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恒瑞医药:RSS0343片获药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-12-12 12:00
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。 ...
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:子公司RSS0343片临床试验获批
Xin Lang Cai Jing· 2025-12-12 09:11
恒瑞医药12月12日公告,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。申请的适应症为慢性鼻窦炎不伴 鼻息肉和慢性阻塞性肺疾病。 ...
恒瑞医药(600276.SH):RSS0343片获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-12-12 09:11
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 制炎症和缓解呼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。 格隆汇12月12日丨恒瑞医药(600276.SH)公布,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。 ...
恒瑞医药:子公司药物获临床试验批准,将开展两项试验
Xin Lang Cai Jing· 2025-12-12 09:00
恒瑞医药公告称,子公司瑞石生物医药收到国家药监局关于RSS0343片的《药物临床试验批准通知 书》,将于近期开展临床试验。该药申请的适应症为慢性鼻窦炎不伴鼻息肉和慢性阻塞性肺疾病。 RSS0343是公司自主研发的小分子1类新药,国内外暂无同类药物获批上市,相关项目累计研发投入约 7228万元。药品研发上市周期长、环节多,存在不确定性,公司将推进项目并披露进展。 ...