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恒瑞医药(01276):注射用SHR-1501获纳入拟突破性治疗品种公示名单
智通财经网· 2025-09-18 09:29
Core Viewpoint - Heng Rui Medicine's subsidiary Shanghai Heng Rui Medicine Co., Ltd. has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center, with a public announcement period of 7 days [1] Group 1: Product Information - SHR-1501 is a self-developed interleukin-15 (IL-15) fusion protein with intellectual property rights, designed to stimulate the proliferation of T cells, B cells, and NK cells in the body [1] - The product enhances the immune response in the bladder when used in conjunction with BCG, achieving a synergistic anti-tumor effect [1] - Unlike IL-2, IL-15 does not stimulate the proliferation of regulatory T cells or induce T cell apoptosis [1] Group 2: Market Context - The foreign counterpart of SHR-1501, Nogapendekin Alfa Inbakicept (marketed as Anktiva), has already been approved for sale in the United States [1] - Currently, there are no approved products targeting the same pathway in the domestic market [1] Group 3: Financial Investment - The cumulative research and development investment for injectable SHR-1501 has reached approximately 102.18 million yuan [1]
恒瑞医药(01276.HK):注射用SHR-1501获纳入拟突破性治疗品种公示名单
Ge Long Hui· 2025-09-18 09:29
Core Viewpoint - Heng Rui Medicine's subsidiary, Shanghai Heng Rui Medicine Co., Ltd., has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center, with a public announcement period of 7 days [1] Group 1 - SHR-1501 is a proprietary interleukin-15 (IL-15) fusion protein developed by the company [1] - The drug stimulates the proliferation of T cells, B cells, and NK cells in the body, enhancing the immune system's ability to eliminate foreign substances such as tumors [1] - When used in conjunction with BCG, SHR-1501 significantly enhances the immune response within the bladder, achieving a synergistic anti-tumor effect [1]
恒瑞医药(01276.HK):子公司SHR-3045注射液类风湿关节炎临床试验获批
Ge Long Hui· 2025-09-18 09:24
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis [1] Company Summary - The SHR-3045 injection is designed to suppress immune cell function, reduce inflammation, and improve clinical symptoms in rheumatoid arthritis treatment [1] - The total research and development investment for the SHR-3045 injection project has reached approximately 35.54 million yuan [1] Industry Summary - Currently, there are no similar drugs approved for market use domestically or internationally [1]
恒瑞医药(01276.HK)子公司获SHR-1139注射液临床批件
Ge Long Hui· 2025-09-18 09:24
Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for clinical trials of SHR-1139 injection, a self-developed biological product aimed at treating ulcerative colitis through mechanisms that inhibit inflammation and maintain epithelial barrier [1] Group 1 - The approval notification for SHR-1139 injection was issued to Guangdong Heng Rui Medicine Co., Ltd., a subsidiary of the company [1] - The clinical trials for SHR-1139 injection are expected to commence shortly [1] - SHR-1139 injection is designed to enhance treatment efficacy in ulcerative colitis by targeting inflammation and epithelial barrier maintenance [1]
恒瑞医药(01276):SHR-1139 注射液获批开展临床试验
智通财经网· 2025-09-18 09:23
SHR-1139 注射液是公司自主研发的一种治疗用生物制品,预期可在溃疡性结肠炎治疗过程中,通过抑制 炎症反应和维持上皮屏障等机制协同增效。经查询,目前国内外尚无同类药物获批上市。截至目前, SHR-1139 注射液相关项目累计研发投入约 7,128 万元。 智通财经APP讯,恒瑞医药(01276)公布,近日,公司子公司广东恒瑞医药有限公司收到国家药品监督管 理局核准签发关于 SHR-1139 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。 ...
恒瑞医药(01276) - 海外监管公告 - 关於药物纳入拟突破性治疗品种公示名单的公告
2025-09-18 09:23
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。 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. 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2025-149 江苏恒瑞医药股份有限公司 关于药物纳入拟突破性治疗品种公示名单的公告 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 ...
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
2025-09-18 09:19
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。 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) Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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 一、药物的基本情况 药物名称:SHR-1139 注射液 剂 型:注射剂 中國上海 2025年9月18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。 ...
恒瑞医药(01276):SHR-3045注射液获准开展临床试验
智通财经网· 2025-09-18 09:18
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-3045 injection, a self-developed biological product aimed at treating rheumatoid arthritis [1] Group 1: Product Development - SHR-3045 injection is designed to inhibit immune cell function, reduce inflammation, and improve clinical symptoms in rheumatoid arthritis treatment [1] - The company has invested approximately 35.54 million yuan in the research and development of SHR-3045 injection to date [1] Group 2: Market Position - Currently, there are no similar drugs approved for market in both domestic and international markets [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
2025-09-18 09:14
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 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。 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")子公司广东恒瑞医 药有限公司和上海恒瑞医药有限公司收到国家药品监督管理局(以下简称"国家 药监局")核准签发关于 SHR-3045 注射液的《药 ...
智通港股52周新高、新低统计|9月18日
智通财经网· 2025-09-18 08:43
Group 1 - A total of 173 stocks reached a 52-week high as of September 18, with notable performers including Brilliant Tomorrow (01351), Hong Kong Broadband (01310), and Meijie Holdings (01389) achieving high rates of 85.26%, 70.25%, and 70.21% respectively [1] - The top three stocks by closing price that reached their 52-week high are: Brilliant Tomorrow (0.600), Hong Kong Broadband (8.630), and Meijie Holdings (0.720) [1] - Other significant stocks that reached their 52-week high include Kaisa Capital (00936) at 50.00%, Yihua Tong (02402) at 42.86%, and Zhongyu Energy (03633) at 37.55% [1] Group 2 - The report includes a detailed list of stocks that reached their 52-week highs, with their respective closing prices and the percentage increase from their previous highs [1] - The data indicates a strong market performance, particularly in the technology and telecommunications sectors, as evidenced by the high rates of increase among the leading stocks [1] - The overall trend suggests a bullish sentiment in the market, with many stocks showing significant recovery or growth compared to their previous performance [1]