Hengrui Pharma(600276)

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加速出海,恒瑞医药与默沙东签下19.7亿美元大单
环球老虎财经· 2025-03-26 03:40
或受此影响,3月26日开盘,恒瑞医药股价小幅上涨,随后稍有回落,截至发稿涨超3%,总市值为2953 亿元。 恒瑞医药方面表示,借助默沙东在心血管领域的领先地位(其抗血小板药物氯吡格雷年销售额超50亿美 元)及覆盖120国的销售网络,可加速实现创新价值转化,同时还能规避海外高昂的研发投入和法规风 险。 实际上,恒瑞医药一直在通过海外授权,来完成其出海战略。粗略统计,恒瑞医药已有13项创新药实现 海外授权。值得一提的是,2024年5月,恒瑞医药将具有自主知识产权的GLP-1类创新药HRS-7535、 HRS9531、HRS-4729许可给美国Kailera公司。彼时,首付款加里程碑付款累计高达约60亿美元,并且 还取得美国Kailera公司19.9%的股权。 加速出海的背后,是恒瑞医药在研发方面的大力投入。2024年前三季度业绩报告显示,其研发费用达 45.49亿元,同比增长22.1%。目前,恒瑞医药已在全球布局 14 个研发中心,组建了超 5500 人的全球研 发团队;在中国获批上市的有19款新分子实体药物(1类创新药)和4款其他创新药(2类新药)。 加速出海,恒瑞医药与默沙东签下19.7亿美元大单 3月25日 ...
恒瑞医药一款2期临床药物近20亿美元卖给默沙东
经济观察网· 2025-03-26 02:55
恒瑞医药一款2期临床药物近20亿美元卖给默沙东 3月25日,恒瑞医药(600276)(600276.SH)宣布与默沙东就其脂蛋白(a)[Lp(a)]口服小分子项目达成 独家许可协议,交易总对价为19.7亿美元。 经济观察报记者瞿依贤根据协议条款,恒瑞医药将HRS-5346在大中华区以外的全球范围内开发、 生产和商业化的独家权利有偿许可给默沙东。恒瑞医药将收取2亿美元的首付款,并有资格获得不超过 17.7亿美元的与特定的开发、监管和商业化相关的里程碑付款,以及如果相关产品获批上市,基于 HRS-5346的净销售额的销售提成。 恒瑞医药上述在研Lp(a)抑制剂的代号为HRS-5346。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2期临床试验。 按照常规时间推算,与默沙东所达成交易中的2亿美元首付款,或在第二季度确认收入。 恒瑞医药执行副总裁、首席战略官江宁军表示,相信默沙东卓越的临床研发实力和全球化布局,将 加速推动HRS-5346的研发进程,未来有望为更多患者提供降低动脉粥样硬化风险的治疗新选择。 作为转型中的大型药企,2023年之前恒瑞医药留给业内的印象是埋头研发。2023年1月 ...
恒瑞医药“出海”新进展!HRS-5346最高可获128亿元的里程碑付款
21世纪经济报道· 2025-03-25 12:51
Core Viewpoint - Heng Rui Medicine has signed an overseas licensing agreement with Merck Sharp & Dohme, potentially earning up to 1.28 billion yuan (approximately 177 million USD) in milestone payments for its oral small molecule project HRS-5346, aimed at treating lipoprotein(a) disorders [2][3]. Group 1: Licensing Agreement Details - The agreement includes an upfront payment of 200 million USD and milestone payments that could total up to 1.77 billion USD, along with sales royalties based on HRS-5346's performance outside Greater China [2][3]. - The licensing agreement is expected to take effect in the second quarter of 2025, which will help expand HRS-5346's overseas market presence [2][3]. Group 2: Product Information - HRS-5346 is currently undergoing Phase II clinical trials in China and is designed to inhibit lipoprotein(a), a unique type of lipoprotein associated with atherosclerosis and other cardiovascular issues [3][4]. - There are currently no similar products approved for sale in domestic or international markets, and preclinical data indicates that HRS-5346 can effectively improve lipoprotein disorders with good safety profiles [4][5]. Group 3: Industry Context - Heng Rui Medicine has been actively pursuing international expansion, with multiple overseas licensing agreements for various products, indicating a strategic shift towards global markets [6][7]. - The Chinese biopharmaceutical industry is witnessing a significant increase in overseas licensing agreements, with the total upfront payments in 2024 expected to exceed 4.94 billion USD, highlighting the growing competitiveness of Chinese pharmaceutical companies on a global scale [7].
恒瑞医药与默沙东就一款心血管创新药达成合作 交易金额最高19.7亿美元
每日经济新闻· 2025-03-25 12:44
Core Viewpoint - HengRui Medicine has entered into a collaboration with Merck to license its oral small molecule project targeting lipoprotein(a) [Lp(a)], with a maximum transaction value of $1.97 billion [1][2] Group 1: Agreement Details - The agreement allows Merck exclusive rights to develop, manufacture, and commercialize HRS-5346 outside Greater China [1] - HengRui will receive an upfront payment of $200 million and is eligible for up to $1.77 billion in milestone payments related to development, regulatory, and commercialization [1] - The agreement is subject to approval under U.S. regulations and is expected to take effect in the second quarter of 2025 [1] Group 2: Product Information - HRS-5346 is an investigational oral small molecule inhibitor of Lp(a), currently undergoing Phase II clinical trials in China [2] - Elevated Lp(a) levels are a common genetic lipid disorder, affecting over 1.4 billion people globally, and are an independent risk factor for atherosclerotic cardiovascular diseases [2] - Targeting Lp(a) with lipid-lowering therapies represents a significant breakthrough in the prevention and treatment of cardiovascular diseases [2] Group 3: Impact on Company - The signing of this agreement is expected to broaden the overseas market for HRS-5346 and enhance HengRui's innovative brand and international performance [2]
3月25日晚间公告 | 恒瑞医药与默沙东达成许可协议;荣盛发展拟对债务进行重组
选股宝· 2025-03-25 12:01
Group 1: Share Buybacks and Equity Transfers - Chipone Microelectronics plans to transfer 8.41% of its shares at a price no less than 85.71 CNY per share [1] - China First Heavy Industries' controlling shareholder intends to transfer 4% of the company [1] - Guoli Co., Ltd. plans to repurchase shares worth between 30 million to 50 million CNY, with a repurchase price not exceeding 73.47 CNY per share [1] Group 2: Investment Cooperation and Business Developments - Heng Rui Medicine has reached a licensing agreement with Merck, potentially receiving up to 1.77 billion USD in milestone payments [2] - China Energy Conservation Investment Corporation is investing approximately 470 million CNY in a 100 MW photovoltaic power generation project [3] - Shuangjie Electric has signed significant contracts totaling 1.555 billion CNY for daily operations [4] - Rongsheng Development is planning to restructure its debts [5] - Runhe Materials intends to invest 400 million CNY in a high-end organic silicon materials project in Zhuhai [6] - Guojijiang Precision Engineering plans to establish a company with an investment of 380 million CNY for a functional diamond material project [7] - Jiazhe New Energy is investing in a 100 MW/400 MWh shared energy storage project in Heilongjiang, with an estimated total investment of about 410 million CNY [7] - Wanrun Co., Ltd. has signed a project cooperation letter of intent with Sinopec Catalyst Co., Ltd. [7] Group 3: Performance Changes - Dalian Heavy Industry expects a net profit growth of 12.22% to 36.77% year-on-year in Q1 2025 [8] - Tailin Microelectronics anticipates a net profit of around 35 million CNY in Q1 2025, representing an approximate 894% year-on-year increase, achieving the best quarterly financial performance in its history [8] - CNOOC Services expects a 4.1% year-on-year net profit growth in 2024 and plans to distribute a dividend of 2.306 CNY per share [9]
恒瑞医药(600276) - 恒瑞医药关于与Merck Sharp & Dohme LLC签署HRS-5346项目授权许可协议的公告
2025-03-25 11:01
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-029 江苏恒瑞医药股份有限公司 关于与 Merck Sharp & Dohme LLC 签署 HRS-5346 项目授权许可协议的公告 (一)许可范围 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。 江苏恒瑞医药股份有限公司(以下简称"恒瑞"或"公司")与 Merck Sharp & Dohme 公司(以下简称"MSD"或"默沙东")达成协议,将恒瑞的脂 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 MSD,MSD 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。 一、许可产品基本信息 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Ⅱ 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。全球约有 14 亿人 Lp(a)水平升高。 二、交易对方基本信息 默沙东(Merck Sharp & Dohme),在美国和加拿大 ...
恒瑞医药(600276) - 恒瑞医药收到关于注射用卡瑞利珠单抗的完整回复信的公告
2025-03-21 09:32
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-028 江苏恒瑞医药股份有限公司 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")收到美国食品药品 监督管理局(以下简称"FDA")关于注射用卡瑞利珠单抗联合甲磺酸阿帕替尼 片用于不可切除或转移性肝细胞癌患者的一线治疗的生物制品许可申请 (Biologics License Application)的完整回复信(以下简称"回复信")。 回复信中 FDA 表示,相关生产场地检查需进一步提交答复,但 FDA 并未在回复信 中说明具体原因。公司将继续积极与 FDA 保持密切沟通,确认具体原因后尽快采 取措施并重新提交申请,以期能够获得批准。 一、药品的基本情况 药品名称:注射用卡瑞利珠单抗 剂型:注射剂 拟定适应症(或功能主治):本品联合甲磺酸阿帕替尼片用于不可切除或转 移性肝细胞癌患者的一线治疗。 二、药品的其他情况 注射用卡瑞利珠单抗已在国内获批九个适应症,分别为:2019 年 5 月获批 用于至少经过二线系统化 ...
恒瑞医药(600276) - 恒瑞医药关于获得药品注册证书的公告
2025-03-21 09:32
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-027 江苏恒瑞医药股份有限公司 关于获得药品注册证书的公告 强直性脊柱炎以慢性炎症和脊柱关节结构损伤为特征,既往治疗如非甾体抗 炎药(NSAID)虽可缓解患者的疼痛,但改善疾病活动性和延缓疾病进展的效果 并不理想,常面临起效慢、应答不足、无法阻止结构损伤等难题[1,2]。此外,传 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")核准签发的《药品注册证书》,批准公司自 主研发的 1 类创新药硫酸艾玛昔替尼片(SHR0302 片)上市,适应症为:用于对 一种或多种 TNF 抑制剂疗效不佳或不耐受的活动性强直性脊柱炎(AS)成人患者。 这标志着强直性脊柱炎口服靶向治疗领域首次实现了中国原研。现将相关情况公 告如下: 一、 药品的基本情况 药品名称:硫酸艾玛昔替尼片 剂型:片剂 规格:4mg 注册分类:化学药品 1 类 受理号:CXHS2300071 处方药/非处方药:处方药 审批结论:根据《中华人民共和国药品管理办法》及有关规定,经审查,本 品符合药品注册的有关要求,批准注册,发给药品注册证书。 ...
恒瑞医药(600276) - 恒瑞医药关于药品纳入拟突破性治疗品种公示名单的公告
2025-03-19 09:15
证券代码:600276 证券简称:恒瑞医药 公告编号:临2025-026 江苏恒瑞医药股份有限公司 关于药品纳入拟突破性治疗品种公示名单的公告 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")子公司苏州盛迪亚生 物医药有限公司的注射用瑞康曲妥珠单抗(SHR-A1811)被国家药品监督管理局药 品审评中心(以下简称"药审中心")纳入拟突破性治疗品种公示名单,公示期7 日,这也是该产品第8次纳入拟突破性治疗品种公示名单。现将相关情况公告如下: 一、药品的基本情况 药品名称:注射用瑞康曲妥珠单抗 受理号:CXSL2000087 药品类型:治疗用生物制品 注册分类:1类 申请日期:2025年2月28日 二、药品的其他相关情况 拟定适应症(或功能主治):用于既往接受含铂化疗及免疫检查点抑制剂治 疗失败的HER2表达(IHC≥1+)的复发或转移性宫颈癌。 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》(20 ...
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
上海证券报· 2025-03-17 18:58
Group 1 - The company Jiangsu Hengrui Medicine Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of HRS-6213 injection, which will be conducted shortly [1][2] - HRS-6213 injection is designed to specifically bind to tumor proteins, emitting positrons during metabolism, which are captured by PET scanners to generate high-resolution images for tumor diagnosis and treatment planning [2] - The total R&D investment for HRS-6213 injection has reached approximately 8.93 million yuan [2]