Hansoh Pharma's HS-10365 capsules NDA accepted by China NMPA

Hansoh Pharmaceutical Group Company Limited announced that on October 23, 2025, the New Drug Application (NDA) for its innovative drug, HS-10365 capsules, was accepted by the National Medical Products Administration (NMPA) of China. HS-10365 is a potent and selective rearranged during transfection (RET) inhibitor.

The acceptance pertains to the treatment of adult patients diagnosed with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). This marks a key step in the potential market approval of HS-10365 capsules in China.

As of the announcement date, Hansoh Pharmaceutical Group's Board of Directors includes Ms. Zhong Huijuan as chairlady and executive director, Ms. Sun Yuan and Dr. Lyu Aifeng as executive directors, and Mr. Lin Guoqiang, Mr. Chan Charles Sheung Wai, and Ms. Yang Dongtao as independent non-executive directors.