Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. announced that its selective RET small molecule inhibitor BYS10 has received feedback from the National Medical Products Administration, allowing it to proceed to Phase II clinical trials, indicating a significant step towards becoming a representative product in the field of innovative anti-tumor drugs in China [2][4]. Group 1: Clinical Development - BYS10 is a selective RET small molecule inhibitor developed by Baiyunshan Pharmaceutical, with specifications of 25mg and 100mg, targeting advanced solid tumors such as non-small cell lung cancer and medullary thyroid carcinoma [4]. - The drug has shown strong and durable anti-tumor activity in Phase I clinical trials, demonstrating good clinical efficacy and tolerability in patients with various RET gene mutations [4]. - The project has invested nearly 150 million RMB in research and development as of August 2025 [6]. Group 2: Market Context - Approximately 70,000 new RET mutation cancer patients are diagnosed annually in China, including 8,000 to 16,000 cases of RET fusion lung cancer, highlighting a significant unmet medical need [4]. - Currently, only two RET inhibitors, Pralsetinib and Selpercatinib, have been approved for sale in China, with projected sales of 154.91 million RMB and 65.45 million RMB respectively in 2024 [5]. - There are no other drugs with a similar structure to BYS10 currently on the market or under registration in China [5]. Group 3: Company Strategy - Baiyunshan Pharmaceutical is transitioning from a traditional pharmaceutical company to a technology-driven enterprise, actively engaging with high-end resource platforms and research teams [6]. - The company has over 200 projects in development, with 22 of them being innovative drug projects [6]. - In the past five years, Baiyunshan has obtained over 60 authorized invention patents, including 7 international patents, and has 6 Class 1 new drugs under research [6].