恒瑞医药：注射用SHR-A1904被药审中心纳入突破性治疗品种名单

Group 1 - The core announcement is that Jiangsu Hengrui Medicine Co., Ltd. and its subsidiary Shanghai Hengrui Medicine Co., Ltd. have had their injectable SHR-A1904 included in the list of breakthrough therapy products by the National Medical Products Administration [1] - 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. In China, there were 479,000 new cases and 374,000 deaths from gastric cancer in 2020, accounting for 44.0% and 48.6% of global cases and deaths, respectively [1] Group 2 - SHR-A1904 is a targeted antibody-drug conjugate (ADC) developed by the company, specifically targeting Claudin18.2, with an effective payload of topoisomerase inhibitor (TOPOi). Claudin proteins are key components of tight junctions (TJ) that maintain various functions and stability of 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. Currently, there are no similar products approved for market globally [2] - The cumulative R&D investment for SHR-A1904 has reached approximately 174 million yuan [2]