Xin Lang Cai Jing·2026-02-12 12:12Core Viewpoint - Recently, HRS-5346, developed by the subsidiary of Heng Rui Medicine, Shandong Shengdi Pharmaceutical Co., Ltd., has been included in the list of breakthrough therapeutic drugs by the National Medical Products Administration (NMPA) for the treatment of elevated lipoprotein(a) levels [1][7]. Group 1: Company Information - HRS-5346 is an oral small molecule Lp(a) inhibitor that works by blocking the initial non-covalent binding between apolipoprotein(a) [apo(a)] and apolipoprotein B100 (ApoB100), thereby inhibiting the formation of disulfide bonds and reducing Lp(a) levels [3][9]. - The company plans to grant global exclusive rights for HRS-5346 outside of Greater China to Merck & Co., Inc. in March 2025 [4][9]. Group 2: Industry Context - Elevated lipoprotein(a) [Lp(a)] levels are the most common single-gene lipid disorder globally, with prevalence rates among Chinese adults exceeding 30 mg/dL and 50 mg/dL at 18.67% and 8.41%, respectively [2][9]. - Lp(a) elevation has been confirmed as an independent risk factor for atherosclerotic cardiovascular diseases (ASCVD), including coronary heart disease, ischemic stroke, peripheral vascular disease, and calcific aortic valve stenosis [2][9]. - Targeting Lp(a) with lipid-lowering therapies represents a potential new direction in the prevention and treatment of cardiovascular diseases, although no specific treatment for lowering Lp(a) is currently available, and such therapies remain in clinical research [2][9].