格隆汇1月27日丨恒瑞医药(600276.SH)公布，近日,公司子公司山东盛迪医药有限公司的HRS-5346片被 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。 脂蛋白(a)[Lp(a)]水平升高是全球最普遍的单基因脂质疾病，是脂蛋白紊乱的典型表现之一。中国成年人 的Lp(a)水平＞30mg/dL和50mg/dL的患病率分别为18.67%和8.41%。高Lp(a)已被证实为动脉粥样硬化性 心血管疾病包括冠心病、缺血性脑卒中、外围血管疾病及钙化性主动脉瓣狭窄等疾病的独立危险因素。 靶向Lp(a)的降脂疗法是心血管疾病防治的重要突破方向之一。HRS-5346是一种Lp(a)口服小分子抑制 剂，经查询，目前国内外尚无同类产品获批上市。截至目前，HRS-5346片相关项目累计研发投入约为 7630万元(未经审计)。 ...

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]