Nuvectis Pharma, Inc. (NASDAQ: NVCT) announced that ciprocopan (NXP100), a once-daily oral complement Factor B inhibitor, received marketing approval from China's National Medicinal Products Administration (NMPA) for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously been treated with complement inhibitors.

The approval was based on a Phase 3 head-to-head study comparing ciprocopan against Soliris (eculizumab) in treatment-naive PNH patients. The study met all primary and secondary endpoints. In the trial, 59.5% of ciprocopan-treated patients reached a hemoglobin target of 12 g/dL, compared with 8.3% in the eculizumab group. Hemoglobin increased from baseline by approximately 5.0 g/dL in the ciprocopan group versus 2.2 g/dL with eculizumab. Additionally, 94.6% of ciprocopan patients required no transfusions during the study, compared with 69.4% in the eculizumab group. No adverse events led to treatment discontinuation or study withdrawal in the ciprocopan arm.

Haisco, Nuvectis's partner, independently developed ciprocopan and holds responsibility for its development, regulatory approvals, and commercialization in China. Under an exclusive license agreement signed in June 2026, Nuvectis holds rights to develop and commercialize ciprocopan outside Greater China, India, and certain Southeast Asian countries.

A separate application for ciprocopan to treat PNH patients previously treated with anti-C5 therapies is currently under review by Chinese regulators.

"We are delighted that ciprocopan received its first marketing approval in China for the treatment of patients with PNH previously untreated with Complement inhibitors, and congratulate our partner Haisco on this tremendous achievement," said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis.

The information in this article is based on a press release statement from Nuvectis Pharma, Inc.