Xin Lang Cai Jing·2026-02-12 07:33Core Viewpoint - The news highlights the submission of SHR-1918, a new lipid-lowering drug developed by Shengdi Pharmaceutical, a subsidiary of Heng Rui Medicine, for the treatment of homozygous familial hypercholesterolemia (HoFH) in adults and adolescents aged 12 and above [1][2]. Group 1: Drug Development and Approval - SHR-1918 is an ANGPTL3 monoclonal antibody that lowers triglyceride (TG) levels and low-density lipoprotein cholesterol (LDL-C) levels by inhibiting the activity of ANGPTL3, which plays a crucial role in lipid metabolism [2][7]. - The drug received breakthrough therapy designation for HoFH from the CDE in September 2024 and was included in priority review last month [2][7]. - A Phase III registration study for SHR-1918 began in December 2024 and was marked as "completed" in November 2025, with results yet to be disclosed [5][10]. Group 2: Clinical Trial Results - A single-arm, non-randomized Phase II clinical study showed that after 12 weeks of treatment with SHR-1918 (600mg, subcutaneously every 4 weeks), LDL-C levels decreased by 59.09% [3][8]. - In a randomized controlled Phase II clinical study, after 16 weeks of treatment, LDL-C levels were reduced by 21.7%, 27.3%, 29.9%, and 22.5% for the 150mg, 300mg, 600mg (every 4 weeks), and 600mg (every 8 weeks) dosage groups, respectively [3][8]. Group 3: Market Context and Competition - HoFH is a rare and severe genetic disorder characterized by a defect or absence of low-density lipoprotein cholesterol receptors (LDLR), leading to increased LDL-C levels in the blood and heightened risk of heart disease and stroke [6][12]. - Current treatment options for HoFH include statins, ezetimibe, lomitapide, mipomersen, PCSK9 monoclonal antibodies, and evinacumab, with evinacumab being the only marketed ANGPTL3 monoclonal antibody, projected to generate $162 million in U.S. sales by 2025 [6][12].