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 ...

Core Viewpoint - The company 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, a self-developed therapeutic biological product aimed at treating atopic dermatitis [1] Group 1 - SHR-1894 injection is expected to protect the skin barrier and suppress inflammation during the treatment of atopic dermatitis [1] - The total research and development investment for this project has reached approximately 40.1 million yuan [1] - Following the approval of the clinical trial notification, the drug must undergo clinical trials and receive further review and approval from the National Medical Products Administration before it can be produced and marketed [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-1894 injection, a self-developed therapeutic biological product aimed at treating atopic dermatitis [1] Group 1 - SHR-1894 injection is expected to protect the skin barrier and inhibit inflammation during the treatment of atopic dermatitis [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]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received the acceptance notice from the National Medical Products Administration for the listing application of HR091506 tablets, intended for the long-term treatment of hyperuricemia in gout patients [1] Group 1: Product Development - HR091506 tablets are developed using gastric retention formulation technology and feature a pulsatile release characteristic, consisting of both immediate-release and delayed-release components [1] - The immediate-release part quickly releases in the stomach to achieve effective blood drug concentration, while the delayed-release part remains in the stomach to sustain the release, aiming to prolong the maintenance time of effective blood drug concentration and improve the rate of achieving uric acid reduction targets [1] - The total R&D investment for the HR091506 project has reached approximately 126.7 million yuan (unaudited) [1]

Core Viewpoint - The company has received acceptance from the National Medical Products Administration for the marketing authorization application of HR091506 tablets, a novel oral sustained-release formulation of febuxostat [1] Group 1: Product Development - HR091506 tablets are developed using gastric retention formulation technology and feature a pulsatile release characteristic [1] - The product consists of a rapid-release component and a delayed-release component, designed to quickly achieve effective blood drug concentration and maintain it over an extended period [1] Group 2: Market Implications - The sustained-release nature of HR091506 aims to improve the rate of achieving target uric acid levels in patients [1]

Core Viewpoint - The announcement indicates that the subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. of Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of SHR-1894 injection, which is expected to play a role in treating atopic dermatitis by protecting the skin barrier and inhibiting inflammation [1] Group 1: Product Development - SHR-1894 injection is a self-developed therapeutic biological product by the company [1] - The clinical trial for SHR-1894 injection will commence shortly following the approval [1] - The total research and development investment for the SHR-1894 injection project has reached approximately 40.1 million yuan [1] Group 2: Market Context - Currently, there are no similar drugs approved for market release domestically or internationally [1]

Core Viewpoint - The report highlights the current premium rates of AH shares, with Northeast Electric (00042), Zhejiang Shibao (01057), and Sinopec Oilfield Service (01033) leading in premium rates, while CATL (03750), China Merchants Bank (03968), and Hansoh Pharmaceutical (01276) are at the bottom of the list [1]. Premium Rate Rankings - The top three AH shares by premium rate are: - Northeast Electric (00042) with a premium rate of 815.25% - Zhejiang Shibao (01057) with a premium rate of 354.93% - Sinopec Oilfield Service (01033) with a premium rate of 295.40% [1]. - The bottom three AH shares by premium rate are: - CATL (03750) with a premium rate of -11.82% - China Merchants Bank (03968) with a premium rate of -2.30% - Hansoh Pharmaceutical (01276) with a premium rate of 1.62% [1]. Deviation Values - The top three shares with the highest deviation values are: - Goldwind Technology (02208) with a deviation value of 21.73% - Jinyu Group (02009) with a deviation value of 19.04% - Sinopec Oilfield Service (01033) with a deviation value of 18.76% [1]. - The bottom three shares with the lowest deviation values are: - Zhejiang Shibao (01057) with a deviation value of -41.23% - Junda Co., Ltd. (02865) with a deviation value of -39.46% - Yangtze Optical Fibre and Cable (06869) with a deviation value of -26.61% [1]. Additional Insights - The report includes a detailed table of the top and bottom AH shares by premium rate and deviation value, providing a comprehensive overview of the current market situation [2].