Ge Long Hui·2025-09-15 19:43Core Viewpoint - Baiyunshan Pharmaceutical Group's BYS10 tablets, a selective RET small molecule inhibitor, have received feedback from the National Medical Products Administration (NMPA) for future clinical trials and potential market application [1] Group 1: Product Development - BYS10 tablets are developed for treating advanced solid tumors, including non-small cell lung cancer (NSCLC) and medullary thyroid carcinoma (MTC) [1] - The formulation specifications for BYS10 tablets are 25mg and 100mg [1] - The clinical trial approval for BYS10 was granted in January 2022, with the first patient signing the informed consent in January 2023 [1] Group 2: Clinical Trial Results - Phase I clinical trial data indicate that BYS10 tablets exhibit strong and durable anti-tumor activity in patients with RET gene mutations across various solid tumors [1] - The drug has shown good clinical activity and tolerability in patients with advanced NSCLC, thyroid cancer, and MTC [1] - Based on the safety and efficacy data from Phase I trials, the NMPA has agreed to the application for a Phase II single-arm clinical trial for BYS10 tablets [1]