Group 1 - The core point of the article is that Heng Rui Medicine has received acceptance for its HR091506 tablet's market approval application from the National Medical Products Administration of China [1] - The application is based on two key Phase III clinical studies, HR091506-301 and HR091506-302, which evaluated the efficacy and safety of HR091506 in patients with gout and hyperuricemia [1] - The HR091506-301 study involved 442 participants across 73 centers, while the HR091506-302 study included 765 participants across 71 centers, both showing significant efficacy over the control group [1] Group 2 - HR091506 is a self-developed oral sustained-release tablet utilizing gastric retention technology, featuring both rapid and delayed release components [2] - The rapid-release part quickly achieves effective blood drug concentration, while the delayed-release part maintains the concentration over a longer period [2] - The total R&D investment for the HR091506 project has reached approximately 127 million yuan (unaudited) [2]

Core Viewpoint - Heng Rui Medicine (01276.HK) has received the acceptance notice from the National Medical Products Administration for the listing application of HR091506 tablets, indicating progress in its drug development pipeline [1] Group 1: Clinical Research - The listing application is based on two key Phase III clinical studies (HR091506-301 and HR091506-302) that are randomized, double-blind, and have a positive control with febuxostat [1] - The HR091506-301 study evaluated the efficacy and safety of HR091506 tablets in patients with gout and hyperuricemia requiring deep uric acid control, involving 442 subjects across 73 centers, led by Professors Zou Hejian and Xue Yu from Huashan Hospital, Fudan University [1] - The HR091506-302 study assessed the efficacy and safety of HR091506 tablets in patients with gout and hyperuricemia, enrolling 765 subjects across 71 centers, with Professor Zhang Zhuoli from Peking University First Hospital as the principal investigator [1] Group 2: Study Results - Results from both studies showed that HR091506 tablets significantly outperformed the control group on primary endpoints [1] - The long-term safety and tolerability of HR091506 tablets in patients with gout and hyperuricemia were found to be good [1]

Core Viewpoint - Heng Rui Medicine has received acceptance for the listing application of HR091506 tablets from the National Medical Products Administration, indicating progress in the drug's approval process [1] Group 1: Clinical Research - The listing application is based on two key Phase III clinical studies (HR091506-301 and HR091506-302) that are randomized, double-blind, and have a positive control with febuxostat [1] - The HR091506-301 study evaluated the efficacy and safety of HR091506 tablets in gout patients with high uric acid levels, involving 442 participants across 73 centers [1] - The HR091506-302 study also assessed the efficacy and safety of HR091506 tablets in gout patients, with 765 participants across 71 centers [1] - Both studies showed that HR091506 tablets significantly outperformed the control group on primary endpoints and demonstrated good long-term safety and tolerability in patients [1] Group 2: Product Development - HR091506 tablets are developed using gastric retention formulation technology, featuring a pulse release characteristic with both immediate and delayed release components [2] - The immediate release part quickly achieves effective blood drug concentration, while the delayed release part maintains the concentration over an extended period [2] - The total R&D investment for HR091506 tablets has reached approximately 127 million yuan (unaudited) [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2026年2月5日 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 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 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-021 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。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2026年2月5日 於本公告日期，董事會成 ...

Core Viewpoint - Heng Rui Medicine has received acceptance notification from the National Medical Products Administration for its HR091506 tablet, aimed at long-term treatment of hyperuricemia in gout patients [1] Group 1: Product Development - HR091506 is a self-developed oral sustained-release tablet utilizing gastric retention technology, featuring pulse release characteristics [1] - The product consists of a rapid-release part and a delayed-release part, designed to quickly achieve effective blood drug concentration and maintain it over an extended period [1] - The cumulative R&D investment for HR091506 has reached approximately 126.7 million yuan (unaudited) [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received acceptance from the National Medical Products Administration for its HR091506 tablet, aimed at long-term treatment of hyperuricemia in gout patients [1] Group 1: Product Development - HR091506 is a self-developed oral sustained-release tablet utilizing gastric retention technology, featuring pulse release characteristics [1] - The product consists of a rapid-release portion that quickly achieves effective blood drug concentration and a delayed-release portion that maintains drug concentration over time [1] - The total R&D investment for the HR091506 project has reached approximately 126.7 million yuan (unaudited) [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-1894 injection, which is expected to begin soon [1] Group 1: Product Development - SHR-1894 injection is a self-developed therapeutic biological product aimed at treating atopic dermatitis, expected to protect the skin barrier and suppress inflammation [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] - The total research and development investment for the SHR-1894 injection project has reached approximately 40.1 million yuan (unaudited) [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-021 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"）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 HR091506 片 的上市许可申请获国家药监局受理。现将相关情况公告如下： 一、药品的基本情况 受理号：CXHS2600022、CXHS2600023 申报阶段：上市 申请人：江苏恒瑞医药股份有限公司 拟定适应症（或功能主治）：用于痛风患者高尿酸血症的长期治疗。 二、药品的临床试验情况 此次申报上市，是基于两项随机、双盲、非布司他片阳性对照的关键Ⅲ期临 床研究（研究编号 HR091506-301、HR091506-302）。HR091506-301 研究是一项 评价 HR091506 片在需尿酸深度达标的痛风伴高尿酸血症患者中的有效性和安全 性Ⅲ期研究，由复旦大学附属华山医院邹和建、薛愉教授担任主要研究者，全国 ...

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"）核准签 发关于 SHR-1894 注射液的《药物临床试验批准通知书》，将于近期开展临床试 验。现将相关情况公告如下： 一、药物的基本情况 药物名称：SHR-1894 注射液 剂 型：注射剂 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-022 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 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。 二、药物的其他情况 SHR-1894 注射液是公司自主研发的一种治疗用生物制品，预期可在特应性 皮炎治疗过程中，发挥保护皮肤屏障和抑制炎症的作用。经查询，目前国内外尚 无同类药物获批上市。截至目前，SHR-1894 注射液相关项目累计研发投入约为 4,010 万元(未经审计)。 三、风险提示 根据我国药品注册相关的法律法规要求，药物在获得药物临床试验批准通知 书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。药 ...