Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2026-02-24 22:35Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received a notice from the National Medical Products Administration regarding the acceptance of its innovative drug SHR-1918 injection for marketing approval, which has been included in the priority review process [1] Drug Basic Information - Drug Name: SHR-1918 Injection - Dosage Form: Injection - Acceptance Number: CXSS2600019 - Application Stage: Marketing - Applicant: Beijing Shengdi Pharmaceutical Co., Ltd. - Indication: Treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH) [1] Clinical Trial Information - The marketing application is based on two clinical trials for HoFH patients: SHR-1918-202 and SHR-1918-301, led by Professor Peng Daoquan from Central South University [2] - SHR-1918-202 is a Phase II multicenter, single-arm trial in adult HoFH patients, showing an average reduction of 59.1% in serum low-density lipoprotein cholesterol (LDL-C) with a significant absolute reduction of 6.6 mmol/L [2] - SHR-1918-301 is a Phase III randomized, double-blind, placebo-controlled trial in patients aged ≥12 years, confirming similar lipid-lowering efficacy and good safety profile [2] Additional Drug Information - Homozygous familial hypercholesterolemia is a rare and life-threatening autosomal dominant genetic disorder characterized by significantly elevated serum LDL-C levels, often exceeding 13 mmol/L, leading to early-onset atherosclerotic cardiovascular disease (ASCVD) [3] - SHR-1918 injection is a monoclonal antibody targeting angiopoietin-like protein 3 (ANGPTL3), aimed at lowering triglycerides (TG) and LDL-C levels [3] - The global sales forecast for a similar drug, EVKEEZA (evinacumab-dgnb) by Regeneron, is approximately $216 million by 2025 [3] - Cumulative R&D investment for SHR-1918 injection is approximately 24.22 million yuan (unaudited) [3]