By Fineline Cube 
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced a licensing agreement with Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276, HKG: 1276) to obtain exclusive rights for SHR6508, a Phase III calcium‑sensing receptor (CaSR) modulator, in Mainland China for the treatment of secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients on hemodialysis.
Deal Overview
| Item | Detail |
|---|---|
| Licensor | Jiangsu Hengrui Pharmaceutical (600276.SH/1276.HK) |
| Licensee | Hansoh Pharmaceutical Group (3692.HK) |
| Product | SHR6508 (allosteric CaSR modulator) |
| Territory | Mainland China (excludes Hong Kong, Macau, Taiwan) |
| Rights | Development, manufacturing, commercialization |
| Indication | SHPT in adult CKD patients undergoing hemodialysis |
| Clinical Stage | Phase III trials ongoing |
Financial Terms
| Component | Value | Details |
|---|---|---|
| Upfront Payment | RMB 30 million (~US$4.2 M) | Paid upon agreement execution |
| Milestone Payments | Up to RMB 190 million | Regulatory & commercialization milestones |
| Royalty Rates | Tiered single‑digit % | On net sales; scales with revenue volume |
| Total Deal Value | Up to RMB 220 million | Excludes royalties |
Product Profile: SHR6508
Mechanism of Action: Allosteric modulator of calcium‑sensing receptor (CaSR) that increases receptor sensitivity to extracellular calcium, thereby reducing parathyroid hormone (PTH) secretion.
Key Differentiation:
- Oral administration (vs. IV alternatives like etelcalcetide)
- Potential for improved safety profile vs. first‑generation calcimimetics
- Complementary to Hansoh’s renal portfolio (existing phosphate binders, vitamin D analogs)
Development Status: Currently in Phase III trials in China; pivotal data expected H2 2026 supporting NDA filing.
Market Opportunity
China CKD & SHPT Landscape:
- CKD Prevalence: ~130 million patients in China; ~500,000 on hemodialysis (2025)
- SHPT Incidence: 30‑50% of dialysis patients develop SHPT → 150,000‑250,000 eligible patients
- Current Treatations: Generic cinacalcet (Amgen’s Sensipar), IV etelcalcetide, vitamin D analogs, phosphate binders
- Market Size: China SHPT drug market valued at ¥2.8 billion (2025), growing at 15% CAGR driven by dialysis population expansion
Unmet Need: 15‑20% of patients are refractory or intolerant to existing therapies; SHR6508 targets this underserved segment.
Strategic Rationale
Portfolio Synergy: SHR6508 strengthens Hansoh’s renal disease franchise, creating a comprehensive CKD‑SHPT offering alongside its marketed phosphate binders and vitamin D products.
Commercial Leverage: Hansoh’s established nephrology sales force (covering 800+ dialysis centers) can rapidly commercialize SHR6508 upon approval, reducing launch costs and accelerating market penetration.
Financial Upside: If approved, SHR6508 could generate peak sales of ¥500‑700 million (US$70‑98 M) by 2030, assuming 20‑25% market share in the SHPT segment.
Competitive Landscape
| Drug | Company | Mechanism | Route | Stage (China) | Annual Cost (¥) |
|---|---|---|---|---|---|
| Cinacalcet (generic) | Various | CaSR agonist | Oral | Marketed | ¥8,000‑12,000 |
| Etelcalcetide | Kyowa Kirin | CaSR agonist | IV | Marketed | ¥25,000‑30,000 |
| SHR6508 | Hengrui → Hansoh | CaSR allosteric modulator | Oral | Phase III | TBD (expected ¥15,000‑20,000) |
| Evadaxistat | AstraZeneca | HIF‑PH inhibitor | Oral | Phase II | Not applicable for SHPT |
Differentiation: SHR6508’s allosteric modulation may offer better tolerability vs. orthosteric cinacalcet, while oral dosing improves patient compliance vs. IV etelcalcetide.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding SHR6508’s clinical development timeline, regulatory approval probability, peak sales forecasts, and market penetration assumptions. Actual results may differ materially due to clinical trial outcomes, competitive dynamics, pricing negotiations, and NRDL reimbursement decisions.-Fineline Info & Tech