RegulatoryJul 23, 2026, 07:33 AM
Nuvectis' Ciprocopan Gets First Global Approval in China for PNH
AI Summary
Nuvectis Pharma, Inc. announced that its drug ciprocopan (NXP100), a once-daily oral Complement Factor B inhibitor, received marketing approval from China's National Medicinal Products Administration (NMPA). This marks the first global approval for the drug, intended for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) previously untreated with Complement inhibitors. The approval is based on robust Phase 3 data demonstrating ciprocopan's superiority over eculizumab in efficacy and safety. Nuvectis holds exclusive rights to commercialize ciprocopan outside Greater China, India, and certain Southeast Asian countries.
Key Highlights
- Ciprocopan (NXP100) received marketing approval from China's NMPA for PNH.
- It is the world's first approved once-daily oral Complement Factor B inhibitor.
- Approved for PNH patients previously untreated with Complement inhibitors.
- Phase 3 study showed 59.5% of ciprocopan patients reached hemoglobin target vs 8.3% for eculizumab.
- Ciprocopan patients had a hemoglobin increase of 5.0 g/dL vs 2.2 g/dL for eculizumab.
- 94.6% of ciprocopan patients did not require transfusions vs 69.4% for eculizumab.
- Nuvectis holds exclusive rights to develop and commercialize ciprocopan outside Greater China, India, and parts of Southeast Asia.
Price Impact
More from NVCT