Nuvectis announced that ciprocopan (NXP100), a once-daily oral complement factor B inhibitor, received marketing approval from China’s NMPA for treating Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients who had not previously been treated with complement inhibitors.

In a Phase 3 head-to-head trial, ciprocopan demonstrated superiority over eculizumab, with 59.5% of patients reaching a 12 g/dL hemoglobin target versus 8.3% on eculizumab, a baseline hemoglobin rise of about 5.0 g/dL versus 2.2 g/dL, and reduced transfusion needs (94.6% not requiring transfusions vs. 69.4%).

The approval is based on a Phase 3 trial comparing ciprocopan directly to Soliris (eculizumab) in treatment-naive PNH patients, in which ciprocopan met all primary and secondary endpoints.

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Nuvectis holds exclusive rights outside Greater China, India, and parts of Southeast Asia under a June 2026 license with Haisco, which developed ciprocopan in China and will continue regulatory approvals and commercialization there.

Nuvectis independently developed ciprocopan and will manage development, regulatory approvals, and commercialization in China.

Haisco independently developed ciprocopan and retains regulatory and commercialization responsibilities in China, while Nuvectis has exclusive development and commercialization rights outside Greater China, India, and portions of Southeast Asia under the June 2026 license.

Nuvectis underscores ongoing development of ciprocopan and other pipeline candidates (NXP900, NXP200) focused on complement-related conditions and oncology.

Nuvectis is a clinical-stage biopharmaceutical company concentrating on therapies for complement-related conditions and oncology.

The broader pipeline includes NXP100 (ciprocopan), NXP900, and NXP200 with continued development in complement-related diseases and cancer.

Nuvectis management and Haisco executives celebrate the milestone, signaling expectations that ciprocopan will capture notable market share in the evolving Factor B inhibitor landscape and expand beyond PNH.

The press release contains forward-looking statements with standard risk disclosures and SEC-related safe harbor language.