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Higher number of approvals for drug clinical trials in South Korea

A significantly higher number of South Korean drugs were approved for phase 3 clinical trials last year, the Ministry of Food and Drug Safety announced Thursday.

Phase 3 clinical trials are the final testing of drugs on patients to assess efficacy and safety before they are distributed to the public.

The ministry said that the largest number of newly approved drugs were anticancer medicine. 
Ministry of Food and Drug Safety (Yonhap)
Ministry of Food and Drug Safety (Yonhap)

Clinical trials involving new drugs in Korea are commonly classified into four phases -- phases 0, 1, 2 and 3. In order for a drug to be approved for phase 3, it has to successfully pass through phases 0, 1 and 2, which require testing on non-human subjects as well as healthy human volunteers to gather efficacy and toxicity information. The drug development process usually takes several years to go through all four phases.

According to the ministry, a total of 53 Korean drugs were approved for phase 3 clinical trials in 2015, a 26 percent increase from the year before.

“It means that more drugs have a chance of being available for sale and public use,” the ministry said in a statement. “We believe this was possible because more investments have been made in the pharmaceutical industry.”

A total of 675 drugs from South Korean and multinational pharmaceutical firms were approved for phase 0, 1 and 2 trials last year, up from 652 drugs the year before.

Among the approved drugs, the biggest proportion of them, at 255, were anticancer drugs. The second largest proportion, at 76, were drugs acting on the cardiovascular system, the ministry said.

“More firms are developing antibody-drug conjugates, an emerging class of biopharmaceutical drugs designed as targeted therapy for cancer patients,” the ministry said.

Among the Korean firms that received approvals for new drugs, Chong Kun Dang was responsible for a total of 30 drugs. This was followed by Hanmi Pharm. Co., which received 18 approvals, and Ildong Pharmaceutical Co., which received 15.

In terms of drugs by multinational pharmaceutical companies, a total of 170 drugs were approved for phase 3 clinical trials, a decrease from 190 the year before.

Norvatis Korea and Janssen received the largest number of approvals, at 18 drugs each. MSD Korea achieved approvals for 17 drugs, while AstraZeneca, 15.

About 55 percent of all clinical trials of the drugs took place in Seoul last year, followed by Gyeonggi Province. Most of the trials were performed at five general hospital in Seoul, including Samsung Medical Center, Seoul National University Hospital, and Asan Medical Center.  

By Claire Lee (dyc@heraldcorp.com)



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