恒瑞医药(01276):注射用SHR-A1904被药审中心纳入突破性治疗品种名单
智通财经网·2025-12-24 10:10

Core Viewpoint - The company, Jiangsu Hengrui Medicine Co., Ltd., has announced that its injectable SHR-A1904 has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration (NMPA) of China [1] Group 1: Industry Context - Gastric cancer is a significant global health issue, ranking fifth in incidence and fourth in mortality worldwide, with approximately 60% of cases occurring in East Asia [1] - In China, gastric cancer is particularly prevalent, with 479,000 new cases and 374,000 deaths reported in 2020, accounting for 44.0% and 48.6% of global gastric cancer incidence and mortality, respectively [1] - The incidence and mortality rates of gastric cancer rank fourth and third among malignant tumors in China, posing a serious threat to public health [1] Group 2: Product Information - SHR-A1904 is a targeted antibody-drug conjugate (ADC) developed by the company, specifically targeting Claudin18.2, with its effective payload being a topoisomerase inhibitor (TOPOi) [2] - Claudin proteins are key components of tight junctions (TJ), maintaining various functions of TJs and stabilizing the intracellular environment [2] - Claudin18.2 is a highly specific cell surface molecule expressed only in differentiated gastric mucosal epithelial cells under normal conditions, but is highly expressed in gastric cancer, pancreatic cancer, and esophageal cancer [2] - Currently, there are no similar products approved for market globally, and the cumulative R&D investment for SHR-A1904 has reached approximately 174 million yuan [2]