试验专业题目：评价BYS10片治疗RET基因融合或突变的晚期实体瘤的安全性、耐受性、药代动力学特 征及有效性的开放、多中心Ⅰ/Ⅱ期临床研究。试验通俗题目：BYS10片治疗RET基因融合或突变的晚 期实体瘤的Ⅰ/Ⅱ期临床研究。 白云山(600332.SH)发布公告，公司分公司广州白云山医药集团股份有限公司白云山制药总厂(以下简 称"白云山制药总厂")研发的选择性RET小分子抑制剂BYS10片于近日收到国家药品监督管理局药品审 评中心(以下简称"CDE")的反馈意见。 ...

Core 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]