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格隆汇公告精选(港股)︱荣昌生物(09995.HK):泰它西普(商品名:泰爱®)治疗原发性乾燥综合征中国III期临床研究达到主要终点
Ge Long Hui· 2025-08-14 14:59
Group 1: Core Insights - Rongchang Biologics (09995.HK) announced that its innovative drug Taitasip (brand name: Tai Ai®) for treating primary Sjögren's syndrome has met the primary endpoint in a Phase III clinical trial in China [1] - Taitasip is the first BLyS/APRIL dual-target fusion protein drug to complete Phase III research in the field of Sjögren's syndrome globally [1] - The clinical trial was a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Taitasip, with the primary endpoint being the change in ESSDAI score at week 24 compared to baseline [1] Group 2: Disease Background and Drug Mechanism - Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands, leading to persistent dry mouth and dry eyes, and can affect multiple organ systems [2] - The prevalence of Sjögren's syndrome in China is estimated to be between 0.3% and 0.7%, with an increasing trend indicating a significant unmet clinical need [2] - Taitasip is a novel dual-target fusion protein developed by the company that simultaneously inhibits the overexpression of BLyS and APRIL, effectively preventing abnormal differentiation and maturation of B cells [2] Group 3: Regulatory and Clinical Recognition - Taitasip has received multiple authoritative guideline recommendations in China, including the "Clinical Practice Guidelines for Sjögren's Syndrome" and the "Expert Consensus on B-cell Targeted Therapy for Rheumatic and Immune Diseases" [2] - Internationally, Taitasip has been granted Fast Track designation by the U.S. FDA for its indication in Sjögren's syndrome and has been approved to conduct global multi-center Phase III clinical trials [2]
恒瑞医药:SHR-7782 注射液获得药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-08-14 10:15
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 soon commence clinical trials [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] Group 2: Financial Investment - The cumulative research and development investment for the SHR-7782 injection project has reached approximately 48.2 million yuan [1]
恒瑞医药(01276.HK)子公司获准开展SHR-7782注射液临床试验 拟用于治疗晚期实体瘤
Ge Long Hui A P P· 2025-08-14 09:53
Core Viewpoint - Heng Rui Medicine (01276.HK) 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 is designed for the treatment of advanced solid tumors [1] Group 1 - The SHR-7782 injection is a self-developed biopharmaceutical product that specifically binds to tumor cell surface antigens [1] - The clinical trial for SHR-7782 injection will commence shortly [1] - The product aims to kill tumor cells and is intended for use in treating advanced solid tumors [1]
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
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、上海恒 瑞医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局核准签发关于注射用 SHR-A2102、 阿得贝利单抗注射液的《药物临床试验批准通知书》,将于近期开展临床试验。 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。 注射用 SHR-A2102 为公司自主研发且具有知识产权的靶向 Nectin-4 的抗体药物偶联物(ADC),其有效 载荷是拓扑异构酶Ⅰ抑制剂(TOP1i)。多种研究表明 Nectin-4 在肿瘤中的高表达与肿瘤的发展和不良预 后密切相关。 ...
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]