Core Viewpoint - Baiyunshan's BYS10, a selective RET inhibitor, has received feedback from the National Medical Products Administration (NMPA) allowing it to proceed to Phase II clinical trials, marking a significant step towards market approval [1][2]. Group 1: Product Development - BYS10 is a high-selectivity RET inhibitor developed by Baiyunshan Pharmaceutical, with formulations of 25mg and 100mg, targeting advanced solid tumors such as non-small cell lung cancer and medullary thyroid carcinoma [1]. - The project has incurred nearly 150 million yuan in R&D expenses as of August 2025, with the first patient signing informed consent in January 2023 [1]. - Phase I clinical trial results indicate strong and durable anti-tumor activity in various RET mutation solid tumors, demonstrating good clinical efficacy and tolerability [1]. Group 2: Clinical Efficacy and Safety - BYS10 shows a 62.5% objective response rate (ORR) and nearly 90% disease control rate in 51 evaluable patients, with specific efficacy rates of 60% for RET fusion lung cancer, 83.3% for thyroid cancer, and 50% for medullary thyroid carcinoma [2]. - Most drug-related adverse reactions are mild (grade 1-2) and manageable, with significant improvements noted in patients with brain metastases [2]. Group 3: Market Context and Competition - Currently, only two RET inhibitors, Pralsetinib and Selpercatinib, have been approved in China, with projected sales of 155 million yuan and 65.45 million yuan respectively for 2024 [3]. - Baiyunshan aims for BYS10 to become a representative product of domestic innovative anti-tumor drugs, addressing a significant treatment gap for RET mutation solid tumors [3]. - The company has secured over 60 authorized invention patents in the past five years and is recognized for its strong R&D capabilities in the field of TRK inhibitors [3].