of drug No. of drug Miscellaneous 112 metabolism (5.5%) agents (399) No. of drug Miscellaneous metabolism agents (399) No. of drug No. of drug products 2,915 products 2,761 products 2,049 products 2,046 products 4,809 approved and (100%) approved and (100%) approved and (100%) approved and (100%) approved and (100%) notified in 2015 notified in 2016 notified in 2017 - 33 - notified in 2018 notified in 2019 Table 22. Approval and Notification of Drug Products by Major Therapeutic Class in 2019 Classification Drug classification code No. of items 111 General anesthetics 2 112 Hypnotics, sedatives, and anxiolytics 5 113 Antiepileptics 81 114 Antipyretics, analgesics, and anti-inflammatory agents 351 116 Anti-vertigo agents Nervous system 117 Psychotropics 146 drug 119 Miscellaneous central nervous system agents 374 121 Local anesthetics 9 122 Skeletal muscle relaxants 63 123 Autonomic nervous system agents 15 124 Antispasmodics 19 5 Subtotal Ophthalmology and ENT 1,070 131 Ophthalmic agents 117 132 Otic and nasal agents 22 Subtotal 139 212 Antiarrhythmic agents 214 Antihypertensives 482 215 Capillary stabilizer 7 217 Vasodilators 2 drugs and blood 218 Hyperlipidemia agents 261 and body fluid 219 Miscellaneous Cardiovascular agents 148 332 Hemostatics 1 333 Anticoagulants 63 339 Miscellaneous blood and body fluid agents 166 Cardiovascular agents Subtotal 2 1,132 141 Antihistamines 58 142 Non-specific immunogen preparations 8 Respiratory 149 Miscellaneous allergic agents 141 organs and 222 Antitussive expectorants 127 Allergy drug 223 Inhalation treatment preparations 10 229 Miscellaneous respiratory organ agents 51 Subtotal - 34 - 395 Classification Digestive tract drug Drug classification code 231 Dental and oral agents 232 Peptic ulcer agents 340 233 Stomachics and digestives 13 234 Antacids 22 235 Emetics and antiemetics 14 237 Intestinal drugs 7 238 Purgatives, clysters 68 239 Miscellaneous digestive organ agents 73 Subtotal Urinary and reproductive system drug 545 Emmenagogue 1 254 Contraceptives 11 255 Agent for urogenital organ(including venereal disease prevantive medicine) 4 256 Hemorrhoidal preparations 259 Miscellaneous urogenital and anal organ agents 144 Subtotal 164 4 311 Vitamin A and D preparations 31 312 Vitamin B1 preparations 4 313 Vitamin B preparations (excluding vitamin B1) 1 314 Vitamin C and P preparations 2 315 Vitamin E and K preparations 1 Multivitamins preparations (excluding multivitamin complex with A and D) 14 319 Miscellaneous vitamins 49 321 Calcium preparations 8 322 Mineral preparations 9 325 Protein and amino acid preparations 17 329 Miscellaneous nourishing nutrients, tonic and alternatives 10 391 Liver disease agents 28 392 Antidotes 4 394 Gout preparations 30 395 Enzyme preparations 12 399 Miscellaneous metabolism agents 152 Subtotal Antidiabetic drug 8 253 316 Metabolic drug No. of items 396 Antidiabetic agents 372 211 Subtotal - 35 - 211 Classification Anticancer drug Drug classification code 421 Antineoplastic agents 25 429 Miscellaneous antitumors 3 Subtotal 28 611 Acting mainly acting on gram-positive bacteria 2 612 Acting mainly acting on gram-negative bacteria 8 Acting mainly acting on gram-positive germ, rickettsia, 614 Antibiotics 615 618 619 and virus Acting mainly acting on gram-negative germ, rickettsia, and virus Acting mainly acting on gram-positive and gram-negative bacteria Miscellaneous antibiotic agents (including complex antibiotic agents) Subtotal Chemotherapeutic No. of items 629 Miscellaneous Chemotherapeutics agent Subtotal 18 6 187 46 267 251 251 Others (classification that does not belong to the above efficacy group) 235 Total 4,809 - 36 - 2 Information on Approval of Drugs (Chemical Drugs) - 37 - 2. Information on Approval of Drugs (Chemical Drugs) The number of chemical drugs approved in 2019 by review type is as follows: new drugs (28), orphan drugs (8), drugs requiring data submissions (196 including 13 incrementally modified drugs), and drug substances (4) items. The highest proportion of drugs requiring data submission (196 items) was taken by drugs with new composition accounting for 54.6% (107 items), followed by drugs with new formulation (same route of administration) and drugs with changes in strength of active ingredients, accounting for 36.2% (71 items) and 6.1% (12 items) respectively (Refer to Table 23). Table 23. Approval of Pharmaceutical Drugs (Chemical Drugs) by Review Type in 2019 Type Review type No. of approved items 1 New drugs New drugs 2 (28) Orphan new drugs Orphan drugs Orphan drugs (8) 3 4 28 0 8 196 Drugs requiring data submission Incrementally 12 New composition 4-1 13 modified new drug Change in strength 1 4-2 New salts or isomers 2 4-3 New composition 4-4 4-5 Drugs requiring data submission 95 11 Change in strength 183 New route of administration 1 4-6 New administration/dosage 3 4-7 New dosage form (same route of administration) 5 Drug substance - 39 - 71 4 The number of new drug items approved in 2019 (excluding new drugs to which post approval change was made including those removed from the orphan drug list) was 28 items, increased by about 2.5 times than 11 items in 2018, of which 24 items (85.7%) were imported items (Refer to Table 24). The number of incrementally modified drugs increased to 13 items in 2019 compared to 6 items in 2018 (new formulation with the same administration route), and the development type and drug efficacy group also were various. In detail, following drugs were approved as incrementally modified drugs: combination drug with new composition (11 items) that proved their improved efficacy, drug of which improved usability through new composition and formulation improvement (liquid → tablet) was acknowledged (1 item); and drug with changes in strength which improved the administration/dosage (1 item) (Refer to Table 28). The Ministry of Food and Drug Safety(MFDS) has been operating the “Pharm Navi Project” since 2014 in order to support the fast commercialization of domestically developed drugs and to support entry into the global market. “Pharm Navi Project” was introduced to provide safe and excellent medicines to patients promptly and to actively support new drug development research. Especially, the new drug pipeline, innovation and unsatisfactory medical field items may be provided with close consulting service through “Medical Product Commercialization Navigator” through which the direction of the overall approval and review process on real time base during the product development. In addition, since July 2018, the MFDS has been operating a “pharm. together,” a government-private sector communication channel in order to derive improvement measures by discussing current problems or issues arising from the drug approval and review process and also making efforts to resolve difficulties related to such process through active and all time communications with the industry. Furthermore, in case of inquiry into the overall approval and review process - 40 - during drug development, consultations with the responsible department through the consultation channel (MFDS website (www.mfds.go.kr) > “Reservation for One-Stop Consultation”) is available. In addition, process of receiving a notice of the review result through an application for “Prior Review” is available for those who wish to obtain a drug item approval (notification) intend to have criteria for preparing data for approval/notification reviewed in advance. - 41 - 2.1. Information on approval of new drugs The number of new drugs approved in 2019 was 32 items (4 manufacturing items and 28 import items), increased by almost 3 times compared to 2018 and the top classifications codes of the approved items are in the order of anticancer drugs (12 items), central nervous system drugs (7 items), miscellaneous chemotherapeutic agents (4 items), and digestive tract drugs (4 items) (See Table 24 ~ Table 26). Table 24. Approval Status of Manufactured/Imported New Drugs (2014-2019) (Chemical Drugs) (Unit: number of items) 2014 2015 2016 2017 2018 2019 Manufactured 3 6 2 1 2 4 Imported 38 22 22 20 9 Total 41 YoY Growth (%) 1) 2) 28 -31.7% 24 -14.3% 3) 4) 21 -12.5% 11 28 5) -47.6% 32 6) 190.9% 1) Including 1 drug removed from the orphan drug list in 2014: (Removed from the orphan drug list) Symbenda Injection 2) Including 4 drug removed from the orphan drug list in 2015: (Removed from the orphan drug list) Xtandi Soft Capsule 40mg, Volibris Tablet 5mg, 10mg and Zytiga Tablet 250mg 3) Including 4 items designated as both new drug and orphan drug, and 3 items removed from the orphan drug list in 2016: (New orphan drugs) Tecfidera Capsule 120, 240mg and Ofev Soft Capsule 100, 150mg, (Removed from the orphan drug list) Jakavi Tablet 5, 15, 20mg 4) Including 4 items removed from the orphan drug list in 2017: (Removed from the orphan drug list) Pomalyst capsule 1, 2, 3, 4 mg 5) Including 3 items which were approved as both new drug and orphan drug in 2018: (Orphan new drug) Prevymis Inj., Prevymis Tab. 240mg, 480mg 6) Including 4 drug removed from the orphan drug list in 2019: (New orphan drugs) Cerdelga cap 84mg (Removed from the orphan drug list) Cabometyx tab. 20, 40 and 60mg - 42 - Table 25. Approval Status of New Drugs by Drug Classification Code (2014-2019) (Chemical Drugs) (Unit: number of items) Blood Nervous Circulatory Respira Coagul system system tory ation Diabetes Meta Chemo bolic therapy inhibitor Anti Anti neopla biotic Allergy stic matter Sensory Liver organ disease Radiologi Anti-ho cal rmone diagnosis drug Outer Digestive skin organs Public sanitary Total cares 2014 16 1 4 0 8 0 2 5 0 1 2 1 1 0 0 0 0 41 2015 8 2 1 3 2 0 5 4 2 0 0 0 1 0 0 0 0 28 2016 2 6 2 0 0 0 2 9 0 0 0 0 0 3 0 0 0 24 2017 0 3 0 0 0 0 2 9 1 4 0 1 0 0 1 0 0 21 2018 0 1 0 0 2 0 4 0 0 0 0 0 1 0 1 2 0 11 2019 7 0 0 0 0 1 4 12 0 0 3 0 0 0 0 4 1 32 In 2019, 5 items of antiepileptic drugs, 2 items of drugs for miscellaneous central nervous system (Parkinson's syndrome adjuvant treatment), 4 items of miscellaneous chemotherapeutic agents, 9 items of anticancer drugs, 3 items of ophthalmic agents, 4 items of digestive tract drugs and 1 item of other public sanitary cares used in disinfection of medical devices were approved. The product names, manufacturers, dates of approval, API, efficacy and effectiveness, mechanism of action for new drugs approved in 2019 in the sequential order of are as follows: ‘Xiidra Eye drops (Lifitegrast)’ (Shire Pharma Korea Co., Ltd., approved on Jan. 9, 2019) is used to treat dry eye in adults. The active ingredient, ‘Lifitegrast’ relieves T cell mediated inflammatory responses by inhibiting the binding between lymphocyte function-related antigen-1 (LFA-1) which is the cell surface protein of lymphocytes and intercellular adhesion molecule-1 (ICAM-1). ‘Biktarvy Tab’ (Gilead Science Korea Ltd., approved on Jan. 18, 2019) is a - 43 - three-drug combination pill for HIV sued in treatment of HIV-1 infection in adults without resistance substitution known for each ingredient of this drug, which shows the stable virus figure inhibiting effects for 3 months or more without experience in antiretroviral therapy, or failure to treat existing antiretroviral therapy (HIV-1 RNA <50 copies/mL). The active ingredients of this drug are ‘Bictegravir/ Emtricitabine/ Tenofovir Alafenamide’. ‘Bictegravir’ is an integrase inhibitor (INSTI), combined on the intergrase active area and blocks the retroviral deoxyribonucleic acid (DNA) integrase step, which is essential for the HIV replication cycle. ‘Emtricitabine’ is a nucleoside reverse transcriptase inhibitor (NRTI), which inhibit HIV replication. ‘Tenofovir Alafenamide’ is a nucleotide reverse transcriptase inhibitor (NtRTI) which inhibits HIV replication. ‘Granatec Eye Drops 0.4% (Ripasudil Hydrochloride Dihydrate)’ (Kowa Korea CL, approved on Feb. 2, 2019) an ophthalmic agents used in reducing intraocular pressure in patients with open-angle glaucoma and hypertension who are inadequate or unable to use topical beta-blockers or prostaglandin derivatives. The active ingredient, ‘Ripasudil Hydrochloride Dihydrate’ inhibits rho-associated, coiled-coil containing protein kinase and lowers intraocular pressure by promoting aqueous humor outflow to the trabecular meshwork Schlemm tube. ‘Briviact Solution, Briviact Tab (Brivaracetam)’ (Korea UBC CL, approved on Mar. 4, 2019)' is an antiepileptics used for additional therapy for partial seizure therapy with or without secondary generalized seizures in patients with epilepsy over 16 years old. The active ingredient, ‘Brivaracetam’ has a high selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, and the binding to SV2A is considered a major mechanism related with the anticonvulsant activity of brivaracetam. - 44 - ‘Tristel Spori Wipes & Form’ (HP&C Limited, approved on Mar. 26, 2019) is used for disinfection of medical devices such as endoscopes and ultrasound probes without lumen. This drug is a public sanitation drug that is not applied directly to the human body. It is a combination preparation of ‘sodium chlorite’ and ‘citric acid’ as active substance and indicates bactericidal action by lysis of chlorine dioxide, which occurs when sodium chlorite and citric acid are mixed. ‘Vosinty Tab (Vonoprazan Fumarate)’ (Takeda Korea Pharmaceutical, approved on Mar. 29, 2019) is used for prevention of recurrence of gastric ulcer or duodenal ulcer in gastric ulcer, erosive gastroesophageal reflux disease and the maintenance therapy after treatment of gastric ulcer or administration of nonsteroidal anti-inflammatory drugs (NSAIDs). The active ingredient, ‘Bonoprazan’ is a potassium-competitive acid blocker (P-CAP), which reversibly blocks the gastric acid pump of gastric wall cells to show gastric acid secretion inhibitory effect. ‘Verzenio Tab (Lifitegrast)’ (Lilly Korea Ltd., approved on May 1, 2019) is a breast cancer drug used in combination administration with aromatase inhibitors as a primary endocrine-based therapy for the treatment of postmenopausal women with advanced or metastatic breast cancer in hormone receptor (HR) - positive and human epithelial growth factor receptor 2 (HER2) - negative and in combination administration with Fulvestrant in treatment of women with advanced or metastatic breast cancer with hormonal receptor (HR) -positive and human epithelial growth factor receptor 2 (HER2) - negative who developed the disease with after endocrine therapy. The active ingredient, ‘Lifitegrast’ acts on CDK (Cyclin-dependent kinase, an enzyme that promotes cancer cell growth) 4 and 6 to inhibit cancer cell growth. ‘Amitiza Soft Cap (Lubiprostone)’ (Takeda Korea Pharmaceutical, approved on May 17, 2019) is used in 1. treatment of chronic idiopathic constipation in adults and 2 treatment of narcotic analgesic (opioid) - induced constipation in adult patients - 45 - with chronic non-cancerous pain. The active ingredient, ‘Lubiprostone’ activates chlorine-carrying proteins in the intestinal lining cells to increase intestinal fluid secretion, thereby increasing motility in the intestine, facilitating bowel movements and alleviating symptoms associated with chronic idiopathic constipation. ‘Ceredelga Cap. 84mg (Eliglustatartartrate)' (Sanofi-aventis Korea, approved on Oct. 2, 2019 as new drug after post approval change was made) is an orphan drug used in the long-term treatment of adult patients with Type 1 Gaucher’s disease (GD1) as CYP2D6 poor metabolizer (PM), intermediate metabolizer (IM) or extensive metabolizer (EM). Once gluceramide remains continuously without breakdown in cells of the human body, metabolic inflammation occurs, which leads to Gaucher disease. The active ingredient in this drug, ‘Eliglustatartartrate’ is a substrate reduction treatment (SRT) that partially reduces the substrate that the glucoserebrosidase enzyme causing Gaucher's disease by inhibiting glucosylceramide synthase should break up. ‘Cabometyx Tab (Cabozantinib)' (IPSEN Korea CL,, approved on Oct. 11, 2019 as new drug after post approval change was made) is an anticancer drug used to treat renal cell cancer and hepatocellular carcinoma. It is used in treatment of patients with advanced kidney cell caarinoma who had been treated with VEGF (Vascular endothelial growth factor) target therapy prior to treatment of kidney cell caarinoma and in treatment of patients with liver cell caarinoma who had been treated with sorafenib prior to treatment of liver cell caarinoma. The active ingredient, ‘cabozantinib’ is a multi-receptor tyrosine kinase inhibitor, and inhibits tumor growth, metastasis, and angiogenesis, showing anticancer effects. ‘Lonsurf Tab’ (Cheil Pharmaceutical Co., Ltd., approved on Oct. 17, 2019) is a complex formulation containing ‘Tipiracil hydrochloride’ and previously approved ingredient ‘Trifluridine’ used in treatment of patients with metastatic colorectal cancer, who have been previously been treated with anticancer chemotherapy based - 46 - on the fluoropyrimidine, oxaliplatin and irinotecan, and have been treated with an anti-VEGF drug or anti-EGFR drug (for RAS wild type) or cannot be treated. This drug inhibits cancer cell DNA synthesis and shows anticancer effect. ‘Tipiracil hydrochloride’ is a thmidine phosphorylase inhibitor that delays Trifluridine metabolism. ‘Lynparza Tab (Olaparib)’ (AstraZeneca Pharmaceutical Co. Ltd, approved on Oct. 29, 2019) is an anticancer drug used for ovarian and breast cancer. It is used in the maintenance therapy in adult patients with advanced BRCA mutation in high grade epithelial ovarian cancers, fallopian tube cancer or primary peritoneal cancer newly diagnosed in response to primary platinum-based chemotherapy (partially or completely), in the single maintenance therapy for adult patients with platinum-sensitive, recurrent, highly epithelial ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) in response to more than secondary platinum-based therapy (partially or completely) and the treatment of adult patients with gBRCA mutation HER2-negative metastatic breast cancer, who have previously had chemotherapy treatment. The active ingredient, ‘Olaparib’ is a poly (ADP-ribose) polymerase (PARP) inhibitor, which kills cancer cells through inhibitory action to repair DNA damage. ‘Kisqali Tab (Ribociclib succinate)’ (Novartis Korea Co., Ltd., approved on Oct. 30, 2019) is an anticancer drug used in patients with advanced or metastatic breast cancer who have hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative. ‘Ribociclib succinate’ is a cyclin-dependent kinase (CDK) 4 and 6 inhibitor that inhibits cancer cell growth through disruption of cell cycle progression. ‘Pipeltro Tab (Doravirine)’ (MSD Korea Ltd, approved on Nov. 20, 2019) is an anti-retroviral agent used in administration with other antiretroviral agents to treat HIV-1 infection in adult patients without antiretroviral treatment experience. The - 47 - active ingredient, ‘Doravirine’ is a pyridinone non-nucleoside reverse transcriptase inhibitor (NNRTI) against HIV-1, which inhibits HIV-1 replication by non-competitively inhibiting HIV-1 reverse transcriptase (RT). ‘Xofluza Tab (Baloxavir marboxil)' (Roche Korea, approved on Nov. 22, 2019) is an influenza infection drug used in treatment of A or B type virus infection in adults and adolescents aged 12 or older (administration begins within 48 hours after onset of the initial symptoms of influenza infection). ‘Baloxavir marboxil’ is a cap-dependent endonuclease (CEN) selective inhibitor, which is converted to ‘Baloxavir’, which exhibits anti-influenza activity through hydrolysis. ‘Baloxavir’ inhibits the replication of the influenza virus by inhibiting the transcription of the influenza virus genome. ‘Ongentis Cap (Opicapone)’ (SK Chemical, approved on Nov. 26, 2019) is an anti-Parkinson's agent used for adjuvant treatment of Levodopa/dopa decarboxylase Inhibitor (DDCI) for patients with Parkinson's syndrome accompanying motor fluctuation symptom not improved by levodopa/dopa decarboxylase Inhibitor (DDCI) standard therapy. The active ingredient ‘Opicapone’ is reversible and selective COMT inhibitor. In patients taking Levodopa and dopa decarboxylase (DDCI), the drug increases the plasma concentration of Levodopa, thereby enhancing the efficacy. ‘Eybelis Eye drops 0.002% (Omidenepag Isopropyl)’ (Santen Pharmaceutical Korea, approved on Dec. 3, 2019) is an ophthalmic agent used for intraocular depression in open-angle glaucoma and hypertension. The active ingredient, ‘Omidenepag Isopropyl’ promotes aqueous humor outflow through the trabecular meshwork passage and uvea sclera passage by stimulation of selective EP2 receptors. - 48 - Table 26. Approval Status of New Drugs in 2019 (Chemical Drugs) No. Mfg./ Import 1 Import Product Xiidra Eye drops (Lifitegrast) Company Date of Approva Code 2019-01-09 Ophthalmic Shire Pharma Korea Co., [131] Ltd. agents Efficacy/Effectiveness (partially omitted) Treatment and of the symptoms of signs dry eye disease in adults. Treatment in of adults HIV-1 who infection have no experience with antiretroviral therapy, or who have stable virus [629] 2 Import Biktarvy Tab Gilead Science Korea Ltd. 2019-01-18 level Miscellaneous without Chemothera -peutics suppression effect for at least 3 months treatment the existing therapy known in antiretroviral (HIV-1 copies/mL) failure and RNA without <50 and resistance-related substitutions for each individual component of this drug Granatec Eye drops 0.4% 3 Import (Ripasudil Hydrochloride Kowa Korea Co., Ltd. [131] 2019-02-21 Ophthalmic agents Dihydrate) Decreased inocular in with patients g la uc o m a and h yp e rte n sio n insufficient pressure open-angle o cu la r who have response to local β-blocker or prostaglandin derivatives or not available to use 4 Import 5 Import 6 Import 7 Import 8 Import 9 Import Briviact Solution (brivaracetam) Briviact Tab. 10mg Additional (brivaracetam) partial Briviact Tab. 25mg Korea UBC (brivaracetam) Co., Ltd. 2019-03-04 [113] Antiepileptics Import Briviact Tab. 50mg Import therapy systemic for with secondary seizures with epilepsy in over 16 years old (brivaracetam) Briviact Tab. 100mg (brivaracetam) Tristel Spori Wipes&Form [739] HP&C Limited 2019-03-26 Other public sanitary cares (vonoprazan Takeda Korea Vosinty Tab. 20mg [232] 2019-03-29 fumarate) 11 seizure without patients Vosinty Tab. 10mg 10 or therapy Pharmaceutical - 49 - Peptic ulcer agents Disinfection instruments endoscopes of medical such and as ultrasound probes without lumen Prevention of recurrence of gastric ulcer or duodenal ulcer in gastric ulcer, erosive gastroesophageal No. Mfg./ Import Product Date of Approva Company Efficacy/Effectiveness (partially omitted) Code reflux disease. maintenance therapy after treatment of gastric ulcer or (vonoprazan administration of fumarate) nonsteroidal anti-inflammatory drugs (NSAIDs) 12 Import Verzenio Tab. 50mg ⦁ (abemaciclib) Combination with administration aromatase inhibitors as a primary endocrine- 13 Import based Verzenio Tab. 100mg therapy treatment (abemaciclib) opausal 14 Import or (abemaciclib) receptor metastatic Lilly Korea Ltd. 2019-05-01 Antineoplastic agents (HR) - human growth [421] positive epithelial factor receptor 2 (HER2) - negative ⦁Combination with administration Fulvestrant treatment of breast Verzenio Tab. 200mg hormonal (abemaciclib) receptor negative the with metastatic cancer with receptor -positive epithelial in women advanced or Import with breast cancer in hormone and 15 the postmen women advanced Verzenio Tab. 150mg for of and (HR) human growth 2 factor (HER2) who - developed disease with after endocrine therapy Amitiza Soft Cap. 16 Import 1. μ 8 g (lubiprostone) Takeda Korea [238] 2019-05-17 Amitiza Soft Cap. 17 Import μ Treatm ent idiopathic Pharmaceutical Purgatives, clysters 24 g chronic in adults 2. Treatment analgesic induced adult (lubiprostone) of constipation of narcotic (opioid) constipation patients with in chronic non-cancerous pain 2019-10-02 Ceredelga Cap. 18 Import 84mg (eliglustat tartrate) Sanofi-aventis Korea Ltd. Co., (Conversion [399] to orphan/ Miscellaneous new drug ) metabolism *Initial agents approval - 50 - Long-term treatment of adult patients with Type 1 Gaucher’s disease (GD1) as CYP2D6 poor metabolizer (PM), ntermediate No. Mfg./ Import Product Date of Approva Company date: metabolizer (IM) or 2015-11-12 19 20 Import Import Efficacy/Effectiveness (partially omitted) Code extensive metabolizer (EM) Cabometyx Tab. 1) Treatment of patients with (cabozantinib) advanced Cabometyx Tab. (cabozantinib) 2019-10-11 treated (release from IPSEN Korea Co., Ltd. Import Cabometyx Tab. growth conversion to [421] new drug) Antineoplastic *Initial agents approval (cabozantinib) with (Vascular orphan and 21 kidney cell caarinoma that has been VEGF endothelial factor) therapy target prior treatment of to kidney cell caarinoma 2) Treatment of patients with date: liver cell 2017-09-26 has been caarinoma treated sorafenib treatment that with prior of liver to cell caarinoma Treatment of patients with metastatic colorectal 22 Mfg. Lonsurf 15 cancer, who have previously been treated with anti-cancer [421] Jeil pharma 2019-10-17 holdings inc. chemotherapy based on Antineoplastic the agents fluoropyrimidine, oxaliplatin and irinotecan, and have been treated or 23 Mfg. Lonsurf 20 not able to be treated with anti-VEGF treatment, anti-EGFR treatment (for RAS wild type) Lynparza Tab. 24 Import Ovarian cancer • 100mg (Olaparib) Maintenance therapy in adult patients with advanced BRCA mutation in high grade epithelial ovarian cancers, fallopian tube Astra Zeneca Lynparza Tab. 25 Import Korea [421] 2019-10-29 cancer or primary Antineoplastic peritoneal cancer newly agents 150mg diagnosed in response to primary (Olaparib) platinum-based chemotherapy (partially • or completely) Single maintenance therapy for adult patients with - 51 - No. Mfg./ Import Product Date of Approva Company Efficacy/Effectiveness (partially omitted) Code platinum-sensitive, recurrent, highly epithelial ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) in response to more than secondary platinum-based therapy (partially or completely) Breast cancer Treatment of adult patients with gBRCA mutation HER2-negative metastatic breast cancer. who have previously had chemotherapy treatment. The patient may have undergone adjuvant therapy before surgery, adjuvant therapy after surgery, or chemotherapy under metastatic conditions. This drug patients is with metastatic used breast who have receptor (HR) human epidermal factor or cancer hormone positive receptor negative in advanced and and growth 2 (HER2) administered in combination as follows. 26 Import Kisqali Tab. 200mg (Ribociclib succinate) Novartis Korea Co., Ltd. [421] 2019-10-30 • Combination with aromatase inhibitors as Antineoplastic a primary endocrine agents therapy in premenopausal, perimenopausal, or • postmenopausal women If the disease has progressed in postmenopausal women undergoing primary or endocrine therapy, use with fulvestrant 27 Import Xofluza Tab. 20mg [629] (baloxavir marboxil) Roche Korea 28 Import 2019-11-22 Xofluza Tab. 20mg Chemothera (baloxavir marboxil) -peutics - 52 - Treatment of influenza A or Miscellaneous B virus and 12 infection in adults adolescents more than years (administration No. Mfg./ Import Product Date of Approva Company Efficacy/Effectiveness (partially omitted) Code begins after within onset symptoms 48 of hours the of initial influenza infection) Administered with other [629] 29 Import Pipeltro Tab MSD Korea (doravirine) Ltd 2019-11-22 antiretroviral agents to treat Miscellaneous HIV-1 infection in adult Chemothera -peutics patients without antiretroviral treatment experience 30 Mfg. Ongentis Cap. 25mg Adjuvant (opicapone) drug [119] decarboxylase Miscellaneous (DDCI) SK Chemicals 31 Mfg. of L e v o d o p a / d o p a 2019-11-26 central Inhibitor for patients Parkinson's Ongentis Cap. 50mg nervous (opicapone) system fluctuation agents improved with syndrome accompanying motor symptom by not levodopa/dopa decarboxylase Inhibitor (DDCI) standard therapy Eybelis Eye drops 32 Import 0.002% (Omidenepag Isopropyl) * Santen Pharmaceutical Korea Co., [131] 2019-12-03 Ophthalmic agents Ltd. Lowering in the open-angle - 53 - eye pressure diseases: glaucoma and ocular hypertension Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. of following precautions for use) 2.2. Information on Approval of orphan drugs As a chemical drug approved in 2019, the number of orphan drugs were 8 items (8 imported items) were orphan new drugs (Refer to Table 27). The approval of orphan drugs by classification code is as follows: 5 items of anticancer drugs, 2 items of miscellaneous central nervous system drugs, and 1 item of ophthalmic agents. From 6 ingredients of orphan drugs approved in 2019, all except ‘Tacrolimus Hydrate’ were newly designated ingredients in 2018 as orphan drugs. Table 27. Approval Status of Orphan Drug in 2019 (Chemical Drugs) No. Mfg./ Import Product Company Date of Approval Code Efficacy/Effectiveness Designation of Orphan Drugs 1. Combination of standardized Serial. 229 No. (Designated in 2018) Ingredient Midostaurin (Oral) 1. Combination of cytarabine and standardized daunorubicin cytarabine and induction therapy daunorubicin with high-dose induction cytarabine consolidation therapy Rydapt Soft 1 Import Cap. 25mg (midostaurin) Novartis [421] Korea Co., 2019-02-14 Antineoplastic Ltd agents cytarabine in newly diagnosed consolidation therapy acute myeloid leukemia patients with positive FLT3 mutation. therapy with high-dose in newly diagnosed Target acute myeloid Disease leukemia patients with positive FLT3 2. Aggressive systemic mutation. mastocytosis. 2. Aggressive systemic systemic mastocytosis. mastocytosis with systemic hematologic mastocytosis with neoplasm, mast cell hematologic leukemia neoplasm, mast cell leukemia Single maintenance therapy for adult patients with Zejula Cap. 100mg 2 Import (Niraparib tosylate monohydrate) Takeda Korea Pharmaceu tical Serial. 233 No. (Designated in 2018) Ingredient Niraparib (Oral) 1. maintenance platinum-sensitive, [421] treatment of adult recurrent, HSROC patients with 2019-03-22 Antineoplastic (including fallopian tube agents cancer or primary Target peritoneal Disease cancer) who responded to more than secondary platinum-based - 54 - platinum-sensitive, recurrent ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy 2. Monotherapy of 1) BRCA mutations (regardless of platinum sensitivity) or 2) platinum-sensitive chemotherapy (partially homologous or completely) recombination Monotherapy of 1) deficiency (HRD) BRCA mutations positive recurrent (regardless of platinum sensitivity) or ovarian cancers 2) (including adult platinum-sensitive patients with tubal homologous cancer or primary recombination deficiency peritoneal cancer) (HRD) positive recurrent that have previously ovarian cancers been administered (including adult patients more than 3 times of with tubal cancer or chemotherapy primary peritoneal 3. Single maintenance cancer) that have therapy for adult previously been patients administered more than Platinum-sensitive 3 times of ovarian cancer chemotherapy (including fallopian tube cancer or primary peritoneal cancer) in response to primary platinum-based therapy (including partial or complete response) [119] Raxone Film 3 Import Coated Tab. 150mg (Idebenone) the treatment of visual Miscellaneous impairment in DKSH Manageme 2019-09-10 nt Ltd. central nervous adolescent and adult patients with Leber’s Hereditary system Optic Neuropathy agents (LHON) [119] Maven Clad 4 Import Tab (Cladribine) Miscellaneous Merck Korea 2019-07-09 central nervous system Treatment of relapsing, remitting multiple sclerosis Vernal 5 Import drops 0.1% keratoconjunctivitis with (Tacrolimus hydrate) [131] Taejoon Pharm. Co., Ltd 2019-07-11 228 No. (Designated in 2018) Ingredient Idebenone(Oral) Target Leber’s Hereditary Optic Disease Neuropathy (LHON) Serial. 232 No. (Designated in 2018) Ingredient Cladribine (Oral) Target Disease agents Allimus Eye Serial. massive papillary Ophthalmic hyperplasia in the eyelid agent conjunctiva (if the effect of an anti-allergic agent is insufficient) - 55 - Treatment of relapsing, remitting multiple sclerosis Serial. 227 No. (Designated in 2017) Ingredient Tacrolimus hydrate(Eye drops) Target Vernal Disease keratoconjunctivitis(if the effect of an anti-allergic agent is Venclexta 6 Import Tab. 100mg Monotherapy in patients (venetoclax) with chronic lymphocytic Venclexta 7 8 Import Import Tab. 50mg AbbVie (venetoclax) Korea Ltd. [421] 237 No. (Designated in 2018) Ingredient venetoclax(Oral) Single administration to leukemia who are chronic lymphocytic 2019-05-29 Antineoplastic relapsed or refractory to agents chemoimmunotherapy Target Venclexta and an inhibitor of B disease Tab. 100mg cell receptor pathway (venetoclax) * insufficient) Serial. leukemias unsuccessful or unsuitable for chemoimmunotherapy and an inhibitor of B cell receptor pathway Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 56 - precautions for use) 2.3. Information on Approval of incrementally modified drugs ‘Incrementally modified drugs’ refers to the drugs which the Minister of MFDS authorizes as incrementally modified or medicinally advanced for the safety, efficacy, and usefulness (medication compliance, convenience, etc.) compared to approved (notified) drugs requiring data submission under Article 2(8) of the Regulations for Pharmaceutical Approval, Notification and Review. The development types of incrementally modified drugs approved for the last 5 years are as follows: development of combination drugs with new composition of active substances (drugs containing 2 or more active ingredients in one product) was noticeable from 2016 to 2017; and 6 SR tablet items with improved administration/dosage by reducing the number of intakes were accepted as incrementally modified drugs in 2018. In 2019, 13 items with improved efficacy (11 items) and improved usability (2 items) were approved as incrementally modified drugs (Refer to Table 28). The detailed acceptance criteria for the incrementally modified drugs (13 items) approved in 2019 are as follows: 11 items of combination products with new composition that proved their improved efficacy (increased treatment effects) (8 items of 2-drug combination for hyperlipidemia and 3 items of 3-drug combination for hypertension); 1 item of pre-treatment bowel cleansing agent for colon screening, of which usefulness was accepted through improvement of administration/dosage of the previously approved items (total dose reduction: 3L, 4L → 2L); and 1 item of pre-treatment bowel cleansing agent for colon screening, of which usability (medication compliance and convenience) was improved through new composition and formulation improvement of active substance (liquid → tablet). - 57 - Table 28. Type of Incrementally Modified Drugs in 2015~2019 Year New composition or combination ratio New dosage form (Same route of administration) New routes of administration Total 2015 7 11 0 18 2016 22 1 1 24 2017 7 4 0 11 2018 0 6 0 6 2019 13 0 0 13 In addition, the MFDS published the 「Incrementally Modified Drug Approval Casebook」 (Guide for Civil Petitioners) focusing on the current information and cases of incrementally modified drugs to ensure the domestic pharmaceutical industries may refer to the Guide for drug research and development. This Guide provides the approval status, items by type, detailed acceptance criteria by case, unaccepted cases, etc. of incrementally modified drugs (112 items) approved for about 10 years since introduction of the incrementally modified drug system (since Aug. 2008) including the incrementally modified drugs approved in 2019. Approval of incrementally modified drugs by acceptance criteria is as follows: the drugs with the improved efficacy (62 items, 55.4%) of which increased treatment effects are proved, and those with the improved usefulness (39 items, 34.8%) resulting from improved formulation accounted for about 90% of all incrementally modified drugs, followed by 7 items (6.3%) recognized for advanced pharmaceutical technology, and 4 items (3.5%) with improved safety (Figure 7). - 58 - Figure 7. Approval of Incrementally Modified Drugs by Acceptance Criteria and by Type (2009-2019) - 59 - Table 29. List of Incrementally Modified Drugs (2009~2019) No. 1 Product Company Hanmi Amosartan Tablet 5/100 mg [214] Antihypertensives (Amlodipine camsylate / Losartan potassium) Cozaar XQ Tablet 5/100mg 4 Remarks 2009-03-31 Cozaar XQ Tablet 5/50mg 3 Code Amosartan Tablet 5/50 mg Pharmaceutical 2 Date of Approval MSD Korea LTD. 2009-11-20 Hanmi Pharmaceutical 2010-02-11 Change of active substance type or compounding ratio (Amlodipine camsylate / Losartan potassium) 5 Potastine OD Tablet (Bepotastine calcium dihydrate) [141] Sodium and formulation Antihistamine changes [114] 6 CLANZA CR Tablet Korea United Pharm Inc. Antipyretics, 2010-04-14 Change in dosage analgesics, and form, strength and anti-inflammatory administration/dosage agents 7 Ridrone Plus Tablet 8 RISENEX-PLUS Tablet 9 Risenplus Tablet 10 Amosartan Tablet 10/50 mg Pacific Pharmaceuticals HANLIM PHARM. DAEWOONG PHARMACEUTICAL Hanmi Pharmaceutical 2010-06-23 2010-06-23 [399] Change of active Miscellaneous substance type or metabolism agents compounding ratio 2010-06-23 2010-10-15 [214] Cozaar XQ Tablet 10/50mg 11 (Amlodipine camsylate Antihypertensives MSD Korea LTD. 2010-10-15 Change of active substance type or compounding ratio / Losartan potassium) [114] Antipyretics, 12 Ultracet ER Tablet Janssen Korea 2010-11-22 Change in dosage analgesics, and form, strength and anti-inflammatory administration/dosage agents [114] 13 LOXFEN CR Tablet SHINPOONG Pharmaceutical Co. Antipyretics, 2011-03-18 Change in dosage analgesics, and form, strength and anti-inflammatory administration/dosage agents [339] 14 Pletaal SR Capsules Korea Otsuka Pharmaceutical 2011-04-19 Miscellaneous blood and body fluid agents [421] 15 16 Apetrol ES Oral suspension Ridonel D Tablet LG Life Science Hanmi Pharmaceutical 2012-03-27 2012-04-03 RISENEX-M Tablet HANLIM PHARM. Change in dosage form, strength and agents administration/dosage [399] Change in dosage 2012-04-03 metabolism agents - 60 - form, strength and administration/dosage Antineoplastic Miscellaneous 17 Change in dosage form, strength and administration/dosage Product Company Date of Approval 18 Letopra Tablet 20mg Ahngook Pharm. 2012-06-18 19 NASAFLEX Nasal Spray HANLIM PHARM. 2012-11-16 No. 20 Moteson Plus Nasal Spray 21 KanarbPlus Tablets 120/12.5mg Hanmi Pharmaceutical Boryung Pharmaceutical 22 23 24 25 26 2012-11-16 2013-01-04 Code Remarks [232] New sodium or isomers Peptic ulcer agent (first in Korea) [132] Change of substance Otic and nasal type or compounding agents ratio [214] Antihypertensives KanarbPlus Tablets 60/12.5mg OLMETAN Tablet 22.08mg JIN YANG (Olmesartan cilexetil) PHARM. CO. Olmexin S Tablet (Olmesartan medoxomil) Olmos-F Tablet 22.08mg (Olmesartan Cilexet il) Olmexetil Tablet 22.08mg (Olmesartan Cilexetil) 2013-01-31 Ahngook Pharm. [214] New sodium or isomers (first in Korea) JEIL PHARMACEUTICAL CO.,LTD. CILOSTAN CR 200 mg Tablet Korea United (Cilostazol) Pharm Inc. 29 Julian Tablet 15mg (Clomipramine hydrochloride) Nenoma Tablet 15mg (Clomipramine HCl) 2013-02-28 Miscellaneous blood and body 30 31 32 (Clomipramine hydrochloride) CTCBIO Inc. CLOJACK Tablet 15mg JIN YANG PHARM. CO. CJ Healthcare 34 Bonviva Plus Tablet 35 Levacalm Tablet 20/160mg 36 Levacalm Tablet 20/160mg 37 Levacalm Tablet 10/80mg 38 Zemimet SR Tablet 25/500mg 39 Miscellaneous Apparently add another Urogenital and efficacy anal organ agents VOGMET Tablet 0.2/250mg VOGMET Tablet 0.2/500mg DEXID Tablet 480mg (R-thioctic acid tromethamine) form, strength and administration/dosage [259] HUONS CO. LTD (Clomipramine hydrochloride) 33 Change in dosage Dongkook Pharm. 2013-03-20 Condencia Tablet 15mg ratio Antihypertensives fluids agents 28 type or compounding SK Chemicals [339] 27 Change of substance DreamPharma LG Chem. LG Chem. 2013-06-17 2013-07-08 2013-07-25 2013-07-25 [396] Antidiabetic agent 2013-11-21 ratio [399] Change of active substance type or metabolism agents compounding ratio [214] Antihypertensives [396] Antidiabetic agent Miscellaneous metabolism agents - 61 - type or compounding Miscellaneous [399] Bukwang Pharm. Change of substance Change of active substance type or compounding ratio Change of active substance type or compounding ratio New sodium or isomers (first in Korea) No. 40 41 42 43 Product Company Date of Approval Zemimet SR Tablet 50/1000mg LG Chem. 2014-11-07 Sapodifil SR Tablet 300mg Alvogen Korea (Sarpogrelate hydrochloride) Co. Ltd Anpran SR Tablet 300mg (Sapogrelate hydrochloride) Anpla X-SR Tablet 300mg (Sarpogrelate hydrochloride) Code [396] Antidiabetic agent 45 [339] CO.,LTD. SK Chemicals DAEWOONG (Sarpogrelate hydrochloride) PHARMACEUTICAL (Sarpogrelate hydrochloride) compounding ratio JEIL ANPLONE SR Tablet 300mg ANFRADE SR Tablet 300mg Change of active substance type or PHARMACEUTICAL 2015-01-23 Miscellaneous blood and body fluids agents 44 Remarks Change in dosage form, strength and administration/dosage CJ Healthcare [114] 46 PELUBI CR TABLET Daewon (Pelubiprofen) Pharmaceutical Antipyretics, 2015-03-13 Change in dosage analgesics, and form, strength and anti-inflammatory administration/dosage agents 47 Tenelia M SR tablet 10/750mg 48 Tenelia M SR tablet 20/1000mg 49 Tenelia M SR tablet 10/500mg 50 51 52 53 54 55 EXON SR TABLET (Eperisone hydrochloride) Exonin CR Tablet (Eperisone hydrochloride) EPESIN SR Tablet (Eperisone hydrochloride) Handok Inc. [122] Myungmoon Pharm. Daewon Pharmaceutical Zemimet SR Tablet50/500mg 56 Sugamet XR Tablet 2.5/500mg 57 Sugamet XR Tablet 2.5/850mg 58 Sugamet XR Tablet 5/1000mg Antidiabetic agent Change of active substance type or compounding ratio SK Chemicals NEREXON SR TABLET (Eperisone hydrochloride) [396] AJU PHARMA CO. (Eperisone hydrochloride) Eperinal SR Tablet 2015-03-31 2015-03-31 Change in dosage Skeletal muscle form, strength and relaxant administration/dosage JEIL PHARMACEUTICAL CO.,LTD. LG Life Science DONG-A ST 2015-10-12 2015-12-31 - 62 - [396] Antidiabetic agent [396] Antidiabetic agent Change of active substance type or compounding ratio Change of active substance type or compounding ratio No. Product 59 Dukarb Tablets 30/5mg 60 Dukarb Tablets 30/10mg Company Boryung Pharmaceutical 61 Dukarb Tablets 60/5mg 62 Dukarb Tablets 60/10mg 63 KARBPIN Tablet 60/5 mg 64 KARBPIN Tablet 60/10 mg Boryung Biopharma Co. 65 KARBPIN Tablet 30/5 mg 66 KARBPIN Tablet 30/10 mg 67 CANDEAMLO Tablet 16/10mg 68 CANDEAMLO Tablet 16/5mg 69 CANDEAMLO Tablet 8/5mg 70 MACHKHAN Tablet 8/5mg 71 MACHKHAN Tablet 16/10mg 72 MACHKHAN Tablet 16/5mg 73 Duvimet XR Tablet 0.25/750mg 74 Duvimet XR Tablet 0.25/1000mg 75 Duvimet XR Tablet 0.5/1000mg SHINPOONG Pharmaceutical Co. CJ Healthcare Chong Kun Dang Pharm. Date of Approval 2016-05-30 2016-05-31 2016-06-24 2016-06-24 2016-06-30 Code [214] Antihypertensives [214] Antihypertensives [214] Antihypertensives [214] Antihypertensives [396] Antidiabetic agent [239] 76 GASTIIN CR Tablet Korea United (Mosapride citrate hydrate) Pharm Inc. 2016-06-30 Miscellaneous digestive organ agents 77 78 79 80 Zemimet SR Tablet 25/1000mg Duvimet XR Tablet 0.25/500mg LIPORAXEL Solution. (Paclitaxel) Safrep solution LG Chem. Chong Kun Dang Pharm. Dae Hwa Pharmaceutical CTCBIO INC. 2016-06-30 2016-09-01 [396] Antidiabetic agent [396] Antidiabetic agent [421] 2016-09-09 Antineoplastic agents 2016-10-06 - 63 - Remarks Change of active substance type or compounding ratio Change of active substance type or compounding ratio Change of active substance type or compounding ratio Change of active substance type or compounding ratio Change of active substance type or compounding ratio Change in dosage form, strength and administration/dosage Change of active substance type or compounding ratio Change of active substance type or compounding ratio New routes of administration [721] Change of active X-ray contrast substance type or media compounding ratio No. 81 82 Product Duocolon Solution 300mL Coolipa Solution Company Alvogen Korea Co. Ltd Ahngook Pharm. Date of Approval Code [721] Change of active 2016-10-06 X-ray contrast substance type or media compounding ratio 2016-10-06 [721] Change of active X-ray contrast substance type or media compounding ratio [229] 83 Surfolase CR Tablet (Acebrophylline) Hyundai Pharm 2017-02-24 Miscellaneous respiratory organ agents 84 85 86 87 88 89 90 91 LEVOTICS CR Tablet Korea United (Levodropropizine) Pharm Inc. Levocare CR Tablet KWANGDONG (Levodropropizine) PHARMACEUTICAL NEOTUSS CR Tablet (Levodropropizine) JW Shinyak 93 94 95 96 97 98 99 100 2017-04-12 2017-04-12 Change in dosage form, strength and administration/dosage Change in dosage Antitussive form, strength and expectorants administration/dosage [222] Change in dosage Antitussive form, strength and expectorants administration/dosage [222] Change in dosage Antitussive form, strength and expectorants administration/dosage Amosartan Plus Tablet 5/80/12.5 mg Amosartan Plus Tablet 5/100/12.5 mg Hanmi Pharmaceutical 2017-06-29 [214] Antihypertensives Change of active substance type or compounding ratio Amosartan Plus Tablet 5/100/25 mg TWOTOPSPLUS TABLET 40/5/12.5mg TWOTOPSPLUS TABLET 80/5/12.5mg ILDONG PHARMACEUTICAL 92 [222] 2017-04-12 Remarks TWOTOPSPLUS TABLET 2017-07-25 CO. [214] Antihypertensives Change of active substance type or compounding ratio 80/10/12.5mg TWOTOPSPLUS TABLET 80/10/25mg Belion SR tablet Hanlim Pharma. (Bepostatine salicylate) Co., Ltd Tari-S SR tablet Sam Chun Dang (Bepostatine salicylate) Pharrm. Co., Ltd Beposta SR tablet (Bepostatine salicylate) Bepo-Q tablet (Bepostatine salicylate) Bepotan SR tablet (Bepostatine salicylate) Daewon Pharmaceutical Co., Ltd. Kwang Dong [141] Antihistamine Pharmaceutical Co., change in dosage form, strength and administration/dosage Ltd Dongkook Pharmaceutical Co., Ltd Beporine SR tablet Sama Pharm. (Bepostatine salicylate) Co., Ltd Cleanviewal Powder 2018-07-30 Taejoon Pharm. Co., Ltd. 2019-02-26 - 64 - [721] Change of active X-ray contrast substance type or media compounding ratio No. 101 102 103 104 105 106 107 108 109 * Product Starfen Cap. Newstatin Duo Cap. Pitaion F Cap Pevaro F Cap. Liloufen Cap. Uptava Cap. Rifestin Cap. PF Cap. Orafang Tab. 110 True Set Tab. 40/5/12.5mg] 111 True Set Tab 80/5/12.5mg 112 True Set Tab 80/5/25mg Company Hanlim Pharma. Co., Ltd Samjin Pharm. Co., Ltd. Dongkook Pharm. Ahngook Pharm. GL Pharm tech Daewon Pharmaceutical Korea Prime Pharm Co., Ltd. Donggwang Pham Co., Ltd. Phambio Inc. Yuhan Corp. Date of Approval Code [218] Change of active 2019-04-03 Hyperlipidemia substance type or agents compounding ratio 2019-04-03 2019-04-03 2019-04-03 2019-04-03 2019-04-03 2019-04-03 2019-04-03 2019-04-11 2019-08-23 [218] Change of active Hyperlipidemia substance type or agents compounding ratio [218] Change of active Hyperlipidemia substance type or agents compounding ratio [218] Change of active Hyperlipidemia substance type or agents compounding ratio [218] Change of active Hyperlipidemia substance type or agents compounding ratio [218] Change of active Hyperlipidemia substance type or agents compounding ratio [218] Change of active Hyperlipidemia substance type or agents compounding ratio [218] Change of active Hyperlipidemia substance type or agents compounding ratio [721] Change of active X-ray contrast substance type or media compounding ratio [214] Antihypertensives Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 65 - Remarks Change of active substance type or compounding ratio precautions for use) 2.4. Information on Approval of Drugs Requiring Data Submission Drugs requiring data submission are drugs that are not new drugs, but need to be evaluated of safety and efficacy include ▴drugs that contain a new salts (isomer) as an active ingredient ▴ drugs belonging to new therapeutic class ▴ active substance with new composition or change in strength ▴ drugs with new administration routes ▴ drugs of new administration/ dosage ▴ new dosage form (same administration route). Among the drugs requiring data submission (13 items excluding incrementally modified drugs) approved in 2019, development of drugs with new composition or changes in content took the largest items (57.9%, 106 items), followed by drugs with new dosage form (same route of administration) (38.8%, 71 items) (Refer to Table 30). Table 30. Approval Status of Drugs Requiring Data Submission in 2019 Review type of drugs requiring for data submission No. of Approved Items 2 New salts or isomers New composition of active ingredient or New composition 95 Change in strength 11 106 change only in contents New routes of administration 1 New administration/dosage 3 New dosage form (same route of administration) 71 183 Total * Excluding Incrementally Modified Drugs (Drugs requiring data submission) - 66 - 1) Drugs with New salt or isomer (2 items) Chemical drugs approved as new salt or isomer are 2 manufacturing items which are as follows: 1 item which changed the salt of Sitagliptin phosphate, an approved diabetic drug into Sitagliptin hydrochloride monohydrate drug; and 1 item of radiopharmaceuticals which combined the radio marker (18F) with esther to Estradiol. Table 31. Approval of Drugs with New Salt or New Isomer that Require Data Submission in 2019 No. Mfg/ Import Product Janulitin Alpha Tab. 100mg 1 Mfg. (Sitagliptin hydrochloride Hydrate) 2 * Mfg. Company Date of Approva Code Efficacy/Effectiveness (Partial summary) Remarks Supplement drug to Daewon Pharmaceu tical Co., [396] 2019-11-19 Antidiabetic agents Ltd. diet and exercise therapy to improve blood sugar control in patients with phosphate → hydrochloride diabetes mellitus 2 FES Inj ASAN (Fluoroestradiol Medical [18F] solution) Center 2019-11-04 [431] Used for positron Agent for emission tomography radiation (PET) Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 67 - Ester compounds precautions for use) 2) Drugs with new composition or changes in strength of active substances (106 items) In case of drugs with new composition, 95 items (83 manufactured items and 12 imported items) were approved. Most of them were as follows: cardiovascular agents were 63 items (63.3%) and metabolism agents (antidiabetic agents and miscellaneous metabolism agents) were 19 items (20.0%). Approval of drugs with the new composition drugs are as follows: hypertension/hyperlipidemia drugs, all of which were combination drugs containing Rosuvastatin (59 items, 62.1%); and diabetes/hyperlipidemia drugs (18 items, 18.9%), of which 14 items (14.7%) were combination product containing Metformin Hydrochloride and Rosuvastatin. Combination product for comorbidity containing rosuvastatin calcium (hypertension/ hyperlipidemia or diabetes/hyperlipidemia) were 73 items accounting for more than two-thirds (76.8%) of drugs with new composition approved in 2019 (Refer to Table 32). In case of drugs with new changes in contents (7 manufactured items and 4 imported items), 11 items were approved there was no specific item with drug classification code taking the most of them (Refer to Table 33). Table 32. Approval of Drugs with New Composition that Require Data Submission in 2019 No. Mfg./ Import Product Company Date of Approval Inist Bio 1 Mfg. 3 4 5 6 7 Mfg. Mfg. Import Mfg. Mfg. Import Active ingredient [399] Bazedoxifene Miscellaneous acetate, metabolism cholecalciferol agents concentrated powder Duowell A Tab. [219] Telmisartan, 80/5/10mg Miscellaneous Amlodipine Baxebita Tab Pharmaceutical 2019-01-29 Co., Ltd. 2 Code Duowell A Tab. Yuhan Corp. 2019-02-08 40/5/10mg Juluca Tab GlaxoSmithKline Korea 2019-02-11 Cardiovascular besylate, agents Rosuvastatin calcium [629] Rilpivirine Miscellaneous hydrochloride, Chemotherape dolutegravir sodium utics (micronised) Rosuampin Tab. [219] 5/10mg Miscellaneous Rosuampin Tab. Yuhan Corp. 2019-02-21 10/10mg Segluromet Tab. Cardiovascular Rosuvastatin calcium, Amlodipine besylate agents MSD Korea Ltd 2019-02-26 - 68 - [396] ertugliflozin No. Mfg./ Import Product Company Date of Approval Code Active ingredient Antidiabetic acid (micronised), 7.5/1000mg 8 9 Import Mfg. 10 Mfg. 11 Mfg. 12 13 14 15 Mfg. Import Import Mfg. 16 Mfg. 17 Mfg. 18 Mfg. L-Pyroglutamic Segluromet Tab. agents 2.5/500mg Metformin hydrochloride Olomax Tab. 40/10/20m Olomax Tab. 20/5/5m Olomax Tab. 20/5/10m Daewoong Pharmaceutical 2019-02-27 Co., Ltd. [219] olmesartan Miscellaneous medoxomil, Cardiovascular Amlodipine besylate, agents Rosuvastatin calcium Olomax Tab. 40/10/10m Segluromet ertugliflozin Tab. 2.5/1000mg Segluromet Tab. MSD Korea Ltd 2019-03-06 [396] L-Pyroglutamic Antidiabetic acid (micronised), agents 7.5/500mg Metformin hydrochloride Ex-one R Tab. 5/80/5mg Ex-one R Tab. 5/80/10mg Ex-one R Tab. CJ Healthcare Co., Ltd 2019-04-15 5/160/10mg [219] Valsartan, Miscellaneous Amlodipine Cardiovascular besylate, agents Rosuvastatin calcium Ex-one R Tab. 5/160/5mg Bikavera Glucose 1.5% Calcium 19 Import 1.75mmol/L Peritoneal sodium chloride, Dialysis Solution Bikavera Glucose 2.3% Calcium 20 Import 1.75mmol/L Peritoneal glucose Fresenius Medical [349] Care 2019-04-25 Korea Other artificial perfusates hydrate, magnesium chloride hexahydrate, Calcium chloride Dialysis Solution dihydrate, sodium Bikavera Glucose bicarbonate 4.25% Calcium 21 Import 1.75mmol/L Peritoneal Dialysis Solution Zephirus 22 Import Inhalation Cap. μ 300/25 g Zephirus 23 Import Huons Co., Ltd. 2019-05-08 Inhalation Cap. [229] Budesonide, Miscellaneous salmeterol respiratory xinafoate organ agents (micronised) μ 150/25 g 24 25 Mfg. Mfg. Duomet XR Tab. 500/5mg Jeil pharma Duomet XR Tab. holdings inc. 2019-05-24 750/5mg - 69 - [396] Metformin Antidiabetic hydrochloride, agents Rosuvastatin calcium No. 26 Mfg./ Import Mfg. 27 Mfg. 28 Mfg. 29 Mfg. 30 Mfg. 31 Mfg. 32 Mfg. 33 Mfg. 34 Import Product Rosutanmet Tab. 750/5mg Rosutanmet Tab. 500/5mg 36 37 38 39 Mfg. Mfg. Mfg. Mfg. 40 Mfg. 41 Mfg. 42 Mfg. 43 Mfg. 44 Mfg. 45 Mfg. 46 Mfg. 47 Mfg. Code [396] Metformin 2019-05-24 Antidiabetic hydrochloride, agents Rosuvastatin calcium Dongkook Pharm. Co., Ltd. 500/5mg Kukje Pharm Clavis Tab. Co., Ltd. 2019-05-24 750/5mg [396] Metformin Antidiabetic hydrochloride, agents Rosuvastatin calcium 500/5mg RM SR Tab. 750/5mg RM SR Tab. 500/10mg Donggwang Pharm. Co., 2019-06-04 Ltd. [396] Metformin Antidiabetic hydrochloride, agents Rosuvastatin calcium RM SR Tab. 750/10mg Bevespi AstraZeneca Aerosphere Pharmaceutical 2019-06-26 Co. Ltd) Telmiwons Plus Tab. 40/5/10mg Glycopyrronium bromide, Formoterol expectorants Telmiwons Plus Tab. 80/5/10mg [222] Antitussives, Myungmoon Pharm Co., 2019-07-03 Ltd.. Import fumarate hydrate [219] Telmisartan, Miscellaneous Amlodipine Cardiovascular besylate, agents Rosuvastatin calcium Qsymia Cap. 7.5mg/46mg Qsymia Cap. [123] 3.75mg/23mg Autonomic Qsymia Cap. Alvogen Korea 2019-07-31 15mg/92mg nervous Phentermine Hydrochloride, topiramate system agents Qsymia Cap. 11.25mg/69mg Duo Met-XR Tab. 1000/5mg Jeil pharma Duo Met-XR holdings inc. 2019-08-09 Tab. 1000/10mg [396] Metformin Antidiabetic hydrochloride, agents Rosuvastatin calcium Nebirosta Tab. [219] 5/20mg Nebirosta Tab. 5/10mg Elyson Pharm. Co., Ltd. Miscellaneous 2019-08-30 Nebirosta Tab. Cardiovascular Nebivolol Hydrochloride, Rosuvastatin calcium agents 2.5/10mg Clavis Tab1000/5mg Jeil pharma Clavis holdings inc. 2019-08-09 Tab1000/10mg [396] Metformin Antidiabetic hydrochloride, agents Rosuvastatin calcium [229] 48 Active ingredient RM SR Tab. μ Mfg. Date of Approval Clavis Tab. 7.2/5.0 g 35 Company Trimbow Inhaler 100/6/12.5 Kolon Pharma 2019-09-17 Miscellaneous Dipropionate anhydrous, respiratory - 70 - Beclomethasone Formoterol fumarate No. Mfg./ Import Product Company Date of Approval Code Active ingredient hydrate(micronised), organ agents Glycopyrronium bromide 49 Mfg. 50 Mfg. 51 Mfg. 52 Mfg. 53 Mfg. 54 Mfg. 55 Mfg. 56 Mfg. 57 Mfg. 58 Mfg. 59 Mfg. 60 Mfg. 61 Mfg. 62 Mfg. 63 Mfg. 64 Mfg. 65 Mfg. 66 67 68 69 70 71 72 Mfg. Mfg. Mfg. Mfg. Mfg. Mfg. Mfg. TR Duo Tab40/5mg TR Duo [219] Tab40/10mg Miscellaneous TR Duo BINEX Co., Ltd. 2019-09-30 Tab80/5mg Cardiovascular Telmisartan, Rosuvastatin calcium agents TR Duo Tab80/10mg Telmirosu Tab80/5mg Telmirosu Tab40/20mg Telmirosu [219] Tab40/10mg Miscellaneous Telmirosu Yungjin Pharm Co., Ltd. 2019-09-30 Tab40/5mg Cardiovascular Telmisartan, Rosuvastatin calcium agents Telmirosu Tab80/20mg Telmirosu Tab80/10mg Telodown Tab40/20mg Telodown Tab80/5mg [219] Telodown Tab80/10mg Telodown Ilyang Pharm Co., Ltd. Miscellaneous 2019-09-30 Tab80/20mg Cardiovascular Telmisartan, Rosuvastatin calcium agents Telodown Tab40/5mg Telodown Tab40/10mg Duosta [219] Tab40/5mg Duosta Tab40/10mg Miscellaneous Celltrion Inc. 2019-09-30 Duosta Cardiovascular Telmisartan, Rosuvastatin calcium agents Tab80/10mg Telmiro One Tab40/5mg Telmiro One Tab40/10mg Telmiro One Tab40/20mg Telmiro One [219] Hana Miscellaneous Pharmaceutical 2019-10-15 Ltd. Cardiovascular agents Tab80/5mg Telmiro One Tab80/10mg - 71 - Telmisartan, Rosuvastatin calcium No. 73 Mfg. 74 Mfg. 75 Mfg. 76 Mfg. 77 Mfg. 78 Mfg. 79 Mfg. 80 Mfg. 81 Mfg. 82 Mfg. 83 Mfg. 84 Mfg. 85 Mfg. 86 Mfg. 87 Mfg. 88 Mfg. 89 Mfg. 90 Mfg. 91 Mfg. 92 Mfg. 93 * Mfg./ Import Mfg. 94 Mfg. 95 Mfg. Product Company Date of Approval Code Active ingredient Telmiro One Tab80/20mg Telo Duo Tab80/5mg Telo Duo Tab80/20 mg [219] Telo Duo Tab80/10 mg CMG Pharm. Telo Duo Co., Ltd. Miscellaneous 2019-10-15 Tab40/5mg Cardiovascular Telmisartan, Rosuvastatin calcium agents Telo Duo Tab40/10 mg Telo Duo Tab40/2mg Rosuwell Tab80/20mg Rosuwell Tab40/20mg Rosuwell Tab40/10mg Rosuwell Tab80/10mg [219] Korea Prime Pharm Co., Miscellaneous 2019-10-15 Ltd. Cardiovascular Telmisartan, Rosuvastatin calcium agents Rosuwell Tab80/5mg Rosuwell Tab40/5mg Eso Duo CKD Pharm. Tab40/800mg Co., Ltd. [232] 2019-10-30 Peptic ulcer agents Esomeprazole Magnesium Trihydrate, sodium bicarbonate Dukaro Tab30/5/5mg Dukaro [219] Tab60/5/5mg Dukaro Boryung Co., Tab60/5/10mg Ltd Miscellaneous 2019-11-13 Dukaro Cardiovascular agents Tab60/10/20mg Fimasartan Potassium Trihydrate Granule, Amlodipine besylate, Rosuvastatin calcium Dukaro Tab30/5/10mg Telmidipine Plus Tab40/5/12.5mg Telmidipine Plus Tab80/10/12.5mg Hana Pharm Telmidipine Plus Co. Ltd. [214] 2019-12-05 Antihypertensiv es Tab80/10/25mg Telmisartan, Amlodipine besylate, Hydrochlorothiazide Telmidipine Plus Tab80/5/12.5mg Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 72 - precautions for use) Table 33. Approval of Drugs with Changes in strength of active substances that Require Data Submission in 2019 No. Mfg/ Import Product Company Date of Approval Synthyroid 1 Mfg. [243] Tab0.112mg Bukwang (levothyroxine Pharm sodium Efficacy/Effectiveness (Partial summary) Code Thyroid and 2019-01-10 parathyroid grand Co., Ltd. Hypothyroidism, mucosal edema, Cretin disease, simple goiter hormones hydrate) 1. Myocardial ischemia hypertension, coronary angina) due fixation arteries or 2 Import Tab2.5mg (Amlodipine besylate) Pfizer the system (dysplastic angina) Pharmac eutical and of coronary to the (stable vasospasm vasoconstriction Norvasc of [214] 2019-02-08 2. Antihypertensi patients heart ves Korea For confirmed Ltd. whose disease recently failure by and or a Reduction risk been angiography has no cardiac not less than - coronary has heart output 40% of hospitalization due to angina - Reduction of coronary angiography risk Prevention Pariet Tab5mg 3 Mfg. (rabeprazole sodium) duodenal Kolmar Korea [232] 2019-02-27 Peptic ulcer agents a of gastric and ulcers in patients with history duodenal of ulcers low-dose aspirin stomach by of and administering 100 mg or less per day Arnuity 50 4 Import Elipta GlaxoSm (fluticasone ithKline furoate Korea [222] 2019-03-22 Maintenance treatment of Antitussives, asthma in children over 5 years expectorants of age, adolescents and adults (microsnised)) Yungjin Sertraline 5 Mfg. 1. Depression Yungjin Tab25mg Pharm (Sertraline Co., Ltd. 2. Treatment of obsessive2019-04-24 [117] Psychotropics hydrochloride) Mfg. Bukwang (levothyroxine Pharm sodium Co., Ltd. Thyroid and 2019-05-07 parathyroid grand Hypothyroidism, mucosal edema, Cretin disease, simple goiter hormones [316] Nice Mfg. (hereinafter [243] 0.0375mg hydrate) 7 and pediatrics omitted) Synthyroid Tab 6 compulsive disorder in adults Levocombi S Korea Solution pharmac Multivitamins 2019-05-21 preparation (excluding eutical multivitamin - 73 - Used in the following cases. - Supporting treatment of post-hepatitis aftermath(???hepatitis sequela), deterioration of No. Mfg/ Import Product Company Date of Approval Efficacy/Effectiveness (Partial summary) Code liver function, and toxic infection - Support for the treatment of megaloblastic anemia or pregnancy, complex A and D) delivery, and lactation - Vitamin B12 or folic acid deficiency syndrome - When treating vitamin deficiency, antibiotics, chemotherapy, and anticancer drugs Treatment of primary Fenorics EH 8 Mfg. hyperlipidemia: Korea Tab United (Fenofibric Pharm acid) Inc. [218] 2019-06-28 Hyperlipidemia agents Hypercholesterolemia (Type IIa), combination of hypercholesterolemia and hypertriglyceridemia (Type IIb) and Nice 9 Import Plenvu Powder Korea pharmac [721] X-ray 2019-08-09 contrast media eutical Import 50mg Novartis (Nilotinib Korea Hydrochloride Co., Ltd. 2019-08-20 Antineoplastic agents Mfg. 45mg (Raloxifene examination Philadelphia chromosome positive chronic myeloid chronic phase. (1.1) [399] Yuhan Corp. Miscellaneous 2019-09-24 metabolism Treatment and osteoporosis in prevention of postmenopausal women agents hydrochloride) * washing leukemia (Ph+ CML) in Yuhan 11 intestine during colon (X-ray, endoscopy) with newly diagnosed [421] Monohydrate) Raloxifene Tab Pre-treatment 1. Treatment of adult patients Tasigna Cap 10 hypertriglyceridemia (Type IV) Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 74 - precautions for use) 3) Drugs with new administration route (1 items) The chemical drug approved with a new route of administration was 1 item of imported drug which was developed as psychoneural agent approved as an oral drug into an inhalation formulation (Refer to Table 34). Table 34. Approval of Drugs with New Route of Administration Requiring Data Submission in 2019 No. Mfg/ Import Product Company Date of Approval The Adasuve 1 Import Inhalant 10mg (Loxapine) Kolon Pharma [117] 2019-12-05 New administration route Efficacy/Effectiveness (Partial summary) Code rapid control mild-to-moderate Psycho in adult -tropics schizophrenia patients or of agitation bipolar → Oral with Inhalant disorder * Detailed approval information (efficacy/effectiveness, dosage/administration, and precautions for use) is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. 4) Drugs with New administration/dosage (4 items) The chemical drugs approved as new administration and dosage are 3 manufacturing items which are single-dose joint cavity injection containing BDDE cross-linked sodium hyaluronate gel as active ingredient. They are drugs which changed administration and dosage of the previously approved (notified) 3-time administration sodium hyaluronate intraarticular injections (Refer to Table 35). Table 35. Approval Status of Drugs with New Administration/Dosage that Require Data Submission in 2019 No. Mfg/ Import Product Company Date of Approval Code Efficacy/Effectiveness (Partially summarized) Humia Inj 1 (1,4-butanediol diglycidyl ether Humedix bridged Sodium Hyaluronic Co., Ltd [399] Mfg. Miscellaneous Osteoarthritis of the Acid Gel) 2019-03-08 blood and knee joint body fluid Shinpoong. 2 Mfg. Hyal Oneshot Inj Co, Ltd - 75 - agents No. Mfg/ Import Product Company Date of Approval Code Efficacy/Effectiveness (Partially summarized) (1,4-butanediol diglycidyl ether bridged Sodium Hyaluronic Acid Gel) Hihyalonce Inj 3 (1,4-butanediol diglycidyl ether Huons bridged Sodium Hyaluronic Co., Ltd. Mfg. Acid Gel) * Detailed approval information (efficacy/effectiveness, dosage/administration, and precautions for use) is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. 5) Drugs with new dosage form (same route of administration) (71 items) The chemical drugs approved for the new dosage form (same route of administration) were 71 items (69 manufactured items and 2 imported items). The development types are as follows: 24 items (33.8%) which developed the existing capsules as other oral solid preparations (6 tablet items, 18 syrup items); 24 items (33.8%) which developed the suspension powder into powder; 14 items (19.7%) which developed IR (tablet or capsule) into ER; and 4 items (5.6%) which developed the liquid drug into adsorbents (drugs included in cotton swabs) (Refer to Table 36). Table 36. Approval Status of Drugs with New Dosage Form (Same Route of Administration) that Require Data Submission in 2019 No. Mfg/ Import 1 Mfg. Product Company Date of approval Code Efficacy//Effectiveness (Partial summary) New dosage form Treatment of Peripheral. Capsule Yuhan Pregabalin SR Yuhan Pregabalin SR 2 Mfg. [119] Tab 300mg (pregabalin) Yuhan Corp. Miscellaneous 2019-01-04 Tab 150mg central nervous Neuropathic Pain in → SR Tab. adults system agents (pregabalin) 3 Mfg. Zelief ER Tab150mg [119] (pregabalin) Miscellaneous LG Chem. 2019-01-11 4 5 Mfg. Mfg. Zelief ER Tab300mg (pregabalin) Suprega CR Tab 300mg (pregabalin) central nervous Treatment of Peripheral. Neuropathic Pain in → Capsule SR Tab. adults system agents [119] GL Pharma Co., Ltd. 2019-01-11 Miscellaneous central nervous - 76 - Treatment of Peripheral. Neuropathic adults Pain in → Capsule SR Tab. Mfg/ No. Import 6 Mfg. 7 Mfg. 8 9 10 11 Mfg. Mfg. Mfg. Mfg. Product Date of Company approval Suprega CR Tab 300mg (pregabalin) Lyicaneuro ER Tab 150mg (pregabalin) Daewon [119] Pharmaceu Miscellaneous tical Co., Mfg. central nervous Ltd. system agents GL Pharm. Miscellaneous Kabalin CR Tab Tech 2019-01-11 150mg (pregabalin) central nervous Gabaneuro ER Tab Capsule Neuropathic Pain in → SR Tab. adults Treatment of Peripheral. Neuropathic Pain in → Capsule SR Tab. adults system agents [119] Gabaneuro ER Tab 300mg (pregabalin) Treatment of Peripheral. [119] Hanlim Pharm. 12 2019-01-11 Kabalin CR Tab 300mg (pregabalin) New dosage form system agents 150mg (pregabalin) Lyicaneuro ER Tab Code Efficacy//Effectiveness (Partial summary) Miscellaneous 2019-01-11 Co., Ltd. 150mg(pregabalin) central nervous Treatment of Peripheral. Neuropathic Pain in → Capsule SR Tab. adults system agents Complementary 13 Import Hidrasec Cap Abbott 100mg (racecadotril) Korea 2019-01-21 [237] Intestinal drugs symptomatic treatment of acute diarrhoea in → Powder Capsule adults 14 Mfg. QnQ Povidone Iodine QnQ prep Solution Pharm [261] 2019-01-22 External disinfectants Sterilization and disinfection at the surgical area → Liquid Adsorbent The treatment of Gasmosa CR Tab 15 Mfg. (Mosapride Citrate Hydrate) Korea [239] Biochem Miscellaneous Pharm. 2019-02-20 digestive organ Inc. agents gastrointenstinal symptoms caused by reduced gastrointenstinal → IR Tab. SR Tab. mobility(heartburn, nausea, vomiting) Dissemination when the demand for thioctic acid increases (in case of severe [399] 16 Mfg. I-della Injection (thioctic acid)(Vial) Aju Pharm Co., Ltd. 2019-02-25 Miscellaneous metabolism agents physical work), Leigh syndrome (Subacute necrotizing encephalomyelopathy), → Ample Inj. Vial Inj. addictive (by streptomycin, kanamycin) and noise (occupational) labyrinthine deafness 17 Mfg. Glias Syrup (choline alfoscerate) [119] Korea Biochem Pharm.INC. 2019-03-29 Miscellaneous central nervous system agents - 77 - - Secondary symptoms due to cerebrovascular deficiencies and metamorphic or → Capsule Syrup Mfg/ No. Import Product Date of Company approval Code Efficacy//Effectiveness (Partial summary) New dosage form degenerative cerebral organic mental syndrome (hereinafter omitted) - Secondary symptoms due to 18 Mfg. Newtirine Syrup (choline alfoscerate) Pharm cerebrovascular [119] Samjin 2019-03-29 Co., Ltd deficiencies and Miscellaneous → Capsule metamorphic or central nervous degenerative cerebral system agents Syrup organic mental syndrome (hereinafter omitted) - Secondary symptoms Korea 19 Mfg. Choliatin Syrup Arlico (choline alfoscerate) Pharm [119] 2019-03-29 Co., Ltd. Miscellaneous central nervous system agents due to c e r e b r o v a s c u l a r deficiencies and metamorphic or degenerative cerebral organic syndrome → Capsule Syrup mental (hereinafter omitted) - Secondary symptoms due to [119] 20 Mfg. A-Colin Syrup Pharvis (choline alfoscerate) Korea 2019-03-29 Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) - Secondary symptoms due to [119] 21 Mfg. Rimenta Syrup BINEX (choline alfoscerate) Co., Ltd. 2019-03-29 Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) - Secondary symptoms due to 22 Mfg. Alz-Choline Syrup (choline alfoscerate) [119] Shinpoong Pharm Co, 2019-03-29 Ltd Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral organic mental syndrome (hereinafter omitted) - 78 - → Capsule Syrup Mfg/ No. Import Product Date of Company approval Code Efficacy//Effectiveness (Partial summary) New dosage form - Secondary symptoms due to 23 Mfg. Alcefin Syrup (choline alfoscerate) [119] Hyundai Pharm. 2019-03-29 Co., Ltd Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) - Secondary symptoms due to Kyongbo 24 Mfg. Neurocholine Syrup Pharmaceu (choline alfoscerate) tical Co, [119] 2019-03-29 Ltd Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) - Secondary symptoms due to Guju 25 Mfg. Cereforin Syrup Pharmaceu (choline alfoscerate) tical Co., [119] 2019-03-29 Ltd. Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) - Secondary symptoms due to [119] 26 Mfg. Memotirin Syrup Aju Pharm (choline alfoscerate) Co., Ltd. 2019-03-29 Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) - Secondary symptoms due to 27 Mfg. Cholitirin Syrup (choline alfoscerate) [119] Nice Korea pharmaceu 2019-03-29 tical Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) 28 Mfg. Gliatamin Syrup (choline alfoscerate) [119] Daewoong Bio Co., Ltd 2019-03-29 Miscellaneous - Secondary symptoms due to central nervous cerebrovascular system agents deficiencies and - 79 - → Capsule Syrup Mfg/ No. Import Product Date of Company approval Code Efficacy//Effectiveness (Partial summary) New dosage form metamorphic or degenerative cerebral organic mental syndrome (hereinafter omitted) - Secondary symptoms due to Korea 29 Mfg. Gria Syrup Prime (choline alfoscerate) Pharm [119] 2019-03-29 Co., Ltd. Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) - Secondary symptoms due to Samik 30 Mfg. Memocode Syrup Pharmaceu (choline alfoscerate) tical Co., [119] 2019-03-29 Ltd. Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) - Secondary symptoms due to 31 Mfg. Cholinal Syrup (choline alfoscerate) [119] Yungjin Pharm 2019-03-29 Co., Ltd. Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) - Secondary symptoms due to 32 Mfg. Cholirin Syrup (choline alfoscerate) [119] WITHUS Pharm. 2019-03-29 Co., Ltd. Miscellaneous central nervous system agents cerebrovascular deficiencies and metamorphic or degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) - Secondary 33 Mfg. Korea [119] Glicetil Syrup United Miscellaneous (choline alfoscerate) Pharm Inc. 2019-03-29 central nervous system agents symptoms due to cerebrovascular deficiencies and metamorphic or degenerative cerebral organic mental - 80 - → Capsule Syrup Mfg/ No. Import Date of Company approval Product Code Efficacy//Effectiveness (Partial summary) New dosage form syndrome (hereinafter omitted) Ramnos Powder (Freeze-Dried 34 Mfg. Lactobacillus casei var. Rhamnosus Improvement of Hanwha Pharma. 2019-03-29 Co., Ltd. [237] Intestinal drugs Culture) intestinal and diarrhea symptoms by → Granule Powder normalization of intestinal microbial flora As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial 35 Import Belviq XR Tab IlDong (Lorcaserin Pharmaceu Hydrochloride Hydrate) tical Co., [123] 2019-04-15 Ltd Autonomic nervous system agents body mass index (BMI) • of: 30 kg/m2 or greater (obese) in the presence of at least → IR Tab. SR Tab one weight-related comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes) or • 27 kg/m2 or greater (overweight) 36 Mfg. Eso-DT ODT 20mg 1. Gastroesophageal (esomeprazole Reflux Disease magnesium dihydrate) (GERD) - Treatment of erosive reflux esophagitis Taejoon Eso-DT ODT 40mg 37 Mfg. (esomeprazole Pharm. [232] 2019-04-16 - Long-term maintenance therapy to prevent Peptic ulcer Co., Ltd. recurrence of agents magnesium dihydrate) esophagitis → Tablet ODT patients - Symptomatic therapy for gastroesophageal reflux disease without esophagitis (hereinafter omitted) As an skin Mfg. cleaning of wounds that are not Hexiwipes4% 38 antibacterial cleanser, (Chlorhexidine Huons Gluconate Co., Ltd. [261] 2019-04-19 External disinfectants Solution) deeper skin layer, of than normal skin surface and hand disinfection → Liquid Adsorbent individuals, and skin disinfection of surgery areas before surgery 39 Mfg. Hexiwipes2% Huons Co., Ltd. 2019-04-19 - 81 - [261] Sanitation and of hygiene health worker's → Liquid Mfg/ No. Import Product Date of Company approval Code (Chlorhexidine External Gluconate Solution) disinfectants Efficacy//Effectiveness (Partial summary) hands New dosage form Adsorbent Secondary symptoms due to cerebrovascular Daewon 40 Mfg. Alfocholine Syrup Pharmaceu (choline alfoscerate) tical Co., 2019-04-22 Ltd. [119] deficiencies and Miscellaneous metamorphic or central nervous system agents degenerative cerebral → Capsule Syrup organic mental syndrome (hereinafter omitted) 41 42 43 44 45 Mfg. Mfg. Mfg. Mfg. Mfg. Hyundai Pregabalin Tab 50mg Hyundai Pregabalin Tab 25mg [119] Hyundai Pharm. 2019-07-29 Co., Ltd Miscellaneous central nervous system agents Gabelin Tab 50mg (pregabalin) Gabelin Tab 25mg [119] Samil. Co., Ltd. 2019-07-29 (pregabalin) Salientok Swap Sol (Salicylic Acid) Miscellaneous central nervous system agents Green Pharm Mfg. 2019-10-24 Co., Ltd. External peripheral and central neuropathic pain in adults → Capsule Tablet (hereinafter omitted) → Liquid Acne treatment Adsorbent and adults, including newborns over 2 (Oseltamivir CJ Co., Ltd [629] weeks (not applicable Powder for Miscellaneous to fetus less than 36 Suspension Chemo therapeutics Flucle Powder 30mg Mfg. (hereinafter omitted) 1. Treatment of infections in children Healthcare 2019-10-28 48 Tablet influenza B virus (Oseltamivir phosphate) pain in adults → Capsule 1. Influenza A and Flucle Powder 45mg Mfg. central neuropathic disinfectants phosphate) 47 peripheral and [261] Flucle Powder 75mg 46 1. Treatment of weeks after conception) (Administration should → Powder begin within 48 (Oseltamivir hours after the initial phosphate) symptoms of influenza infection.) (hereinafter omitted) 1. Influenza A and Easy Flu Powder 49 Mfg. influenza B virus 30mg (Oseltamivir infections in phosphate) children and adults, Easy Flu Powder 50 Mfg. [629] including newborns Powder for Miscellaneous over 2 weeks (not Suspension Chemo applicable to fetus 45mg (Oseltamivir phosphate) CTC Bio Co., Ltd. 2019-10-28 therapeutics Easy Flu Powder 51 Mfg. less than 36 weeks after 75mg (Oseltamivir conception) phosphate) (Administration should begin within - 82 - → Powder Mfg/ No. Import Product Date of Company approval Code Efficacy//Effectiveness (Partial summary) New dosage form 48 hours after the initial symptoms of influenza infection.) (hereinafter omitted) 1. Influenza A and Tami Inful Powder 52 Mfg. influenza B virus 75mg (Oseltamivir infections in children phosphate) and adults, including Tami Inful Powder 53 Mfg. 45mg (Oseltamivir phosphate) newborns over 2 Hutex Korea Pharmaceu 2019-10-28 tical Co., Tami Inful Powder 54 Mfg. [629] weeks (not applicable Powder for Miscellaneous to fetus less than 36 Suspension Chemo therapeutics Ltd weeks after conception) (Administration should → Powder begin within 48 hours 30mg (Oseltamivir after the initial phosphate) symptoms of influenza infection.) (hereinafter omitted) Anyflu Powder 75mg 55 56 Mfg. Mfg. 1. Influenza A and (Oseltamivir influenza B virus phosphate) infections in children Anyflu Powder 45mg and adults, including (Oseltamivir newborns over 2 phosphate) Ahngook [629] Pharmaceu Miscellaneous tical Co., Anyflu Powder 30mg 57 Mfg. 2019-10-28 Ltd Chemo therapeutics weeks (not applicable to fetus less than 36 weeks after conception) Powder for → Suspension Powder (Administration should (Oseltamivir begin within 48 hours phosphate) after the initial symptoms of influenza infection.) (hereinafter omitted) 1. Influenza A and Tamiselva Powder 58 Mfg. influenza B virus 75mg (Oseltamivir infections in children phosphate) and adults, including Tamiselva Powder 59 Mfg. newborns over 2 45mg (Oseltamivir phosphate) Korea [629] United Miscellaneous Pharm 2019-10-28 Inc. 60 Mfg. Chemo therapeutics weeks (not applicable to fetus less than 36 weeks after conception) Tamiselva Powder (Administration should 30mg (Oseltamivir begin within 48 hours Powder for → Suspension Powder after the initial phosphate) symptoms of influenza infection.) (hereinafter omitted) 61 Mfg. Boryung Tami Boryung 2019-10-28 - 83 - [629] 1. Influenza A and Powder for Mfg/ No. Import Product Date of Company approval Code Powder 75mg 62 Mfg. infections in children phosphate) and adults, including Boryung Tami newborns over 2 Powder 45mg weeks (not (Oseltamivir applicable to fetus Miscellaneous Co., Ltd Mfg. New dosage form influenza B virus (Oseltamivir phosphate) 63 Efficacy//Effectiveness (Partial summary) less than 36 Chemo weeks after therapeutics conception) Boryung Tami (Administration Powder 30mg should begin within (Oseltamivir 48 hours after the phosphate) initial symptoms of → Suspension Powder influenza infection.) (hereinafter omitted) A-flu Powder 30mg 64 65 Mfg. Mfg. 1. Influenza A and (Oseltamivir influenza B virus phosphate) infections in A-flu Powder 45mg children and adults, (Oseltamivir including newborns phosphate) over 2 weeks (not [629] Boryung Biopharma 2019-10-28 Co., Ltd. A-flu Powder 75mg 66 Mfg. Miscellaneous applicable to fetus Powder for less than 36 Suspension Chemo weeks after therapeutics conception) → Powder (Administration (Oseltamivir should begin within phosphate) 48 hours after the initial symptoms of influenza infection.) (hereinafter omitted) [114] 67 Mfg. Acelex Tab 2mg (Polmacoxib) Antipyretics, Crystal Genomics 2019-10-30 Co., Ltd. analgesics, and anti-inflammato ry agents Hanmi Tams OD Tab 68 Mfg. 0.4mg (Tamsulosin hydrochloride) Mfg. Pharm. Miscellaneous 2019-11-29 Co., Ltd. urogenital and anal organ Komiflu Powder 45mg 70 Mfg. (Oseltamivir phosphate) 71 Mfg. (degenerative → Capsule Tablet arthritis) Urinary disorders caused by benign prostatic hypertrophy → Capsule Tablet agents 1. Influenza A and (Oseltamivir phosphate) osteoarthritis [259] Hanmi Komiflu Powder 30mg 69 Alleviation of symptoms or signs of [629] Kolon Pharma 2019-12-24 Miscellaneous Chemo therapeutics Komiflu Powder 75mg influenza B virus infections in children and adults, including newborns over 2 weeks (not applicable to fetus - 84 - Powder for → Suspension Powder Mfg/ No. Import Product Date of Company approval Code Efficacy//Effectiveness (Partial summary) New dosage form less than 36 weeks after conception) (Administration (Oseltamivir should begin within phosphate) 48 hours after the initial symptoms of influenza infection.) (hereinafter omitted) * Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 85 - precautions for use) 3 Information on Approval of Biopharmaceuticals - 86 - 3. Information on Approval of Biopharmaceuticals According to the analysis of biopharmaceuticals approved in 2019 based on regulatory review pathways, there were 7 new drugs, 29 drugs requiring data submission (24 other drugs requiring data submission) and 1 orphan drugs (excluding 2 orphan new drugs) (Refer to Table 37), More specifically, 6 biologics, 29 recombinant protein products, and 1 Cell therapy Products, and 1 other products(human placenta-derived drugs) were approved (Refer to Table 38). 37. Approvals Status of Biopharmaceuticals by Review Type in 2019 <Including Drugs for Export Only and Drug Substances> No. of Approved Products Total Manufactured Imported No. Review Type 1 New drugs 7 0 7 1-1 New drugs 5 0 5 1-2 Orphan new drugs 2 Orphan drugs (except for Orphan new drugs) 2 3 3-1 0 2 Drugs requiring data submission 1 29 0 17 1 12 Incrementally modified drugs 0 0 0 3-2 Biosimilar products 4 2 2 3-3 Other drugs requiring data submission 24 14 10 3-4 Cell therapy Products 1 Total 37 1 17 0 20 * Including 1 human placenta-derived drugs out of 24 other drugs requiring data submission <Excluding Drugs for Export Only and Drug Substances> No. of Approved Products Total Manufactured Imported No. Review Type 1 New drugs 7 0 7 1-1 New drugs 5 0 5 1-2 Orphan new drugs 2 Orphan drugs (except for Orphan new drugs) 3 Drugs requiring data submission 0 7 2 2 1 19 0 1 12 3-1 Incrementally modified drugs 0 0 0 3-2 Biosimilar products 4 2 2 3-3 Other drugs requiring data submission 14 4 10 3-4 Cell therapy Products 1 Total 27 1 7 * Including 1 human placenta-derived drugs out of 14 other drugs requiring data submission - 88 - 0 20 Table 38. Approval Status of Biopharmaceuticals in 2019 <Including Drugs for Export Only and Drug Substances> Types Total Total Biologics No. of Approved Items Manufactured Imported 37 17 20 6 6 0 Remarks Drugs requiring data submission (6, including 3 Drugs forexport only) New drugs (7), Orphan (1, Recombinant Protein products excluding orphan new drug), Drugs 29 9 20 requiring data submission (21, including Drugs for export only(6) and Drug Substances(1)) Cell therapy products Gene therapy products Others 1 1 0 - 0 0 0 - 1 1 0 Human placenta-derived drugs(1) The MFDS has been operating the “Biopharmaceutical Priming Project” since 2014 in order to support the rapid commercialization of domestically developed biopharmaceuticals and their entry into global market. The “Biopharmaceutical Priming Project” was introduced to facilitate the development and product promotion of safe and effective domestic biopharmaceutical products of high quality. This project ensures differentiated consultation service considering customer characteristics and development stages. In addition, since 2017, MFDS has operated “Technical support for advanced convergence products” to support the development and commercialization of cutting-edge convergence medical products to serves as a consultation window for item classification of advanced convergence medical products, item classification of the products and item classification and planning development of the product in the process of development. - 89 - Furthermore, in case of inquiries about the overall approval and review process when developing biopharmaceuticals, consultations with the responsible department through the consultation service (MFDS website (www.mfds.go.kr) > “Reservation for One-Stop consultation”) is available. - 90 - 3.1. Information on Approval of Biopharmaceuticals In 2019, 6 items were approved (6 manufactured items / 4 vaccines, and 2 botulinum toxin). 11 items in 2018 (8 manufactured items, 3 imported items/ 9 vaccines, 1 botulinum toxin and 1 blood product), 12 items in 2017 (11 manufactured items, 1 imported item / 8 vaccines, 2 botulinum toxins, 2 blood products), and 20 items in 2016 (15 manufactured items, 5 imported items / 16 vaccines, 4 botulinum toxins) were approved, which shows the item approval of biopharmaceuticals is decreasing since 2016. Vaccines approved in 2019 include 3 influenza vaccines and 1 combined vaccine (Refer to Table 39). In case of influenza vaccines, vaccine production with strains suggested by the World Health Organization (WHO) every year is recommended and they are classified as fertilized eggs vaccines and cell culture vaccines by manufacturing method. Influenza vaccine approved in 2019 includes 1 item for domestic use (Boryung Pharmaceutical Co., Ltd., Bial Flutech III Tetra Vaccine Pre-filled Syringe), 2 items for export only (SK Biosciences Co., Ltd., SKYCellflu Quadrivalent inj. (for export), SKYCellflu Quadrivalent Multi inj. (for export), which are all tetravalent influenza vaccines. ‘BR Flutec III Tetra Vaccine Prefilled Syringe’ is a product which Boryuong Pharmaceutical Co., Ltd. obtained its approval as a manufactured item and is used for prevention of influenza diseases caused by influenza A viruses and influenza B viruses contained in this vaccine in children aged 6 months or older, adolescents and adults. - 91 - SK bioscience Co., Ltd.' ‘SKYCellflu Quadrivalent inj.’ and ‘SKYCellflu Quadrivalent Multi inj.’ vaccines have been approved as product for export only. The combined vaccine licensed in 2019 is Boryeong Biopharma's ‘Boryuong Biopharma Co., LTD’, and is a product approved for prevention of diphtheria, tetanus, pertussis and polio in children aged 2 months or older. In case of botulinum toxin products, 4 items newly approved in 2016, 2 items in 2017, 1 item in 2018, and 2 items in 2019 (one for domestic use and the other for export only) only) respectively (Refer to Table 39). ‘Wondertox Inj 100unit’ is a product which Chong Kun Dang Pharmaceutical Corp. succeeded its status through transfer of the approved item from Huons. This product has been approved for temporary improvement in the appearance of moderate to severe glabellar lines assocoated with corrugator and/or procerus muscle activity in adult patients aged between 19 and 65. PharmaResearch BIO Co., Ltd.'s ‘Re N ToxTM Injection 100 Units (for export)' was approved for temporary improvement in the appearance of moderate to severe glabellar lines assocoated with corrugator and/or procerus muscle activity in adult patients aged between 19 and 65. In the case of blood products, there were no newly approved items in 2019 compared to 2 items in 2017 and 1 item in 2018 (Refer to Table 39). MFDS has operated 「Global Vaccine Commercialization Support Group」 from 2010 as part of the customized support to enhance Korea’s capacity for vaccine self-sufficiency. MFDS will continue to provide technical support to increase the nation’s self-sufficiency of essential preventive vaccines and core vaccines. - 92 - Table 39. List of Biopharmaceuticals Approved in 2019 No. Mfg/ Import Name of ingredient Product Company Date of approval Efficacy/Effectiveness Remarks temporary improvement in Re N Tox TM Injection 100 Units 1 Mfg. (Clostridium Botulinum toxin type A) the appearance of moderate Clostridium Botulinum toxin type A Pharma Research BIO Co., to severe 2019-02-15 assocoated and/or Ltd (for export) activity glabellar with corrugator procerus in adult lines muscle Requiring data submission patients aged between 19 and 65. SKYCellflu Quadrivalent inj. (surface antigen, 2 Mfg. inactivated, prepared in cell cultures) (for export) Purified Prevention of influenza inactivated diseases caused by influenza virus influenza A viruses and surface antigen A and Purified inactivated SK influenza B viruses Bioscience 2019-02-18 contained in this vaccine Co., Ltd. in children over 3 years influenza virus old, adolescents and surface antigen B adults Purified Prevention of influenza Requiring data submission SKYCellflu Quadrivalent Multi inj. (surface antigen, 3 Mfg. inactivated, prepared in cell cultures) inactivated diseases caused by influenza virus influenza A viruses and surface antigen A and Purified inactivated SK influenza B viruses Bioscience 2019-02-22 contained in this vaccine Co., Ltd. in children over 3 years influenza virus old, adolescents and surface antigen B adults Purified Prevention of influenza Requiring data submission (for export) BR Flutec III Tetra Vaccine Prefilled 4 Mfg. Syringe (Influenza split vaccine) inactivated diseases caused by influenza virus influenza A viruses and surface antigen A Boryung and Purified Co., Ltd influenza B viruses 2019-07-02 contained in this vaccine inactivated in children over 6 months influenza virus old, adolescents and surface antigen B Requiring data submission adults temporary improvement in 5 Mfg. the appearance of moderate Chong Wondertox Inj. 100unit Clostridium (Clostridium Botulinum toxin Botulinum toxin type A type A) Kun to Dang severe 2019-08-12 assocoated Pharmaceu tical Corp.. and/or activity glabellar with procerus in adult lines corrugator muscle Requiring data submission patients aged between 19 and 65. Boryung DTaP-IPV Vaccine Prefilled Syringe (Adsorbed 6 Mfg. diphtheria, tetanus, acellular pertussis and refined inactivated polio combination vaccine) Purified diphtheria toxoid, purified tetanus toxoid, purified pertussis protective antigen, inactivated polio Boryung Biopharma 2019-08-26 Co., Ltd. virus type 1, inactivated polio virus type 2, - 93 - Prevention of diphtheria, tetanus, pertussis and polio in children over 2 months after born Requiring data submission No. Mfg/ Import Product Name of ingredient Company Date of approval Efficacy/Effectiveness Remarks inactivated polio virus type 3 * Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 94 - precautions for use) 3.2. Information on Approval of Recombinant Protein Products 29 recombinant protein products were approved in 2019 (9 manufactured items and 20 imported items) including 7 new drugs (including orphan new drugs), 1 orphan drug (excluding 2 orphan new drug) and 21 drugs requiring data submission (including 6 items for export and 1 items of drug substance) (Refer to Table 40). In 2019, items designated as new drugs (including orphan new drugs) were a total of 6 ingredients and 7 items. New drugs approved in 2018 were 4 ingredients and 4 items, and 7 items were approved in 2019 which shows an increase in the number of new drug approval. Like 2018, 1 orphan drugs (except orphan new drugs) was approved in 2019. ‘Besponsa Inj (Inotuzumab ozogamicin)’ (Pfizer Korea. Jan. 3, 2019) is the antibody-drug conjugates (ADCs), a covalent bond of an IgG4 monoclonal antibody, which specifically recognizes human CD22, and the small molecule N-acetyl-gamma-calicheamicin through a linker and was approved as an orphan drug used in treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ‘Hemlibra S.C Inj (Emicizumab, Gene Recombination)’ (JW Pharmaceutical Corp., Jan. 17, 2019) as a bispecific monoclonal antibody for coagulation factor 9 and 10, was approved as an orphan new drug used in routine prophylaxis or to reduce bleeding frequency in patients with hemophilia A (congenital blood coagulation factor VIII deficiency) with inhibitors for factor VIII. ‘Evenity Inj. Prefilled Syringe (Romosozumab, Gene Recombination)’ (Amgen Korea Ltd, May 31, 2019) is a monoclonal antibody that has a double effects on bones by binding sclerostin, a glycoprotein, which plays a major role in inhibiting osteoblast-mediated bone formation, with at high affinity by promoting bone - 95 - formation and causing changes in the expression of osteoclast mediators, thereby decreasing bone resorption. This product was approved as a new drug used in treatment of p1ostmenopausal women and men osteoporosis patients with high risk of fracture. ‘Facenra Pre-filled Syringe Inj. 30mg (Benralizumab)’ (Astra Zeneca Korea, Jun. 5, 2019) is a monoclonal antibody that induces apoptosis of eosinophils in the presence of NK cells by binding with high affinity to IL-5Rα on the surface of human eosinophils; and was approved as a new drug for use in the additional maintenance therapy for severe eosinophilic asthma treatment that is not adequately controlled in existing treatment of adults. ‘Emgality 120mg/mL Prefilled Sysringe Inj(Galcanezumab, Genetic Recombination), Emgality 120mg/mL Prefilled Pen Inj(Galcanezumab, Genetic Recombination)’(Lilly Korea Ltd. Sep. 05, 2019) is a humanized Immunoglobulin (subclass) G4 (IgG4) monoclonal antibody designed to bind calcitonin gene-related peptide (CGRP) inhibiting its activity as a sensory neuropeptide in the trigeminal system –a fundamental mechanism was approved as a new durgs used in the prophylaxis of migraine in adults. ‘Skyrizi Prefilled Syringe Inj (Risankizumab, Gene Recombination)’ (AbbVie Korea, Dec. 3, 2019) is a monoclonal antibody that induces apoptosis of eosinophils in the presence of NK cells by binding with high affinity to IL-23 on the surface of human eosinophils and was approved as a new drug for the treatment of moderate to severe adult plaque psoriasis requiring phototherapy or systemic therapy (including biological therapy) ‘Bavencio Inj (Avelumab)’ (Merck Limited Korea, Mar. 22, 2019) is an Immuno-oncology drug that blocks the interaction of PD-L1 and PD-1 receptors through binding to programmed death ligand 1(PD-L1) and was approved as an - 96 - orphan drug used for treatment of metastatic Merkel cell cancer in adults. For biosimilar products, 3 type of ingredients and 4 items were approved. Since the approval of monoclonal antibody biosimilar drug item in 2012 for the first time in the world, a total of 15 types and 25 items were approved until 2019. Out of them, the domestically developed biosimilar products are a total of 11 types and 19 items (Refer to Table 41). ‘Etoloce 50mg Prefilled pen Inj (Etanercept)’ (Samsung Bioepis Aug 19, 2019.) is a domestically developed biosimilar product and was developed with domestic technologies and is a product that developed compared against the reference product, Enbrel 50 mg Pre-filled (Etanercept) of Pfizer Korea in addition to Etoloce 50mg Pre-filled syringe (etanercept) approved on Sep 7, 2015. ‘Terosa cartridge Inj (Teriparatide)’ (Daewon Pharmaceuticals, Oct. 29, 2019) is a biosimilar product developed compared against the reference product, Forsteo Inj. (Teriparatide) of Lilly Korea. ‘Panpotin Prefilled Syringe Inj. 2000IU (Epoetin alfa)', Panpotin Prefilled Syringe Inj. 4000IU (Epoetin alfa)' (PanGen Biotech Inc., Nov 28, 2019) are biosimliar products domestically developed with domestic technologies and is a product that developed compared against the reference product, Eprex Injection (recombinant human erythropoietin) of Janssen Korea. In 2019, the number of general item approval cases for gene recombinant drugs including new drugs tended to increase slightly compared to 2018. - 97 - Table 40. List of Approved Recombinant Protein Products in 2019 No. Mfg/ Import Product Name of ingredient Company Inotuzumab Pfizer ozogamicin Korea Ltd. Date of approval Efficacy/Effectiveness (partially summarized) Remarks Treatment of adults with 1 Import Besponsa Inj 2019-01-03 relapsed or refractory B-cell Orphan precursor acute lymphoblastic new drug leukemia (ALL) Routine prophylaxis to prevent or reduce the JW 2 Import Hemlibra S.C Inj Emicizumab Pharma ceutical frequency of bleeding 2019-01-17 episodes in patients with hemophilia A (congenital Corp. Orphan new drug factor VIII deficiency) with factor VIII inhibitors 1) Treatment of Evenity Inj. 3 Import Pre-filled osteoporosis in postmenopausal Amgen Romosozumab Syringe Korea 2019-05-31 Limited women at high risk of fracture 2) Osteoporosis in men at high New drug risk of fracture to increase bone mass An add-on maintenance Facenra 4 Import Prefilled Syringe Astra Benralizumab Inj. 30mg Zeneca treatment in adult patients with 2019-06-05 Korea severe eosinophilic asthma New drug inadequately controlled despite current treatment Emgality 5 Import 120mg/mL New drug Prefilled Sysringe Inj galcanezumab Emgality 6 Import Lilly Korea Ltd. 2019-09-05 Prophylaxis of migraine in adults 120mg/mL New drug Prefilled Pen Inj Treatment of moderate to 7 Import Skyrizi Pre-filled Syringe Inj Risankizumab AbbVie Korea Ltd. severe plaque psoriasis in 2019-12-03 adults who require phototherapy New drug or systemic therapy (including biological therapy) 8 Import Bavencio Inj Avelumab Merck Ltd. Korea Monotherapy for the treatment 2019-03-22 of adult patients with metastatic Merkel cell caarinoma(MCC) Orphan drug Adults 1) Rheumatoid arthritis 2) Psoriatic arthritis Etoloce 50mg 9 Import Pre-filled pen Etanercept Inj Samsung Bioepis 2019-08-19 3) Axial spondyloarthritis(Ankylosing Biosimilar spondylitis, Non-radiographic axial spondyloarthritis) 4) Plaque psoriasis 1) Treatment of osteoporosis in Daewon 10 Import Terrosa Cartridge Inj Teriparatide Pharma ceutical postmenpoausal women and in 2019-10-29 Co., Ltd. - 98 - men at increased risk of fracture 2) Treatment of osteoporosis Biosimilar No. Mfg/ Import Product Name of ingredient Company Date of approval Efficacy/Effectiveness (partially summarized) Remarks associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture 11 Mfg. Panpotin The following anemia in Prefilled Syringe patients with chronic kidney Inj. 2000IU Panpotin 12 13 Mfg. Import Import Biotech Inc. 2019-11-28 1) Symptomatic anemia 2) Anemia requiring blood Inj. 4000IU transfusion (Adult) Humira Pen Inj. Rheumatoid Crohn's 80mg/0.8mL Adalimumab Pre-filled AbbVie Korea Ltd. Biosimilar failure Prefilled Syringe Humira 14 Epoetin alfa PanGen disease Psoriasis, 2019-02-14 Intestinal arthritis, in adult, Ulcerative colitis, Behcet`s disease, Hidradenitis suppurativa, Uveitis Syringe Inj. (Pediatric) 80mg/0.8mL Disease Pediatric Crohn’s Biosimilar Requiring data submission Requiring data submission Melanoma, non-small cell lung 15 Import Opdivo Inj. 240mg cancer, renal cell carcinoma, ONO Nivolumab PHARMA 2019-04-11 KOREA classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, Requiring data submission gastric adenocarcinoma (Adult) Rheumatoid Psoriatic Humira 16 Import Pre-filled Syringe Inj. Adalimumab AbbVie Korea Ltd. arthritis, arthritis, Axial spondyloarthritis, Psoriasis, Crohn's Psoriasis, disease, Ulcerative 2019-04-25 Behcet`s colitis, disease, Intestinal Hidradenitis (Pediatric) Disease, Disease, data submission suppurativa, Uveitis 20mg/0.2mL Requiring Pediatric Juvenile Crohn’s idiopathic Pediatric Plaque Psoriasis, Uveitis Pergoveris Pen 17 Import Requiring Inj. 300/150I 18 Import data Stimulation of follicular 300/150IU development in women with Pergoveris Pen Follitropin alfa, Merck Ltd. Inj 900/450IU Iutropin alfa Korea 2019-04-29 severe luteinizing hormone(LH) with endogenous LH level < 1.2 IU/L and follicle stimulating 19 Import Pergoveris Pen hormone Import Kwikpen Inj 21 22 Import Import FlexTouch Inj data submission Requiring submission Insulin lispro 100unit/mL Xultophy Requiring data Inj 450/225IU Humalog HD 20 submission insulin degludec, liraglutide Lilly Korea Ltd. 2019-08-12 Novo Nordisk Pharma Follitropin Ferring Prefilled Pen delta Pharma insulin therapy Co-administration 2019-08-23 ceutical Rekovelle Diabetes mellitus requiring with - 99 - data submission oral hypoglycemic agents to improve glycaemic control in adults with type 2 diabetes 2019-12-27 Requiring Requiring data submission Controlled ovarian stimulation Requiring for the development of multiple data No. Mfg/ Import Name of ingredient Product Company Date of approval Efficacy/Effectiveness (partially summarized) Remarks follicles in women undergoing assisted reproductive ceuticals technologies (ART) such as an Korea Co in vitro fertilisation (IVF) or Ltd submission intracytoplasmic sperm injection (ICSI) cycle Dong-A Recombinant filgrastim 23 Mfg. concentration solution Ⅱ Recombinant Dong-A ST filgrastim Co., Ltd. 2019-06-25 For Pharmaceutical and Drug manufacturing Substance (Drug Substance) Indicated for treatment of female infertility in the following clinical situations: 1. Controlled ovarian Gonadopin NF 24 Mfg. Injection Solution Prefilled Syringe Human follicle stimulating hormone hyperstimulation to Dong-A ST Co., Ltd. 2019-07-08 induce the development of for export multiple follicles in medically assisted reproducion program 2. Anovulation in women who have not been responsive to treatment with Clomiphene citrate Leucostim 25 Mfg. μg Injection 300 for export (for export) 1. Neutropenia in patients Leucostim 26 Mfg. receiving chemotherapy for μg Injection 150 for export solid cancer (for export) 2. Neutropenia in patients Leucostim 27 Mfg. μg Injection 75 (for export) Leucostim Injection 28 29 Mfg. Mfg. receiving chemotherapy for for export blood tumor (Acute Myeloid Recombinant Dong-A ST filgrastim Co., Ltd. 2019-07-11 Leukemia) 3. Peripheral blood stem cell Prefilled mobilization Syringe 4. Promotion of increase in for export (for export) number of Leucostim neutrophils in Injection hematopoietic stem cell transplantation Prefilled for export μ Syringe480 g (for export) * Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 100 - precautions for use) ∼ Table 41. List of Approved Biosimilars (2012 2019) Reference Product (API) Efficacy/effectiveness Date of (Partially summarized) approval No. Product name Company 1 Remsima Injection100mg Celltrion 2 Herzuma Injection150mg Celltrion 3 Herzuma Injection440mg Celltrion Scitropin A cartridge Scigen Korea Genotropin Injection 5mg Ltd. (somatropin) Scitropin A cartridge Scigen Korea Genotropin Injection 10mg Ltd (somatropin) Davictrel Injection Hanwha Enbrel Rheumatoid arthritis, 25 mg Chemical (Etanercept) Psoriasis Samsung Enbrel Rheumatoid arthritis, Bioepis (Etanercept) Psoriasis Basaglar Cartridge Lilly Korea Lantus 100Unit/mL Ltd. (Insulin glargine) Basaglar Kwikpen Lilly Korea Lantus 100Unit/mL Ltd. (Insulin glargine) Samsung Remicade Rheumatoid arthritis, Bioepis (Infliximab) Ulcerative colitis, etc. Mabthera Rheumatoid arthritis, (Rituximab) Lymphoma, etc. Samsung Humira Rheumatoid arthritis, Bioepis (adalimumab) Psoriatic arthritis etc. Samsung Herceptin Breast cancer, Gastric Bioepis (Trastuzumab) cancer 4 5 6 → Remicade Rheumatoid arthritis, (Infliximap) Ulcerative colitis, etc. 2012-07-20 Mfg 2014-01-15 Mfg 2014-01-15 Mfg Poor growth of children 2014-01-.28 Import Poor growth of children 2014-01-.28 Import Herceptin Breast cancer, Gastric (Trastuzumab) cancer Herceptin Breast cancer, Gastric (Trastuzumab) cancer 2014-11-11 (Withdrawal 7 (name change) Etoloce 50mg Prefilled Import 2015-09-07 9 → Renflexis Injection 10 100mg (name change) Remaloce Injection 100mg 11 Truxima Injection → Celltrion 2015-11-25 Diabetes (Withdrawal Injection 40mg (name change) Adalloce Prefilled Diabetes 2015-11-25 Import 2015-12-04 (Domestically Import developed) 2015-07-16 (export only) Samfenet Injection 150mg - 101 - Mfg 2016-11-16 Import 2017-09-20 (Domestically developed) Syringe Injection 100mg 13 Import 2015-09-30) Hadlima Prefilled Syringe 12 (Domestically developed) Syringe 8 Mfg 2019-09-25) Brenzys 50mg Prefilled Syringe Mfg/ Import Import 2017-11-08 (Domestically developed) No. Product name Company 14 Glarzia Prefilled Pen Green Cross 15 Eucept Prefilled Syringe Inj. 16 Eucept Auto Injector Inj. 17 Nesbell PFS Inj. 20 18 19 20 21 22 Nesbell PFS Inj.30 Nesbell PFS Inj.40 Nesbell PFS Inj.60 Nesbell PFS Inj.120 Etoloce 50mg Prefilled pen Inj LG Chem. LG Chem. Chong Kun Dang Pharm. Chong Kun Dang Pharm. Chong Kun Dang Pharm. Chong Kun Dang Pharm. Chong Kun Dang Pharm. Samsung Bioepis Co., Ltd. Daewon 23 Terosa cartridge Inj Pharmaceutical Co., Ltd. Reference Product (API) Efficacy/effectiveness Date of (Partially summarized) approval Lantus Diabetes (Insulin glargine) Enbrel Rheumatoid arthritis, (Etanercept) psoriasis, etc. Enbrel Rheumatoid arthritis, (Etanercept) psoriasis, etc. Nesp (Darbepoetin alpha) Anemia in patients with chronic renal failure, etc. Nesp (Darbepoetin alpha) Anemia in patients with chronic renal failure, etc Nesp (Darbepoetin alpha) Anemia in patients with chronic renal failure, etc Nesp (Darbepoetin alpha) Anemia in patients with chronic renal failure, etc Nesp (Darbepoetin alpha) Anemia in patients with chronic renal failure, etc Enbrel Rheumatoid arthritis, (Etanercept) psoriasis, etc. Forsteo Osteoporosis (Teriparatide) Mfg/ Import 2018-03-07 Import 2018-03-16 Mfg 2018-03-16 Mfg 2018-11-29 Mfg 2018-11-29 Mfg 2018-11-29 Mfg 2018-11-29 Mfg 2018-11-29 Mfg 2019-08-19 (Domestically Import developed) 2019-10-29 Import 2019-11-28 Mfg 2019-11-28 Mfg Eprex 24 Panpotin Prefilled Syringe PanGen (Recombinant Anemia in patients with Inj. 2000IU Biotech Inc. human chronic renal insufficiency erythropoietin) Eprex 25 Panpotin Prefilled Syringe PanGen (Recombinant Anemia in patients with Inj. 4000IU Biotech Inc. human chronic renal insufficiency erythropoietin) * Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 102 - precautions for use) 3.3. Information on Approval of Cell Therapy Products Since domestically developed ‘Chondron’ was approved as the first cell therapy product in Korea in 2001, 16 products have been approved to date (Refer to Table 42). Bio Solution's ‘Cartilife (Basol autologous cartilage-derived chondrocytere)’ (Apr. 24, 2019) is composed of autologous cartilage-derived chondrocytes as active ingredient; and was approved as a chondrocyte cell therapy for the treatment of knee cartilage defect (ICRS grade III or IV, defect area 2 ~ 10cm2). Through the conditional approval system (since Jul, 2016), it is expected that the approval of cell therapy products for the treatment of life-threatening diseases or severe irreversible diseases will be increased. ∼ Table 42. List of Approved Cell Therapy Products (2001 2019) No. Mfg/ Import Product Ingredients Company Date of approval Efficacy/effectiveness (Partially summarized) Treatment 1 Mfg Chondron Autologous Sewon chondrocytes Cellontech of focal Remarks cartilage defect in knee joint (defect size: 2001-01-30 not more than 15cm 2 in single 2 lesion, not more than 20cm in multiple lesion) Creation of functional skin layer by transplanting to 1) the burn where 2 Mfg Holoderm Autologous Tego Science, keratinocytes Inc. 2002-12-10 second degree burn takes not less than 30% of the body surface area, 2) the burn where third degree burn takes not less than 10% of the body surface 1. Promoting re-epithelization of 2005-03-21 3 Mfg Kaloderm Allogeneic Tego Science, keratinocytes Inc. deep-seated second degree burn, 2010-06-24 - 103 - 2. Promoting wound healing of diabetic foot ulcer No. Mfg/ Import Product Ingredients Company Date of approval Efficacy/effectiveness (Partially summarized) Remarks Creation of functional skin layer by Basol 4 Mfg Keraheal Autologous keratinocyte transplanting to 1) the burn where Biosolution Co;.., Ltd 2006-05-03 second degree burn takes not less than 30% of the body surface area, 2) the burn where third degree burn takes not less than 10% of the body surface CreaVax-R 5 Mfg CC Injection Immune 6 Mfg Autologous dendritic cells JW CreaGene 2007-05-15 Autologous cell LC Activated T Injection Lymphocytes Metastatic renal cell carcinoma capable of nephrectomy Adjuvant therapy for whose tumor has Export only patients been removed after curative resection GC Cell 2007-08-06 for Hepatocellular (Operation, Carcinoma Radio Frequency Ablation, Percutaneous Ethanol Injection Therapy) 7 Mfg RMS Autologous Sewon Ossron Osteoblasts Cellontech 2009-08-26 Promoting local bone formation Minimally 8 Mfg Queencell manipulated autologous-adipo ANTEROGEN 2010-03-26 S Biomedics 2010-05-11 Improvement of subcutaneous fat defect se cells 9 Mfg CureSkin Injection Autologous dermal fibroblasts Improvement of area from came Improvement Mfg the scar acne treatment process Autologous bone 10 dented of left ventricular ejection fraction in patients who Hearticellgra marrow-derived Pharmicell Co. m-AMI mesenchymal Ltd. 2011-07-01 stem cells had reperfused acute myocardial infarction by angioplasty coronary within 72 hours after chest pain Human Umbilical Cord 11 Mfg Cartistem Blood-derived Mesenchymal Treatment Medipost Co. Ltd d e fe c ts 2012-01-18 of cartilage p a tie n ts d e g e n e ra tive traumatic Stem Cells knee in or w ith repetitive osteoarthritis(ICRS grade IV) Autologous 12 Mfg Cupistem adipose-derived mesenchymal ANTEROGEN 2012-01-18 Treatment of fistula due to Crohn's disease Orphan drug stem cells Autologous bone 13 Mfg Neuronata marrow-derived R Injection mesenchymal Alleviate Corestem Inc. 2014-07-30 stem cells lateral sclerosis with riluzole - 104 - the disease progression rate of amyotrophic in combination Orphan drug No. Mfg/ Import 14 Mfg 15 Mfg Rosmir 16 Mfg Cartilife Product Ingredients Company Keraheal- Bosol Allogeneic Biosolution Allo keratinocytes Co., Ltd Autologous Tego Science, fibroblasts Inc. Basol autologous cartilage-derived chondrocytes * Biosoluton Co., Ltd. Date of approval 2015-10-16 2017-12-27 Efficacy/effectiveness (Partially summarized) Promoting Improvement of - 105 - moderate-to -severe nasojugal groove defect of (ICRS knee grade cartilage III or IV, 2 defect area 2 to 10 cm ) Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. of deep second degree burn Treatment 2019-04-24 re-epithelization Remarks precautions for use) 4 Information on Approval of Herbal Medicinal Preparations - 107 - 4. Information on Approval of Herbal Medicinal Preparations Herbal medicinal preparations approved in 2019 were a total of 56 items. As compared with 27 items in 2015, 31 items in 2016, 44 items in 2017 and 42 items in 2018, the number was increased by 107.4%, 80.7%, 27.3% and 33.3% respectively (Refer to Table 43). The approval by review type is analyzed as follows: there were 5 drugs requiring data submission which were drugs with new composition (1 item), drugs with change in contents (2 items), and drugs with new formulation (Viscous extract, liquid) (2 items). In addition, the highest number was taken by drugs approved base on equivalence data including bioequivalence test (31 items), followed by drugs approved for herbal health insurance medicine based on herbal medicinal preparations listed in the Korean traditional medicine books (10 items), herbal substance (7 items), and drugs substance (3 items). Table 43. Approval of Herbal Medicinal Preparations by Review Type in 2019 (Unit: number of items) Type Review type No. of Approved Items Total Manufactured Imported 56 56 0 Total 1 New drugs 0 0 0 2 Orphan drugs 0 0 0 New composition 1 1 0 Change in contents 2 2 0 New efficacy and effectiveness and dosage 0 0 0 New routes of administration 0 0 0 New formulation 2 2 0 0 0 0 31 31 0 10 10 0 Drug Substance 3 3 0 Herbal Substance 7 7 0 3-1 3-2 Drug requiring 3-3 data submission When the documents are based on documents other 3-4 than Korean Medicine book 4 Proof of equivalence Herbal 5 Other medicines medicinal preparations listed traditional medicine books - 109 - in Korean Moreover, the approval by drug classification type was analyzed as follows: prescription drugs (36 items), OTC drugs (10 items), drug substances (3 items), and herbal substances (7 items) (Refer to Table 44). Table 44. Approval of Herbal Medicinal Preparations 2019 (Unit: number of items) Item Approval Types Item Total Total Prescribed OTC Drug Substance Herbal substances 56 36 10 3 7 Herbal Medicinal Manufactured 56 36 10 3 7 Preparations Imported 0 0 0 0 0 4.1 Information on Approval of Herbal Medicinal Preparations as Prescription Drug From the herbal medicinal preparations approved in 2019, prescription drugs were 36 domestically manufactured items with 7 ingredients (Refer to Table 45). 10 items including ‘Hutiren 2X Tab (artemisia asiatica 95% ethanol ext. (20→1))’ are generic drugs of ‘Stillen 2X Tab (Artemisia Herb 95% Ethanol Soft Ext(20→1))’ approved in 2015. Their efficacy and effectiveness are ‘Improvement of gastric mucosal lesions (wheezing, bleeding, redness, edema) due to acute gastritis and chronic gastritis.’ ‘Safety and efficacy data’ of these products were reviewed by submitting the data on comparative dissolution test with comparator as per Article 3(1)(2) of the Regulation on Approval or Notification of Korean Traditional Medicine/Herbal Medicine Preparations. ‘Umcamin Plus Syrup’ is a combination product containing pelargonium sidoides 11% ethanol extract (1→8∼10) and Ivy leaf 30% ethanol extract (5∼7.5→1) and ‘safety and efficacy data’was reviewed by submitting the data on combination - 110 - product of new composition as per [Attached Table 1] 2. Pharmaceutical drug of composition and specification of the Regulation on Approval or Notification of Korean Traditional Medicine/Herbal Medicine Preparations. ‘Hansin Mesima-F Solution (Phellinus Linteus Mycelliun Ext.)’ is an item that has a different formulation from the previously approved item and ‘Safety and efficacy data’ was reviewed by submitting the data as specified in [Attached Table 1] 9. New dosage form (same administration route) of the Regulation on Approval or Notification of Korean Traditional Medicine/Herbal Medicine Preparations. 16 items including ‘Unimega Soft Cap (Omega-3-acid ethyl esters 90)’ are generic drug of Omacor Soft Cap. (Omega-3-sanethyl ester 90) approved in 2005 and their efficacy and effectiveness are ‘Prevention of secondary occurrence after myocardinal infarction’ and ‘dietary supplements to reduce elevated triglyceride levels in patients with endogenous hypertriglyceridemia.’ As a generic drug of prescription drug/new drug, this drug submitted bioequivalence test results in accordance with Article 4(1)3 of the Regulation on Safety of Pharmaceuticals, etc. and ‘Omethyl QTlet Soft Cap. (Omega-3-acid ethyl esters90)’ and ‘Omacomini Soft Cap. 2g (Omega-3-acid ethyl esters90)’ were approved as drugs only with increase in strength related with ‘Omacor Soft Cap. (Omega-3-San ethyl ester 90)', 4 items including ‘Uniila Tab.’ are generic drugs of ‘Layla Tab’, which was approved in 2012, and its efficacy and effectiveness are ‘relieving symptoms of osteoarthritis’. ‘Safety and efficacy data’ of these products were reviewed by submitting comparative dissolution test data with comparator in accordance with Article 3(1)2 of the Regulation on Approval or Notification of Korean Traditional Medicine/Herbal Medicine Preparations. ‘Hanpoong Yeoldahansotang Ext. Tab (Dongeuisusobowon)’ is an item that corresponds to change in dosage form of the previously approved granule, and was - 111 - approved by submitting data on specification and test methods, etc. Table 45. Approval of Herbal Medicinal Preparations as Prescription Drug in 2019 No. Mfg/ Import Product 1 Mfg. (artemisia asiatica 95% Company Hutiren 2X Tab ethanol ext. (20 Mfg. → 1)) → (artemisia asiatica 95% ethanol ext. (20 1)) Gestaren 2X Tab 3 Mfg. → (artemisia asiatica 95% ethanol ext.(20 1)) Shuren 2X Tab 4 Mfg. → 1)) Utaren 2X Tab 5 Mfg. → (artemisia asiatica 95% ethanol ext.(20 harmaceutical 2019-01-11 Co., Ltd) Guju Pharmaceutical 2019-01-17 Co., Ltd. Medica Korea Co., Ltd 2019-01-17 Aprogen (artemisia asiatica 95% ethanol ext. (20 1)) Pharmaceuticals 2019-01-17 Co., Ltd. Shinpoong Pharm. Co, Ltd) 1. Improvement of 2019-01-22 Mfg. → (artemisia asiatica 95% ethanol ext.(20 Mfg. Theragen ETEX 2019-01-22 (swelling), bleeding, agents rubefaction, edema): Acute gastritis, chronic gastritis → (artemisia asiatica 95% ethanol ext. (20 lesions (erosion Peptic ulcer 1)) Stin 2X Tab 7 gastric mucosal [232] Gastiren 2X Tab 6 Classification Efficacy/Effectiveness Code Hutex Korea Mucoren 2X Tab 2 Date of approval 1)) PMG Pharm Co., Ltd. 2019-01-23 Artilren 2X Tab 8 Mfg. (Artemisia Herb 95% → Ethanol Soft Ext.(20 Co., Ltd. Mfg. → asiatica 95% ethanol ext.(20 1)) S-tiren 2X Tab 10 Mfg. 2019-01-23 1)) Ediol 2X Tab (artemisia 9 Korea Pharma → (artemisia asiatica 95% ethanol ext.(20 1)) Eden Pharma Co., Ltd. Huvist Pharm. Co., Ltd. 2019-02-14 2019-02-18 [229] Han Hwa 11 Mfg. Umcamin Plus Syrup Pharma.Co., Miscellaneous 2019-02-14 Ltd. respiratory Acute bronchitis organ agents 1. Uterine bleeding and leukorrhea, Hansin Mesima-F 12 Mfg. Solution Han Kook (Phellinus Linteus Shin Yak Corp. [421] 2019-03-06 Mycelliun Ext.) Antineoplastic agents menstrual irregularity, intestinal bleeding, intestinal and gastrointestinal function activation, detoxification - 112 - No. Mfg/ Import Product Company Date of approval Classification Efficacy/Effectiveness Code 2. Gastrointestinal cancer, liver cancer, improvement of immune function by combined chemotherapy (with administration) after excision surgery Cough, sputum caused by the [222] 13 Mfg. Synatura Syrup Aju Pharm Co., Ltd. 2019-03-08 Antitussive following diseases: acute upper respiratory expectorants tract infections, chronic inflammatory bronchitis 14 Mfg. Uniila Tab 15 Mfg. Rasbone Tab 16 Mfg. Rayon Tab 17 Mfg. Auslera Tab 18 Mfg. (Omega-3-acid ethyl Unimega Soft Cap esters 90) 19 Mfg. Mfg. Korea Prime Pharm.Co., Ltd. AUSKORA Pharm.Co, Ltd. Union Korea Pharm Co, Ltd. Ahbkook esters 90) Ltd. Cap (Omega-3-acid (Omega-3-acid ethyl esters 90) 2019-03-13 [114] 2019-04-03 Mfg. (Omega-3-acid ethyl Easement of analgesics, and osteoarthritis 2019-04-03 anti-inflammator symptoms y agents 2019-04-11 Dietary supplements 2019-03-14 to reduce elevated patients 2019-03-22 1) Single-dose Boryung Co., Ltd therapy for 2019-03-22 hypertriglyceridemia (Type IV) Pharvis Korea Co, Ltd. 2) Combination 2019-03-27 [218] Hyperlipidemia therapy with statin drugs for the combination type of Intropharm Inc. 2019-03-27 agents hypercholesterolemia esters 90) Dongkoo Omega-3 Soft 23 Mfg. Cap (Omega-3-acid ethyl esters 90) Dalim Omega-3 Soft 24 Mfg. Cap (Omega-3-acid ethyl esters 90) with endogenous hypertriglycerideemia Romaco Soft Cap 22 Antipyretics, triglyceride levels in Newpharm Co, Ometin Soft Cap Mfg. Co, Ltd. Sumega Soft Cap ethyl esters 90) 21 Medics Pharm. (Omega-3-acid ethyl Boryung Omega-3 Soft 20 Union Korea Pharm Co., Ltd. and DongKoo Bio & Pharma hypertriglyceridemia 2019-03-27 (Type IIb) 3) Combination therapy with statin Dalim Biotech Co, Ltd. 2019-03-29 drugs in patients with hypercholesterolemia and Omatree Soft Cap 25 Mfg. (Omega-3-acid ethyl esters 90) Medica Korea Co, Ltd hypertriglyceridemia 2019-03-29 - 113 - complex (Type IIb) whose triglyceride No. Mfg/ Import Product Olmark Soft Cap Junghun 26 Mfg. (Omega-3-acid ethyl Pharmaceutical esters 90) Co., Ltd. Super Mega Soft Cap 27 Mfg. (Omega-3-acid ethyl esters 90) Megatigy Soft Cap 28 Mfg. (Omega-3-acid ethyl esters 90) 29 Mfg. Mfg. Date of approval Classification Efficacy/Effectiveness Code 2019-07-11 Hanpoong Pharm & Foods 2019-10-04 Co, Ltd. Medics Pharm. Co, Ltd. Jeil Omega3 Soft Cap Cheil (Omega-3-acid ethyl Pharmaceutical esters 90) 30 Company 2019-10-04 2019-10-15 Co., Ltd. Rotigy Soft Cap Wooridul (Omega-3-acid ethyl Pharmaceutical esters 90) Ltd. 2019-10-22 levels are not controlled OcrinSoft Cap 31 Mfg. (Omega-3-acid ethyl Suheung 2019-10-31 esters 90) 32 33 Mfg. Mfg. Komaco Soft Cap Hutex Korea (Omega-3-acid ethyl Pharmaceutical esters 90) Co, Ltd Omega One Soft Cap Hana (Omega-3-acid ethyl Pharmaceutical esters 90) Omethyl QTlet Soft Cap 34 Mfg. (Omega-3-acid ethyl esters 90) Omacomini Soft Cap. 35 Mfg. 2g (Omega-3-acid ethyl esters 90) Hanpoong 36 Mfg. Yeoldahansotang Ext. Tab (Dongeuisusobowon) * 2019-12-20 2019-12-31 Ltd. Korea United Pharm Inc. Kunil Pharm. Co, Ltd. 2019-04-15 2019-07-11 Hanpoong Pharm & Foods 2019-08-14 Co, Ltd. [235] Emetics and Nausea and vomit of antiemetics Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 114 - Tae Eum type precautions for use) 4.2 Approval of Herbal Medicinal Preparations as OTC drugs The OTC drugs from herbal medicinal preparations approved in 2019 include 8 items of ‘Mix extract’listed in the Korean traditional medicine books, and 2 items formulated with soft extracts (Refer to Table 46). T able 46. Approval of Herbal Medicinal Preparations as OTC drugs in 2019 No. Mfg/ Import Product 1 Mfg. Paedoksan Viscous Kyungbang Ginseng extract (Extract Mix) Company Date of Approval Kyung Bang Pharmaceutical. 2019-01-03 Co.Ltd., Efficacy/ Effectiveness Remarks For oriental health Insurance OTC Purulent diseases Hanpoong 2 Mfg Hanpoong Takrisodokeum Viscous extract such as Pharm & Foods 2019-02-21 lymphadenitis, OTC peri-analitis and Co, Ltd,. mastitis Hanpoong Haengsotang 3 Mfg 4 Mfg 5 Mfg 6 Mfg Viscous extract (Extract Mfg Co, Ltd,. IWorld Doinseunkitang Tab. I-World Pharm (Extract Mix) Corp. IWorld Sosihotang Tab I-World Pharm (Extract Mix) Corp. IWorld Siihocheongkantang I-World Pharm Tab. (Extract Mix) Corp. Hoichunyanggyeoksan Viscous extract (Extract Mix) 8 Mfg 9 Mfg Pharm & Foods 2019-04-05 Mix) Kyungbang 7 Hanpoong 2019-06-19 2019-08-13 2019-08-29 Kyung Bang Pharmaceutical. 2019-09-06 Co.Ltd., IWorld Sihogyejitang Tab. I-World Pharm (Extract Mix) Corp. IWorld Sihosogantang Tab I-World Pharm (Extract Mix) Corp. 2019-09-17 2019-09-25 Hanpoong 10 Mfg Hanpoong Sogunjungtang Viscous extract Pharm & Foods 2019-12-09 Co, Ltd,. * For oriental health Insurance For oriental health Insurance For oriental health Insurance For oriental health Insurance For oriental health Insurance For oriental health Insurance For oriental health Insurance - 115 - OTC OTC OTC OTC OTC OTC Stamina reduction, abdominal pain, cold OTC sweat, and thirsty Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. OTC precautions for use) 4.3 Information on approval of Drug substances and Herbal substances For drug substance, 3 items such as ‘Bolak Cinamon Bark·Gambir·Cardamon· Capsicum 50% Ethnaol Viscous extract(5→1)(API)’ and ‘Hanpoong Ssanghwatang Viscous extract(3.13→1)(API)’ and Hansol Licorice Viscous extract(2.0~2.5→1) (API), and for herbal substance, 7 items including ‘Sol to B Muscovitum powder’ were approved (Refer to Table 47). Table 47. Approval of Herbal Medicinal Preparations in 2019(Drug Substance and Herbal Substance) No. Mfg/ Import Product Company Date of Approval Bolak Co., Ltd. 2019-04-16 Efficacy/ Effectiveness Remarks Bolak Cinamon Bark·Gambir·Cardamon· 1 Mfg. Capsicum 50% Ethnaol → Viscous extract(5 1) Other prescription Drug drugs substances (API) Hanpoong Ssanghwatang Viscous 2 Mfg extract(3.13 → Hanpoong Pharm & Foods 1) 2019-06-13 Other prescription Drug drugs substances Co, Ltd,. (API) Hansol Licorice Viscous 3 Mfg extract(2.0~2.5 → Hansol Pharm. 1) 2019-12-30 Co., Ltd. Other prescription Drug drugs substances (API) Sol to B Sol to B Muscovitum 4 Mfg Pharmaceutial 2019-02-26 powder Other prescription Herbal drugs substance Company Saerom Pharm. 5 Mfg Saerom Doochongcho 2019-02-27 Co., Ltd. 6 Human Wonji Licorice & Humanherb Co., Giner Formulation Ltd. Mfg 2019-03-22 Saerom Pharm. 7 Mfg Saerom Hyunggaecho 2019-09-23 Co., Ltd. Saerom Pharm. 8 Mfg Saerom Euiyiincho 2019-09-30 Co., Ltd. CK Pharm Co., 9 Mfg CK Yeojungsiljoojeung 2019-10-31 Ltd. CK 10 Mfg CK Co, Ltd. 2019-11-11 Cheonnamseongbaekbanja * Other prescription Herbal drugs substance Other prescription Herbal drugs substance Other prescription Herbal drugs substance Other prescription Herbal drugs substance Other prescription Herbal drugs substance Other prescription Herbal drugs substance Detailed approval information (efficacy/effectiveness, dosage/administration, and is available at ‘Drug safety world(http://nedrug.mfds.go.kr)’. - 116 - precautions for use) Appendix Information on departments responsible for pharmaceutical petitions, etc Table 48. Information on departments responsible for pharmaceutical petitions, etc. (As of April, 2020) Item Department Detailed Petition Service · Preliminary review and management related to drug review and approval · Approval of drugs for manufacturing and import (including changes) · Registration of DMF · Preliminary review and management related to biopharma Innovative Convergence Products -ceuticals review and approval Support Department · Approval of biopharmaceuticals for manufacturing and import (including changes) · Preliminary review and management related to herbal medicines, etc. review and approval · Approval of herbal medicines, etc. for manufacturing and import (including changes) · Approval of quasi-drugs for manufacturing and import Pharmaceutical Policy Division Pharmaceutical Management · Drug marking and labeling Division · Renewal of drugs Pharmaceutical Safety Evaluation Division Safety Bureau · Reevaluation and re-review of drugs · Risk management plan Pharmaceutical Quality Division Pharmaceutical · Designation of orphan drug · GMP evaluation and guidance of drugs · Inspection of drug substance (DMF) · Approval of clinical protocols Clinical Trials Management Division · Inspection of clinical trials · Control of clinical trial and non-clinical (GLP) institutionals Pharmaceutical Approval and Patent Management Division · Listing and management of the patent lists · Management of patents linked to medical products (approval for priority sales items, etc.) · Approval of drug mfg., import/ export and items Narcotics Policy Division · Quality control of narcotic drugs · Designation of temporary narcotics Narcotics Management Division · Follow-up management of narcotics Drug Review Management · Notification of pre-review Division 710 Drugs for prescription 731 Preservative NIFDS 741 Capsules Drug Evaluation Department Pharmaceutical Standardization Division 799 Drugs not classified separately and not primarily used for treatment (those not containing safety and efficacy review) · Review of registration data for drug substances (excluding ingredients of new drugs) · Quality control of drug substances · Review of generic drug specification and test methods - 117 - 110 Drugs for central nervous system 120 Drugs for peripheral nervous system 130 Drugs for sensory organs 190 Other drugs for the nervous system out of drugs for other nervous systems and sensory organs 210 Drugs for circulatory systems 264 Drugs for pain-relieving, antipruritic, convergence, anti Cardiovascular and Neurology Products Division -inflammatory 300 Metabolic drugs (excluding other metabolic drugs(390)) 800 Narcotics · Safety/efficacy review · Review of clinical trial protocols · Preliminary review · General management re-review, RMP of re-evaluation; periodic report and review result; of and PSUR review 140 Allergy drugs 220 Drugs for respiratory organ 230 Drugs for digestive organ 240 Hormone drugs (including anti-hormonal agents) 250 Drugs for urogenital and anal organ 260 Dermatologic drugs (excluding 264) Oncology and Antimicrobial Products Division 290 Other drugs for individual organs 400 Drugs for functional activation of tissue cells 600 Anti-pathogenic biological drugs 720 Drugs for diagnosis 730 Drugs for public sanitary cares · Safety/efficacy review · Review of clinical trial protocols · Preliminary review · Review of re-evaluation of re-review result report New drug, drugs requiring data submission, etc. Gastroenterology and Metabolism Products Division · Review of registration data for drug substances · Quality control of drug substances · Review of drug product specification and test methods · Review of clinical trial protocols (Quality part) · Preliminary review · Review of biological equivalence test plan · Review of biological equivalence test result report review · Review of reliability assessment of biological equivalence test · Review of biological equivalence examination re-evaluation Bioequivalence · Evaluation Division Review of drug equivalency test result report review (including manufacturing (import) item approval/notification) · Review of report of drug equivalence test result (approval/report) · Safety/efficacy review and review of clinical trial protocols of other metabolic drugs (390) Biopharma · -ceuticals and Biopharmaceutical Quality Herbal Medicine Management Division Bureau Biological preparations, manufacturing and import/export items, GMP evaluation and guidance · Inspection of drug substance of human placenta-derived drugs (DMF) - 118 - · Re-review and re-evaluation of biopharmaceuticals · Risk Management Plan Herbal Medicine Policy Division Cosmetics Policy Division · Preliminary GMP evaluation for herbal medicine · GMP evaluation such as cosmetics Quasi-Drug Policy Division · Quasi-drug GMP evaluation Biopharma -ceuticals Review Management · Notification of pre-review Division Biologics and human placenta-derived drugs · Quality and safety/efficacy review Biologics Division · Review of clinical trial plan · Preliminary review · Review of re-evaluation of re-review result report Recombinant Protein Products Recombinant Protein Products Biopharma Division · Review of clinical trial plan · Preliminary review -ceuticals and NIFDS · Quality and safety/efficacy review · Review of re-evaluation and re-review result report Cell therapy, gene therapy, etc. Herbal Medicine Evaluation Cell and Gene Department Therapy Products Division · Quality and safety/efficacy review · Review of clinical trial protocols · Preliminary review · Review of re-evaluation/re-review result report · Quality and safety/ efficacy review Herbal Medicinal Products Division · Review of drug equivalence (including bioequivalence test) · Review of clinical trial protocol · Pre-review · Review of re-evaluation/re-review result report · Review of functional cosmetics · Quasi-drugs Cosmetics Evaluation Division · Safety/efficacy review · Quality data review · Pre-review - 119 - 2019 Drug Approval Report Date of J uly, 2020 Publication Publisher Lee Eui-k yung Editor in Kim Young-ok , Kim S ang-b ong Chief Editor Kim Myeong-ho, Oh J oung-weon, Chae J oo-young, Kim Youn-su, Kim S oo-J i, J eong Hee-j eong, Kim J ung-shin, D o Won-im, Kim Won-il, Park Bak Hyang, Eom S uk -hyeon, In-hye, Hwang S u-j eong, Park J u J ung-hun, Kim Won-hee, Park Min-gyeong, Kim J ee-su, Nam J usun, Kim Mi-ae, Kim J i-ye, Hwang Yun-mi, Yu Hue-sun, Park Yeo sung-gu, Kang J eun-geun, National Institute of Contributor S un-young, Lee J i-na, Choi S eon-lim, J i-hye, Lee J i-yeong, Lee J eong-hwa Lee J i-hye Food and D rug S af ety Evaluation D rug Evaluation D epartment, B iopharmaceuticals&Herb al Medicine Innovative Convergence Products S upport D epartment, Organization Ministry of Food D rug S af ety (MFD S )