Zhi Tong Cai Jing·2026-02-24 09:45Core Viewpoint - Heng Rui Medicine's subsidiary, Beijing Shengdi Pharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the marketing authorization application of its innovative drug SHR-1918 injection, which has been included in the priority review process [1] Group 1 - The application for market approval is based on two clinical trials targeting patients with Homozygous Familial Hypercholesterolemia (HoFH): SHR-1918-202 and SHR-1918-301, led by Professor Peng Daoquan from Central South University Xiangya Second Hospital [2] - The SHR-1918-202 study is a Phase II multicenter, single-arm trial conducted in adult HoFH patients, with results published in the Journal of the American College of Cardiology, 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, indicating substantial and sustained LDL-C level reduction with good safety and tolerability [2] - The SHR-1918-301 study is a randomized, double-blind, placebo-controlled Phase III clinical trial involving HoFH patients aged 12 and older, conducted across 16 clinical research centers nationwide, with lipid-lowering efficacy characteristics highly consistent with the SHR-1918-202 study results and good safety [2]