HENGRUI PHARMA(01276)
Search documents
恒瑞医药(01276)9月23日斥资8993.56万元回购129.8万股A股
智通财经网· 2025-09-23 10:19
智通财经APP讯,恒瑞医药(01276)发布公告,于2025年9月23日斥资8993.56万元回购129.8万股A股。 ...
恒瑞医药(01276) - 翌日披露报表
2025-09-23 10:13
呈交日期: 2025年9月23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/出售價 (註4) | 已發行股份總數 | | 於下列日期開始時的結存(註1) | 20 ...
恒瑞医药旗下HRS-3095片获批开展临床试验 用于治疗慢性自发性荨麻疹(CSU)
Ge Long Hui· 2025-09-23 09:49
Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of HRS-3095 tablets, aimed at treating chronic spontaneous urticaria (CSU) [1] Group 1: Clinical Trial Approval - The clinical trial application for HRS-3095 tablets was accepted on July 7, 2025, and has met the requirements for drug registration [1] - The drug is designed for patients suffering from chronic spontaneous urticaria (CSU) [1] Group 2: Drug Development - HRS-3095 tablets are a self-developed small molecule compound targeting immune cells, showing promising therapeutic effects for allergic diseases [1] - Preclinical data indicates that HRS-3095 can effectively improve skin allergy symptoms in mice [1] - Currently, there are no approved drugs targeting the same mechanism for CSU in both domestic and international markets [1] Group 3: Research Investment - The total research and development investment for the HRS-3095 project has reached approximately 16.03 million yuan [1]
恒瑞医药(01276):阿得贝利单抗注射液新适应症的药品上市许可申请获国家药监局受理
智通财经网· 2025-09-23 09:46
Core Viewpoint - The company, Heng Rui Medicine, announced that its subsidiary, Shanghai Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the new indication application of its drug, Adebali monoclonal antibody injection [1] Group 1: Product Information - Adebali monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody developed by the company, which can specifically bind to the PD-L1 molecule to block the PD-1/PD-L1 pathway that leads to tumor immune tolerance, thereby reactivating the immune system's anti-tumor activity [1] - Similar products available in the market include Atezolizumab (brand name: Tecentriq), Avelumab (brand name: Bavencio), and Durvalumab (brand name: Imfinzi), which have been approved for sale in the United States, with Atezolizumab and Durvalumab also approved in China [1] Group 2: Market Context - The combined global sales of Atezolizumab, Avelumab, and Durvalumab are approximately $9.648 billion for the year 2024 [1] - The cumulative research and development investment for the Adebali monoclonal antibody injection project has reached approximately 939 million yuan [1]
恒瑞医药:阿得贝利单抗注射液新适应症药品上市许可申请获国家药监局受理
Ge Long Hui· 2025-09-23 09:44
格隆汇9月23日丨恒瑞医药(01276.HK)发布公告,近日,公司子公司上海盛迪医药有限公司收到国家药 监局下发的《受理通知书》,公司阿得贝利单抗注射液新适应症的药品上市许可申请获国家药监局受 理。 根据披露,本品联合含铂化疗作为新辅助治疗,术后继续以本品作为单药辅助治疗,用于治疗可手术切 除的Ⅱ、ⅢA和ⅢB期且无已知表皮生长因子受体(EGFR)突变或间变性淋巴瘤激酶(ALK)重排的成人非 小细胞肺癌(NSCLC)患者。公司阿得贝利单抗注射液已于2023年2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.HK)旗下HRS-3095片获批开展临床试验 用于治疗慢性自发性荨麻疹(CSU)
Ge Long Hui· 2025-09-23 09:43
Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for clinical trials of HRS-3095 tablets, aimed at treating Chronic Spontaneous Urticaria (CSU) [1] Group 1: Clinical Trial Approval - The clinical trial approval notice for HRS-3095 was issued based on compliance with the Drug Administration Law of the People's Republic of China [1] - The application for HRS-3095 was accepted on July 7, 2025, and has met the requirements for drug registration [1] Group 2: Drug Development - HRS-3095 is a small molecule compound developed by the company that targets immune cells and shows promising therapeutic effects for allergic diseases [1] - Preclinical data indicates that HRS-3095 can effectively improve skin allergy symptoms in mice [1] - Currently, there are no approved drugs targeting the same mechanism for CSU in both domestic and international markets [1] Group 3: Research Investment - The total research and development investment for the HRS-3095 project has reached approximately 16.03 million yuan [1]
恒瑞医药(01276.HK):阿得贝利单抗注射液新适应症药品上市许可申请获国家药监局受理
Ge Long Hui· 2025-09-23 09:43
根据披露,本品联合含铂化疗作为新辅助治疗,术后继续以本品作为单药辅助治疗,用于治疗可手术切 除的Ⅱ、ⅢA和ⅢB期且无已知表皮生长因子受体(EGFR)突变或间变性淋巴瘤激酶(ALK)重排的成人非 小细胞肺癌(NSCLC)患者。公司阿得贝利单抗注射液已于2023年2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。 格隆汇9月23日丨恒瑞医药(01276.HK)发布公告,近日,公司子公司上海盛迪医药有限公司收到国家药 监局下发的《受理通知书》,公司阿得贝利单抗注射液新适应症的药品上市许可申请获国家药监局受 理。 ...
恒瑞医药(01276):SHR7280片的药品上市许可申请获国家药监局受理
智通财经网· 2025-09-23 09:39
2024年11月,SHR7280 片Ⅲ期临床试验(SHR7280-302)达到了方案预设的主要研究终点。该研究是以醋 酸加尼瑞克注射液为对照,在不孕症女性受试者中开展的多中心、随机、双盲双模拟、非劣效性Ⅲ期临 床研究,由北京大学第三医院乔杰院士担任主要研究者,研究共入组 317 例不孕症女性受试者。研究结 果表明,在辅助生殖技术控制性卵巢刺激治疗中,口服 SHR7280 片与皮下注射醋酸加尼瑞克注射液具 有相当的临床疗效,SHR7280 可有效预防早发LH峰,防止提前排卵,且整体安全性良好。 智通财经APP讯,恒瑞医药(01276)发布公告,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SHR7280片的药品上市许可申请获国家药监局受理。 ...
恒瑞医药(01276):HRS-3095片获准开展临床试验
智通财经网· 2025-09-23 09:39
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-3095 tablets, a targeted small molecule compound for allergic diseases [1] Group 1: Clinical Trial Approval - The company's subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., has been authorized to conduct clinical trials for HRS-3095 tablets [1] - The approval signifies a significant step in the development of HRS-3095, which is expected to address allergic diseases effectively [1] Group 2: Product Development - HRS-3095 is a self-developed small molecule compound that shows promising results in preclinical studies, particularly in improving skin allergy symptoms in mice [1] - There are currently no approved drugs targeting the same mechanism for the CSU indication in both domestic and international markets [1] Group 3: Research Investment - The cumulative research investment for the HRS-3095 project has reached approximately 16.03 million yuan [1]
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
2025-09-23 09:34
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9月23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。 受理号:CXSS2500099 证券代码:600276 证券简称:恒瑞医 ...