Download 2019+Drug+Approval+Report

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 )