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恒瑞医药(01276) - 海外监管公告 - 关於药品上市许可申请获受理并纳入优先审评程序的提示性公...

2026-02-10 12:34
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 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-024 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理并纳入优先审评程序 的提示性公告 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 ...
恒瑞医药(600276.SH):注射用瑞康曲妥珠单抗药品上市许可申请获受理并纳入优先审评程序
Ge Long Hui A P P· 2026-02-10 09:31
格隆汇2月10日丨恒瑞医药(600276.SH)公布,公司子公司苏州盛迪亚生物医药有限公司收到国家药品监 督管理局下发的《受理通知书》,公司注射用瑞康曲妥珠单抗的药品上市许可申请获受理,且已被纳入 优先审评程序。 公司注射用瑞康曲妥珠单抗已于2025年5月在国内获批上市,适用于治疗存在HER2(ERBB2)激活突 变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌(NSCLC)成人患 者。 ...
恒瑞医药(600276) - 恒瑞医药关于药品上市许可申请获受理并纳入优先审评程序的提示性公告

2026-02-10 09:15
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-024 一、药品的基本情况 药品名称:注射用瑞康曲妥珠单抗 剂型:注射剂 受理号:CXSS2600018 申报阶段:上市 申请人:苏州盛迪亚生物医药有限公司 拟定适应症(或功能主治):本品适用于治疗经奥沙利铂、氟尿嘧啶和伊立 替康治疗失败的 HER2 阳性结直肠癌成人患者。 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理并纳入优先审评程序 的提示性公告 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 生物医药有限公司收到国家药品监督管理局(以下简称"国家药监局")下发的 《受理通知书》,公司注射用瑞康曲妥珠单抗的药品上市许可申请获受理,且已 被纳入优先审评程序。现将相关情况公告如下: 在经奥沙利铂、氟尿嘧啶类和伊立替康治疗失败的 HER2 阳性晚期结直肠癌受试 者中的有效性和安全性,并探索该药物的免疫原性及药代动力学特征。本研究由 上海高博肿瘤医院李进院长和浙江大学医学院附属第二医院袁瑛 ...
恒瑞医药:注射用瑞康曲妥珠单抗上市许可申请获受理并优先审评
Xin Lang Cai Jing· 2026-02-10 08:53
恒瑞医药公告称,子公司苏州盛迪亚生物医药有限公司收到国家药监局下发的《受理通知书》,注射用 瑞康曲妥珠单抗的药品上市许可申请获受理并纳入优先审评程序。该药品已于2025年5月在国内获批用 于治疗特定肺癌,此次新适应症为治疗经奥沙利铂等治疗失败的HER2阳性结直肠癌成人患者。截至目 前,相关项目累计研发投入约17.73亿元。药品研发上市存在不确定性,公司将及时披露进展。 ...
智通AH统计|2月9日
智通财经网· 2026-02-09 08:17
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] Group 1: Top AH Premium Rates - Northeast Electric (00042) has the highest AH premium rate at 831.03%, with H-share priced at 0.290 HKD and A-share at 2.25 CNY [1] - Zhejiang Shibao (01057) follows with a premium rate of 347.33%, H-share at 5.810 HKD and A-share at 21.7 CNY [1] - Sinopec Oilfield Service (01033) ranks third with a premium rate of 304.44%, H-share at 0.900 HKD and A-share at 3.04 CNY [1] Group 2: Bottom AH Premium Rates - Contemporary Amperex Technology (03750) has the lowest AH premium rate at -13.97%, with H-share priced at 513.500 HKD and A-share at 368.82 CNY [1] - China Merchants Bank (03968) has a premium rate of -3.80%, H-share at 49.220 HKD and A-share at 39.53 CNY [1] - Heng Rui Medicine (01276) shows a minimal premium rate of -0.35%, with H-share at 69.050 HKD and A-share at 57.45 CNY [1] Group 3: Top Deviation Values - Sinopec Oilfield Service (01033) leads in deviation value at 26.29%, indicating a significant difference from its average premium rate [1] - Beijing Jingcheng Machinery Electric (00187) has a deviation value of 22.66% [1] - Longpan Technology (02465) ranks third with a deviation value of 19.24% [1] Group 4: Bottom Deviation Values - Junda Co., Ltd. (02865) has the lowest deviation value at -66.46%, indicating a substantial drop from its average premium rate [1] - Zhejiang Shibao (01057) follows with a deviation value of -42.67% [1] - Yangtze Optical Fibre and Cable (06869) shows a deviation value of -33.26% [1]
孙飘扬“借船出海”破局内卷 恒瑞医药创新药收入占比突破60%
Chang Jiang Shang Bao· 2026-02-08 23:53
中国创新药正步入全面收获期。在刚刚过去的2025年,我国生物医药产业创新活力迸发——全年76个创 新药获批,国产占比超八成;对外授权交易总额突破1300亿美元,创历史新高。 以仿制药起家,到转型创新药,"药王"恒瑞医药(600276)(600276.SH、01276.HK)的发展历程堪称是 中国医药产业升级的缩影。从以仿制药为营收支柱,到创新药收入占比突破60%,复出五年,孙飘扬带 领恒瑞医药转型攻坚,通过持续创新、差异化与国际化破局行业"内卷"。 2026年2月1日,恒瑞医药第九届董事会任期届满,68岁的孙飘扬会否继续担任董事长一职?恒瑞医药的 创新药全球化征程会走向怎样的新高度? 仿制药巨头大象转身 将时间拨回2020年,那一年,恒瑞医药以超6100亿元的市值傲视群雄,稳坐A股"医药一哥"。当年,恒 瑞医药的营业收入和归母净利润分别达到277.35亿元、63.28亿元的高峰。当年,在执掌恒瑞医药近三十 年后,孙飘扬决定退居幕后,将恒瑞交给职业经理人团队。 也是在那一年,国家药品集采政策全面实施,宣告着仿制药的高利润时代终结。以仿制药起家的恒瑞医 药危机悄然浮现。 随着集采不断扩围,市场被蚕食,2021年, ...
时代电气2025年盈利逾40亿元 越秀地产1月销售同比下滑超3成





Xin Lang Cai Jing· 2026-02-06 12:34
Company News - Beijing Capital International Airport Co., Ltd. (00694.HK) expects a net loss of approximately RMB 6.0 billion to RMB 7.6 billion in 2025, a year-on-year reduction of about 45.3% to 56.8%, benefiting from the recovery in aviation market demand and enhanced cost control [1] - Times Electric (03898.HK) anticipates total operating revenue of approximately RMB 28.761 billion in 2025, a year-on-year increase of 15.46%, with a net profit of about RMB 4.105 billion, up 10.88% year-on-year [1] - Hong Kong Tong Holdings (00032.HK) issued a profit warning, expecting a year-on-year increase in profit attributable to shareholders to approximately HKD 660 million for the fiscal year 2025 [1] - Datang Environment Industry Group (01272.HK) issued a profit warning, expecting pre-tax profit to rise to approximately RMB 700 million to RMB 710 million in 2025 [1] Power Generation - Datang New Energy (01798.HK) completed power generation of 3.272 million MWh in January, a year-on-year increase of 6.69% [2] - Longyuan Power (00916.HK) achieved power generation of 7.1627 million MWh in January, a year-on-year growth of 12.05%, with wind power generation increasing by 8.11% and solar power generation rising by 42.25% [2] - Jiangshan Holdings (00295.HK) reported total power generation of approximately 18.3 thousand MWh in January, a year-on-year decrease of 22.13% [4] Real Estate - Yuexiu Property (00123.HK) reported contract sales of approximately RMB 4.201 billion in January, a year-on-year decline of about 36.4% [2] - Poly Real Estate (01238.HK) recorded total contract sales of approximately RMB 470 million in January, a year-on-year decrease of 31.98% [2] - Greenland Hong Kong (00337.HK) reported contract sales of approximately RMB 508 million in January, a year-on-year increase of about 287.79% [3] Other Developments - CloudTop New Drug (01952) received approval for the new drug application of Vedolizumab for treating moderate to severe ulcerative colitis in adults in China [4] - Zhonghang Science and Technology (02357.HK) plans to invest RMB 58 million to acquire a 10% stake in Zhonghang Jierui [4] - Kelun-Biotech (06990.HK) received approval for the fourth indication of its core product TROP2ADC for treating 2L+ HR+/HER2- breast cancer [4] Financing and Buyback Activities - Kingsoft Corporation (03888.HK) repurchased approximately 1.1142 million shares for about HKD 29.9994 million, with repurchase prices ranging from HKD 26.8 to HKD 27 [7] - Geely Automobile (00175.HK) repurchased approximately 1.665 million shares for about HKD 27.1612 million, with repurchase prices between HKD 15.94 and HKD 16.44 [7] - October Rice Field (09676.HK) repurchased 780,000 shares for approximately HKD 7.3357 million, with repurchase prices between HKD 9.3 and HKD 9.46 [7] - China Galaxy (06881.HK) completed the issuance of corporate bonds totaling RMB 6 billion [7]
恒瑞医药:HRS-4642注射液被纳入突破性治疗品种名单
Zhi Tong Cai Jing· 2026-02-06 10:37
Core Viewpoint - Heng Rui Medicine's HRS-4642 injection has been included in the list of breakthrough therapies by the National Medical Products Administration, indicating a significant advancement in the treatment of advanced or metastatic pancreatic cancer with KRAS G12D mutations [1] Group 1 - The HRS-4642 injection is used in combination with gemcitabine and albumin-bound paclitaxel for first-line treatment [1]
恒瑞医药(01276.HK):“HRS-4642注射液”被药审中心纳入突破性治疗品种名单
Ge Long Hui· 2026-02-06 10:35
注册分类:1类 申请日期:2025年12月24日 格隆汇2月6日丨恒瑞医药(01276.HK)公告,近日,江苏恒瑞医药股份有限公司的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。 药物名称:HRS-4642注射液 受理号:CXHL2400083 药物类型:化学药品 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。 ...
恒瑞医药(01276):HRS-4642注射液被纳入突破性治疗品种名单
智通财经网· 2026-02-06 10:34
智通财经APP讯,恒瑞医药(01276)公布,近日,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。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。 ...