Huadong Medicine's GLP-1/GCG/FGF21 Trispecific Agonist DR10624 Granted Breakthrough Therapy Designation for Severe Hypertriglyceridemia

▎Armstrong

On January 4, 2026, DR10624 Injection developed by Doer Biologics, a subsidiary of Huadong Medicine, is proposed to be included in the breakthrough therapy designation for the treatment of severe hypertriglyceridemia (sHTG).

DR10624 is the world's first GLP-1/GCG/FGF21 tri-agonist, and its Phase II clinical data for sHTG was recently disclosed at the AHA 2025 Annual Meeting.At week 12, 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%.

Recently, sHTG has achieved numerous clinical breakthroughs. At the AHA 2025 conference,Ionis Pharmaceuticals Announced Top-Line Data from Phase III Clinical Trials CORE and CORE2 of APOC3 ASO Drug Olezarsen: Fasting Triglyceride Levels Reduced by Up to 72% (Placebo-Corrected), Acute Pancreatitis Events Decreased by 85%—A First and Only Achievement of This Therapeutic Goal for Severe Hypertriglyceridemia (sHTG).

Summary

sHTG Patients at Significantly Increased Risk of Acute Pancreatitis with Fatal Potential; Over 1 Million High-Risk sHTG Patients in the U.S. Alone Indicate a Huge Market with Significant Unmet Clinical Needs. APOC3 siRNA Has Completed Proof of Concept (POC), Demonstrating Excellent Efficacy for sHTG from the Perspective of Lipid Metabolism. DR10624, as a Triple Agonist, Features a More Comprehensive Mechanism of Action, Offering Beneficial Effects on Blood Glucose Control, Lipid Metabolism, Fibrosis, and Uric Acid Regulation, Potentially Providing a Novel Treatment Option for sHTG.