South Korea approved more clinical trials in 2015

Print 02 March 2016
Matthew Driskill / FiercePharmaAsia

South Korea's Ministry of Food and Drug Safety announced this week that a "significant number" of South Korean drugs were approved for Phase III trials in 2015.

Ministry officials said 53 South Korean drugs were approved for Phase III trials, a 26% increase from 2014. The ministry also said a total of 675 drugs from South Korean and multinational drugmakers were approved for trials that would lead up to Phase III trials, compared to 652 in 2014, according to a report in the Korea Herald.

The largest number of drugs that were approved for trials, 255, were for anticancer drugs with the second-largest number, 76, being for cardiovascular drugs.

Clinical trials in South Korea are classified into Phase 0, Phase I, Phase II and Phase III. Drugs going into Phase III trials in South Korea have to be tested on non-human subjects and healthy human volunteers to "gather efficacy and toxicity information," the report said.

The South Korean ministry said the increased number of drugs approved for Phase III trials means "more drugs have a chance of being available for sale and public use," and it attributed the increase to larger investments being made in the country's strong pharmaceutical industry.

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

Drugmaker Chong Kun Dang had 30 trials approved, according to the report, followed by Hanmi Pharma with 18 approvals and Ildong Pharmaceutical with 15 approvals.

Foreign drugmakers had 170 treatments approved for Phase III trials last year compared to 190 the year before.

The report added that 55% of all clinical trials took place in Seoul followed by the country's Gyeonggi province.   

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