Group 1 - The core point of the news is the performance and holdings of the China Europe Medical Health Mixed A Fund, which has shown a recent decline in net value but positive returns over various time frames [1] - As of August 12, 2025, the latest net value of the fund is 1.9165 yuan, reflecting a decrease of 0.56%. The fund's one-month return is 7.20%, six-month return is 23.93%, and year-to-date return is 22.17% [1] - The fund's top ten stock holdings account for a total of 54.73%, with notable positions in WuXi AppTec (10.39%), Hengrui Medicine (9.69%), and Kanglong Chemical (5.05%) among others [1] Group 2 - The China Europe Medical Health Mixed A Fund was established on September 29, 2016, and as of June 30, 2025, it has a total scale of 15.638 billion yuan [1] - The fund is managed by two key individuals: Ms. Ge Lan, who has been the fund manager since its inception, and Ms. Zhao Lei, who took over management on July 4, 2025 [2]

2025 年 3 月，海曲泊帕乙醇胺片Ⅲ期临床试验(HR-TPO-ITP-Ⅲ-PED)达到了方案预设的主要研究终点。 该研究是一项在儿童和青少年原发免疫性血小板减少症患者中评价海曲泊帕乙醇胺片的有效性和安全性 的多中心、随机、双盲及开放性的Ⅲ期研究，由首都医科大学附属北京儿童医院王天有教授担任主要研 究者，共入组 100 例 6 岁及以上儿童和青少年原发免疫性血小板减少症患者。试验组在主要终点上显著 优于对照组，且长期治疗的安全性、有效性良好。 恒瑞医药(01276)公布，近日，公司收到国家药品监督管理局下发的《受理通知书》，公司海曲泊帕乙 醇胺片的药品上市许可申请获国家药监局受理，适应症为：适用于既往对糖皮质激素、免疫球蛋白等治 疗反应不佳的持续性及慢性原发免疫性血小板减少症(ITP)成人及≥6 岁的儿童患者。 ...

海曲泊帕乙醇胺片已获批上市两个适应症，分别为：2021年6月获得国家药监局批准用于既往对糖皮质 激素、免疫球蛋白等治疗反应不佳的慢性原发免疫性血小板减少症成人患者的治疗，以及用于对免疫抑 制治疗疗效不佳的重型再生障碍性贫血成人患者的治疗。 恒瑞医药(600276.SH)发布公告，近日，公司收到国家药品监督管理局(简称"国家药监局")下发的《受理 通知书》，公司海曲泊帕乙醇胺片的药品上市许可申请获国家药监局受理，适应症为：适用于既往对糖 皮质激素、免疫球蛋白等治疗反应不佳的持续性及慢性原发免疫性血小板减少症(ITP)成人及≥6岁的儿 童患者。 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-114 二、药品的临床试验情况 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理的提示性公告 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。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）收到国家药品监督 管理局（以下简称"国家药监局"）下发的《受理通知书》，公司海曲泊帕乙醇 胺片的药品上市许可申请获国家药监局受理，适应症为：适用于既往对糖皮质激 素、免疫球蛋白等治疗反应不佳的持续性及慢性原发免疫性血小板减少症（ITP） 成人及≥6 岁的儿童患者。现将相关情况公告如下： 一、药品的基本情况 药品名称：海曲泊帕乙醇胺片 剂型：片剂 受理号：CXHS2500092、CXHS2500093、CXHS2500094 申报阶段：上市 申请人：江苏恒瑞医药股份有限公司 拟定适应症（或功能主治）：适用于既往对糖皮质激素、免疫球蛋白等治疗 反应不佳的持续性及慢性原发免疫性血小板减少症（ITP）成人及≥6 岁的儿童 患者。 2025 年 3 月，海曲泊帕乙醇胺片Ⅲ期临床 ...

2025年3月，海曲泊帕乙醇胺片Ⅲ期临床试验(HR-TPO-ITP-Ⅲ-PED)达到了方案预设的主要研究终点。 该研究是一项在儿童和青少年原发免疫性血小板减少症患者中评价海曲泊帕乙醇胺片的有效性和安全性 的多中心、随机、双盲及开放性的Ⅲ期研究，由首都医科大学附属北京儿童医院王天有教授担任主要研 究者，共入组100例6岁及以上儿童和青少年原发免疫性血小板减少症患者。试验组在主要终点上显著优 于对照组，且长期治疗的安全性、有效性良好。 格隆汇8月12日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")收到国 家药品监督管理局(以下简称"国家药监局")下发的《受理通知书》，公司海曲泊帕乙醇胺片的药品上市 许可申请获国家药监局受理，适应症为：适用于既往对糖皮质激素、免疫球蛋白等治疗反应不佳的持续 性及慢性原发免疫性血小板减少症(ITP)成人及≥6岁的儿童患者。 海曲泊帕乙醇胺片已获批上市两个适应症，分别为：2021年6月获得国家药监局批准用于既往对糖皮质 激素、免疫球蛋白等治疗反应不佳的慢性原发免疫性血小板减少症成人患者的治疗，以及用于对免疫抑 制治疗疗效不佳的重型再生障碍性贫血成 ...

Core Viewpoint - Heng Rui Medicine has received the acceptance notice from the National Medical Products Administration for its drug application of Haequbopag Ethanolamine Tablets, aimed at treating adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to previous treatments [1][2] Company Summary - Haequbopag Ethanolamine Tablets are an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production by activating the TPO-R mediated STAT and MAPK signaling pathways [2] - The company has invested approximately 44.587 million yuan in the research and development of Haequbopag Ethanolamine Tablets to date [2] Industry Summary - Similar products already available in the international market include Eltrombopag (GlaxoSmithKline/Novo Nordisk, brand name Promacta), Avatrombopag (Dova Pharmaceuticals, brand name Doptelet), and Lusutrombopag (Shionogi, brand name Mulpleta) [2] - The total global sales of these similar products are projected to be approximately 2.59 billion USD in 2024 [2] - In China, Eltrombopag was approved in 2017 under the name Aequbopag Ethanolamine Tablets, Avatrombopag was approved in 2020 as Maleic Acid Avatrombopag Tablets, and Lusutrombopag was approved in 2023 as Lusutrombopag Tablets [2]

Core Viewpoint - Heng Rui Medicine has received the acceptance notice from the National Medical Products Administration for its drug application of Haequbopamine Ethanolamine Tablets, indicating progress in the approval process for a new treatment for immune thrombocytopenic purpura (ITP) [1] Group 1 - The drug application is specifically for adult patients and children aged 6 years and older who have had poor responses to previous treatments such as corticosteroids and immunoglobulins [1]

Core Viewpoint - Jiangsu Hengrui Medicine has received the acceptance notice from the National Medical Products Administration for its drug application of Hecuqipar Ethanolamine Tablets, targeting the treatment of persistent and chronic primary immune thrombocytopenia (ITP) in adults and children aged 6 and above [1] Group 1: Product Development - The drug has already been approved for two adult indications [1] - The Phase III clinical trial is expected to reach its primary endpoint by March 2025 [1] - The total research and development investment for this drug has reached approximately 44.587 million yuan [1] Group 2: Market Potential - ITP is a common bleeding disorder in children and adolescents, indicating a strong clinical treatment demand [1] - Similar products are already available in foreign markets, with an estimated global sales of approximately 2.59 billion dollars in 2024 [1]

Core Viewpoint - Heng Rui Medicine has received the acceptance notice from the National Medical Products Administration for its drug application of Haequbopag Ethanolamine Tablets, which is intended for treating adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to previous treatments [1][2] Company Summary - Haequbopag Ethanolamine Tablets are an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production by activating the TPO-R mediated STAT and MAPK signaling pathways [2] - The company has invested approximately 44.587 million yuan in the research and development of Haequbopag Ethanolamine Tablets [2] Industry Summary - Similar products already available in international markets include Eltrombopag (GlaxoSmithKline/Novo Nordisk, brand name Promacta), Avatrombopag (Dova Pharmaceuticals, brand name Doptelet), and Lusutrombopag (Shionogi, brand name Mulpleta) [2] - In China, Eltrombopag was approved in 2017 under the name Aequbopag Ethanolamine Tablets, Avatrombopag was approved in 2020 as Maleic Acid Avatrombopag Tablets, and Lusutrombopag was approved in 2023 as Lusutrombopag Tablets [2] - The global sales of these similar products are projected to reach approximately 2.59 billion USD in 2024 [2]

1月1日晚间，恒瑞医药公告称，近日公司收到美国食品药品监督管理局（简称"FDA"）的认证函，公司 项目注射用SHR-A2009获得美国FDA授予快速通道资格（FTD）。复星医药日前公告称，公司控股子公 司药品获美国FDA快速通道资格。复星医药表示，此次获得FTD认证，将有利于加快推进该新药的临床 试验以及上市注册进度。 ADC赛道热度攀升 回望2023年，创新药赛道风起云涌，成为中国药企出海突破元年。业内人士表示，随着创新产品在海外 相继获批上市，中国创新药出海逐步进入到集中收获阶段。中国企业在国际市场竞争力持续提升，创新 和出海有望成生物医药产业增长亮点。 加快新药研发 "SHR-A2009是恒瑞医药历史上第一个获得美国FDA快速通道资格认定的创新药。"恒瑞医药董事、首席 战略官江宁军博士表示，这个称号有助于加速SHR-A2009用于治疗重大疾病和解决未满足临床需求。 据了解，注射用SHR-A2009是公司自主研发的一款以HER3为靶点的抗体药物偶联物。SHR-A2009于 2021年进入临床研究，目前已经推进至Ⅱ期临床。截至目前，注射用SHR-A2009相关项目累计已投入研 发费用约4992万元。 无独有 ...