Ge Long Hui·2025-09-15 11:09Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited has received feedback from the National Medical Products Administration (NMPA) regarding its selective RET small molecule inhibitor BYS10 tablets, which are currently undergoing clinical trials for treating advanced solid tumors with RET gene fusions or mutations [1] Clinical Trial Information - The clinical trial registration number is CTR20220752, and the trial protocol number is BYS10-001 [1] - The trial aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of BYS10 tablets in treating advanced solid tumors with RET gene fusions or mutations [1] - This is an open-label, multi-center Phase I/II clinical study [1] Product Overview - BYS10 tablets are developed by Baiyunshan Pharmaceutical's manufacturing plant and are selective RET small molecule inhibitors [1] - The formulation specifications are 25mg and 100mg, with indications for non-small cell lung cancer and medullary thyroid carcinoma among other advanced solid tumors [1] - As of August 2025, the project has incurred research and development expenses amounting to RMB 146 million [1]