By Fineline Cube 
Novartis (NYSE: NVS) announced that the National Medical Products Administration (NMPA) has approved Cosentyx (secukinumab) for adult patients with active, non-radiographic axial spondyloarthritis (nr-axSpA) who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) and exhibit objective signs such as elevated C-reactive protein (CRP) and/or MRI evidence.
Regulatory Milestone & Drug Profile
| Item | Detail |
|---|---|
| Company | Novartis (NYSE: NVS) |
| Drug | Cosentyx (secukinumab) |
| Mechanism | Interleukin-17A (IL-17A) inhibitor |
| New Indication | Active nr-axSpA in adults |
| Approval | NMPA marketing authorization |
| Previous Approvals | Plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, hidradenitis suppurativa |
| Clinical Basis | Global Phase III PREVENT study |
PREVENT Study Key Efficacy Data
| Endpoint | Result | Comparison |
|---|---|---|
| ASAS40 Response at Week 16 | 40.0% | vs. 28.0% placebo (P < 0.05) |
| Sustained Improvement | Through Week 52 | Maintained efficacy |
| Secondary Endpoints | Significant improvements | Pain, physical mobility, health-related quality of life |
| Safety Profile | Favorable | Consistent with known safety profile |
Market Impact & Commercial Outlook
- China nr-axSpA Market: Estimated ¥3–5 billion : (~US$420–700 million) by 2028, driven by improved diagnosis and biologic adoption
- Competitive Landscape: Competes with TNF inhibitors and IL-17 inhibitors; Cosentyx’s established safety profile offers advantage
- Strategic Value: Expands Cosentyx’s immunology franchise in China; positions Novartis as leader in axial spondyloarthritis management
- Revenue Potential: Analysts project ¥1.5–2.0 billion (US$210–280 million) peak annual sales for nr-axSpA indication by 2030
- Patient Population: Estimated 300,000–500,000 nr-axSpA patients in China with inadequate NSAID response
- Next Steps: Commercial launch expected Q2 2026; physician education programs targeting rheumatologists to commence immediately
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, market penetration, and revenue projections for Cosentyx in China. Actual results may differ due to competitive dynamics, market adoption rates, and reimbursement negotiations.-Fineline Info & Tech