Workflow
SAL0139片
icon
Search documents
信立泰:关于SAL0139获得临床试验批准通知书的公告
Zheng Quan Ri Bao· 2025-11-21 12:09
Core Points - The company, Xinlitai, has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0139 tablets, aimed at treating hyperlipidemia [2] Group 1 - The approval includes a Clinical Trial Approval Notification, allowing the company to proceed with the clinical trials [2]
信立泰(002294.SZ):SAL0139获得临床试验批准通知书
Ge Long Hui A P P· 2025-11-21 08:15
Core Viewpoint - The company, Xinlitai (002294.SZ), has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0139, aimed at treating hyperlipidemia [1] Group 1 - The drug SAL0139 is a self-developed innovative small molecule medication [1] - The approval allows the company to commence clinical trials for the treatment of hyperlipidemia [1]
信立泰:SAL0139片临床试验获批
Xin Lang Cai Jing· 2025-11-21 08:07
Core Viewpoint - The company, Xinlitai, has received approval from the National Medical Products Administration for its innovative small molecule drug SAL0139 tablets to conduct clinical trials for the treatment of hyperlipidemia [1] Group 1 - The drug SAL0139 is developed independently by the company [1] - The clinical trial approval is a significant step towards the drug's potential market entry [1] - The company will conduct the clinical trials in accordance with national drug registration regulations and requirements [1]
信立泰:自主研发药物SAL0139获临床试验批准
Xin Lang Cai Jing· 2025-11-21 08:07
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0139 for treating hyperlipidemia, indicating potential growth in its chronic disease product pipeline [1] Group 1: Clinical Trial Approval - The company announced that it has obtained a Clinical Trial Approval Notice for SAL0139 from the National Medical Products Administration [1] - The drug has shown potential in lowering LDL-C during preclinical studies [1] Group 2: Product Pipeline and Market Impact - Successful development and approval of SAL0139 would enhance the company's innovative product pipeline in the chronic disease sector [1] - The long drug development cycle and high risks associated with pharmaceutical research mean that there is uncertainty from clinical trials to market approval, with no immediate impact on short-term performance [1]
信立泰:创新小分子药物SAL0139获批开展治疗高脂血症临床试验
Zhi Tong Cai Jing· 2025-11-21 08:07
Core Viewpoint - The company, Xinlitai (002294.SZ), has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0139, aimed at treating hyperlipidemia [1] Group 1: Company Developments - Xinlitai has been granted a Clinical Trial Approval Notice for SAL0139, which is a self-developed drug targeting hyperlipidemia [1] - The drug SAL0139 has shown potential in preclinical studies to lower low-density lipoprotein cholesterol (LDL-C), a key risk factor for cardiovascular diseases [1] Group 2: Industry Context - Hyperlipidemia is a significant metabolic disease that can lead to various complications if not controlled, with LDL-C accumulation being a critical risk factor for cardiovascular diseases [1] - The successful development and approval of SAL0139 could provide new treatment options for patients, enhance patient compliance, and address unmet clinical needs in the chronic disease sector [1]
信立泰(002294.SZ):创新小分子药物SAL0139获批开展治疗高脂血症临床试验
智通财经网· 2025-11-21 08:06
智通财经APP讯,信立泰(002294.SZ)发布公告,近日,公司收到国家药品监督管理局核准签发的《临床 试验批准通知书》,同意公司自主研发的创新小分子药物SAL0139片(项目代码:SAL0139)开展治疗高 脂血症的临床试验。 临床前研究显示,SAL0139具有降低LDL-C的潜力,若能研发成功并获批上市,将有望为更多患者提供 新的用药选择,提高患者依从性,满足未被满足的临床需求,并进一步丰富公司慢病领域的创新产品管 线。 高脂血症是一种隐匿性强、危害广泛的代谢性疾病,长期未控制可引发多系统并发症,低密度脂蛋白胆 固醇(LDL-C)相关的高胆固醇积累是导致心脑血管疾病的关键风险因素。 ...
信立泰:SAL0139片获得临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2025-11-21 08:05
(文章来源:每日经济新闻) 每经AI快讯,11月21日,信立泰(002294.SZ)公告称,公司收到国家药品监督管理局核准签发的《临床 试验批准通知书》,同意公司自主研发的创新小分子药物SAL0139片开展治疗高脂血症的临床试验。 SAL0139具有降低LDL-C的潜力,若能研发成功并获批上市,将有望为更多患者提供新的用药选择。药 品研发周期长、风险较高,从临床到上市受到多方面因素影响,存在不确定性,短期内对公司业绩不会 产生实际影响。 ...
信立泰:SAL0139片临床试验申请获得受理
Zheng Quan Ri Bao Wang· 2025-09-05 15:09
Core Viewpoint - The company, Xinlitai, has received approval from the National Medical Products Administration for its clinical trial application of the innovative small molecule drug SAL0139 tablets [1] Group 1 - The company announced on the evening of September 5 that it has received a notice of acceptance for its clinical trial application [1] - The drug SAL0139 is developed independently by the company [1]
信立泰(002294.SZ):SAL0139药品临床试验申请获得受理
Ge Long Hui A P P· 2025-09-05 11:34
Core Viewpoint - The company, Sinopharm (002294.SZ), has received a notice of acceptance from the National Medical Products Administration for its innovative small molecule drug SAL0139, which targets hyperlipidemia and aims to provide new treatment options for patients with high cholesterol levels [1] Group 1: Drug Development - SAL0139 is an innovative small molecule drug developed by the company, with the project code SAL0139 [1] - The clinical trial application for SAL0139 has been accepted, indicating progress in the drug development process [1] - Preclinical studies suggest that SAL0139 has the potential to lower low-density lipoprotein cholesterol (LDL-C), a key risk factor for cardiovascular diseases [1] Group 2: Market Implications - If successfully developed and approved, SAL0139 could offer new medication options for patients with hyperlipidemia, addressing unmet clinical needs [1] - The introduction of SAL0139 is expected to enhance patient compliance and expand the company's innovative product pipeline in the chronic disease sector [1]
信立泰:SAL0139药品临床试验申请获受理
Zhi Tong Cai Jing· 2025-09-05 11:27
Core Viewpoint - The company, Xinlitai (002294.SZ), has received a notice of acceptance from the National Medical Products Administration for its clinical trial application of the innovative small molecule drug SAL0139, which is intended for the treatment of hyperlipidemia [1] Company Summary - The drug SAL0139 is developed by the company and possesses independent intellectual property rights [1] - The application submitted by the company is specifically for conducting clinical trials of SAL0139 for hyperlipidemia treatment [1]