新华制药
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新华制药:磷酸奥司他韦干混悬剂获药品注册证书
Zheng Quan Shi Bao Wang· 2025-12-23 09:23
Core Viewpoint - Xinhua Pharmaceutical has received the drug registration certificate for Oseltamivir Phosphate Dry Suspension from the National Medical Products Administration, indicating a significant advancement in its product offerings for influenza treatment and prevention [1] Group 1: Product Approval - The drug is approved for the treatment of influenza A and B in patients aged 2 weeks and older [1] - It can also be used for the prevention of influenza A and B in individuals aged 1 year and above [1]
新华制药获得磷酸奥司他韦干混悬剂药品注册证书
Zhi Tong Cai Jing· 2025-12-23 09:18
Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Oseltamivir Phosphate Oral Suspension, which is indicated for the treatment of influenza A and B in patients aged 2 weeks and older [1] Group 1 - The product is effective in treating both influenza A and B, although clinical application data for influenza B is limited [1] - Patients are advised to use the product within 48 hours of the onset of symptoms [1] - The product can also be used for the prevention of influenza A and B in individuals aged 1 year and older [1]
新华制药(000756.SZ)获得磷酸奥司他韦干混悬剂药品注册证书
智通财经网· 2025-12-23 09:17
Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Oseltamivir Phosphate Dry Suspension, which is indicated for the treatment of influenza A and B in patients aged 2 weeks and older [1] Group 1 - The product is effective for treating both influenza A and B, although clinical data for influenza B is limited [1] - Patients are advised to use the product within 48 hours of the onset of symptoms [1] - The product can also be used for the prevention of influenza A and B in individuals aged 1 year and older [1]
新华制药(000756.SZ):获得磷酸奥司他韦干混悬剂药品注册证书
Ge Long Hui A P P· 2025-12-23 09:15
格隆汇12月23日丨新华制药(000756.SZ)公布,收到国家药品监督管理局核准签发的磷酸奥司他韦干混 悬剂《药品注册证书》。本品用于2周龄及以上年龄患者的甲型和乙型流感治疗(磷酸奥司他韦能够有 效治疗甲型和乙型流感,但是乙型流感的临床应用数据尚不多)。患者应在首次出现症状48小时以内使 用。本品也可用于1岁及1岁以上人群的甲型和乙型流感的预防。 ...
山东新华制药股份(00719.HK)申报的磷酸奥司他韦干混悬剂获得药品注册证书
Jin Rong Jie· 2025-12-23 09:01
山东新华制药股份(00719.HK)公布,近日,公司收到国家药品监督管理局核准签发的磷酸奥司他韦干混 悬剂《药品注册证书》。 本文源自:金融界AI电报 ...
新华制药(000756) - 关于获得磷酸奥司他韦干混悬剂药品注册证书的公告


2025-12-23 09:00
证券代码:000756 证券简称:新华制药 公告编号:2025-70 山东新华制药股份有限公司 关于获得磷酸奥司他韦干混悬剂药品注册证书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假记载、误 导性陈述或重大遗漏。 近日,山东新华制药股份有限公司(以下简称"新华制药"或"公司")收到国家药品 监督管理局核准签发的磷酸奥司他韦干混悬剂(以下简称"本品")《药品注册证书》。现将 相关情况公告如下: 注册分类:化学药品3类 申请人:山东新华制药股份有限公司 申请事项:药品注册(境内生产) 受理号:CYHS2401142 药品批准文号:国药准字H20256303; 证书编号:2025S03820; 一、基本情况 药品名称:磷酸奥司他韦干混悬剂 剂型:口服混悬剂 规格:0.36g(按C16H28N2O4计) 药品分类:非处方药 三、对上市公司的影响及风险提示 新华制药申报的磷酸奥司他韦干混悬剂于2025年12月获得药品注册证书,丰富了公司 抗病毒药物产品线,有利于提升公司综合竞争力。 因药品销售业务易受到国内医药行业政策变动、招标采购、市场环境变化等因素影响, 存在不确定性,敬请广大投资者理性 ...
新华制药:获得磷酸奥司他韦干混悬剂药品注册证书
Xin Lang Cai Jing· 2025-12-23 08:57
Core Viewpoint - The approval of the Oseltamivir Phosphate Dry Suspension by the National Medical Products Administration enhances the company's antiviral product line and overall competitiveness, although sales may be influenced by policy and market factors [1] Group 1: Product Approval - The company has received the drug registration certificate for Oseltamivir Phosphate Dry Suspension, classified as a non-prescription chemical drug (Category 3) [1] - The drug is indicated for the treatment of influenza A and B in patients aged 2 weeks and older, and for prevention in individuals aged 1 year and above [1] Group 2: Timeline and Market Impact - The company submitted the application materials in March 2024, which were accepted, and received approval in December 2025 [1] - The estimated sales of Oseltamivir-related formulations in Chinese public medical institutions for 2024 are approximately 5.9 billion [1] Group 3: Competitive Position - The approval enriches the company's antiviral drug product line, thereby enhancing its comprehensive competitiveness in the market [1] - However, the sales of the product may face uncertainties due to various factors such as policy and market conditions [1]
山东新华制药股份申报的磷酸奥司他韦干混悬剂获得药品注册证书
Zhi Tong Cai Jing· 2025-12-23 08:53
本品用于 2 周龄及以上年龄患者的甲型和乙型流感治疗(磷酸奥司他韦能够有效治疗甲型和乙型流感, 但是乙型流感的临床应用数据尚不多)。患者应在首次出现症状 48 小时以内使用。本品也可用于 1 岁及 1 岁以上人群的甲型和乙型流感的预防。 新华制药申报的磷酸奥司他韦干混悬剂于2025年12月获得药品注册证书,丰富了公司抗病毒药物产品 线,有利于提升公司综合竞争力。 智通财经APP讯,山东新华制药股份(00719)公布,近日,公司收到国家药品监督管理局核准签发的磷酸 奥司他韦干混悬剂《药品注册证书》。 ...
山东新华制药股份(00719.HK):获得磷酸奥司他韦干混悬剂药品注册证书
Ge Long Hui· 2025-12-23 08:50
格隆汇12月23日丨山东新华制药股份(00719.HK)发布公告,近日,公司收到国家药品监督管理局核准签 发的磷酸奥司他韦干混悬剂(以下简称"本品")《药品注册证书》。本品用于2周龄及以上年龄患者的甲 型和乙型流感治疗(磷酸奥司他韦能够有效治疗甲型和乙型流感,但是乙型流感的临床应用数据尚不 多)。患者应在首次出现症状48小时以内使用。本品也可用于1岁及1岁以上人群的甲型和乙型流感的预 防。 ...
新华制药:公司致力于医药主业可持续健康发展
Zheng Quan Ri Bao Wang· 2025-12-19 15:14
证券日报网讯 12月19日,新华制药(000756)在互动平台回答投资者提问时表示,公司一直以来致力 于医药主业可持续健康发展。 ...