HENGRUI PHARMA(01276)
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恒瑞医药(01276.HK):瑞维鲁胺片获得药物临床试验批准通知书
Ge Long Hui· 2025-11-03 10:12
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of Rivoceranib tablets, a second-generation AR inhibitor, which is expected to enhance its market position in the treatment of metastatic hormone-sensitive prostate cancer [1] Group 1: Product Development - Rivoceranib tablets are a second-generation AR inhibitor that offers stronger AR inhibition without agonistic effects compared to first-generation inhibitors [1] - The product was approved for market launch in 2022 for treating patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) [1] Group 2: Market Context - Rivoceranib tablets are entering a competitive market with other second-generation AR inhibitors such as Enzalutamide, Apalutamide, and Darolutamide already available [1] - According to EvaluatePharma, the global sales for similar products are projected to reach approximately $11.037 billion in 2024 [1] Group 3: Investment and R&D - The cumulative R&D investment for Rivoceranib tablets has reached approximately 693.09 million yuan [1]
恒瑞医药(01276):HRS-5965 胶囊拟纳入优先审评程序
智通财经网· 2025-11-03 10:10
Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical's HRS-5965 capsules have been proposed for inclusion in the priority review list by the National Medical Products Administration [1] Group 1: Product Information - HRS-5965 capsules are a complement factor B inhibitor designed to suppress complement-mediated hemolytic reactions and improve hemoglobin levels [1] - The target indication is Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare acquired hemolytic disease characterized by the lack of CD55 and CD59, leading to complement-mediated intravascular hemolysis [1] Group 2: Market Context - PNH has been included in the national list of rare diseases due to its low incidence/prevalence [1] - Currently, the only drug approved for this indication is Novartis' Iptacopan (Fabhalta®), which is projected to have a global sales revenue of approximately $129 million in 2024 according to EvaluatePharma [1] Group 3: R&D Investment - The cumulative R&D investment for the HRS-5965 project has reached approximately 209.94 million yuan [1]
恒瑞医药(01276):瑞维鲁胺片获准开展临床试验
智通财经网· 2025-11-03 10:09
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Rivolumab tablets, a second-generation AR inhibitor, which is expected to enhance its market position in the treatment of metastatic hormone-sensitive prostate cancer [1] Company Summary - Rivolumab tablets are a second-generation AR inhibitor that offers stronger AR inhibition without agonistic effects compared to first-generation inhibitors [1] - The product was approved for market launch in 2022 for treating patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) [1] - Cumulative R&D investment in Rivolumab tablets has reached approximately 693 million yuan [1] Industry Summary - The global sales of similar second-generation AR inhibitors, including Enzalutamide, Apalutamide, and Darolutamide, are projected to total approximately 11.037 billion USD in 2024 [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
2025-11-03 10:03
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。 中國上海 2025年11月3日 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 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。 受 理 号:CXHL2500815 审批结论:根据《中华人民共和国药品管 ...
恒瑞医药(01276.HK):子公司HRS-5965胶囊拟纳入优先审评程序
Ge Long Hui· 2025-11-03 09:59
Core Viewpoint - Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, has announced that its HRS-5965 capsules are proposed to be included in the priority review list by the National Medical Products Administration (NMPA) of China, indicating a significant step towards potential market approval for a treatment targeting paroxysmal nocturnal hemoglobinuria in adults who have not previously received complement inhibitors [1] Drug Information - Drug Name: HRS-5965 Capsules [1] - Dosage Form: Capsule [1] - Applicant: Chengdu Shengdi Pharmaceutical Co., Ltd. [1] - Proposed Indication: Treatment for adult patients with paroxysmal nocturnal hemoglobinuria who have not previously received complement inhibitor therapy [1] Priority Review Justification - The application meets the requirements outlined in the "Drug Registration Management Measures" and the announcement regarding the "Review Procedures for Breakthrough Therapy Drugs" issued by the NMPA [1] - The drug is categorized under priority review for "clinically urgent shortage drugs, innovative drugs, and modified new drugs for the prevention and treatment of major infectious diseases and rare diseases" [1]
恒瑞医药(01276) - 海外监管公告 - 关於回购公司A股股份的进展公告
2025-11-03 09:59
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11月3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。 江苏瑞医药股份有限公司(以下简称"公司")于 2025 年 8 月 20 ...
恒瑞医药(01276) - 海外监管公告 - 关於药物拟纳入优先审评程序的公告
2025-11-03 09:53
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。 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。 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11月3日 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-16 ...
恒瑞医药(01276)11月3日耗资632.23万元回购10万股A股

Zhi Tong Cai Jing· 2025-11-03 08:56
智通财经APP讯,恒瑞医药(01276)公布,2025年11月3日耗资632.23万元回购10万股A股股份。 该信息由智通财经网提供 ...
恒瑞医药(01276) - 翌日披露报表
2025-11-03 08:44
FF305 公司名稱: 江蘇恒瑞醫藥股份有限公司 呈交日期: 2025年11月3日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | A | | 於香港聯交所上市 | 否 | | | 證券代號 (如上市) | 600276 | 說明 | | A股(於上海證券交易所上市) | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份(不包括庫存股份)數 目 | | 佔有關事件前的現有已發 行股份(不包括庫存股 份)數目百分比 (註3) | 庫存股份數目 | 每股發行/ ...
智通AH统计|11月3日
智通财经网· 2025-11-03 08:16
Core Insights - The article highlights the top and bottom AH premium rates for various stocks as of November 3, with Northeast Electric (00042) leading with a premium rate of 918.87% [1] - The article also provides a detailed ranking of stocks based on their deviation values, indicating significant discrepancies between H-shares and A-shares [1][3] AH Premium Rate Rankings - Northeast Electric (00042) has the highest AH premium rate at 918.87%, followed by Hongye Futures (03678) at 251.83% and Sinopec Oilfield Service (01033) at 251.28% [1] - The lowest AH premium rates are observed in CATL (03750) at -17.20%, China Merchants Bank (03968) at 0.68%, and Hengrui Medicine (01276) at 2.81% [1] Deviation Value Rankings - The top three stocks with the highest deviation values are Northeast Electric (00042) at 86.45%, Yangtze Optical Fibre and Cable (06869) at 28.54%, and Chenming Paper (01812) at 26.52% [1] - Conversely, the stocks with the lowest deviation values include COSCO Shipping Energy (01138) at -12.73%, First Tractor Company (00038) at -12.34%, and CNOOC Services (02883) at -12.09% [1][3] Additional Insights - The article includes a detailed table of the top ten and bottom ten AH stocks based on premium rates and deviation values, providing a comprehensive overview of the current market situation [1][2][3]