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恒瑞医药(01276):SHR-7782 注射液获得药物临床试验批准通知书
智通财经网· 2025-08-14 09:49
Core Viewpoint - Heng Rui Medicine (01276) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-7782 injection, which will commence shortly [1] Group 1: Product Development - SHR-7782 injection is a self-developed therapeutic biological product that specifically binds to tumor cell surface antigens to kill tumor cells, intended for the treatment of advanced solid tumors [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] - The total research and development investment for the SHR-7782 injection project has reached approximately 48.2 million yuan [1]
恒瑞医药(01276) - 海外监管公告 - 关於获得药物临床试验批准通知书的公告
2025-08-14 09:45
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. 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14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。 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。 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董 ...
智通AH统计|8月14日
智通财经网· 2025-08-14 08:21
Core Insights - The article highlights the top and bottom AH premium rates for various stocks, indicating significant discrepancies between H-shares and A-shares [1][2] - Northeast Electric (00042) leads with a premium rate of 785.25%, while CATL (03750) shows a negative premium rate of -20.14% [1] AH Premium Rate Rankings - The top three stocks with the highest AH premium rates are: - Northeast Electric (00042): 785.25% - Fudan Zhangjiang (01349): 230.34% - Hongye Futures (03678): 226.10% [1] - The bottom three stocks with the lowest AH premium rates are: - CATL (03750): -20.14% - Hengrui Medicine (01276): -5.11% - China Merchants Bank (03968): 4.67% [1] Deviation Values - The stocks with the highest deviation values are: - Andeli Juice (02218): 28.98% - Fudan Zhangjiang (01349): 27.73% - Jinli Permanent Magnet (06680): 14.39% [1] - The stocks with the lowest deviation values are: - BYD Company (01211): -150.95% - Northeast Electric (00042): -72.83% - Longpan Technology (02465): -44.57% [1] Additional Insights - The top ten stocks with the highest deviation values include: - Andeli Juice (02218): 219.55% premium rate - Fudan Zhangjiang (01349): 230.34% premium rate - Jinli Permanent Magnet (06680): 79.07% premium rate [2] - The bottom ten stocks with the lowest deviation values include: - BYD Company (01211): 11.96% premium rate - Northeast Electric (00042): 785.25% premium rate - Longpan Technology (02465): 108.84% premium rate [2]
恒瑞医药(01276):注射用SHR-A2102、阿得贝利单抗注射液获得药物临床试验批准通知书
智通财经网· 2025-08-13 09:21
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of two innovative drugs, SHR-A2102 and Adebali monoclonal antibody injection, indicating progress in its oncology pipeline [1] Group 1: Drug Development - SHR-A2102 is a targeted antibody-drug conjugate (ADC) developed by the company, specifically targeting Nectin-4, which is associated with tumor progression and poor prognosis [1] - Adebali monoclonal antibody 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 [1] - Adebali monoclonal antibody injection (brand name: Ailili) was approved for market in March 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide [1]
恒瑞医药(01276.HK):注射用SHR-A2102、阿得贝利单抗注射液获批开展临床试验
Ge Long Hui· 2025-08-13 09:18
Group 1 - Company subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd. received approval from the National Medical Products Administration for clinical trials of SHR-A2102 and Adebeli monoclonal antibody injection [1] - SHR-A2102 is a targeted antibody-drug conjugate (ADC) developed by the company, targeting Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i) [1] - Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis; currently, there is one similar product approved globally, Enfortumab vedotin, with projected global sales of approximately $1.949 billion in 2024 [1] Group 2 - Adebeli monoclonal antibody 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] - Adebeli monoclonal antibody injection (brand name: Ailili) was approved for use in first-line treatment of extensive-stage small cell lung cancer in March 2023; similar products include Atezolizumab, Avelumab, and Durvalumab, with combined projected global sales of approximately $9.648 billion in 2024 [2] - The cumulative R&D investment for Adebeli monoclonal antibody injection is approximately 901.3 million yuan [2]
恒瑞医药(01276) - 海外监管公告 - 关於获得药物临床试验批准通知书的公告
2025-08-13 09:10
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。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-115 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 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")子公司苏州盛迪亚 生物医药有限公司、上海恒瑞医药有限公司、上海 ...
智通AH统计|8月13日
智通财经网· 2025-08-13 08:20
Group 1 - The article highlights the top three companies with the highest AH premium rates as Northeast Electric (800.00%), Hongye Futures (224.47%), and Andeli Juice (219.79%) [1] - The bottom three companies with the lowest AH premium rates are Ningde Times (-22.45%), Hengrui Medicine (-4.84%), and China Merchants Bank (4.09%) [1] - The article provides a detailed ranking of the top ten and bottom ten AH stocks based on their premium rates and deviation values [1] Group 2 - The top three companies with the highest deviation values are Andeli Juice (30.94%), Beijing Beichen Industrial (16.61%), and Jinli Permanent Magnet (15.22%) [1] - The bottom three companies with the lowest deviation values are BYD Company (-158.79%), Northeast Electric (-64.08%), and Longpan Technology (-41.16%) [1] - The article includes a comprehensive table listing the premium rates and deviation values for the top and bottom AH stocks [2]
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]
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。 ...