近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司天津恒瑞医 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 HRS-1738 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。现 将相关情况公告如下： 一、 药物的基本情况 药物名称：HRS-1738 注射液 剂 型：注射剂 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-032 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。 三、 风险提示 根据我国药品注册相关的法律法规要求，药物在获得药物临床试验批准通知 书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。药品 从研制、临床试验报批到投产的周期长、环节多，药品研发及至上市容易受到一 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。公司将 按国家有关规定积极推进上述研发项目，并及时对项目后续进展情况履行信息披 露义务。 特此公告。 江苏恒瑞医药股份有限公司董事会 申请事项： ...

受 理 号：CXHL2500040 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 1 月 8 日受理的 HRS-5817 注射液临床试验申请符合药品注册的有关要求，同 意本品在超重或肥胖适应症开展临床研究。 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-033 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"）子公司福建盛迪医 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 HRS-5817 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。现 将相关情况公告如下： 一、 药物的基本情况 药物名称：HRS-5817 注射液 剂 型：注射剂 申请事项：临床试验 二、药物的其他情况 HRS-5817 注射液为一款自主研发的 1 类化学药物。临床前数据显示， HRS-5817 可在肥胖动物模型中发挥减重效果，且安全性良好。经查询，目前国 内 ...

Group 1 - The market showed signs of recovery with the ChiNext index leading gains, driven by active capital and strong performance in the pharmaceutical sector, particularly in innovative drug stocks [1] - Heng Rui Medicine announced a licensing agreement with Merck for its oral small molecule inhibitor HRS-5346, which expands its international market presence and accelerates global R&D, enhancing confidence in the innovative drug sector [1] - China Galaxy noted that the pharmaceutical sector has experienced a long adjustment period, resulting in low overall valuations and public fund underweighting, but anticipates a recovery in the pharmaceutical market driven by policy support [2] Group 2 - The innovative drug industry and medical device exports are expected to benefit from policy support and growing market demand, with leading companies in niche sectors likely to stand out [2] - The recovery of pharmaceutical consumption is anticipated to gradually manifest with economic recovery and consumption upgrades [2] - Overall, the pharmaceutical sector presents structural opportunities that warrant close attention [2]

Group 1 - China Aluminum reported a net profit of 12.4 billion yuan for 2024, an increase of 85.38% year-on-year, with a proposed cash dividend of 0.135 yuan per share [1] - Lihua Technology's net profit for 2024 decreased by 25.41% to 245 million yuan, with a proposed cash dividend of 0.7 yuan per 10 shares [1][2] - Zhongjing Food achieved a net profit of 175 million yuan in 2024, up 1.81% year-on-year, proposing a cash dividend of 8 yuan per 10 shares [3][4] - Sanwei Chemical's net profit fell by 6.92% to 263 million yuan, with a proposed cash dividend of 3 yuan per 10 shares [5] - Meino Biological's project for corn protein processing has received construction approval, with an investment of approximately 391 million yuan [6][7] Group 2 - Guangdian Electric's net profit surged by 411.28% to 74.73 million yuan, proposing a cash dividend of 0.7 yuan per 10 shares [13][14] - Xin'ao Co. reported a net profit of 4.493 billion yuan for 2024, down 36.64%, with a proposed cash dividend of 10.3 yuan per 10 shares [15] - Huaren Pharmaceutical's subsidiary received approval for a raw material drug, enhancing its product line [16] - Huanxin Technology received a project confirmation from BAIC Group for two display screen products, expected to enter mass supply [17] - Haitong Development plans to purchase four bulk carriers for a total of 59.25 million USD to expand its fleet [18] Group 3 - Guochuang High-tech won a bid for an asphalt procurement project worth 128 million yuan [22][23] - Huayi Pharmaceutical's subsidiary received overseas marketing approvals for several products [24] - Haisco's innovative drug HSK41959 has received clinical trial approval [25] - Hetai Machinery's subsidiary obtained a patent for a dust-proof chain technology [28] - Le Xin Medical's fetal heart rate monitor registration renewal application has been accepted [29] Group 4 - Feilong Co. became a designated supplier for an international client's electronic oil pump project, with expected sales of approximately 160 million yuan [29] - Yunnan Copper reported a net profit of 1.265 billion yuan for 2024, down 19.9%, with a proposed cash dividend of 2.4 yuan per 10 shares [42] - China Merchants Bank's net profit increased by 1.22% to 148.39 billion yuan, proposing a cash dividend of 20 yuan per 10 shares [43] - Shuanghui Development's net profit decreased by 1.26% to 4.989 billion yuan, with a proposed cash dividend of 7.5 yuan per 10 shares [44]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-031 二、 药品的其他情况 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抑制剂（TOPi）。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。目前全球共有 1 款同类产品获批上市，为 Enfortumab vedotin（商品名：Padcev），经查询， 2023 年该产品全球销售额约为 7.15 亿美元。截至目前，注射用 SHR-A2102 相关 药品名称 注射用 SHR-A2102 阿得贝利单抗注射液 贝伐珠单抗注射液 剂型 注射剂 申请事项 临床试验 受理号 CXSL2400915 CXSL2400913 CXSL2400911 审批结论 根据《中华人民共和国药品管理法》及有关规定，经审查，2024 年 12 月 26 日受理的注射用 SHR-A2102、阿得贝利单抗注射液、贝 伐珠单抗注射液符合药品注册的有关要求，同意本次临床试验申请， 具体为：一项注射用 SHR-A2102 联合其他抗肿瘤治疗在晚期实体瘤 受试者 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-030 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"）收到国家药品监督 管理局（以下简称"国家药监局"）核准签发关于注射用 SHR-9803 的《药物临 床试验批准通知书》，将于近期开展临床试验。现将相关情况公告如下： 一、 药物的基本情况 药物名称：注射用 SHR-9803 剂 型：注射剂 受 理 号：CXSL2500026 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 1 月 8 日受理的注射用 SHR-9803 临床试验申请符合药品注册的有关要求，同 意本品单药在晚期实体瘤患者中开展临床试验。 二、药物的其他情况 注射用 SHR-9803 为 1 类治疗用生物制品，能够激活抗肿瘤免疫活性，从而 达到治疗肿瘤的目的。注射用 SHR-9803 能够特异性结合和清除肿瘤内调节性 T 细胞（Regulatory T c ...

深夜利好！恒瑞医药与默沙东签订19.7亿美元独家 协议 扬子晚报网3月26日讯(记者范晓林实习生朱秋璇)3月25日晚间，中国创新药龙头恒瑞医药 （600276）(600276.SH)宣布与美国跨国药企默沙东(Merck&Co,Inc.股票代码：MRK)达成独家许可协 议，将其自主研发的产品a HRS-5346在大中华区以外的全球权益授予后者。 默沙东将获得HRS-5346在大中华地区以外的全球范围内开发、生产和商业化的独家权利。 公告显示，HRS-5346是一种在研的Lp(a)口服小分子抑制剂，目前正在中国进行二期临床试验。 Lp(a)升高是一种遗传决定的疾病，也是心血管疾病的独立危险因素。据统计，全球约有14亿人口Lp(a) 水平升高。 根据双方敲定的协议条款，在交易款项安排上，恒瑞医药可即刻收获2亿美元的首付款，后续还有 望凭借该项目特定的开发、监管以及商业化进展，获得不超过17.7亿美元的里程碑付款。 若 HRS-5346相关产品顺利获批上市，恒瑞医药还将基于其净销售额，按一定比例获取销售提成， 交易总额上限高达19.7亿美元。HRS-5346作为一款口服小分子Lp(a)抑制剂，目前正在中国国内积极开 ...

Core Viewpoint - HengRui Medicine has entered into a licensing agreement with Merck to develop and commercialize the HRS-5346 project, a significant move in the pharmaceutical industry targeting Lp(a) as a cardiovascular risk factor [1][2]. Group 1: Licensing Agreement Details - The agreement allows Merck exclusive rights to develop, produce, and commercialize HRS-5346 outside Greater China, with an upfront payment of $200 million and potential milestone payments of up to $1.77 billion, plus sales royalties [1]. - The agreement is expected to take effect in the second quarter, but the approval and milestone payment timelines for HRS-5346 remain uncertain [1]. Group 2: Lp(a) and Cardiovascular Disease - Elevated Lp(a) is an independent risk factor for atherosclerotic cardiovascular disease (ASCVD), affecting approximately 1.4 billion people globally, with traditional medications showing limited efficacy in lowering Lp(a) levels [2][3]. - Current treatments, including statins and PCSK9 inhibitors, have limited impact on Lp(a), necessitating the development of targeted therapies [2][3]. Group 3: HRS-5346 and Market Potential - HRS-5346 works by blocking the covalent binding of apolipoprotein(a) with low-density lipoprotein (LDL), significantly reducing Lp(a) levels and improving atherosclerosis risk [3]. - As an oral small molecule drug, HRS-5346 offers better patient compliance and has the potential to become a market breakthrough [3]. Group 4: Industry Trends and Competitors - The development of Lp(a) inhibitors signifies a shift in cardiovascular treatment from broad lipid-lowering strategies to precision-targeted therapies, with several companies, including Novartis and Eli Lilly, advancing their own Lp(a) targeting drugs [4]. - Other domestic companies such as Jingxin Pharmaceutical, Xinlitai, WuXi AppTec, and Shiyao Group are also exploring this target, currently in preclinical stages [4].

港股概念追踪|恒瑞医药与默沙东达成许可协议 港股 创新药"含金量"普遍提升（附概念股） 恒瑞医药公告，公司与默沙东达成协议，将脂蛋白（a）[Lp（a）]口服小分子项目（包括名为HRS-5346 的先导化合物）有偿许可给默沙东，默沙东将获得HRS-5346在大中华地区以外全球范围内开发、生产 和商业化的独家权利。 根据协议，恒瑞授予默沙东在全球范围内（大中华地区除外）开发、生产和商业化HRS-5346的独家权 利。 默沙东将向恒瑞支付2亿美元首付款，恒瑞有资格获得与开发、监管和商业化相关的里程碑付款，最高 可达17.7亿美元。 根据HRS-5346在大中华地区以外的销售情况，默沙东还将向恒瑞支付相应的销售提成。 智通财经APP获悉，自2023年底以来，跨国药企与本土创新药企之间的商务拓展（BD）合作持续升 温，今年更是涌现出多个引人瞩目的合作项目。 今年年初，DeepSeek引爆全球市场，在生物医药领域的创新也颇受华尔街市场关注。 如此也使得，一众跨国药企瞄准研发生产之际，也有不少跨国药企选择探索释放数据、技术和人工智能 的潜力，积极探索与中国本土生物技术公司的合作与伙伴关系，加速数字化布局，寻求新的突破及市场 ...

Core Insights - Heng Rui Medicine has entered into a significant licensing agreement with Merck for its oral small molecule project targeting lipoprotein(a), with an upfront payment of $200 million and potential milestone payments up to $1.77 billion [3][4] - The Hong Kong Stock Connect Innovation Drug ETF (159570) has seen substantial inflows, with net subscriptions exceeding 240 million yuan and a total of over 800 million yuan in the last 60 days, indicating strong investor interest in innovative drug companies [4][6] - The trend of Chinese innovative drug companies expanding overseas is accelerating, with at least 262 license-out transactions expected from 2020 to 2024, totaling over $150 billion [4][5] Company Developments - Heng Rui Medicine's licensing deal with Merck includes exclusive rights for global development, production, and commercialization outside Greater China for the drug HRS-5346 [3][4] - Other companies like United Pharmaceuticals and Innovent Biologics have also secured significant licensing agreements, indicating a broader trend in the industry [3][5] - The recent performance of stocks within the Hong Kong Stock Connect Innovation Drug ETF shows a mixed picture, with notable gains from companies like 3SBio and declines from companies like Yunnan Baiyao [3][4] Market Trends - The Hong Kong Stock Connect Innovation Drug ETF has reached a new high in shares, reflecting a doubling in size over the past month, driven by increased investor confidence [4][6] - The overall market for innovative drugs is expected to benefit from AI advancements, improved financing conditions, and potential fiscal support, which could enhance profit margins for these companies [4][6] - The ETF's composition highlights a strong focus on leading companies in the innovative drug sector, with over 68% of its weight in the top ten holdings [6][7]