恒瑞医药SHR—A1811等药物纳入拟突破性治疗品种公示名单

Core Viewpoint - Heng Rui Medicine announced that its subsidiaries Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. have had their injectable drugs SHR-A1811 and Adebali monoclonal antibody included in the list of proposed breakthrough therapies by the National Medical Products Administration [1] Group 1: Product Information - SHR-A1811 is indicated for first-line treatment of PD-L1 positive (CPS≥1) locally recurrent unresectable or metastatic triple-negative breast cancer [1] - SHR-A1811 works by binding to HER2-expressing tumor cells, inducing cell cycle arrest and apoptosis through toxin release in the lysosome [1] - Adebali monoclonal antibody is a humanized anti-PD-L1 monoclonal antibody, approved for first-line treatment in combination with carboplatin and etoposide for extensive-stage small cell lung cancer patients [1] Group 2: Regulatory Approval - Both injectable drugs have received market approval and are now part of the regulatory framework for breakthrough therapies in China [1]