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

NEW YORK, March 24, 2025 /PRNewswire/ -- 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 tolerability. The FDA's Fast Track designation is expected to accelerate the commercialization of SGC001, thereby providing more effective treatment options for patients with AMI.

FDA Fast Track Designation is a regulatory mechanism intended to expedite the development and approval of new drugs. This designation facilitates interaction and communication with FDA throughout the drug development process, enables a rolling review during the marketing application submission, and provides greater access to priority review and accelerated approval pathways. As a result, it reduces the overall approval timeline, allowing patients to benefit from critical therapies sooner. Typically, this designation is awarded to treatments targeting serious or life-threatening conditions with unmet medical needs, provided they demonstrate meaningful innovation and are supported by robust clinical data.