Huadong Medicine's First-in-Class Triple Agonist DR10624 Injection Nominated for Breakthrough Therapy Designation for Severe Hypertriglyceridemia

On January 4, the CDE website showed that Huadong Medicine Co., Ltd., a holding subsidiary of Huadong MedicineDoer Biologics' Application for Class 1 New DrugDR10624 Injection Proposed for Inclusion in Breakthrough Therapy Category,Applicable toSevere Hypertriglyceridemia。

Screenshot source: CDE official website

DR10624 was developed by Doer Biologics based on its proprietary MultipleBody platform technology.A world-firstTri-Target Long-Acting Agonist Targeting FGF21R, GCGR, and GLP-1RBy simultaneously modulating the three receptor-mediated signaling pathways, it exerts a synergistic effect, thereby achieving the effects of lowering blood glucose, reducing weight, and decreasing lipid levels.

InAmerican Heart Association 2025 Scientific Sessions（AHA 2025）Up,Doer Biologics Reports for the First TimeDR10624 for the treatment of severe hypertriglyceridemia（SHTG）Phase II Clinical Trial(DR10624-201 Study)The main results.

DR10624-201 is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study conducted in China, aimingEvaluation of the efficacy and safety of subcutaneous injection of DR10624 in SHTG subjects. The primary efficacy endpoint is fasting triglycerides.（TG）Compared with baseline changes, secondary endpoints include changes in liver fat content assessed by MRI-PDFF, lipid profile, etc.

Clinical trial results show,DR10624 Demonstrates Significant Comprehensive Metabolic Improvement in SHTG Patients; at Week 12, All Dose Groups of DR10624 Showed Superiority Over PlaceboTriglyceride LevelsSignificantly reduced, with a median percentageThe maximum reduction reached 74.5%.; and the DR10624 dose groupsLiver Fat Content（LFC）Both significantly decreased, median percentageThe maximum reduction reached 67%。

Besides,Compared with the placebo group, the DR10624 50 mg titration dose group showed a significant increase in adiponectin levels after 12 weeks of treatment.(Note: Great improvement in insulin sensitivity of the subjects)Significant reduction in uric acid levels(Beneficial to organs such as kidneys and heart), as well as the efficacy of weight loss. Additionally, in subjects with baseline HbA1c ≥6.5%, it can reduce HbA1c levels by 0.68%.(Clinically Significant)。

DR10624 demonstrated good safety and tolerability across all dose groups in the study. The severity of adverse reactions was mainly mild to moderate. The most common TEAEs included nausea, changes in appetite, and injection site reactions.

Screenshot source: Insight Database