Home Hansoh Pharmaceutical's NDA for HS-10365 Capsules Accepted by China's NMPA for RET Fusion-Positive NSCLC

Hansoh Pharmaceutical's NDA for HS-10365 Capsules Accepted by China's NMPA for RET Fusion-Positive NSCLC

Oct 23, 2025 18:23 CST Updated 18:23
Hansoh Pharma

Pharmaceutical Research, Production, and Sales

Hansoh Pharma (03692) announced that on October 23, 2025, the New Drug Application (NDA) for the group's innovative drug, HS-10365 capsule, a highly selective rearranged during transfection (RET) inhibitor, was accepted by the National Medical Products Administration (NMPA) of China. It is intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for RET gene fusions.