April 19, 2024

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[THE INVESTOR] Chinese drug maker Zai Lab is seeking regulatory approval in the country to conduct early-stage clinical trials of a controversial lung cancer drug candidate HM61713 it had licensed from South Korea’s Hanmi Pharmaceutical, according to industry sources on Feb. 2.

Zai Lab has recently filed an application for phase 1 clinical program of the non-small cell lung cancer treatment with the China Food and Drug Administration and unveiled the candidate as a part of its drug pipeline under the code name of ZL-2303 via its website.

The move seems to have restored Hanmi’s confidence in HM61713 which faced a major setback when its partner Boehringer Ingelheim returned its license in September which caused a sharp drop in its share price and a multitrillion won loss in market cap.

Zai’s decision to give an impetus to the development of the cancer-fighting drug comes about a year after the Chinese firm signed a license agreement with Hanmi to develop and commercialize HM61713 in China, Hong Kong and Taiwan markets in November 2015.

About 45 percent of the world’s non-small cell lung cancer patients are Chinese.

HM61713 is a third-generation cancer-fighting drug for the treatment of lung cancer patients who have developed a tolerance to existing cancer-fighting drugs.

Meanwhile, Hanmi is currently undergoing global phase 2 clinical trials for HM61713, which had been under way by Boehringer Ingelheim, and is preparing for phase 3 clinical trials in Korea.

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