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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
Jin Rong Jie· 2025-08-13 03:57
Core Viewpoint - Heng Rui Medicine (01276) has seen a stock price increase of over 3%, currently at HKD 77.75, with a trading volume of HKD 146 million, following the acceptance of its drug application by the National Medical Products Administration (NMPA) [1] Group 1: Company Developments - Heng Rui Medicine has received the "Acceptance Notification" from the NMPA for its drug application of Haequbopag Ethanolamine Tablets, which is indicated for adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had poor responses to previous treatments [1] - The Phase III clinical trial (HR-TPO-ITP-III-PED) for Haequbopag Ethanolamine Tablets achieved its primary research endpoint as planned in March 2025, demonstrating significant efficacy and safety in children and adolescents with primary immune thrombocytopenia [1] - The study was a multicenter, randomized, double-blind, and open-label Phase III trial, led by Professor Wang Tianyou from Beijing Children's Hospital, involving 100 participants aged 6 and above [1]
主力资金流入前20:东方财富流入9.82亿元、杭钢股份流入9.42亿元
Jin Rong Jie· 2025-08-13 03:50
Core Insights - The article highlights the top 20 stocks with significant inflows of main capital as of August 13, with 东方财富 leading at 9.82 billion yuan [1] Group 1: Stock Inflows - 东方财富 received an inflow of 9.82 billion yuan, making it the top stock [1] - 杭钢股份 followed closely with an inflow of 9.42 billion yuan [1] - 宁德时代 attracted 7.60 billion yuan in capital [1] - 药明康德 saw an inflow of 7.15 billion yuan [1] - 湖南天雁 had 6.70 billion yuan in inflows [1] - 中国长城 received 6.27 billion yuan [1] - 新易盛 attracted 5.30 billion yuan [1] - 沪电股份 saw 4.71 billion yuan in inflows [1] - 长城军工 received 4.33 billion yuan [1] - 航天科技 attracted 4.19 billion yuan [1] - 中兵红箭 saw inflows of 3.99 billion yuan [1] - 豪威集团 received 3.87 billion yuan [1] - 恒瑞医药 attracted 3.70 billion yuan [1] - 飞龙股份 saw 3.61 billion yuan in inflows [1] - 中银证券 received 3.46 billion yuan [1] - 荣科科技 attracted 3.45 billion yuan [1] - 天孚通信 saw inflows of 3.36 billion yuan [1] - 东吴证券 received 3.17 billion yuan [1] - 华泰证券 attracted 3.14 billion yuan [1] - 兄弟科技 saw 3.03 billion yuan in inflows [1]
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
Core Viewpoint - Heng Rui Medicine (01276) has seen a stock price increase of over 3%, currently at 77.75 HKD, following the acceptance of its drug application by the National Medical Products Administration (NMPA) for its drug, Haequibopamine Ethanolamine Tablets, aimed at treating immune thrombocytopenia (ITP) in adults and children aged 6 and above [1] Group 1 - The company received an acceptance notice from the NMPA for its drug application [1] - The drug is indicated for patients with persistent and chronic primary immune thrombocytopenia who have had poor responses to previous treatments such as corticosteroids and immunoglobulins [1] - The Phase III clinical trial (HR-TPO-ITP-III-PED) for Haequibopamine Ethanolamine Tablets achieved its primary endpoint as planned in March 2025 [1] Group 2 - The Phase III study was a multicenter, randomized, double-blind, and open-label trial evaluating the efficacy and safety of the drug in children and adolescents with primary immune thrombocytopenia [1] - The study was led by Professor Wang Tianyou from the Capital Medical University Affiliated Beijing Children's Hospital, enrolling 100 patients aged 6 and above [1] - The treatment group showed significant superiority over the control group in the primary endpoint, with good safety and efficacy observed during long-term treatment [1]
医保商保“双目录”初审揭幕,高价创新药冲刺入列,创新药ETF沪港深(159622)涨超1.6%持续溢价交易
Sou Hu Cai Jing· 2025-08-13 02:56
Core Viewpoint - The adjustment of the national medical insurance and commercial health insurance drug directories is a significant event for the innovative drug investment landscape in the second half of the year, with over 650 drugs entering the basic medical insurance directory and commercial insurance innovative drug directory [1][2]. Group 1: Medical Insurance Directory Adjustments - A total of 534 drug generic names passed the initial review for the basic medical insurance directory, with 310 drugs being added to the directory, a significant increase from 249 in 2024 [2]. - The directory adjustments allow newly approved innovative drugs to have the opportunity to enter the insurance directory, including several notable drugs such as the lung cancer drug Gorailis and the autoimmune drug Fuanqi [2]. Group 2: Commercial Health Insurance Directory - The commercial health insurance innovative drug directory has approved 121 drugs, including five CAR-T therapies and a domestic vaccine, marking a new approach for market access for preventive biological products [3]. - Notable CAR-T therapies that made it into the directory include products from Fosun Kite, Huyuan Bio, and WuXi AppTec, with the latter's product achieving $808 million in revenue in the first half of the year, reflecting a doubling in growth [3]. Group 3: Future Outlook for Innovative Drugs - The upcoming months will see significant overseas pharmaceutical conferences and further developments in the medical insurance directories, providing ample opportunities for speculation and investment in innovative drugs [4]. - The domestic innovative drug sector is expected to benefit from increased clinical data catalysts and a rebound in funding and secondary market activity, enhancing the demand for new drug development [4].
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
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].
恒瑞医药(600276.SH):注射用瑞康曲妥珠单抗、阿得贝利单抗注射液纳入拟突破性治疗品种公示名单
Ge Long Hui· 2025-08-12 18:09
Core Viewpoint - Heng Rui Medicine's subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. have had 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 - The injectable SHR-A1811 targets HER2-expressing tumor cells, inducing apoptosis through a mechanism involving toxin release in lysosomes [1] - Adalimumab 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 [1]
恒瑞医药海曲泊帕乙醇胺片上市许可申请获受理
Bei Jing Shang Bao· 2025-08-12 14:03
Core Viewpoint - Heng Rui Medicine has received acceptance from the National Medical Products Administration for its drug application of Haequparib Ethanolamine Tablets, aimed at treating patients with chronic immune thrombocytopenia (ITP) who have had poor responses to previous treatments [1] Group 1 - The drug Haequparib Ethanolamine Tablets is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production by activating the STAT and MAPK signaling pathways [1] - The drug has already been approved for two indications prior to this application [1] - The target patient population includes adults and children aged 6 years and older with persistent and chronic primary immune thrombocytopenia [1]
8月12日易方达医疗保健行业混合A净值下跌1.73%,近1个月累计上涨12.81%
Sou Hu Cai Jing· 2025-08-12 13:21
Core Viewpoint - E Fund Healthcare Industry Mixed A Fund (110023) has shown significant performance with a recent net value of 4.5530 CNY, despite a slight decline of 1.73% [1] Performance Summary - The fund's one-month return is 12.81%, ranking 628 out of 4566 in its category [1] - Over the past six months, the fund has achieved a return of 48.74%, ranking 108 out of 4413 [1] - Year-to-date, the fund's return stands at 49.47%, with a ranking of 158 out of 4375 [1] Holdings Summary - The top ten stock holdings of E Fund Healthcare Industry Mixed A account for a total of 58.14%, with the following key positions: - Heng Rui Medicine: 7.39% - Rejing Biology: 7.00% - Xinlitai: 6.73% - BeiGene-U: 6.47% - Haizhi Science: 6.00% - Nocren Health-U: 5.21% - Yipinhong: 5.08% - Kelun Pharmaceutical: 5.07% - Shutaishen: 5.05% - Baili Tianheng: 4.14% [1] Fund Details - E Fund Healthcare Industry Mixed A was established on January 28, 2011, and as of June 30, 2025, it has a total scale of 3.944 billion CNY [1] - The fund manager is Yang Zhenshao, who holds a PhD in Science and has experience as an investment manager, industry researcher, and assistant fund manager at E Fund [1]
8月12日工银前沿医疗股票C净值下跌0.81%,近1个月累计上涨7.38%
Sou Hu Cai Jing· 2025-08-12 12:19
金融界2025年8月12日消息,工银前沿医疗股票C(010685) 最新净值3.2900元,下跌0.81%。该基金近1个 月收益率7.38%,同类排名279|656;近6个月收益率28.87%,同类排名62|637;今年来收益率28.12%, 同类排名105|635。 简历显示:赵蓓女士:硕士,曾在中再资产管理股份有限公司担任投资经理助理。2010年加入工银瑞信,现 任研究部副总监、医疗保健研究团队负责人,2014年11月18日至今,担任工银医疗保健行业股票型基金基 金经理;2015年4月28日至今,担任工银瑞信养老产业股票型基金基金经理;2016年2月3日至今,担任工银瑞 信前沿医疗股票型基金基金经理。2018年7月30日至2019年12月23日起担任工银瑞信医药健康行业股票 型证券投资基金基金经理。2020年05月20日至2022年6月14日担任工银瑞信科技创新6个月定期开放混合 型证券投资基金基金经理。2025年4月9日起担任工银瑞信新经济灵活配置混合型证券投资基金(QDII)基 金经理。 工银前沿医疗股票C股票持仓前十占比合计59.44%,分别为:恒瑞医药(9.51%)、科伦药业 (9.16%)、信立 ...
8月12日中欧医疗健康混合A净值下跌0.56%,近1个月累计上涨7.2%
Sou Hu Cai Jing· 2025-08-12 11:51
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]