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Facts & Stats

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Review of 2014 Clinical Trial Approvals in Korea

The review of clinical trial approvals for 2014 reveals a total of 652 approvals, a 7.4% increase compared to the 607 approvals for year 2013 and a 48.5% increase over that recorded in year 2010.

In 2014, 220 clinical trials (361 including Investigator Sponsored Trials) approved were local industry sponsor clinical trials; this is a slight decline (3%) from the 227 approvals issued in year 2013. In contrast, clinical trial approvals for multinational clinical trials increased significantly. (248 cases -> 285 cases, an increase of 15%)


*The figure includes both IST(Investigator Sponsored Trials), and CST (Company Sponsored Trials)

Clinical trials approved last year show that

  • - Phase I trials by local, multinational pharmaceutical companies are continuously increasing.
  • - The focus of the trials is -- by efficacy -- on tumors and, on small molecules.
  • - Local pharmaceuticals are focused on heart drugs, whereas multinational ones concentrate on cancer drugs.
  • - Trials are concentrated in the Seoul metropolitan area and large hospitals.

Increased Phase I Trials for Both local and Multinational Pharmaceuticals

Phase I clinical trials of local pharmaceutical companies increased 17% from 130 cases (2013) to 152 cases (2014) and 102.7% compared to 2010.

Table 5
Type Industry-Sponsored Trial Investigator- Sponsored Trial Total Trials
Total local Multinational
Year
2010
340 140 200 99 439
Year
2011
398 209 189 105 503
Year
2012
498 208 290 172 670
Year
2013
475 227 248 132 607
Year
2014
505
(△6.3%)
220
(▽3.0%)
285
(△14.9%)
147
(△11.3%)
652
(△7.4%)

* Local Trial: Clinical Trials that involves only korean site
* Multinational Trial: Trials that invovles sites in muilinational countries


Phase I clinical trials by multinational pharmaceutical companies increased 60% from 130 cases (2013) to 152 cases (2014). This can be attributed to enhanced clinical trial operational capabilities and adequacy of manpower, facilities, and infrastructure of Korea.



Clinical Trial Approvals by Phase (‘10∼‘14)

Table 5
Type Local Clinical Trials Multinational Clinical Trials
Phase 1 Phase 2 Phase 3 Others Total Phase 1 Phase 2 Phase 3 Others Total
Year
2010
75 31 31 3 140 23 57 119 1 200
Year
2011
130 37 41 1 209 19 60 107 3 189
Year
2012
128 30 47 3 208 32 75 180 3 290
Year
2013
130 38 58 1 227 25 65 154 4 248
Year
2014
152 25 42 1 220 40 51 190 4 285

Focused on tumors (by therapeutic class) and small molecules

The therapeutic areas of industry sponsored studies approved were; in decreasing order of numbers -- 210 of tumor, 89 of cardiovascular system, 58 of central nervous system, and 55 of endocrine system.

In 2013, there were -- in decreasing order of cases numbers -- 157 cases studies of tumor, 80 cases of cardiovascular system, 51 cases of central nervous system, and 46 cases of endocrine system. The number of cases increased in all the top 4 therapeutic classes mentioned.



Clinical Trial Approvals by Therapeutic Class (‘10∼‘14)

Table 5
Type Tumor Cardio-vascular
System
Endo- crine System Central Nervous System Digestive System Urinary System Antibi- otics Respi- ratory System Immu- nosup- pressive Blood Others Total
Year
2010
112 49 54 48 33 25 16 17 27 32 26 439
Year
2011
112 69 41 47 29 37 34 32 27 35 40 503
Year
2012
184 59 57 68 56 31 49 43 46 27 50 670
Year
2013
157 80 51 46 40 39 30 30 20 19 95 607
Year
2014
210 89 55 58 33 32 55 27 21 14 58 652

By type, there were 465 studies (71%) for combination drugs, 169(26%) for biologics, and 18(3%) for botanical drugs (Korean medicine).

- Among biologics, there were 109 recombinant therapeutics, 31 cell/gene therapy, and 29 of biologic agent. Genetic recombination medicine increased by 24% from the 88 cases in 2013.



Clinical Trial Approvals by Medication Type (‘10∼‘14)

Table 5
Type Combination
drugs
Biologics Botanical
drugs
(Herbal medicine)
Total Genetic
recombinant
Biological
agent
Cell therapy Gene therapy
Year
2010
322 92 65 9 14 4 25
Year
2011
378 107 76 16 11 4 18
Year
2012
486 159 103 28 23 5 25
Year
2013
435 155 88 38 26 3 17
Year
2014
465
(△6.8%)
169
(△9.0%)
109
(△23.8%)
29
(▽23.6%)
24
(▽7.6%)
7
(△133.3%)
18
(△5.8%)

Disparity between local and multinational pharmaceuticals in the distribution of trials across therapeutic classes

The number of clinical trials for local pharmaceuticals was 60 for cardiovascular system, 30 for endocrine system, 20 for tumor, 20 for urinary system, and 17 for central nervous system.

- The high number of trials involving drugs for cardiovascular systems is a result of local pharmaceutical companies’ focus on developing treatment for hypertension, hyperlipidemia, diabetes, and other adult chronic diseases in response to population aging.

On the other hand, in the case of multinational pharmaceutical companies, there were 132 for tumor, 25 for antibiotics, 23 for central nervous system, 20 for cardiovascular system, and 20 for endocrine system. There was a disparity with local pharmaceutical companies in the distribution of trials across therapeutic classes.

- A recent noticeable trend is the emergence of new paradigms in clinical trials such as target therapy that can overcome drug resistance and immune checkpoint blockade that uses the body’s immune system to destroy cancer cells. Anti-cancer drug trials increased 30% compared to year 2013 (101 trials), showing that multinationals are focused on anti-cancer development.

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