登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：600276 证券简称：恒瑞医药 公告编号：临2025-145 并纳入优先审评程序的提示性公告 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"）子公司苏州盛迪亚生物医药有限公司收到国家药 品监督管理局（以下简称"国家药监局"）下发的《受理通知书》，公司注射用瑞康曲妥珠单抗（SHR- A1811）用于治疗既往接受过一种或一种以上抗HER2药物治疗的局部晚期或转移性HER2阳性成人乳腺 癌患者的新适应症上市许可申请获国家药监局受理，且已被纳入优先审评程序。现将相关情况公告如 下： 一、药品的基本情况 药品名称：注射用瑞康曲妥珠单抗 剂型：注射剂 受理号：CXSS2500094 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理 申报阶段：上市 申请人：苏州盛迪亚生物医药有限公司 拟定适应症（或功能主治）：本品适用于治疗既往接受过一种或一种以上抗HER2药物治疗的局部晚期 或转移性HER2阳性成人乳腺癌患者。 二、药品的临 ...

Core Viewpoint - Heng Rui Medicine has received acceptance notification from the National Medical Products Administration for its drug application of Haequibopam Ethanolamine Tablets, aimed at treating chemotherapy-induced thrombocytopenia in adult patients [1] Group 1: Drug Development - The Phase III clinical trial (SHR8735-301) for Haequibopam Ethanolamine Tablets achieved its primary research endpoint as planned in May 2025 [1] - The study evaluated the efficacy and safety of Haequibopam Ethanolamine Tablets in patients with chemotherapy-induced thrombocytopenia through a multicenter, randomized, double-blind, placebo-controlled design [1] - A total of 213 adult patients with chemotherapy-induced thrombocytopenia were enrolled in the study, led by Professor Ma Jun from Harbin First Hospital and Professor Qin Shukui from Nanjing Tianyinshan Hospital [1] Group 2: Study Results - The results indicated that the treatment group significantly outperformed the control group on the primary efficacy endpoint [1] - The safety and tolerability of Haequibopam Ethanolamine Tablets were reported to be good [1]