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South Korean clinical trial data for 2016 reflects the global boom in biologics R&D and the decline in development of synthetic drugs. A series of clinical trial failures by major South Korean pharmaceutical firms may also have weakened overall drug development activities.





Despite a drop in overall clinical trial approvals in South Korea last year, trials for biologics continued to climb, reflecting robust R&D activities in biosimilars and cell therapies on the back of the government's support for the biotech industry.


The Ministry of Food and Drug Safety has granted 226 approvals for clinical trials of biologics last year, up from 202 a year earlier. By types of biologics, clinical trials for cell therapies have shown the biggest increase of 32%, largely due to strong interest in allogeneic cell therapies as they have higher commercial potential and can be mass produced.


Biologics accounted for 36% of the total clinical trials approved in the country last year, up from 30% and 26% in 2015 and 2014, respectively, the MFDS said in a statement.






A Phase I trial of Kangstem Biotech's human umbilical cord blood mesenchymal stem cell therapy hUCB-MSC3 inj, a Phase II of Green Cross Lab Cell's allogeneic natural killer cell therapy MG4101, a Phase IIa of Vaxcell-Bio Therapeutics' immuno oncology therapy Vax-NK/HCC and a Phase III of SillaJen Inc. 's oncolytic immunotherapy Pexa-Vec are among the cell and gene therapy trials approved by the MFDS last year.


South Korean clinical trials for biosimilars were also active last year on the back of rapid pipeline progress at Celltrion Inc. and Samsung Bioepis Co. Ltd.. Samsung Bioepis has received the green light from the MFDS for a Phase III clinical trial of SB 8, its biosimilar version of Avastin (bevacizumab), while Celltrion has received approval for trials of CT-P13, its biosimilar infliximab.


Meanwhile, overall clinical trial approvals by the MFDS declined to 628 in 2016 from 674 a year earlier, led by a 14% drop in clinical trial approvals for synthetic drugs. The ministry noted that the fall in clinical trials largely reflects a drop in novel compound candidates, an increase in the domestic generics market and the global trend of lower R&D productivity.






Domestic pharmas, particularly smaller companies, have actively launched generics last year amid easier regulations.


A general cautious sentiment following clinical trial failures by Hanmi Pharmaceutical Co. Ltd. and few other domestic firms may also have partially weakened R&D activities by pharmaceutical companies last year.


By therapeutic area, oncology drugs still accounted for the largest portion last year, although the actual number of clinical trials fell from 2015. Among oncology trials, immuno-oncology trials accounted for 76% last year, reflecting the strong global interest in this area.


A Phase I/II study of Yuhan's EGFR tyrosine-kinase inhibitor YH25448, a Phase I of Cellid's immunotherapeutic vaccine BVAC-C and Phase I trials of Tagrisso (osimertinib) were among the approvals for oncology drug trials last year.



Trial Approvals

Meanwhile, approvals for clinical trials in South Korea fell 22%, reflecting an overall drop in every clinical trial phase, but particularly a steep drop in Phase II.


In the case of multiple country clinical trials in South Korea, total approvals declined 9%, but approvals for Phase I trials increased 14% as South Korea is seeking to attract more early phase trials from global pharmaceutical companies.


In its effort to transform South Korea into a global clinical trial hub, the Korea Clinical Trial Global Initiative's chair Min Soo Park said last year that one of its goals is to attract highly value-added early phase clinical trials from global pharma firms. Early phase trials look at several factors such as characteristics of the drug, its impact on different people and patients, while late phase studies only look at certain definitive statistical numbers. (Also see "INTERVIEW: Korea Initiative Aims To Create Global Clinical Trial Hub" - Scrip, 27 Jun, 2016.)


Another point worth noting from last year's clinical trial data was an increase in investigator-initiated trials as Korean researchers diversify clinical trials to explore administration methods and dosages that meet the domestic medical situations and characteristics of patients.


Among domestic pharmas, Daewoong Pharmaceutical Co. Ltd. topped with 16 clinical trial approvals from the MFDS, followed by Chong Kun Dang Pharmaceutical Corp. and Dong-A ST Co. Ltd. , while Eli Lilly & Co. was the most active multinational in the country with 15 approvals, followed by Janssen and MSD.



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