HENGRUI PHARMA(01276)

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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
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]
恒瑞医药(01276):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
智通财经网· 2025-08-12 09:16
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。 ...
恒瑞医药(01276.HK):海曲泊帕乙醇胺片上市许可申请获受理
Ge Long Hui· 2025-08-12 09:00
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 ...
恒瑞医药(01276) - 海外监管公告 - 关於药品上市许可申请获受理的提示性公告
2025-08-12 08:53
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1276) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定,江蘇恒瑞醫藥股份有限公司(「本公司」)在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下,僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年8月12日 於本公告日期,董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生;(ii)非執行董事郭叢照女士;及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-11 ...
智通AH统计|8月12日
智通财经网· 2025-08-12 08:17
Core Insights - The article highlights the top and bottom AH premium rates for various stocks, indicating significant disparities in market valuations between A-shares and H-shares [1][2] - Northeast Electric (00042) leads with a premium rate of 785.25%, while CATL (03750) shows a negative premium rate of -24.17%, suggesting potential investment opportunities and risks [1] AH Premium Rate Rankings - The top three stocks with the highest AH premium rates are: - Northeast Electric (00042) at 785.25% - Hongye Futures (03678) at 224.58% - Andeli Juice (02218) at 221.77% [1] - The bottom three stocks with the lowest AH premium rates are: - CATL (03750) at -24.17% - Heng Rui Medicine (01276) at -3.29% - China Merchants Bank (03968) at 5.44% [1] Deviation Values - The stocks with the highest deviation values are: - Andeli Juice (02218) at 34.56% - Beijing Beichen Industrial (00588) at 25.56% - Jinli Permanent Magnet (06680) at 17.10% [1] - The stocks with the lowest deviation values include: - BYD Company (01211) at -163.29% - Northeast Electric (00042) at -86.52% - Longpan Technology (02465) at -40.42% [1][2] Additional Insights - The article provides a detailed table of the top ten and bottom ten AH stocks based on premium rates and deviation values, which can serve as a reference for investors [1][2]
港股公告掘金 | 百胜中国中期净利润5.07亿美元 同比增加1.6%
Zhi Tong Cai Jing· 2025-08-11 15:19
Major Events - Tianyue Advanced (02631) plans to globally offer 47.7457 million H-shares from August 11 to August 14 [1] - Hengrui Medicine (01276) has its injection drugs listed in the proposed breakthrough treatment varieties public notice [1] - Shoucheng Holdings (00697) invests in Southern Universal Data Center REIT and Southern Runze Technology Data Center REIT [1] - Boyaa Interactive (00434) is included in the MSCI Global Small Cap Index [1] Financial Performance - Yum China (09987) reports a net profit of $507 million, an increase of 1.6% year-on-year [1] - Master Kong Holdings (00322) announces a profit attributable to shareholders of 2.271 billion yuan, up 20.5% year-on-year [1] - Q Tech (01478) reports a profit of 308 million yuan, a significant increase of 167.59% year-on-year [1] - Hang Wan Technology (01523) announces a net profit of approximately $21.665 million, up about 13.4% year-on-year, with a dividend of 12.34 HK cents per share [1] - Ruipu Lanjun (00666) reports a gross profit of approximately 829 million yuan, a year-on-year growth of 177.8% [1] - Kingdee International (00268) sees a revenue increase of 11.24% to 3.192 billion yuan, with strong growth in cloud business [1] - Yuyuan Group (00551) reports a profit attributable to shareholders of $171 million, a decrease of 7.2% year-on-year [1] - Boyaa Interactive (00434) reports a profit attributable to shareholders of 226 million HKD, down 27.8% year-on-year [1] - Chongqing Machinery and Electric (02722) expects a net profit attributable to shareholders to increase by about 50% year-on-year [1] - Anton Oilfield Services (03337) anticipates a significant profit increase of 41.6% to 60.5% year-on-year [1] - Sany International (00631) expects a net profit of approximately 1.234 billion to 1.332 billion yuan, an increase of 25% to 35% year-on-year [1] - Datang Renewable (01798) reports a cumulative power generation of approximately 21.3563 million MWh in the first seven months, an increase of 11.75% year-on-year [1] - China Jinmao (00817) reports a cumulative contracted sales amount of 61.807 billion yuan in the first seven months, up 23.12% year-on-year [1] - New Town Development (01030) reports a cumulative contract sales amount of approximately 11.99 billion yuan in the first seven months, down 55.66% year-on-year [1] - Dongfeng Motor Group (00489) reports automobile sales of approximately 978,500 units in the first seven months, a decrease of about 8.9% year-on-year [1] - Hopson Development Holdings (00754) reports a total contracted sales amount of approximately 9.047 billion yuan in the first seven months, down 12.49% year-on-year [1] - Yuyuan Group (00551) reports a net operating income of approximately $667.5 million in July, a year-on-year decrease of 1.9% [1]
恒瑞医药(01276.HK)子公司两款产品获国家药监局拟突破性治疗公示
Ge Long Hui· 2025-08-11 09:03
格隆汇8月11日丨恒瑞医药(01276.HK)发布公告,近日,公司子公司苏州盛迪亚生物医药有限公司、上海盛迪医药有限公司的注射用瑞康曲妥珠单抗(SHR-A1811)、阿得贝利单抗注射液被国 ...
恒瑞医药(01276):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
智通财经网· 2025-08-11 09:03
智通财经APP讯,恒瑞医药(01276)发布公告,近日公司子公司苏州盛迪亚生物医药有限公司、上海盛迪 医药有限公司的注射用瑞康曲妥珠单抗(SHR-A1811)、阿得贝利单抗注射液被国家药品监督管理局药品 审评中心纳入拟突破性治疗品种公示名单,公示期7日,这也是瑞康曲妥珠单抗第9 次纳入拟突破性治 疗品种公示名单。 注射用瑞康曲妥珠单抗可通过与HER2表达的肿瘤细胞结合并内吞,在肿瘤细胞溶酶体内通过蛋白酶剪 切释放毒素,诱导细胞周期阻滞从而诱导肿瘤细胞凋亡。公司注射用瑞康曲妥珠单抗已于2025年 5月获 批上市,适用于治疗存在 HER2 (ERBB2)激活突变且既往接受过至少一种系统治疗的不可切除的局部晚 期或转移性非小细胞肺癌(NSCLC)成人患者。 阿得贝利单抗注射液是公司自主研发的人源化抗PD-L1单克隆抗体,能通过特异性结合PD-L1分子从而 阻断导致肿瘤免疫耐受的PD-1/PD-L1通路,重新激活免疫系统的抗肿瘤活性,从而达到治疗肿瘤的目 的。公司阿得贝利单抗注射液(商品名:艾瑞利)已于2023年3月获批上市,获批的适应症为与卡铂和依 托泊苷联合用于广泛期小细胞肺癌患者的一线治疗。 ...
恒瑞医药(01276) - 海外监管公告 - 关於药品纳入拟突破性治疗品种公示名单的公告
2025-08-11 08:52
(股份代號:1276) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) 根據中華人民共和國的有關法例規定,江蘇恒瑞醫藥股份有限公司(「本公司」)在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下,僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年8月11日 於本公告日期,董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生;(ii)非執行董事郭叢照女士;及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码:600276 证券简称:恒瑞医药 公告编号:临2025-113 ...
智通AH统计|8月11日
智通财经网· 2025-08-11 08:21
截止8月11日收盘,东北电气(00042)、弘业期货(03678)、安德利果汁(02218)分列AH溢价率前三位,溢 价率分别为770.97%、221.01%、219.72%;宁德时代(03750)、恒瑞医药(01276)、招商银行(03968)分列 AH溢价率末三位,溢价率分别为-24.16%、-5.73%、6.71%。其中安德利果汁(02218)、北京北辰实业股 份(00588)、山东墨龙(维权)(00568)的偏离值位居前三,分别为34.07%、19.49%、12.60%;另外,比 亚迪股份(01211)、东北电气(00042)、龙蟠科技(02465)的偏离值位居后三,分别 为-170.41%、-108.95%、-46.01%。 前十大AH股溢价率排行 | 股票名称 | H股(港元) | A股 | 溢价率↓ | 偏离值 | | --- | --- | --- | --- | --- | | 东北电气(00042) | 0.310 | 2.25 | 770.97% | -108.95% | | 弘业期货(03678) | 4.760 | 12.76 | 221.01% | -11.05% | | 安德利果 ...