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]

Core Insights - The article highlights the recent achievements of Chinese pharmaceutical companies, particularly Heng Rui Medicine and Fosun Pharma, in obtaining Fast Track Designation (FTD) from the FDA for their innovative drugs, indicating a significant step in the internationalization of Chinese pharmaceuticals [1][2]. Group 1: Fast Track Designation - Heng Rui Medicine's SHR-A2009 is the first innovative drug from the company to receive FDA's Fast Track Designation, which is expected to expedite its clinical trials and market registration [2]. - Fosun Pharma's subsidiary, Hanhui, also received FTD for HLX42, a drug targeting advanced non-small cell lung cancer, with a cumulative R&D investment of approximately 6.285 million yuan [2]. - The FTD status allows for increased communication with the FDA during the drug development process, facilitating quicker identification and resolution of issues [3]. Group 2: ADC Market Growth - Both SHR-A2009 and HLX42 are part of the Antibody-Drug Conjugate (ADC) sector, which has seen a surge in interest and investment from Chinese companies [4]. - As of December 2023, over 20 ADC transactions have occurred, with a total value exceeding 35 billion USD, indicating a robust market for these innovative therapies [4]. - The global ADC market is projected to grow from 11.4 billion USD in 2023 to 64.7 billion USD by 2030, with a compound annual growth rate (CAGR) of 28.1% [4]. Group 3: International Expansion of Chinese Pharma - 2023 is marked as a breakthrough year for Chinese innovative drugs entering international markets, with several companies achieving FDA approvals [6]. - Chinese pharmaceutical companies are encouraged to develop competitive products to capture overseas market share while also focusing on domestic and international sales strategies [6]. - The recognition of Chinese innovation in the global pharmaceutical ecosystem is increasing, as evidenced by successful licensing agreements for various innovative therapies [6].

Core Insights - The article emphasizes the importance of selecting good companies, waiting for reasonable prices, and maintaining long-term investments in the stock market [1][9] Investment Returns - Over the past decade, investments in A-shares yielded nearly five times returns, averaging an annualized return of 16%, which is below the target of tenfold returns set ten years ago [1][2] - A 10% annualized return is significantly more beneficial compared to the current bank interest rates of around 2% [2] Investment Approach - The article advocates for a serious approach to stock investment, highlighting that stocks represent ownership in companies rather than mere trading instruments [3][4] - It suggests that understanding financial statements and key performance indicators (KPIs) is crucial for evaluating companies [7] Long-term Investment Strategy - The long-term performance of various investment assets shows that stocks, particularly those of leading companies, provide substantial returns, with some companies achieving an annualized return of 27.18% [6][7] - The article encourages young investors to set clear investment goals and adopt a diversified asset allocation strategy to mitigate risks [8][9] Recommended Investment Practices - Young investors are advised to start with index funds and gradually explore sector-specific ETFs to benefit from different industry growths [9] - The importance of global investment opportunities is highlighted, suggesting that young investors should not limit themselves to domestic markets [9]

Core Insights - Heng Rui Medicine's subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. have their injectable drugs SHR-A1811 and Adalimumab included in the National Medical Products Administration's list of proposed breakthrough therapies, marking the ninth inclusion for SHR-A1811 [1] Group 1: Company Developments - The injectable SHR-A1811 is designed to bind to HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release in lysosomes [2] - SHR-A1811 received approval for market launch in May 2025, targeting adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously undergone at least one systemic therapy [2] - Cumulative R&D investment for SHR-A1811 has reached approximately 1.259 billion yuan [2] Group 2: Product Information - Adalimumab injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [2] - Adalimumab injection (brand name: Ailili) was approved for market launch in March 2023, indicated for first-line treatment in extensive-stage small cell lung cancer patients in combination with carboplatin and etoposide [2] - Cumulative R&D investment for Adalimumab injection has reached approximately 901 million yuan [2] Group 3: Industry Context - The incidence of breast cancer is rapidly increasing in China, ranking as the second most common cancer among women [1] - Triple-negative breast cancer (TNBC) accounts for 10% to 15% of all breast cancer cases, with a higher prevalence in younger women and a lower disease-free survival rate [1] - The approval and application of tumor immunotherapy drugs, such as PD-L1 inhibitors, have improved progression-free survival and overall survival for patients with advanced TNBC [1]