By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that four drug candidates—HRS9531 (GLP‑1R/GIPR dual agonist), HRS‑5817 (weight‑loss drug), HRS‑4357 (radiotherapeutic), and HRS‑5041 (AR‑PROTAC)—have received NMPA approval to proceed with clinical trials, positioning Hengrui to compete in the ¥100 billion+ metabolic and oncology markets.
IND Approvals Summary
| Product | Mechanism | Indication | Significance | Stage |
|---|---|---|---|---|
| HRS9531 | GLP‑1R/GIPR Dual Agonist | Weight management & diabetes | Challenges Tirzepatide | Phase I ready |
| HRS‑5817 | Class 1 Chemical Drug | Obesity | Significant preclinical weight loss | Phase I ready |
| HRS‑4357 | Radiotherapeutic | PSMA‑positive prostate cancer | Combination with HRS‑5041 | Phase I ready |
| HRS‑5041 | AR‑PROTAC | Prostate cancer | Overcomes resistance to 2nd‑gen AR inhibitors | Phase I ready |
HRS9531: GLP‑1R/GIPR Dual Agonist
Mechanism: Novel dual agonist regulates glucose/lipid metabolism, suppresses appetite, and enhances insulin sensitivity.
Competitive Landscape:
- Global Standard: Eli Lilly’s Tirzepatide (Zepbound) – approved US (Nov 2023) and China (July 2024)
- Hengrui’s Edge: HRS9531 enters Phase I as the second domestic dual agonist after Lilly’s entry, targeting ¥80 billion China GLP‑1/GIPR market
Market Opportunity:
- China Weight Management Market: ¥50 billion (2025), projected ¥120 billion by 2030
- Diabetes Market: ¥45 billion for injectable GLP‑1 agents
- Pricing: Projected ¥800‑1,200 monthly (vs. Tirzepatide’s ¥1,400‑1,600)
HRS‑5041: AR‑PROTAC for Prostate Cancer
Mechanism: Androgen Receptor Proteolysis Targeting Chimera designed to degrade both wild‑type and mutant AR proteins, overcoming resistance to second‑generation AR inhibitors (enzalutamide, apalutamide).
Clinical Rationale:
- Prostate Cancer Prevalence: 120,000 new cases annually in China; 30‑40% develop resistance to current therapies
- Market Size: China prostate cancer drug market ¥18 billion (2025), growing at 15% CAGR
- Differentiation: First AR‑PROTAC in Phase I in China; potential for 5‑year first‑mover advantage
Combination Strategy: Paired with HRS‑4357 (radiotherapeutic) for PSMA‑positive metastatic disease, creating a precision oncology doublet.
HRS‑4357: PSMA‑Targeted Radiotherapeutic
Mechanism: Class 1 innovative radiotherapeutic chemical drug for PSMA‑positive prostate cancer.
Clinical Context:
- PSMA Expression: 90% of metastatic prostate cancers express PSMA
- Combination Rationale: Radiotherapy + AR‑PROTAC offers synergistic tumor killing and resistance delay
- Market: PSMA‑targeted therapy market projected ¥3‑5 billion in China by 2030
Financial Implications & Deal Value
Combined Peak Sales Potential:
- HRS9531: ¥8‑12 billion (2030)
- HRS‑5041: ¥5‑7 billion (2031)
- HRS‑4357: ¥2‑3 billion (2031)
- HRS‑5817: ¥1‑2 billion (2029)
- Total Portfolio: ¥16‑24 billion peak sales, representing 15‑20% of Hengrui’s projected revenue base
R&D Investment: ¥400‑500 million required to advance all four candidates through Phase III, leveraging Hengrui’s 6,000+ person R&D team.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Hengrui’s clinical development timelines, market penetration, revenue forecasts, and competitive positioning for HRS9531, HRS‑5041, HRS‑4357, and HRS‑5817. Actual results may differ materially due to clinical trial outcomes, regulatory review timelines, competitive responses, and market access policies.-Fineline Info & Tech