Core Viewpoint - Heng Rui Medicine has received orphan drug designation from the US FDA for its product, injection of Rikan Trastuzumab combined with Adebali monoclonal antibody and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma [1][3] Group 1: Orphan Drug Designation - The orphan drug designation allows the company to benefit from US policy support in product development, registration, and commercialization [1][3] - Orphan drugs are defined as medications used for the prevention, treatment, or diagnosis of rare diseases [1] Group 2: Gastric Cancer Statistics - In 2022, gastric cancer ranked 5th in global cancer incidence and mortality, with 968,400 new cases and 659,900 deaths worldwide [1] - In China, there were 358,700 new cases and 260,400 deaths, ranking 5th in incidence and 3rd in mortality [1] Group 3: Product Details - Injection of Rikan Trastuzumab targets HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release [2] - The product is set to be approved for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received at least one systemic treatment [2] - Competing products include Ado-trastuzumab emtansine (Kadcyla) and Fam-trastuzumab deruxtecan (Enhertu), with combined global sales projected at approximately $6.557 billion in 2024 [2] Group 4: Clinical Trial and Market Exclusivity - The orphan drug designation will expedite clinical trials and market registration processes [3] - The company will enjoy various policy supports, including tax credits for clinical trial costs, waiver of new drug application fees, and 7 years of market exclusivity post-approval [3]

据了解，恒瑞医药本次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 腺癌适应症获得孤儿药资格认定后，能够加快推进临床试验及上市注册的进度。同时，可享受一定的政 策支持，包括但不限于临床试验费用的税收抵免、免除新药申请费、产品获批后将享受7年的市场独占 权。 目前，国内外指南推荐一线治疗标准方案在临床取得一定效果，但仍存在生存期较短、预后不佳等未被 满足临床需求。 公告显示，注射用瑞康曲妥珠单抗可通过与HER2表达的肿瘤细胞结合并内吞，在肿瘤细胞溶酶体内通 过蛋白酶剪切释放毒素，诱导细胞周期阻滞从而诱导肿瘤细胞凋亡。公司注射用瑞康曲妥珠单抗已于 2025年5月在国内获批上市，适用于治疗存在HER2(ERBB2)激活突变且既往接受过至少一种系统治疗的 不可切除的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者。经查询，目前国外已上市的同类产品有 Ado-trastuzumab emtansine(商品名Kadcyla)和Fam-trastuzumab deruxtecan(商品名Enhertu)。 Kadcyla由罗氏公司开发，2019年国内已进口上市；Enhertu由阿斯利康和第一三共 ...