Xin Lang Cai Jing·2025-03-26 06:31Core 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].