By Fineline Cube Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for HS-10568 (SHR6508), a novel calcium-sensing receptor (CaSR) allosteric modulator, for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) undergoing hemodialysis.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) |
| Drug Candidate | HS-10568 (SHR6508) |
| Drug Class | Calcium-sensing receptor (CaSR) allosteric modulator |
| Regulatory Authority | National Medical Products Administration (NMPA), China |
| Application Type | New Drug Application (NDA) |
| Status | Accepted for review |
| Target Indication | Secondary hyperparathyroidism (SHPT) in CKD patients on hemodialysis |
| Announcement Date | 11 Jun 2026 |
Drug Profile & Mechanism of Action
- Molecule: HS-10568 (SHR6508) – CaSR allosteric modulator
- Target: Calcium-sensing receptor (CaSR) on parathyroid gland cells
- Mechanism: Enhances receptor sensitivity to extracellular calcium, leading to reduced parathyroid hormone (PTH) secretion
- Therapeutic Rationale: Addresses the underlying pathophysiology of SHPT by restoring calcium-mediated feedback inhibition of PTH production
- Development Stage: NDA submitted; Phase 3 clinical trials completed
Secondary hyperparathyroidism affects approximately 40-60% of dialysis patients in China, representing a significant unmet medical need. Current treatments include vitamin D analogs and calcimimetics, but many patients experience inadequate response or treatment-limiting side effects. HS-10568’s novel mechanism offers potential for improved efficacy and tolerability in this challenging patient population.
Market Opportunity & Commercial Outlook
- Patient Population: Estimated 700,000+ hemodialysis patients in China with SHPT indication
- Competitive Landscape: Competes against Amgen’s Sensipar/Mimpara (cinacalcet) and newer calcimimetics; first domestically developed CaSR modulator in China
- Pricing Strategy: Expected premium pricing reflecting innovative status and improved therapeutic profile
- Revenue Potential: Peak annual sales projected at RMB 800 million – 1.2 billion (USD 110-165 million) in China market
- Global Expansion: Hansoh plans international development following Chinese approval, targeting markets in Southeast Asia and Latin America
The NDA acceptance represents a significant milestone for Hansoh’s specialty pharmaceutical strategy, demonstrating the company’s capability to develop innovative therapies for complex chronic conditions prevalent in China’s aging population.
Forward‑Looking Statements
This brief contains forward-looking statements regarding regulatory review timelines, market opportunities, and commercial projections. Actual outcomes may differ due to regulatory decisions, competitive dynamics, and market adoption factors.-Fineline Info & Tech