-- Announcement on Subsidiary’s Drug Entering Key Clinical Trials
Securities code: 600332 Securities abbreviation: Baiyunshan Announcement number: 2025-070
Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd.
Announcement on the Branch’s Drug Entering Key Clinical Trials
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.
The selective RET small molecule inhibitor BYS10 tablets developed by Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Pharmaceutical Factory (hereinafter referred to as "Baiyunshan Pharmaceutical Factory"), a branch of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. (hereinafter referred to as the "Company"), recently received feedback from the Center for Drug Evaluation of the State Drug Administration (hereinafter referred to as "CDE"). The relevant information is now announced as follows:
1. Clinical trial related situations
Trial registration number: CTR20220752
Test protocol number: BYS10-001
Professional title of the trial: An open, multi-center phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and effectiveness of BYS10 tablets in the treatment of advanced solid tumors with RET gene fusion or mutation
Popular title of the trial: Phase I/II clinical study of BYS10 tablets in the treatment of advanced solid tumors with RET gene fusion or mutation
2. Introduction to the main information of BYS10 tablets
BYS10 tablets are selective RET small molecule inhibitors developed by Baiyunshan Pharmaceutical Factory. The preparation specifications are 25mg and 100mg. The indications are non-small cell lung cancer, medullary thyroid cancer and other advanced solid tumors. Baiyunshan Pharmaceutical General Factory received the "Drug Clinical Trial Approval Notice" issued by the State Food and Drug Administration in January 2022. For details, please refer to the "Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Announcement on the Branch's Obtaining the Drug Clinical Trial Approval Notice" issued by the company on January 4, 2022 (Announcement No.: 2022-001). In April 2022, the clinical trial of BYS10 tablets was announced for the first time in CDE. In January 2023, the first subject signed an informed consent form. Phase I clinical trial data of BYS10 tablets show that BYS10 tablets have potent and durable anti-tumor activity, and show good clinical activity and tolerability in patients with various solid tumors with RET gene mutations, such as advanced non-small cell lung cancer (NSCLC), thyroid cancer (TC), and medullary thyroid cancer (MTC). Based on the safety and efficacy data of Phase I, CDE recently approved BYS10 tablets to apply for marketing in the future through Phase II single-arm clinical trials.
After inquiries, there are currently only two new RET inhibitor drugs approved for marketing in the world, Pralsetinib (BLU-667) and Selpercatinib (LOXO-292). These two drugs were approved for marketing in China in March 2021 and October 2022 respectively. Minenet data shows that the domestic market sales of Pralsetinib and Selpercatinib in 2024 will be RMB 154.91 million and RMB 65.45 million respectively. Currently, there is no drug listing or registration application information at home or abroad that has the same structure as BYS10 tablets.
As of August 2025, RMB 146.0935 million has been invested in research and development expenses for this project.
3. Risk warning
Innovative drugs are characterized by high technology, high risk, and high added value. Whether the results of key registered clinical trials can support the submission of drug marketing applications in the future, whether they can ultimately obtain conditional approval for marketing or formal approval for marketing, and when they will be approved are all uncertain. Investors are advised to pay attention to investment risks. The subsequent research and development expenses of this project will further increase, but it is not expected to have a significant impact on the company's financial status and operating results in the short term. The company will fulfill its information disclosure obligations in a timely manner based on the actual progress of drug research and development.
Announcement is hereby made.
Board of Directors of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd.
September 15, 2025