By Fineline Cube 
Novartis AG (NYSE: NVS) announced that remibrutinib tablets received National Medical Products Administration (NMPA) approval for the treatment of chronic spontaneous urticaria (CSU) in adults who remain symptomatic despite H1 antihistamine treatment, based on positive results from the REMIX‑1 and REMIX‑2 Phase 3 trials.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Remibrutinib tablets |
| Company | Novartis AG (NYSE: NVS) |
| Agency | NMPA (China) |
| Approval Type | New drug approval |
| Indication | Chronic spontaneous urticaria (CSU) |
| Study Basis | REMIX‑1 and REMIX‑2 Phase 3 trials |
| Key Features | BTK inhibitor; fast onset (1 week); durable effect (52 weeks) |
Drug Profile
- Mechanism: Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK cascade and inhibits histamine and inflammatory mediator release responsible for itchy wheals and swelling
- Clinical Efficacy: REMIX‑1 and REMIX‑2 demonstrated significant improvement as early as Week 1, with durable effects up to Week 52 in patients refractory to second‑generation antihistamines
- Safety Profile: Maintained good tolerability and safety during long‑term treatment; adverse events consistent with BTK inhibitor class
- Innovation: First BTK inhibitor approved for CSU in China, offering a new targeted mechanism beyond antihistamines
Market Context & Outlook
| Metric | Value |
|---|---|
| China CSU Patients | ~1.8 million adults (2024) |
| Antihistamine‑Refractory Share | ~40% (720,000 patients) |
| CSU Market Size (China) | ¥3.2 billion (US$440 million) |
| Growth CAGR | 12% (2024‑2030) |
| Peak Sales Forecast (Remibrutinib) | ¥2.0‑2.8 billion (~US$270‑380 million) by 2032 |
| Market Share Target | 30‑35% of refractory CSU patients |
| Competition | Roche’s Xolair (omalizumab) dominates biologics; no approved BTK inhibitors; Novartis’s first‑mover advantage |
- Reimbursement Path: NMPA approval triggers Priority Review for NRDL inclusion; potential listing Q4 2026
- Next Catalysts: Phase III data publication Q1 2026; U.S. sNDA filing H2 2026
- Strategic Value: Strengthens Novartis’s immunology franchise in China; repurposes BTK platform from oncology to inflammatory diseases
Forward‑Looking Statements
This brief contains forward‑looking statements regarding remibrutinib’s commercial launch, market penetration, and reimbursement outcomes. Actual results may differ materially due to risks including competitive responses, market adoption rates, and NRDL negotiation outcomes.-Fineline Info & Tech