Hengrui Medicine's CDK4/6 inhibitor accepted for approval

Jiangsu Hengrui Medicine (SSE:600276) announced that its marketing authorization application for Hydroxyethyl Mesylate Dalvesilib tablets, a CDK4/6 inhibitor, has been accepted by the National Medical Products Administration. The drug is intended for use in combination with endocrine therapy for HR-positive, HER2-negative early or locally advanced breast cancer. Clinical trials, involving over 5,000 patients across approximately 150 centers, demonstrated that Dalvesilib significantly reduced recurrence risk compared to endocrine therapy alone. Dalvesilib has already been approved for certain HR-positive, HER2-negative breast cancer treatments in China. The global market for similar products reached USD 108.64 million in 2023, while Hengrui's cumulative R&D investment in this project is CNY 120,042,000. The company cautioned investors about the uncertainties inherent in drug development and approval processes.