Tides Express | Huadong Medicine's Triple-Target Agonist DR10624 Receives FDA IND Approval for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

DR10624 is a globally first-in-class, long-acting trispecific agonist that targets the fibroblast growth factor 21 receptor (FGF21R), glucagon receptor (GCGR), and glucagon-like peptide-1 receptor (GLP-1R), independently developed by Doer Biologics. DR10624 is composed of an N-terminal chimeric peptide segment targeting GLP-1R/GCGR fused with an engineered IgG1 Fc, and a recombinant FGF21 mutant fused to the C-terminus of the Fc region.

DR10624 Injection has successfully completed the Phase II clinical study for severe hypertriglyceridemia (SHTG) and obtained positive topline results after unblinding. Previously, at the EASL Congress 2025, Doer Biologics presented Phase Ib/IIa clinical trial results from New Zealand showing that DR10624 treatment for obesity combined with hypertriglyceridemia reduced liver fat by up to 89% and decreased triglycerides by over 70% relative to baseline. In November 2025, the results of the Phase II clinical study ("DR10624-201 Study") for DR10624 in treating severe hypertriglyceridemia were announced at the AHA Scientific Sessions 2025. After 12 weeks of treatment, compared to placebo, all dose groups of DR10624 showed a significant reduction in triglyceride levels, with the highest median percentage decrease reaching 74.5%. Additionally, compared to the placebo group, liver fat content was significantly reduced across all DR10624 dose groups, with the highest median percentage decrease reaching 67%.

Another Phase II clinical study of DR10624 injection, involving metabolic dysfunction-associated steatohepatitis (MASH) with a high risk of liver fibrosis and metabolic dysfunction-associated steatohepatitis combined with alcohol-related steatotic liver disease, completed the enrollment of its first participant in April 2025. In addition, the clinical trial applications for DR10624 in China for weight management in people with type 2 diabetes, overweight or obesity, and in the United States for severe hypertriglyceridemia were successively approved. In January 2026, DR10624 was designated as a breakthrough therapy by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), with the proposed indication being severe hypertriglyceridemia.