Sungen Biomedical's world-first new drug SGC001 monoclonal antibody receives FDA fast track approval

On March 17, 2025, US time, the world's first acute myocardial infarction (AMI) antibody drug, SGC001, developed by Sungen Biomedical—an innovative biopharmaceutical company incubated by Beijing Hotgen Biotech Co., Ltd. (SH.688068)—received Fast Track Designation from the United States Food and Drug Administration (FDA). Currently, SGC001 is under clinical research for patients with AMI. Completed clinical trials in healthy individuals have demonstrated its favorable safety profile and tolerabil