Group 1 - Company and its subsidiaries received approval from the National Medical Products Administration for clinical trials of HRS-4508 tablets, SHR-A1811 injection, Adebali monoclonal antibody injection, and Bevacizumab injection [1] - HRS-4508 is a novel, efficient, selective tyrosine kinase inhibitor that inhibits tumor cell proliferation [1] - The total R&D investment for HRS-4508 project is approximately 36.42 million yuan [1] Group 2 - SHR-A1811 injection binds to HER2-expressing tumor cells and induces apoptosis through a unique mechanism [2] - SHR-A1811 was approved for use in treating adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations [2] - The total R&D investment for SHR-A1811 project is approximately 1.26 billion yuan [2] Group 3 - Bevacizumab is a humanized anti-VEGF monoclonal antibody that has been approved in multiple countries since 2004 [3] - The global sales of Bevacizumab are projected to be approximately 5.655 billion USD in 2024 [3] - The total R&D investment for Bevacizumab injection project is approximately 3.45 million yuan [3]

审批结论：根据美国《联邦食品、药品和化妆品法案》第526条,授予注射用瑞康曲妥珠单抗联合阿得贝 利单抗注射液和化疗用于胃癌或胃食管结合部腺癌适应症的孤儿药资格。 一、药品的基本情况 药品名称：注射用瑞康曲妥珠单抗 适应症：联合阿得贝利单抗注射液和化疗用于胃癌或胃食管结合部腺癌 申请编号：DRU-2025-10850 申请人：江苏恒瑞医药股份有限公司 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）产品注射用瑞康曲妥珠单抗联合阿得贝利单抗注 射液和化疗用于胃癌或胃食管结合部腺癌适应症获得美国食品药品监督管理局（以下简称"美国FDA"） 授予的孤儿药资格认定。孤儿药又称罕见病药，是指用于预防、治疗、诊断罕见病的药品。本次公司获 得美国FDA孤儿药资格认定，将有机会在产品研发、注册及商业化等方面享受美国的政策支持。现将相 关情况公告如下： 2025年8月6日 二、药品的其他情况 [1]．Freddie Bray et al. Global cancer statistics 2022 ...