药品研发与上市

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港股异动 | 恒瑞医药(01276)涨超3% 海曲泊帕乙醇胺片药品上市许可申请获国家药监局受理
智通财经网· 2025-08-13 03:17
消息面上,恒瑞医药发布公告,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。 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。 智通财经APP获悉,恒瑞医药(01276)涨超3%,截至发稿,涨3.19%,报77.75港元,成交额1.46亿港元。 ...
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
Shang Hai Zheng Quan Bao· 2025-08-12 20:41
Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received acceptance from the National Medical Products Administration for the marketing authorization application of its drug, HAIQUPOLPA 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]. Drug Basic Information - Drug Name: HAIQUPOLPA Ethanolamine Tablets - Dosage Form: Tablets - Acceptance Number: CXHS2500092, CXHS2500093, CXHS2500094 - Application Stage: Marketing - Indication: For adults and children aged ≥6 years with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to corticosteroids and immunoglobulins [1][2]. Clinical Trial Information - The Phase III clinical trial (HR-TPO-ITP-III-PED) for HAIQUPOLPA Ethanolamine Tablets achieved its primary endpoint in March 2025. The study evaluated the efficacy and safety of the drug in children and adolescents with primary immune thrombocytopenia, involving 100 participants aged 6 and above. The treatment group showed significant improvement over the control group, with good long-term safety and efficacy [1][2]. Approved Indications - HAIQUPOLPA Ethanolamine Tablets have already been approved for two indications: 1. Treatment of chronic primary immune thrombocytopenia in adults with inadequate response to corticosteroids and immunoglobulins (approved in June 2021). 2. Treatment of severe aplastic anemia in adults with poor response to immunosuppressive therapy [2]. Disease Context - ITP is an acquired autoimmune bleeding disorder characterized by skin and mucosal bleeding, with severe cases leading to internal bleeding and even intracranial hemorrhage. It is the most common bleeding disorder in children and adolescents, with an annual incidence rate of 1.6-5.3 per 100,000 for primary ITP in children aged 1 month to 18 years. Approximately 80% of cases resolve within 12 months, but about 20% persist for over a year, indicating a significant clinical treatment demand [2][3]. Market Context - HAIQUPOLPA Ethanolamine Tablets are a non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production. Similar products available internationally include Eltrombopag, Avatrombopag, and Lusutrombopag. The global sales of these similar products are approximately $2.59 billion. In China, Eltrombopag was approved in 2017, Avatrombopag in 2020, and Lusutrombopag in 2023 [3][4].
华润双鹤:湘中制药氢溴酸伏硫西汀片获药品注册证书
news flash· 2025-06-05 08:54
Group 1 - The core point of the article is that China Resources Double Crane (华润双鹤) announced that its subsidiary, Xiangzhong Pharmaceutical, received a drug registration certificate from the National Medical Products Administration for Hydrobromide Vortioxetine Tablets, which are used to treat adult depression [1] - The drug has been under development since 2021 and is expected to be approved for market launch by May 27, 2025 [1] - The total research and development investment for the drug has reached 12.1484 million yuan [1] Group 2 - In 2023, the global sales revenue for the drug reached 1.999 billion USD, while the domestic market sales totaled 214 million yuan [1]