Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for the clinical trial of HRS-8364 tablets, which will be conducted for advanced solid tumors [1] Group 1: Drug Information - Drug Name: HRS-8364 tablets [1] - Dosage Form: Tablet [1] - Application Type: Clinical trial [1] - Acceptance Numbers: CXHL2500944, CXHL2500945 [1] - Approval Conclusion: The clinical trial application for HRS-8364 tablets, accepted on September 2, 2025, meets the requirements for drug registration and is approved for clinical trials in advanced solid tumors [1]

Core Viewpoint - The announcement highlights that Jiangsu Hengrui Medicine Co., Ltd.'s subsidiary, Suzhou Merrimack Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of injection-based Rukang Trastuzumab, which is set to be launched in China by May 2025 for treating specific lung cancer patients [1][2]. Group 1 - The injection-based Rukang Trastuzumab is indicated for adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy [1]. - The mechanism of action involves binding to HER2-expressing tumor cells, leading to internalization and release of toxins within the tumor cells' lysosomes, inducing cell cycle arrest and apoptosis [1]. - The released toxins exhibit high membrane permeability, enhancing the anti-tumor efficacy through a bystander killing effect [1]. Group 2 - Competing products in the market include Roche's Ado-trastuzumab emtansine and AstraZeneca's collaboration with Daiichi Sankyo on Fam-trastuzumab deruxtecan, both of which are already available in China [1]. - Other similar products include Rongchang Biopharmaceutical's Vedisizumab, approved in 2021, and Kelun's Botuzumab, expected to be approved in 2025 [2]. - The global sales of similar products are projected to reach approximately $6.557 billion from 2024 onwards, with the cumulative R&D investment for Rukang Trastuzumab amounting to about 141.475 million yuan [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。 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。 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 2025年11月25日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 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 ...

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。 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"）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 HRS-8364 片的《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： 中國上海 2025年11月25日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生 ...

Core Insights - The article highlights the top and bottom AH share premium rates, with Northeast Electric (00042) leading at 831.03% and Ningde Times (03750) at -4.55% [1][2][3] Premium Rate Rankings - The top three AH share premium rates are: - Northeast Electric (00042): 831.03% - Hongye Futures (03678): 270.00% - Sinopec Oilfield Service (01033): 268.92% [1][2] - The bottom three AH share premium rates are: - Ningde Times (03750): -4.55% - China Merchants Bank (03968): -1.71% - Heng Rui Medicine (01276): 3.65% [1][3] Deviation Value Rankings - The top three stocks with the highest deviation values are: - China Shipbuilding Defense (00317): 53.01% - Guanghetong (00638): 25.36% - GAC Group (02238): 22.12% [1][4] - The bottom three stocks with the lowest deviation values are: - Longpan Technology (02465): -31.76% - Northeast Electric (00042): -23.74% - Ganfeng Lithium (01772): -14.15% [1][5]

智通财经APP获悉，香港联交所最新资料显示，11月20日，GIC Private Limited增持恒瑞医药(01276)95.2 万股，每股作价68.7975港元，总金额约为6549.52万港元。增持后最新持股数目为5766.56万股，最新持 股比例为22.33%。 ...

格隆汇11月24日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司子公司成都盛迪医药有 限公司收到国家药品监督管理局的通知，批准公司帕立骨化醇软胶囊上市。现将相关情况公告如下： 规格：1μg、2μg 注册分类：化学药品3类 受理号：CYHS2400770、CYHS2400772 处方药/非处方药：处方药 一、药品的基本情况 药品名称：帕立骨化醇软胶囊 剂型：胶囊剂 批准的适应症：用于预防和治疗成人慢性肾脏病(CKD)3-4期继发性甲状旁腺功能亢进症(SHPT)。 SHPT是CKD患者常见的严重并发症之一，在CKD早期(肾小球滤过率<80mL/[min·1.73m2])即可出现， 并随着肾功能的恶化而加重。帕立骨化醇是一种合成的维生素D类似物，通过与维生素D受体结合抑制 甲状旁腺激素(PTH)的分泌，从而降低血清PTH水平。帕立骨化醇软胶囊由Abbvie公司研制开发，于 2005年5月获FDA批准上市，尚未在国内上市。公司为该品种在国内的首家仿制药企业，本次获批视同 通过仿制药质量和疗效一致性评价。截至目前，帕立骨化醇软胶囊项目累计研发投入约5,794万元。 ...

Core Viewpoint - Heng Rui Medicine has received acceptance for its drug application for Sulfate Emmaxetine Tablets from the National Medical Products Administration, marking a significant step in expanding its product portfolio in the autoimmune disease treatment market [1][2]. Group 1: Drug Development and Clinical Trials - The clinical trial for Sulfate Emmaxetine Tablets in treating radiographic negative axial spondyloarthritis achieved its primary endpoint as planned by September 2025, demonstrating efficacy and safety in a multicenter, randomized, double-blind, placebo-controlled Phase III study involving 304 adult patients [1]. - The Emmaxetine group showed significant superiority over the placebo group in both primary and key secondary endpoints, with good safety and tolerability profiles compared to other JAK1 inhibitors, without new safety signals identified [1]. Group 2: Market Context and Competitive Landscape - Sulfate Emmaxetine Tablets have already been approved for four indications in China, including active ankylosing spondylitis and moderate to severe rheumatoid arthritis, among others [2]. - The drug is a highly selective JAK1 inhibitor, which exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [2]. - Currently, the only similar oral drug approved globally for radiographic negative axial spondyloarthritis is AbbVie's Upadacitinib (RINVOQ), which is projected to generate approximately $5.971 billion in global sales in 2024 [2]. - The total R&D investment for Sulfate Emmaxetine projects has reached approximately 1.091 billion yuan [2].

格隆汇11月24日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司收到国家药品监督管理 局下发的《受理通知书》，公司提交的硫酸艾玛昔替尼片药品上市许可申请获国家药监局受理。现将相 关情况公告如下： 受理号：CXHS2500141 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)：本品适用于对非甾体抗炎药(NSAID)应答不佳或不耐受且存在客观炎症征象 (表现为 C 反应蛋白[CRP]升高和/或磁共振成像[MRI]异常)的活动性放射学阴性中轴型脊柱关节炎成人 患者。 一、药品的基本情况 药品名称：硫酸艾玛昔替尼片 剂型：片剂 ...

格隆汇11月24日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司收到国家药品监督管理 局下发的《受理通知书》，公司提交的硫酸艾玛昔替尼片药品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 药品名称：硫酸艾玛昔替尼片 剂型：片剂 受理号：CXHS2500141 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)：本品适用于对非甾体抗炎药(NSAID)应答不佳或不耐受且存在客观炎症征象 (表现为 C 反应蛋白[CRP]升高和/或磁共振成像[MRI]异常)的活动性放射学阴性中轴型脊柱关节炎成人 患者。 ...