Beijing Sungen Biomedical’s SGC001 Receives FDA Fast Track Designation for AMI Treatment

China-based Beijing Sungen Biomedical Technology Co., Ltd, an antibody developer incubated by Hotgen Biotech Co., Ltd (SHA: 688068), has announced receiving Fast Track Designation from the United States Food and Drug Administration (FDA) for its SGC001, which is described as the world’s first acute myocardial infarction (AMI) antibody drug.

Drug Development and Approval Progress
SGC001, an AMI monoclonal antibody (mAb) for emergency use, was cleared for studies in the US and China in May and August of last year, respectively. The completed study in healthy populations has demonstrated its good safety and tolerability, paving the way for further clinical development and potential market approval.-Fineline Info & Tech