Dor Bio's First-in-Class Triple Agonist DR10624 Receives FDA Approval for Clinical Trials in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

On January 14, Huadong Medicine announced that its controlled subsidiary, Doer Biologics, received a notification from the U.S. FDA. The clinical trial application for the DR10624 injection submitted by Doer Biologics has been approved by the U.S. FDA, allowing clinical trials to be conducted in the United States.Indication: Metabolic Associated Steatohepatitis (MASLD)。

DR10624 is a self-developed product by Doer Biologics.A long-acting trispecific agonist targeting fibroblast growth factor 21 receptor (FGF21R), glucagon receptor (GCGR), and glucagon-like peptide-1 receptor (GLP-1R).This product consists of a chimeric peptide segment targeting GLP-1R/GCGR at the N-terminus, fused with an engineered IgG1 Fc, and a recombinant FGF21 mutant fused at the C-terminus of the Fc.

DR10624 Injection has been successfully completedSevere Hypertriglyceridemia (SHTG)Phase 2 clinical study and obtained positive topline results after unblinding.In November 2025, the results of the Phase 2 clinical study (DR10624-201 study) were presented at the AHA Scientific Sessions 2025. After 12 weeks of treatment, compared with placebo, all dose groups of DR10624 achieved a significant reduction in triglyceride levels, with the median percentage decrease reaching up to 74.5%. Meanwhile, compared with the placebo group, liver fat content was significantly reduced in all dose groups of DR10624, with the median percentage decrease reaching up to 67%.Previously, Doer Biologics presented DR10624 treatment at the EASL Congress 2025.Obesity with HypertriglyceridemiaThe results of the Phase 1b/2a clinical study in New Zealand showed a maximum reduction of 89% in liver fat and a relative decrease of over 70% in triglycerides from baseline.

Another Item of DR10624 InjectionMetabolic Associated Fatty Liver Disease with High Risk of Liver FibrosisAndMetabolic Associated Fatty Liver Disease with Alcohol-related SteatosisThe phase 2 clinical study is expected to complete the enrollment of the first subject in April 2025. In addition, DR10624 is used forWeight Management Indications for Type 2 Diabetes, Overweight or Obese PopulationsClinical Trials in China and forSevere HypertriglyceridemiaThe U.S. clinical trial application has also been approved successively. In January 2026, DR10624 was designated as a breakthrough therapy by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), with the proposed indication being severe hypertriglyceridemia.

References:
[1]Huadong Medicine's Controlled Subsidiary Doer Biologics' World-First Triple Agonist DR10624 for Metabolic Associated Fatty Liver Disease Granted US IND. From https://mp.weixin.qq.com/s/-8U4iHiL4NGgjGGce6FBVQ

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