April 26, 2024

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[THE INVESTOR] The number of new drugs developed by South Korean pharmaceutical companies and approved by the country’s health authorities has declined this year, industry data showed Nov. 29.

According to the Ministry of Food and Drug Safety, Hanmi Pharmaceutical’s lung cancer treatment HM61713 was the sole new drug that received approval from the agency this year, compared to five drugs in 2015. 

Hanmi’s drug also known as Olmutinib was conditionally approved for sale in Korea in May after completing just first and second phase clinical trials held locally.

After three patients died from side effects of Olmutinib during clinical trials, adequacy of approval on Olmutinib sparked debates here but the ministry retained its earlier decision.

Data from the health agency also showed that less than half the number of incrementally modified drugs were approved in 2016 when compared to 2015 data.

A total of eight modified drugs were permitted for sale here till end-October, down from 18 last year.

The approved modified drugs this year include four high blood pressure treatments, malaria drug for infants, a functional dyspepsia drug, an oral anti-cancer medicine and a X-ray contrast medium.

Industry watchers said that the majority of new drug candidates of Korean firms are currently undergoing phase 1 or 2 clinical trials which resulted in fewer applications for endorsement.

By Park Han-na (hnpark@heraldcorp.com)