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人福医药:子公司两款药品获药品注册证书
Core Viewpoint - The company has received regulatory approval for two new pharmaceutical products, indicating a positive development in its product pipeline and potential revenue growth [1] Group 1: Product Approvals - The company's subsidiary, Yichang Renfu Pharmaceutical, has been granted a drug registration certificate for the injection of heavy tartrate de-norepinephrine, which is used for blood pressure control in certain acute hypotensive states [1] - The company's wholly-owned subsidiary, Renfu Puke Pharmaceutical, has received approval for ethyl eicosapentaenoate soft capsules, aimed at reducing triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) in conjunction with dietary control [1]
人福医药:二十碳五烯酸乙酯软胶囊获得药品注册证书
Zhi Tong Cai Jing· 2025-09-02 09:16
Group 1 - The core point of the article is that Renfu Pharmaceutical's subsidiary, Renfu Puke Pharmaceutical (Wuhan) Co., Ltd., has received approval from the National Medical Products Administration for the registration of Eicosapentaenoic Acid Ethyl Ester Soft Capsules, allowing the company to sell this product in the domestic market [1] - The approval of Eicosapentaenoic Acid Ethyl Ester Soft Capsules enriches the company's product line [1] - The market launch of this product is expected to have a positive impact on the company's performance [1]
人福医药:子公司重酒石酸去甲肾上腺素注射液获得药品注册证书
Xin Lang Cai Jing· 2025-09-02 09:16
Core Viewpoint - The announcement indicates that the company has received regulatory approval for a new medication, which could enhance its product portfolio and market position in the pharmaceutical industry [1] Company Summary - The company, Renfu Pharmaceutical, announced on September 2 that its subsidiary, Yichang Renfu Pharmaceutical, has received a drug registration certificate from the National Medical Products Administration for a new injectable medication [1] - The newly approved drug, heavy tartrate deactivated epinephrine injection, is intended for use in managing acute hypotensive states and as an adjunct treatment for cardiac arrest and severe hypotension [1] Industry Summary - The approval of this medication reflects ongoing regulatory support for new pharmaceutical products, which may lead to increased competition and innovation within the industry [1] - The drug's application in critical care scenarios highlights the growing demand for effective treatments in emergency medicine, potentially impacting market dynamics [1]
人福医药:重酒石酸去甲肾上腺素注射液获药品注册证书
Xin Lang Cai Jing· 2025-09-02 09:16
Core Viewpoint - The approval of the drug by the National Medical Products Administration signifies the company's qualification to sell the product in the domestic market, enhancing its product line and potential revenue streams [1] Group 1: Company Developments - Yichang Renfu Pharmaceutical, a subsidiary of Renfu Pharmaceutical, has received the drug registration certificate for Dexamethasone Injection from the National Medical Products Administration [1] - The drug is indicated for the control of blood pressure in certain acute hypotensive states, as well as for the auxiliary treatment of cardiac arrest and severe hypotension [1] - The projected national sales for the drug in 2024 are approximately 2.1 billion yuan [1]
人福医药:二十碳五烯酸乙酯软胶囊获药品注册证书
Xin Lang Cai Jing· 2025-09-02 09:16
Core Viewpoint - The announcement highlights the approval of a new drug, Eicosapentaenoic Acid Ethyl Ester Soft Capsules, by the National Medical Products Administration, aimed at treating severe hypertriglyceridemia and reducing cardiovascular event risks in specific patient populations [1] Group 1: Drug Approval - The drug has received a registration certificate from the National Medical Products Administration [1] - It is intended for adult patients with severe hypertriglyceridemia (≥500 mg/dL) [1] - The drug is to be used in conjunction with dietary control to lower triglyceride levels [1] Group 2: Indications and Usage - The drug is indicated for use alongside statins in patients diagnosed with cardiovascular diseases or diabetes who have two or more additional cardiovascular risk factors and hypertriglyceridemia (≥150 mg/dL) [1] - It aims to reduce the risk of cardiovascular events such as myocardial infarction, stroke, coronary artery revascularization, and unstable angina requiring hospitalization [1]
人福医药:子公司二十碳五烯酸乙酯软胶囊获得药品注册证书
Xin Lang Cai Jing· 2025-09-02 09:16
人福医药9月2日公告, 全资子公司人福普克药业(武汉)有限公司近日收到国家药品监督管理局核准签发 的二十碳五烯酸乙酯软胶囊的《药品注册证书》。该药品在控制饮食的基础上,用于降低重度高甘油三 酯血症(≥500mg/dL)成年患者的甘油三酯(TG)水平。与他汀类药物联合使用,用于确诊心血管疾病或糖 尿病伴≥2种其他心血管疾病危险因素,合并高甘油三酯血症(≥150mg/dL)的成年患者,以降低心血管事 件风险(心肌梗死、卒中、冠状动脉血运重建和不稳定型心绞痛需住院治疗)。 ...
人福医药(600079) - 人福医药关于二十碳五烯酸乙酯软胶囊获得药品注册证书的公告
2025-09-02 09:15
证券代码:600079 证券简称:人福医药 编号:临 2025-107 人福医药集团股份公司 五、注册分类:化学药品4类 六、申请事项:药品注册(境内生产) 七、药品批准文号:国药准字H20255247和国药准字H20255248 关于二十碳五烯酸乙酯软胶囊获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误 导性陈述或者重大遗漏,并对其内容的真实性、准确性和完整性承担法 律责任。 人福医药集团股份公司(以下简称"公司")全资子公司人福普克药业(武汉)有 限公司(以下简称"武汉普克")近日收到国家药品监督管理局核准签发的二十碳五烯 酸乙酯软胶囊的《药品注册证书》。现将批件主要内容公告如下: 一、药品名称:二十碳五烯酸乙酯软胶囊 二、证书编号:2025S02630、2025S02631 三、剂型:胶囊剂 四、规格:0.5g和1.0g 人福医药集团股份公司董事会 二〇二五年九月三日 八、药品批准文号有效期:至2030年08月25日 九、上市许可持有人:人福普克药业(武汉)有限公司 十、药品生产企业:人福普克药业(武汉)有限公司 十一、审批结论:根据《中华人民共和国药品管理法》及有关规 ...
人福医药(600079) - 人福医药关于重酒石酸去甲肾上腺素注射液获得药品注册证书的公告
2025-09-02 09:15
证券代码:600079 证券简称:人福医药 编号:临 2025-108 关于重酒石酸去甲肾上腺素注射液获得药品注册证书的公告 人福医药集团股份公司 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误 导性陈述或者重大遗漏,并对其内容的真实性、准确性和完整性承担法 律责任。 人福医药集团股份公司(以下简称"公司"或"人福医药")控股子公司宜昌人福 药业有限责任公司(以下简称"宜昌人福",公司持有其80%的股权)近日收到国家药 品监督管理局核准签发的重酒石酸去甲肾上腺素注射液的《药品注册证书》。现将批件 主要内容公告如下: 一、药品名称:重酒石酸去甲肾上腺素注射液 二、批件号:2025S02573 三、剂型:注射剂 四、规格:4ml:8mg 五、注册分类:化学药品3类 六、申请事项:药品注册(境内生产) 七、药品批准文号:国药准字H20255191 八、药品批准文号有效期:至2030年08月25日 九、上市许可持有人:宜昌人福药业有限责任公司 十、药品生产企业:宜昌人福药业有限责任公司 十一、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,本品 符合药品注册的有关要求,批准注册,发给药品注册 ...
人福医药(600079.SH):重酒石酸去甲肾上腺素注射液获得药品注册证书
智通财经网· 2025-09-02 09:08
Core Viewpoint - The approval of the drug registration certificate for heavy tartrate norepinephrine injection by the National Medical Products Administration marks a significant milestone for the company, allowing it to sell the product in the domestic market and enhancing its product line [1] Group 1 - The company’s subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., holds 80% of the shares and has received the drug registration certificate [1] - The approval signifies the company’s qualification to market the drug in China, which is expected to have a positive impact on its business [1] - The addition of this product to the company's portfolio will further enrich its offerings in the pharmaceutical market [1]
人福医药(600079.SH):二十碳五烯酸乙酯软胶囊获得药品注册证书
智通财经网· 2025-09-02 09:02
Core Viewpoint - The approval of the eicosapentaenoic acid ethyl ester soft capsule by the National Medical Products Administration marks a significant milestone for the company, enabling it to sell this product in the domestic market, which is expected to positively impact its business operations [1] Company Summary - The company's wholly-owned subsidiary, Wuhan Puke Pharmaceutical Co., Ltd., has received the drug registration certificate for eicosapentaenoic acid ethyl ester soft capsules [1] - This product approval enriches the company's product line, indicating a strategic expansion in its offerings [1] - The market launch of this product is anticipated to bring positive effects to the company's overall performance [1]