Baiyunshan: CDE agrees to BYS10 tablets' future use of phase II single-arm clinical trial for marketing application

Baiyun Mountain(00874) announced that BYS10 tablets, a selective RET small molecule inhibitor developed by Guangzhou Baiyunshan Pharmaceutical Co., Ltd. Guangzhou Baiyunshan Pharmaceutical General (hereinafter referred to as "Guangzhou Baiyunshan Pharmaceutical General"), a branch of the company, recently received feedback from the Center for Drug Evaluation (hereinafter referred to as "CDE") of the National Medical Products Administration.

BYS10 Tablets: A Selective RET Small Molecule Inhibitor Developed by Guangzhou Baiyunshan Pharmaceutical Co., Ltd. Guangzhou Baiyunshan Pharmaceutical General, are available in 25mg and 100mg formulations. The indications include advanced solid tumors such as non-small cell lung cancer (NSCLC) and medullary thyroid carcinoma (MTC). In January 2022, Guangzhou Baiyunshan Pharmaceutical General obtained the Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA). In April 2022, the clinical trial of BYS10 Tablets was first publicly announced on the Center for Drug Evaluation (CDE) platform. In January 2023, the first subject signed the informed consent form. Phase I clinical trial data of BYS10 Tablets showed potent and sustained anti-tumor activity, demonstrating favorable clinical efficacy and tolerability in patients with various solid tumors harboring RET gene mutations, such as advanced non-small cell lung cancer (NSCLC), thyroid cancer (TC), and medullary thyroid carcinoma (MTC). Based on the safety and efficacy data from Phase I, the CDE recently approved BYS10 Tablets to proceed with a Phase II single-arm clinical trial application for market approval.

According to the inquiry, currently, there are only two RET inhibitor drugs approved for marketing worldwide: Pralsetinib (BLU-667) and Selpercatinib (LOXO-292). These two drugs were approved for marketing in China in March 2021 and October 2022, respectively. Data from the Menet database shows that the sales revenue of Pralsetinib and Selpercatinib in the Chinese market in 2024 is RMB 154.91 million and RMB 65.45 million, respectively. Currently, there is no drug with a structure identical to BYS10 tablets that has been marketed or for which registration has been applied both in China and internationally.