Hansoh (3692) Announces NDA Acceptance for HS-10365 Capsules by NMPA

Bulletin Express

2025/10/23

Hansoh Pharmaceutical Group Company Limited (3692) announced that on October 23, 2025, the National Medical Products Administration of China accepted the New Drug Application (NDA) for HS-10365 capsules. HS-10365 is described as a potent and selective rearranged during transfection (RET) inhibitor, intended for adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer.

According to the announcement, this development represents a significant milestone in the Group’s efforts to advance treatments for RET fusion-positive NSCLC. The application’s acceptance marks an important regulatory step and reflects progress in the company’s innovative drug pipeline. The chairlady of the board, Zhong Huijuan, issued the announcement on behalf of Hansoh Pharmaceutical Group Company Limited on October 23, 2025.

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