Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of HRS9531 injection, a novel dual agonist targeting GIPR and GLP-1R with global intellectual property rights [1] Group 1: Product Development - The HRS9531 injection is designed to regulate glucose and lipid metabolism, suppress appetite, and enhance insulin sensitivity, thereby improving blood sugar levels and aiding weight loss [1] - The injection is expected to provide comprehensive benefits for patients with metabolic dysfunction-related fatty liver disease (MASH) by improving liver lipid accumulation, reducing inflammation, and potentially improving liver fibrosis [1] - There are currently no similar drugs approved for the MASH indication globally, indicating a unique market opportunity for the company [1]

Core Viewpoint - Heng Rui Medicine has completed the first batch of shipments for new drugs approved for market release in 2025, which are now being sold domestically [1] Group 1: New Drug Approvals and Sales - The company has successfully launched new drugs approved for 2025 and has completed initial shipments [1] - The drug SHR-A1811 has been approved for the second-line treatment of HER2-mutant non-small cell lung cancer in China, with the second-line treatment for HER2-positive breast cancer currently under review for market approval [1] Group 2: Revenue Recognition and Licensing Deals - As of the end of Q3, the company has recognized part of the upfront payments from external licensing deals, including $200 million from Merck [1] - Upfront payments from the GSK deal amounting to $500 million have been received and recorded as contract liabilities, but revenue recognition is pending due to unfulfilled contractual obligations as of Q3 [1] - The company will provide updates on revenue recognition in future periodic reports published on the exchange website [1] Group 3: Future Development Plans - The company plans to cautiously evaluate and steadily advance overseas research and development for SHR-A1811 based on the specific circumstances of different indications [1]

（文章来源：证券日报） 证券日报网讯 12月12日，恒瑞医药在互动平台回答投资者提问时表示，公司本次共有20款产品/适应症 通过新版国家医保目录调整，覆盖肿瘤、代谢、心血管疾病、免疫系统疾病、眼科等多个治疗领域；其 中瑞康曲妥珠单抗（HER2 ADC）、艾玛昔替尼（JAK1）、夫那奇珠单抗（IL-17A）、瑞卡西单抗 （PCSK9）等10款产品首次进入医保目录，将促进公司产品惠及更多患者。本次商保目录内无公司产 品。公司多年来始终致力于将推动医药创新与履行社会责任紧密结合，未来将继续坚守"以患者为中 心"的初心，加速推进前沿药物的研发与上市，并积极响应国家政策，努力提升患者用药可及性与可负 担性。 ...

恒瑞医药(01276.HK)发布公告，近日，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 局核准签发关于 SHR-A1811(sc)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。 ...

Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for clinical trials of SHR-A1811(sc) injection, which will commence shortly [1] Group 1: Product Development - The SHR-A1811 is designed to bind to HER2-expressing tumor cells and release toxins within the lysosomes, inducing cell cycle arrest and triggering apoptosis in tumor cells [1] - The released toxins exhibit high membrane permeability and can exert a bystander killing effect, enhancing anti-tumor efficacy [1] - SHR-A1811(sc) is a subcutaneous formulation developed based on the injectable SHR-A1811, expected to shorten clinical administration time and improve convenience of administration [1]

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of SHR-A1811(sc) injection, which will be conducted in patients with advanced solid tumors [1][2]. Group 1: Company Information - Hengrui Medicine's subsidiary, Suzhou Sediya Biopharmaceutical Co., Ltd., is responsible for the clinical trial of SHR-A1811(sc) injection [1]. - The clinical trial application for SHR-A1811(sc) injection was accepted on September 10, 2025, and has met the requirements for drug registration [2]. Group 2: Drug Information - The drug SHR-A1811(sc) is an injectable formulation intended for use in clinical trials [2]. - The approval allows for the drug to be tested specifically in patients with advanced solid tumors [2].

RSS0343是公司自主研发的一款口服、强效和高选择性的小分子1类新药，在动物模型中具有很强的抑 制炎症和缓解唿吸道相关组织损伤的作用。针对慢性鼻窦炎不伴鼻息肉和慢性阻塞性肺疾病，国内外目 前暂无同类药物获批上市。截至目前，RSS0343片相关项目累计研发投入约7228万元。 恒瑞医药（600276）(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")子公司瑞石 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RSS0343片的《药物 临床试验批准通知书》，将于近期开展临床试验。 ...

受理号：CXHL2500996、CXHL2500997、CXHL2500998 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025年9月11日受理的HRS9531 注射液临床试验申请符合药品注册的有关要求，同意本品开展代谢相关脂肪性肝炎的临床试验。 剂型：注射剂 申请事项：临床试验 格隆汇12月12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福建盛迪医药有 限公司收到国家药品监督管理局核准签发关于HRS9531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。 药物名称：HRS9531注射液 ...

Group 1 - Core viewpoint: Jiangsu Hengrui Medicine Co., Ltd.'s subsidiary, Ruishi Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of RSS0343 tablets, which will commence shortly [1] Group 2 - Drug name: RSS0343 tablets [2] - Dosage form: Tablet [2] - Application matter: Clinical trial [2] - Acceptance numbers: CXHL2501022, CXHL2501023, CXHL2501024, CXHL2501025 [2] - Approval conclusion: The clinical trial application for RSS0343 tablets, submitted on September 22 and 23, 2025, meets the requirements for drug registration and is approved to conduct two clinical trials [2] - Indications: Chronic sinusitis without nasal polyps and chronic obstructive pulmonary disease [2]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of RSS0343, a new oral drug targeting chronic sinusitis and chronic obstructive pulmonary disease [1] Group 1: Drug Development - RSS0343 is a self-developed small molecule Class 1 new drug with strong anti-inflammatory effects and the ability to alleviate respiratory tract-related tissue damage in animal models [1] - There are currently no similar drugs approved for market in China or internationally for the treatment of chronic sinusitis without nasal polyps and chronic obstructive pulmonary disease [1] - The total research and development investment for the RSS0343 project has reached approximately 72.28 million yuan [1]