By Fineline Cube Huadong Medicine Co., Ltd (SHE: 000963) announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for DR10624, a first‑in‑class long‑acting triple‑specific agonist, to initiate a clinical study in metabolic dysfunction‑associated steatotic liver disease (MASLD). The drug has already completed a Phase II study in severe hypertriglyceridemia (SHTG) with positive results.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Huadong Medicine Co., Ltd (SZ: 000963) |
| Drug | DR10624 (triple‑specific agonist) |
| Application | IND approval |
| Agency | US FDA |
| Indication | Metabolic dysfunction‑associated steatotic liver disease (MASLD) |
| Approval Date | 14 Jan 2026 |
| Clinical Stage | Phase II completed for SHTG; Phase I ready for MASLD |
| Innovation | First triple agonist targeting FGF21R, GCGR, and GLP‑1R |
Drug Profile & Mechanism
- Targets: FGF21 receptor (FGF21R), glucagon receptor (GCGR), and GLP‑1 receptor (GLP‑1R)
- Structure: Fusion protein comprising:
- N‑terminal chimeric peptide targeting GLP‑1R/GCGR
- Engineered IgG1 Fc fragment for extended half‑life
- Recombinant FGF21 mutant fused at C‑terminus
- Mechanism: Simultaneously activates three key metabolic pathways to improve lipid metabolism, glucose control, and liver fat reduction
- Differentiation: First‑in‑class triple agonist vs. single‑target (GLP‑1) or dual‑target (GIP/GLP‑1) competitors
Clinical Evidence
| Study | Indication | Status | Key Findings |
|---|---|---|---|
| Phase II | Severe hypertriglyceridemia (SHTG) | Completed | Positive top‑line results following unblinding |
| Phase I | Advanced solid tumors | Ongoing (US) | Focus on patients with brain metastases |
| Next | MASLD | IND approved | Phase I initiation planned Q2 2026 |
Market Opportunity
| Parameter | China | Global |
|---|---|---|
| MASLD Patients | 180 million | 900 million |
| MASH/MASLD‑Cirrhosis (2030E) | 45 million | 180 million |
| SHTG Patients | 8 million | 30 million |
| Addressable Market (2030E) | $12 billion | $45 billion |
| Triple Agonist Penetration | 0 % | 0 % |
| DR10624 Peak Revenue (2032E) | ¥3.5 billion | $1.8 billion |
Key Competitors:
- GLP‑1 agonists: Novo Nordisk (semaglutide), Eli Lilly (tirzepatide) – diabetes/MASH
- FGF21 analogs: Akero Therapeutics (efruxifermin), 89bio (pegozafermin) – MASH only
- Dual agonists: Eli Lilly (tirzepatide – GIP/GLP‑1) – metabolic diseases
- DR10624 – First triple agonist with liver‑directed FGF21 activity plus GLP‑1/GCGR benefits
Strategic Positioning
- Platform Value: DR10624 represents Huadong’s first global innovative asset with potential in multiple metabolic diseases (MASLD, SHTG, obesity, NASH)
- Development Path: Fast‑track FDA designation likely for MASLD given unmet need; China NDA planned for 2029 following US Phase II data
- Manufacturing: Huadong’s Hangzhou biologics facility (capacity 5,000 L) will produce DR10624 for global trials
- Commercial Reach: Existing 4,000‑person endocrinology sales force can rapidly launch upon approval
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and commercial projections for DR10624. Actual results may differ due to clinical trial outcomes, competitive dynamics, and market access challenges.-Fineline Info & Tech