October 23, 2025
Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announces that the New Drug Application(NDA) of the Group’s innovative drug “HS-10365 capsules”, a potent and selective rearranged during transfection (RET) inhibitor, has been accepted by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
HS-10365 is a Class 1 innovative drug independently developed by the company. As a small-molecule, highly selective RET receptor tyrosine kinase inhibitor, it can act directly on intracellular protein tyrosine kinases, bind competitively with ATP, and inhibit tyrosine kinase phosphorylation, thereby effectively controlling tumor growth.
At the 114th Annual Meeting of the American Association for Cancer Research (AACR) in 2023, the preliminary result of the Phase I trial was first released[1]. The results showed that HS-10365 had an overall response rate (ORR) of 83.3% in treatment-naive patients with advanced RET fusion-positive NSCLC and 66.7% in previously treated NSCLC patients, demonstrating promising anti-tumor activity in patients with advanced RET fusion-positive NSCLC, along with manageable safety profile and good tolerability, while results from subsequent registration clinical trials will be disclosed at international conference recently.
References
[1] Shun Lu, et al. HS-10365, a highly potent and selective RET tyrosine kinase inhibitor, demonstrates robust activity in RET fusion positive NSCLC patients [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT201.
