By Fineline Cube 
Huadong Medicine (SHE: 000963) announced that the Investigational New Drug (IND) application for DR10624 Injection, filed by its subsidiary Zhejiang Doer Biologics Co., Ltd., has been approved by the U.S. Food & Drug Administration (FDA) to conduct clinical trials. The drug targets Severe Hypertriglyceridemia (SHTG) and represents a globally first‑in‑class, long‑acting trispecific agonist engaging the FGF21R, GCGR, and GLP‑1R pathways.
Key Highlights
- FDA IND Approval – First step toward advancing DR10624 into U.S. phase‑I/II studies.
- First‑In‑Class Trispecific – Simultaneously activates FGF21, glucagon, and GLP‑1 receptors to normalize lipid metabolism.
- Positive Phase II Topline – DR10624 achieved clinically meaningful reductions in triglyceride levels in SHTG patients.
- Strategic Expansion – China INDs for type‑2 diabetes and weight‑management in overweight/obese populations have already received approval.
About DR10624
| Feature | Detail |
|---|---|
| Structure | Chimeric peptide (GLP‑1R/GCGR) fused to engineered IgG1 Fc, with recombinant FGF21 mutant at Fc C‑terminus. |
| Mechanism | Long‑acting trispecific agonist that modulates metabolic signaling via FGF21R, GCGR, and GLP‑1R. |
| Development Status | Phase II topline data positive; IND approved for U.S. trials; Chinese INDs pending further clinical work. |
Implications for Metabolic Therapeutics
- Broad Metabolic Reach – DR10624’s multi‑receptor engagement offers a comprehensive approach to dyslipidemia, diabetes, and obesity.
- Portfolio Growth – Positions Huadong as a key player in emerging metabolic disease markets.
- Regulatory Momentum – FDA approval paves the way for accelerated U.S. development and potential global launch.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech