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恒瑞医药(01276) - 海外监管公告 - 关於药物纳入突破性治疗品种名单的公告
2026-02-06 10:29
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 2026年2月6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。 证券代码:600276 证券简称:恒瑞医药 公告编号:临2026-023 ...
恒瑞医药(600276.SH):HRS-4642注射液纳入突破性治疗品种名单 目前国内外尚无同类药物获批上市
智通财经网· 2026-02-06 09:59
Core Viewpoint - Heng Rui Medicine's HRS-4642 injection has been included in the list of breakthrough therapies by the National Medical Products Administration, targeting advanced or metastatic pancreatic cancer with KRAS G12D mutation [1] Group 1: Product Development - HRS-4642 is a self-developed KRAS G12D inhibitor in a liposomal formulation [1] - The product is intended for use in combination with gemcitabine and albumin-bound paclitaxel as a first-line treatment [1] - Currently, there are no similar drugs approved for market domestically or internationally [1] Group 2: Market Context - Pancreatic cancer is a common malignant tumor of the digestive system, with 510,566 new cases reported globally in 2022, ranking 12th among malignant tumors [1] - The disease resulted in 467,005 deaths in 2022, making it the 6th leading cause of cancer-related deaths, accounting for approximately 5% of global cancer mortality [1]
恒瑞医药(600276) - 恒瑞医药关于药物纳入突破性治疗品种名单的公告
2026-02-06 09:15
证券代码:600276 证券简称:恒瑞医药 公告编号:临2026-023 受理号:CXHL2400083 药物类型:化学药品 注册分类:1类 江苏恒瑞医药股份有限公司 关于药物纳入突破性治疗品种名单的公告 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")的HRS-4642注射液被 国家药品监督管理局药品审评中心(以下简称"药审中心")纳入突破性治疗品 种名单。现将相关情况公告如下: 一、药物的基本情况 药物名称:HRS-4642注射液 江苏恒瑞医药股份有限公司董事会 2026 年 2 月 6 日 申请日期:2025年12月24日 拟定适应症(或功能主治):本品联合吉西他滨和紫杉醇(白蛋白结合型) 用于携带KRAS G12D突变的晚期或转移性胰腺癌的一线治疗。 理由及依据:经审核,本申请符合《药品注册管理办法》和《国家药监局关 于发布<突破性治疗药物审评工作程序(试行)>等三个文件的公告》(2020年 第82号)有关要求,同意纳入突破性治疗药物程序。 二、药物的其他相关情况 胰腺 ...
恒瑞医药:HRS-4642注射液纳入突破性治疗品种名单,目前国内外尚无同类药物获批上市
Xin Lang Cai Jing· 2026-02-06 08:48
恒瑞医药2月6日公告,公司的HRS-4642注射液被国家药品监督管理局药品审评中心纳入突破性治疗品 种名单,拟定适应症为联合吉西他滨和紫杉醇(白蛋白结合型)用于携带KRAS G12D突变的晚期或转 移性胰腺癌的一线治疗。截至目前,相关项目累计研发投入约2.54亿元。经查询,目前国内外尚无同类 药物获批上市。 ...
恒瑞医药:HRS-4642注射液纳入突破性治疗品种名单
Mei Ri Jing Ji Xin Wen· 2026-02-06 08:41
Core Viewpoint - Heng Rui Medicine's HRS-4642 injection has been included in the list of breakthrough therapies by the National Medical Products Administration, targeting first-line treatment for advanced or metastatic pancreatic cancer with KRAS G12D mutation [1] Group 1: Product Development - HRS-4642 is a liposomal formulation KRAS G12D inhibitor that specifically binds to KRAS G12D, inhibiting the phosphorylation of MEK and ERK proteins to exert anti-tumor effects [1] - The total R&D investment for the related project has reached approximately 254 million yuan [1] Group 2: Regulatory and Market Context - The inclusion in the breakthrough therapy list indicates potential expedited development and approval processes, which may enhance market opportunities for the product [1] - Drug development is subject to various uncertainties related to technology, approval, and policy factors [1]
恒瑞医药:HRS - 4642注射液纳入突破性治疗品种名单
Xin Lang Cai Jing· 2026-02-06 08:36
恒瑞医药公告称,近日其HRS - 4642注射液被药审中心纳入突破性治疗品种名单。该注射液为化学药品 1类,拟定用于携带KRASG12D突变的晚期或转移性胰腺癌一线治疗,2025年12月24日申请。它是公司 自研的KRASG12D抑制剂,国内外尚无同类药物获批上市,相关项目累计研发投入约2.54亿元。药品研 发受多因素影响,存在不确定性风险,公司会推进项目并披露进展。 ...
智通AH统计|2月6日
智通财经网· 2026-02-06 08:19
Core Viewpoint - The report highlights the premium rates of AH shares, with Northeast Electric, Zhejiang Shibao, and Sinopec Oilfield Services leading in premium rates, while CATL, China Merchants Bank, and WuXi AppTec are at the bottom of the list [1][2][3]. Premium Rate Rankings - The top three AH shares by premium rate are: - Northeast Electric (00042) with a premium rate of 831.03% - Zhejiang Shibao (01057) with a premium rate of 353.97% - Sinopec Oilfield Services (01033) with a premium rate of 302.25% [2] - The bottom three AH shares by premium rate are: - CATL (03750) with a premium rate of -11.84% - China Merchants Bank (03968) with a premium rate of -3.56% - WuXi AppTec (02359) with a premium rate of 1.72% [3] Deviation Value Rankings - The top three shares by deviation value are: - Dazhu CNC (03200) with a deviation value of 60.25% - Muyuan Foods (02714) with a deviation value of 37.19% - Beijing Jingcheng Machinery Electric (00187) with a deviation value of 27.09% [1][4] - The bottom three shares by deviation value are: - Zhejiang Shibao (01057) with a deviation value of -39.99% - Junda Co., Ltd. (02865) with a deviation value of -35.13% - Yangtze Optical Fibre and Cable (06869) with a deviation value of -23.61% [1][5]
恒瑞医药:子公司获SHR-1894注射液《药物临床试验批准通知书》
Zheng Quan Ri Bao· 2026-02-05 14:14
Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of SHR-1894 injection, aimed at treating atopic dermatitis, marking a significant development as no similar drugs have been approved domestically or internationally [1] Company Summary - The company has invested 40.1 million yuan in the SHR-1894 project [1]
恒瑞医药SHR-1894注射液临床试验获批
Bei Jing Shang Bao· 2026-02-05 10:18
Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of SHR-1894 injection, a self-developed biological product aimed at treating atopic dermatitis [1] Group 1 - SHR-1894 injection is expected to protect the skin barrier and suppress inflammation during the treatment of atopic dermatitis [1] - Currently, there are no similar drugs approved for market release domestically or internationally [1]
恒瑞医药HR091506片上市许可申请获受理
Bei Jing Shang Bao· 2026-02-05 10:18
Core Viewpoint - Heng Rui Medicine has received acceptance for its HR091506 tablet application from the National Medical Products Administration, aimed at long-term treatment of hyperuricemia in gout patients [1] Group 1 - The HR091506 tablet is developed using gastric retention formulation technology and features a pulsatile release characteristic [1] - The product consists of a rapid-release part and a delayed-release part, designed to quickly achieve effective blood drug concentration and maintain it over an extended period [1] - The goal of HR091506 is to improve the rate of achieving target uric acid levels in patients [1]