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恒瑞医药(01276.HK):瑞石生物”RSS0343片“获药物临床试验批准
Ge Long Hui· 2025-12-12 11:58
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]
恒瑞医药(01276):RSS0343片获药物临床试验批准通知书
智通财经网· 2025-12-12 11:57
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]
恒瑞医药(01276):HRS9531注射液获药物临床试验批准通知书
智通财经网· 2025-12-12 11:55
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]
恒瑞医药(01276):HRS-1780片获药物临床试验批准通知书
智通财经网· 2025-12-12 11:49
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-1780 tablets, which are intended for treating heart failure in adults with left ventricular ejection fraction ≥ 40% [1] Group 1: Company Developments - The subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. will soon initiate clinical trials for HRS-1780 tablets [1] - The total research and development investment for the HRS-1780 project has reached approximately 67.8 million yuan [1] Group 2: Industry Context - HRS-1780 tablets are classified as mineralocorticoid receptor antagonists and are part of a broader category of treatments for heart failure [1] - Current primary medications for heart failure include angiotensin receptor/neprilysin inhibitors and sodium-glucose cotransporter 2 inhibitors [1]
恒瑞医药:HRS-1780片获药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-12-12 11:46
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。 ...
恒瑞医药(01276.HK):子公司“HRS-1780片”获临床试验批准
Ge Long Hui· 2025-12-12 11:45
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]
恒瑞医药(600276.SH):SHR-A1811(sc)注射液获得药物临床试验批准通知书
Ge Long Hui· 2025-12-12 11:26
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。 ...
恒瑞医药(600276.SH):HRS-1780片获得药物临床试验批准通知书
Ge Long Hui· 2025-12-12 10:03
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。 ...
恒瑞医药(600276.SH):HRS9531注射液获得药物临床试验批准通知书
Ge Long Hui· 2025-12-12 10:03
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。 HRS9531注射液是以HRS9531为主要活性成分,具有全球自主知识产权的新型靶向抑胃肽受体 (GIPR)和胰高血糖素样肽-1受体(GLP-1R)的双激动剂,可在体内调节糖脂代谢、抑制食欲和增强 胰岛素敏感性,从而起到改善血糖和减轻体重的效果。对于代谢功能障碍相关脂肪性肝炎(MASH)患 者,HRS9531注射液有望通过改善肝脏脂质堆积、减轻炎症反应及潜在改善肝纤维化带来综合获益。 ...
晚间公告|12月12日这些公告有看头
Di Yi Cai Jing· 2025-12-12 09:54
Group 1 - Longsheng Technology plans to invest approximately 350 million yuan to establish an innovative center for embodied intelligent robots in Wuxi, with the company responsible for about 200 million yuan of land and construction costs, and its subsidiary Longsheng Weirui managing the center's operations with an investment of around 150 million yuan [2] - Zhongyuan Home's stock price has experienced significant short-term volatility, with a notable increase exceeding the Shanghai Composite Index, indicating potential irrational speculation risks [2] - Hengrui Medicine's HRS9531 injection has received clinical trial approval from the National Medical Products Administration, targeting metabolic dysfunction-related fatty liver disease (MASH), with no similar drugs approved globally [3] Group 2 - Guodian Power's subsidiary plans to invest 7.218 billion yuan in the construction of the Guoneng Jianbi Phase VIII project, which includes two 1 million kilowatt ultra-supercritical reheat coal-fired generating units [4] - Tianji Co., Ltd. intends to provide financial support of up to 600 million yuan to its subsidiaries, with a revolving credit structure over a 12-month period [5] - Zhiguang Electric plans to acquire minority stakes in its subsidiary Zhiguang Energy through a combination of share issuance and cash payment [6] Group 3 - Jiahuan Energy intends to use up to 100 million yuan of its own funds for futures trading in 2026, focusing on hedging and investment in PVC and caustic soda [7] - ZTE Corporation plans to repurchase 1 billion to 1.2 billion yuan of its A-shares to implement an employee stock ownership plan or equity incentive [9] - Xingyu Co., Ltd. has completed its first share repurchase, acquiring 131,600 shares for a total payment of approximately 16.44 million yuan [10] Group 4 - Zhongchao Holdings' board secretary Chen Cheng has completed the sale of 52,500 shares, representing 0.0038% of the company's total shares, in compliance with relevant laws and regulations [12] - *ST Zhisheng has won a bid for a project worth 104 million yuan, which represents 62.82% of the company's audited revenue for 2024, potentially positively impacting future performance [14]