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]

Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of HRS9531 injection, a novel dual agonist targeting GIPR and GLP-1R, aimed at improving metabolic disorders and weight management [1] Group 1: Product Development - The HRS9531 injection is based on the active ingredient HRS9531, which has global independent intellectual property rights [1] - The drug is designed to regulate glucose and lipid metabolism, suppress appetite, and enhance insulin sensitivity, leading to improved blood sugar levels and weight loss [1] Group 2: Target Indication - HRS9531 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 [1]

HRS-1780 片是盐皮质激素受体拮抗剂，临床拟用于治疗左室射血分数≥40% 的成人心力衰竭。目前治 疗心衰的主要药物包括血管紧张素受体/脑啡肽酶抑制剂和钠-葡萄糖共转运蛋白2抑制剂等。截至目 前，HRS-1780 片相关项目累计研发投入约为6780万元。 智通财经APP讯，恒瑞医药(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 司山东盛迪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HRS-1780片的 《药物临床试验批准通知书》，将于近期开展临床试验。 ...

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")子公司山东 盛迪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HRS-1780片的《药物 临床试验批准通知书》，将于近期开展临床试验。 HRS-1780片是盐皮质激素受体拮抗剂，临床拟用于治疗左室射血分数≥40%的成人心力衰竭。目前治疗 心衰的主要药物包括血管紧张素受体/脑啡肽酶抑制剂和钠-葡萄糖共转运蛋白2抑制剂等。截至目前， HRS-1780片相关项目累计研发投入约为6780万元。 ...

Group 1 - The core announcement is that Jiangsu Hengrui Medicine Co., Ltd.'s subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HRS-1780 tablets [1] - HRS-1780 is a tablet formulation intended for clinical trials, with the application numbers CXHL2500992 and CXHL2500993 [2] - The approval indicates that HRS-1780 meets the requirements for drug registration as per the Drug Administration Law of the People's Republic of China, allowing the initiation of clinical trials [2] Group 2 - The intended indication for HRS-1780 is the treatment of adult patients with heart failure and a left ventricular ejection fraction of ≥40% [2]

公司注射用瑞康曲妥珠单抗（SHR-A1811）已于2025年5月在国内获批上市，给药途径为静脉输注，适 用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移 性非小细胞肺癌（NSCLC）成人患者。SHR-A1811可通过与HER2表达的肿瘤细胞结合并内吞，在肿瘤 细胞溶酶体内通过蛋白酶剪切释放毒素，诱导细胞周期阻滞从而触发肿瘤细胞凋亡。其释放的毒素具有 高透膜性，可发挥旁观者杀伤效应，进一步提高抗肿瘤疗效。SHR-A1811(sc)是在注射用SHR-A1811的 基础上开发的皮下制剂，有望缩短临床给药时长，提高给药便捷性。 格隆汇12月12日丨恒瑞医药(600276.SH)公布，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。 ...

财经频道更多独家策划、专家专栏，免费查阅>> 责任编辑：钟离 格隆汇12月12日丨恒瑞医药(600276.SH)公布，公司子公司山东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HRS-1780片的《药物临床试验批准通知书》，将于近期开展临床试验。HRS-1780片 是盐皮质激素受体拮抗剂，临床拟用于治疗左室射血分数≥40%的成人心力衰竭。目前治疗心衰的主要 药物包括血管紧张素受体/脑啡肽酶抑制剂和钠-葡萄糖共转运蛋白2抑制剂等。 ...