By Fineline Cube Huadong Medicine Co., Ltd (SHE: 000963) announced that its subsidiary Doer Biologics has received National Medical Products Administration (NMPA) approval for a clinical trial filing for DR10624, a first‑in‑class long‑acting trispecific agonist targeting FGF21R, GCGR, and GLP‑1R, for the treatment of hypertriglyceridemia. The drug has already demonstrated strong Phase II results in severe hypertriglyceridemia (sHTG).
Regulatory Milestone & Drug Profile
| Item | Detail |
|---|---|
| Company | Huadong Medicine Co., Ltd (000963.SZ) |
| Subsidiary | Doer Biologics |
| Drug | DR10624 |
| Mechanism | Trispecific agonist (FGF21R + GCGR + GLP‑1R) |
| Indication | Hypertriglyceridemia |
| Approval | NMPA clinical trial filing accepted |
| Innovation | First‑in‑class long‑acting trispecific agonist |
| Structure | N‑terminal GLP‑1R/GCGR chimeric peptide fused to engineered IgG1 Fc, with FGF21 mutant at C‑terminus |
| Clinical Data | Phase II sHTG study: up to 89% liver fat reduction, >70% triglyceride decrease |
Clinical Data & Strategic Advantage
- Phase II Results: Successfully completed Phase II in severe hypertriglyceridemia, demonstrating up to 89% reduction in liver fat and >70% relative decrease in triglycerides from baseline
- Triple Mechanism: Simultaneously targets FGF21R (metabolic regulation), GCGR (glucose control), and GLP‑1R (insulin secretion and satiety)
- Metabolic Benefits: FGF21 component enhances lipid metabolism while GLP‑1/GCGR components address glycemic control and weight management
- Unmet Need: Severe hypertriglyceridemia affects ~10 million : patients in China; current therapies offer limited efficacy
Market Impact & Commercial Outlook
- Hypertriglyceridemia Market: China market valued at ¥15 billion : (~US$2.1 billion) in 2025; growing at 12% CAGR due to rising metabolic syndrome prevalence
- Competitive Landscape: Competes with fenofibrates, prescription omega‑3s, and emerging ANGPTL3 inhibitors; DR10624’s multi‑target approach offers differentiation
- Revenue Potential: Analysts project ¥3–5 billion (US$420–700 million) peak annual sales if approved, based on superior efficacy data
- Strategic Value: Positions Huadong Medicine as a leader in metabolic disease innovation; validates Doer Biologics’ trispecific platform for additional indications
- Next Steps: Phase III trial initiation expected Q2 2026; US and EU regulatory strategy under evaluation
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for DR10624. Actual results may differ due to clinical trial outcomes, competitive dynamics, and NMPA review processes.-Fineline Info & Tech