点评： 1） Lp(a)升高是动脉粥样硬化性心血管疾病（ASCVD）的独立危险因素，全球约14 亿人受此影响。 Lp(a)由遗传主导，其致动脉粥样硬化效力是LDL 的5-6 倍，且通过促炎、促血栓、抑制纤溶等多途径加 速心血管疾病进展。遗传学证据表明，降低Lp(a)可减少风险。全球约20%-30%人群Lp(a)水平超标，传 统药物（如他汀类）对Lp(a)的降幅有限（约10%-20%），PCSK9 抑制剂虽可降低Lp(a) 14%-35%，但仍 无法满足高风险患者需求，因此亟需特异性靶向药物。 医药生物行业事件点评报告：恒瑞医药授权默沙东 LP(A)口服小分子抑制剂 国内药企再获重磅BD 事件：3 月25 日，恒瑞医药与默沙东达成协议，将HRS-5346 项目有偿许可给默沙东，默沙东获大中华 地区以外全球范围开发、生产和商业化独家权利。默沙东支付2 亿美元首付款，恒瑞最高可获17.7 亿美 元里程碑付款及销售提成。协议预计二季度生效，HRS-5346 海外获批上市及里程碑付款存在不确定 性。 3） Lp(a)抑制剂的研发标志着心血管疾病治疗从"广谱降脂"向"精准靶向"转变。目前，ASO 和siRNA 药物在进度 ...

Core Viewpoint - HengRui Medicine has entered into an exclusive licensing agreement with Merck for its Lp(a) oral small molecule project, HRS-5346, with a total transaction value of $1.97 billion [1]. Group 1: Licensing Agreement Details - The agreement grants Merck exclusive rights to develop, manufacture, and commercialize HRS-5346 outside Greater China, with HengRui receiving an upfront payment of $200 million [1]. - HengRui is also eligible for up to $1.77 billion in milestone payments related to development, regulatory, and commercialization, along with sales royalties based on net sales if the product is approved [1]. Group 2: Clinical Background and Market Potential - HRS-5346 is currently undergoing Phase II clinical trials in China and targets elevated Lp(a) levels, which affect over 1.4 billion people globally and are an independent risk factor for atherosclerotic cardiovascular diseases [1]. - Targeting Lp(a) represents a significant breakthrough in the prevention and treatment of cardiovascular diseases [1]. Group 3: Strategic Implications for HengRui - This marks HengRui's first strategic collaboration with a major multinational company, enhancing its internationalization efforts [3]. - The transaction is expected to close in the second quarter of 2025, contingent upon regulatory approvals and customary conditions [3][4]. - HengRui's recent licensing activities have accelerated since the appointment of its Chief Strategy Officer in January 2023, indicating a shift towards more aggressive business development strategies [2].