By Fineline Cube 
China‑based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) confirmed that China’s National Medical Products Administration (NMPA) has accepted the marketing filing for its HRS9531 Injection, a novel dual agonist targeting the GLP‑1 and GIP receptors for long‑term weight management.
Product Profile
- Indication – Adults with BMI ≥ 28 kg/m² (obesity) or BMI ≥ 24 kg/m² (overweight) plus at least one weight‑related comorbidity (hyperglycemia, hypertension, dyslipidemia, OSA, fatty liver, etc.).
- Mechanism – Dual GLP‑1/GIP receptor agonist, developed in‑house, designed to enhance satiety and improve insulin sensitivity.
- Safety – Phase 3 data demonstrate a favorable safety and tolerability profile.
Phase 3 Success
| Metric | Result |
|---|---|
| Primary Endpoint | Met (significant weight reduction vs. placebo) |
| Key Secondary Endpoints | Met (including waist circumference, HbA1c, BP) |
| High‑Dose Mean Weight Loss | 19.2 % |
| ≥20 % Weight Loss | 44.4 % of subjects |
| Trial Size | 567 adults with obesity/overweight + comorbidity |
The clinical trial (HRS9531‑301) enrolled 567 participants, achieving all primary and key secondary endpoints, positioning HRS9531 as a strong contender in the obesity‑drug market.
Global Licensing & Commercial Strategy
In May 2024, Hengrui licensed the global rights (excluding Greater China) to Kailera Therapeutics for the development, production, and commercialization of HRS9531. Key terms:
- Upfront Payment + Milestones – Totaling > $6 B.
- Equity – Hengrui acquired a 19.9 % stake in Kailera.
- Exclusivity – Kailera holds exclusive rights outside China, ensuring a focused global rollout.
Implications for the Market
- Competitive Edge – The dual‑agonist mechanism offers a differentiated profile versus existing GLP‑1 monotherapies.
- Growth Potential – With 44.4 % of high‑dose patients losing ≥20 % of body weight, HRS9531 could capture a sizable share of the obesity‑treatment segment.
- Strategic Partnership – The $6 B milestone package underscores investor confidence and provides a robust pipeline for Kailera.-Fineline Info & Tech