By Fineline Cube CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for prusogliptin/metformin fixed‑dose combination (FDC) sustained‑release tablets, an adjunct therapy for type 2 diabetes mellitus (T2DM) in adults inadequately controlled on metformin monotherapy.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | CSPC Pharmaceutical Group Ltd. (HKEX: 01093) |
| Drug | Prusogliptin/Metformin FDC sustained‑release |
| Application | NDA (New Drug Application) |
| Agency | NMPA (China) |
| Indication | T2DM adjunct to diet/exercise: (1) metformin‑IR patients; (2) currently on prusogliptin + metformin |
| Filing Date | 13 Jan 2026 |
| PDUFA Target | Q3 2026 (eligible for priority review) |
| Formulation | Once‑daily sustained‑release FDC simplifies therapy |
Drug Profile & Mechanism
- Components:
- Prusogliptin: CSPC’s proprietary DPP‑4 inhibitor (blocks GLP‑1 degradation, enhances insulin secretion)
- Metformin: Biguanide (reduces hepatic glucose output, improves insulin sensitivity)
- Synergistic Benefits:
- Superior A1C reduction vs. metformin monotherapy (‑1.4 % vs. ‑0.8 %)
- Lower hypoglycemia incidence (3.2 % vs. 8.5 % with sulfonylurea combos)
- Weight‑neutral profile and favorable GI tolerability due to sustained‑release matrix
- Adherence Improvement: Once‑daily FDC reduces pill burden from 3‑4 tablets to 1
Market Impact & Competitive Landscape
| Parameter | 2026E | 2027E | 2028E |
|---|---|---|---|
| China T2DM Patients | 142 million | 148 million | 153 million |
| Inadequately Controlled on Metformin | 61 million | 64 million | 67 million |
| FDC Penetration Rate | 0 % | 8 % | 18 % |
| Annual Cost (¥) | – | ¥960 | ¥920 |
| CSPC Revenue (¥) | – | ¥4.68 billion | ¥11.1 billion |
- Current Market: Dominated by Janumet (sitagliptin/metformin, MSD) and Kombiglyze (saxagliptin/metformin, AZ)
- Differentiation:
- Prusogliptin is a novel DPP‑4 inhibitor with higher selectivity and lower drug‑drug interaction potential vs. older agents
- Sustained‑release FDC improves tolerability and patient compliance
- Competitive Moat: CSPC’s domestic manufacturing cost advantage (30‑40 % lower than MNCs) positions it for NRDL negotiation success and volume‑based procurement wins
Strategic Positioning & Next Steps
- Manufacturing: CSPC’s Shijiazhuang facility (annual capacity: 5 billion tablets) ready for commercial production; dedicated FDC line operational by Q4 2026
- Commercial Reach: Existing diabetes sales force (1,200 reps) covers 8,000 tier‑2/3 hospitals; target 15 % share of China’s DPP‑4 market by 2028
- Global Ambitions: CSPC plans ex‑China partnerships for Southeast Asia and Latin America; US IND possible by 2028 if Phase III data is robust
- Pipeline Synergy: FDC complements CSPC’s GLP‑1/GIP/GCG triple agonist (pre‑clinical) and SGLT2 inhibitor (Phase III), creating a comprehensive metabolic franchise
Forward‑Looking Statements
This brief contains forward‑looking statements regarding NMPA review timelines, market penetration, and revenue forecasts for prusogliptin/metformin FDC. Actual results may differ due to competitive responses, NRDL pricing negotiations, and manufacturing scale‑up challenges.-Fineline Info & Tech