By Fineline Cube Hualan Biological Engineering Inc. (SHE: 002007) announced that the National Medical Products Administration (NMPA) has approved a clinical trial for HL08, its next‑generation GLP‑1 receptor agonist, for a new indication in weight control for obese patients. The fusion protein design extends half‑life while retaining Exendin‑4’s physiological functions.
Regulatory Milestone & Drug Profile
| Item | Detail |
|---|---|
| Company | Hualan Biological Engineering Inc. (002007.SZ) |
| Drug | HL08 (recombinant Exendin‑4‑Fc fusion protein) |
| Approval | NMPA clinical trial authorization |
| New Indication | Weight control in obese patients |
| Mechanism | GLP‑1 receptor agonist |
| Design | Exendin‑4 fused with IgG2 Fc fragment via specific linker peptide |
| Key Advantage | Extended biological half‑life, enhanced dosing convenience |
| Preclinical Data | Demonstrated weight loss, lipid metabolism improvement, β‑cell protection |
Mechanism of Action & Clinical Benefits
- Extended Half‑Life: Fusion with IgG2 Fc fragment significantly prolongs biological half‑life while retaining Exendin‑4’s natural physiological functions
- Glucose‑Dependent Action: Achieves glucose‑lowering effects in a glucose concentration‑dependent manner
- Multiple Metabolic Effects: Promotes insulin secretion, inhibits glucagon secretion, delays gastric emptying, increases satiety
- β‑Cell Protection: Protects islet β‑cell function, suitable for type 2 diabetes patients with metabolic syndrome
- Metabolic Benefits: Significant effects on weight loss and lipid metabolism improvement
Market Impact & Commercial Outlook
- China Obesity Market: Valued at ¥50 billion (~US$7 billion) in 2025, growing at 25% CAGR driven by GLP‑1 therapies
- Competitive Landscape: Competes with semaglutide (Novo Nordisk) and tirzepatide (Eli Lilly); HL08’s extended half‑life offers dosing convenience
- Revenue Potential: Analysts project ¥2–3 billion (US$280–420 million) peak annual sales by 2028 if approved for obesity
- Strategic Value: Expands Hualan’s metabolic disease franchise beyond diabetes; positions company in high‑growth obesity segment
- Next Steps: Phase I/II obesity trial initiation expected Q2 2026; potential for expedited NMPA review given unmet medical need
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for HL08. Actual results may differ due to clinical trial outcomes, competitive dynamics, and NMPA review processes.-Fineline Info & Tech