Huadong Medicine's Subsidiary Receives FDA Approval to Initiate Clinical Trials of DR10624 Injection for MASLD

Gelonghui January 14 | Huadong Medicine (000963.SZ) announced that its controlling subsidiary, Zhejiang Doer Biologics Co., Ltd., has received a notice from the U.S. FDA. The clinical trial application for DR10624 Injection submitted by Doer Biologics has been approved by the U.S. FDA and can now proceed with clinical trials in the United States for the indication of Metabolic Associated Steatotic Liver Disease (MASLD). DR10624 is a globally first-in-class long-acting trispecific agonist independently developed by Doer Biologics, targeting FGF21R, GCGR, and GLP-1R. The drug has successfully completed a Phase II clinical study for severe hypertriglyceridemia and achieved positive topline results. This clinical trial approval will not have a significant impact on the company’s near-term performance.