Hengrui’s HRS‑4729 GLP‑1 Triple Agonist Receives NMPA Approval for MASLD & MASH

Hengrui’s HRS‑4729 GLP‑1 Triple Agonist Receives NMPA Approval for MASLD & MASH

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its investigational drug HRS‑4729 Injection has obtained approval from the National Medical Products Administration (NMPA) to initiate clinical trials for the treatment of metabolic dysfunction‑associated steatotic liver disease (MASLD) and metabolic dysfunction‑associated steatohepatitis (MASH).

Product Profile

  • Mechanism – Triple agonist targeting
  • GLP‑1 Receptor (GLP‑1R)
  • GIP Receptor (GIPR)
  • Glucagon Receptor (GCGR)
  • Clinical Advantage – Compared with dual GLP‑1/GIP agonists, HRS‑4729:
  • Enhances GCGR activation → ↑ energy expenditure
  • Lowers plasma lipids & improves weight‑loss efficacy
  • Regulates glucose & lipid metabolism while suppressing appetite
FeatureBenefit
Triple‑receptor actionSuperior metabolic control vs dual agonists
First‑in‑class statusNo approved product worldwide

Regulatory & Commercial Milestones

EventDateSignificance
NMPA Approval to initiate trials5 Sep 2025Paves way for MASLD/MASH clinical development
Licensing to Hercules Pharmaceuticals (US)May 2025Up to USD 6 B payment & 19.9% equity stake
  • Strategic Value – Strengthens Hengrui’s GLP‑1 portfolio and positions the company at the forefront of next‑generation metabolic therapeutics.

Market Outlook

  • Disease Burden – MASLD/MASH projected to affect > 300 M adults worldwide; Chinese market alone > 20 M patients.
  • Competitive Landscape – Existing GLP‑1 agonists (liraglutide, semaglutide) treat diabetes and obesity but lack GCGR activity.
  • Commercial Potential – Successful trials could unlock a multi‑billion‑dollar market, especially given the unmet need for effective liver‑centric metabolic agents.-Fineline Info & Tech