Workflow
Hengrui Pharma(600276)
icon
Search documents
恒瑞医药瑞拉芙普α注射液获批上市
Bei Jing Shang Bao· 2026-01-07 11:17
北京商报讯(记者 王寅浩 宋雨盈)1月7日,恒瑞医药发布公告称,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的通知,批准公司自主研发的1类创新药瑞拉芙普α注射液上市。批准 的适应症为瑞拉芙普α注射液联合氟尿嘧啶类和铂类药物用于经充分验证的检测评估PD-L1阳性 (CPS≥1)的局部晚期不可切除、复发或转移性胃及胃食管结合部腺癌的一线治疗。 ...
恒瑞医药:1类创新药瑞拉芙普α注射液获批上市
Xin Lang Cai Jing· 2026-01-07 10:39
恒瑞医药1月7日晚间公告,公司子公司苏州盛迪亚生物医药有限公司收到国家药监局的通知,批准公司 自主研发的1类创新药瑞拉芙普α注射液上市。批准的适应症:本品联合氟尿嘧啶类和铂类药物用于经 充分验证的检测评估PD-L1阳性(CPS≥1)的局部晚期不可切除、复发或转移性胃及胃食管结合部腺癌 的一线治疗。经查询,国内外尚无同类产品获批上市。截至目前,瑞拉芙普α注射液相关项目累计研发 投入约71,130万元。 ...
恒瑞医药(600276.SH):瑞拉芙普α注射液获得药品注册批准
Ge Long Hui A P P· 2026-01-07 10:39
格隆汇1月7日丨恒瑞医药(600276.SH)公布,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 理局的通知,批准公司自主研发的1类创新药瑞拉芙普α注射液上市。瑞拉芙普α注射液是公司自主研发 并具有知识产权的抗PD-L1/TGF-βRII双功能融合蛋白,本品能够通过特异性阻断PD-1/PD-L1的相互作 用,同时中和肿瘤微环境中的TGF-β,发挥抗肿瘤作用。经查询,国内外尚无同类产品获批上市。截至 目前,瑞拉芙普α注射液相关项目累计研发投入约71,130万元。 ...
恒瑞医药(600276) - 恒瑞医药关于获得药品注册批准的公告
2026-01-07 10:30
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2026-004 药品名称:瑞拉芙普α注射液 剂型:注射剂 规格:300mg(6ml)/瓶 注册分类:治疗用生物制品 1 类 受理号:CXSS2400101 江苏恒瑞医药股份有限公司 关于获得药品注册批准的公告 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 生物医药有限公司收到国家药品监督管理局(以下简称"国家药监局")的通知, 批准公司自主研发的 1 类创新药瑞拉芙普α注射液上市。现将相关情况公告如下: 一、药品的基本情况 处方药/非处方药:处方药 批准的适应症:本品联合氟尿嘧啶类和铂类药物用于经充分验证的检测评估 PD-L1 阳性(CPS≥1)的局部晚期不可切除、复发或转移性胃及胃食管结合部腺 癌的一线治疗。 三、风险提示 公司高度重视药品研发,并严格控制药品研发、制造及销售环节的质量及安 全。药品获得批件后生产和销售容易受到一些不确定性因素的影响。敬请广大投 资者谨慎决策,注意防范投资风险。 特 ...
恒瑞医药:瑞拉芙普α注射液获批上市
人民财讯1月7日电,恒瑞医药(600276)1月7日公告,近日,公司子公司苏州盛迪亚生物医药有限公司收 到国家药监局的通知,批准公司自主研发的1类创新药瑞拉芙普α注射液上市。该药品联合氟尿嘧啶类 和铂类药物用于经充分验证的检测评估PD-L1阳性(CPS≥1)的局部晚期不可切除、复发或转移性胃及 胃食管结合部腺癌的一线治疗。经查询,国内外尚无同类产品获批上市。 转自:证券时报 ...
恒瑞医药:1类创新药瑞拉芙普α注射液获批上市 国内外尚无同类产品获批上市
Mei Ri Jing Ji Xin Wen· 2026-01-07 10:08
每经AI快讯,1月7日,恒瑞医药(600276)(600276.SH)公告称,公司子公司苏州盛迪亚生物医药有限 公司收到国家药监局通知,批准公司自主研发的1类创新药瑞拉芙普α注射液上市。该药品联合氟尿嘧 啶类和铂类药物用于经充分验证的检测评估PD-L1阳性(CPS≥1)的局部晚期不可切除、复发或转移性胃 及胃食管结合部腺癌的一线治疗。经查询,国内外尚无同类产品获批上市。截至目前,瑞拉芙普α注射 液相关项目累计研发投入约7.11亿元。 ...
长线资金争当基石“怕抢不到单”,瑞银称2026年港股IPO将继续火热
Di Yi Cai Jing· 2026-01-07 09:57
瑞银预测,2026年港股IPO数量将达150家至200家,募资额将超3000亿港元。 中资企业蜂拥赴港上市,IPO大单频现,走过火热的2025年,港股IPO在2026年能否延续强劲势头? "我们认为,港股IPO的热度在今年能够得以延续,基础支撑是存在的。"瑞银集团中国区总裁及瑞银证 券董事长胡知鸷对第一财经表示,中国香港的全球领先国际金融中心地位、港股IPO排队企业数量充足 等,将共同支撑港股IPO继续走热。 瑞银预测,2026年全年,港股上市企业数量将达到150家至200家,募资额有望超过3000亿港元。 从基石投资者参与热度来看,港股IPO项目仍备受追捧。就在本周,MiniMax(稀宇科技)将于1月9日 登录港交所,其吸引了14名基石投资者,包括Aspex、Eastspring、阿里巴巴、易方达等,认购总额约 27.23亿港元,占到募资总额的六成以上。 胡知鸷观察到,此前,部分海外项目发行难度较高,因此需要有一定比例的基石投资者,以增加发行确 定性。"现在这种情况反过来了,是投资人要去争当基石,或者锚定(投资者),核心原因只有一个, 怕抢不到单。" "抢着要做基石" 就在几天前,2025年收官之际,港交所 ...
医药-景气延续-持续重点推荐创新药械产业链
2026-01-07 03:05
Summary of Key Points from the Conference Call Industry Overview - The pharmaceutical industry is experiencing sustained growth, particularly in the innovative drug and device sectors, with leading companies such as WuXi AppTec, Tigermed, United Imaging, and Lepu Medical being highlighted as key players [1][2] - The consumer healthcare sector is expected to recover to positive growth by 2026 after a period of price stabilization, with a focus on underperforming segments like dental and ophthalmic products [1][5] - The brain-computer interface industry is at a critical juncture with technological breakthroughs and clinical validations, supported by policies and the production plans of companies like Neuralink, presenting significant investment opportunities [1][15] Company Recommendations - Recommended companies in the A-share market include: - Heng Rui Medicine - Kelun Pharmaceutical - East China Pharmaceutical - Enhua Pharmaceutical - Teva Biopharmaceuticals - Jingxin Pharmaceutical - Yifan Biopharmaceuticals - WuXi AppTec - Tigermed - Lepu Medical - United Imaging - In the Hong Kong market, recommended companies include: - Hansoh Pharmaceutical - 3SBio - Kelun Biotech - Kintor Pharmaceutical - Yifan Biopharmaceuticals - BeiGene [3] Market Trends and Performance Expectations - The overall strategy for the pharmaceutical sector remains unchanged, with a focus on innovative drugs and devices, expecting a positive shift in performance in Q1 2026 despite a downturn in 2025 [2] - The blood products sector faced significant pressure in 2024, but recovery is anticipated in 2025 due to new product launches [6] - The Chinese medical device market is expected to see optimistic revenue growth in 2026, driven by new product launches and successful bidding processes [11] - United Imaging is projected to have a strong market performance in 2026, benefiting from improved bidding data and expected overseas growth of over 30% [3][12] Specific Sector Insights - The innovative drug sector is actively evolving globally, with China significantly participating in the global R&D landscape, particularly in oncology and metabolic disease treatments [4] - The weight loss and metabolic drug sector is seeing numerous catalysts, with companies like Heng Rui and BoRui focusing on long-acting injection formulations and oral lipid formulations [1][17] - In the autoimmune sector, companies like Yifan, Haizhi, and Kangnuo are highlighted for their oral drugs and long-acting bispecific antibodies, with significant collaborations enhancing their market potential [1][19] Additional Considerations - The pharmacy sector is recommended to focus on leading companies like Yifeng, which is pursuing growth through mergers and acquisitions [7] - The microelectrophysiology market is expected to accelerate revenue growth in 2026 due to the launch of new products and successful bidding processes [10] - The impact of medical insurance negotiations on the GLP-1 market is crucial for increasing penetration rates, with positive policy support for innovative drug development [21]
恒瑞医药再涨超4% 两款前列腺癌创新药获批临床 国内外未有同类产品获批上市
Zhi Tong Cai Jing· 2026-01-07 02:26
Core Viewpoint - Heng Rui Medicine (600276) (01276) has seen its stock price increase by over 4%, currently trading at 77.8 HKD with a transaction volume of 103 million HKD, following the announcement of two innovative drugs receiving approval for clinical trials targeting PSMA-positive prostate cancer [1] Group 1: Drug Approvals - Heng Rui Medicine announced that its two self-developed innovative drugs, HRS-4357 injection and HRS-5041 tablets, have been approved by the National Medical Products Administration for clinical trials [1] - HRS-4357 is a Class 1 radioactive therapeutic drug, and this approval represents an expansion based on its previous single-agent clinical trials [1] - HRS-5041 is a novel androgen receptor protein degradation-targeting small molecule drug, designed to treat prostate cancer by degrading AR proteins, with potential to overcome resistance to existing therapies [1] Group 2: Market Context - The announcement highlights that there are currently no similar products approved for market release, both domestically and internationally [1]
港股异动 | 恒瑞医药(01276)再涨超4% 两款前列腺癌创新药获批临床 国内外未有同类产品获批上市
智通财经网· 2026-01-07 02:23
Core Viewpoint - Heng Rui Medicine (01276) has seen a stock price increase of over 4%, currently trading at 77.8 HKD, with a transaction volume of 103 million HKD, following the announcement of two innovative drugs receiving approval for clinical trials in prostate cancer treatment [1]. Group 1: Drug Approvals - Heng Rui Medicine announced that its two self-developed innovative drugs, HRS-4357 injection and HRS-5041 tablets, have been approved by the National Medical Products Administration for clinical trials targeting prostate-specific membrane antigen (PSMA) positive prostate cancer [1]. - HRS-4357 is a Class 1 radioactive therapeutic drug, and this approval represents an expansion based on its previous single-agent clinical trials [1]. - HRS-5041 is a novel androgen receptor protein degradation-targeting chimeric small molecule drug, designed to treat prostate cancer by degrading AR proteins, with potential to overcome resistance to existing therapies [1]. - The announcement highlighted that there are currently no similar products approved for market release domestically or internationally [1].