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白云山:CDE同意BYS10 片未来采用Ⅱ期单臂临床试验申请上市
Zhi Tong Cai Jing· 2025-09-15 11:04
Core Viewpoint - Baiyunshan Pharmaceutical's selective RET small molecule inhibitor BYS10 has received feedback from the National Medical Products Administration (NMPA) for its clinical trial application, indicating progress towards potential market approval [1] Group 1: Company Developments - Baiyunshan Pharmaceutical's subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., has developed BYS10, which is indicated for advanced solid tumors such as non-small cell lung cancer and medullary thyroid carcinoma [1] - The clinical trial for BYS10 began with approval from the NMPA in January 2022, and the first patient signed the informed consent in January 2023 [1] - Phase I clinical trial results show that BYS10 exhibits strong and durable anti-tumor activity in patients with RET gene mutations, demonstrating good clinical efficacy and tolerability [1] Group 2: Industry Context - Currently, only two RET inhibitors, Pralsetinib (BLU-667) and Selpercatinib (LOXO-292), have been approved for sale in China, with sales projected at RMB 154.91 million and RMB 65.45 million respectively for 2024 [2] - There are no other drugs with a similar structure to BYS10 that have been registered or approved in the domestic or international markets [2]