Haisco's independently developed Class 1 innovative drug, Ciprocopan Succinate Tablets—a next-generation complement Factor B inhibitor (CFBi)—was granted early marketing approval on July 23, 2026 through priority review and approval for the treatment of adult patients with. paroxysmal nocturnal hemoglobinuria (PNH) who are complement inhibitor-naïve.
CFBis (including Ciprocopan) have received recommendations from authoritative guidelines and are considered a first-line treatment.[1-3]
Ciprocopan incorporates a more metabolically stable moiety, targets a key step in the alternative complement pathway, and leverages deuteration technology to drive structural advancement.[4-6]
Half-life was extended to 21.1-38.5 hours[7], enabling once-daily dosing,
Clinical drug interaction risk is lower, and food intake has no effect.[4,7]
1. Chinese Medical Association Hematology Society Red Blood Cell Diseases (Anemia) Group. Chinese Guidelines for the Diagnosis and Treatment of Paroxysmal Hypersomnia [J]. Chinese Journal of Hematology, 2024, 45(08): 727-737
2. Zhejiang Provincial Medical Association Hematology Society, Zhejiang PNH Working Group. Expert Consensus on Complement Inhibitors for Paroxysmal Hypersomnia Hemoglobinuria in Zhejiang Province (2025 Edition) [J]. Zhejiang Medical Journal, 2025, 47(6):561-565, 570
3. https://www.onkopedia-guidelines.info/en/onkopedia/guidelines/paroxysmal-nocturnal-hemoglobinuria-pnh/@guideline/html/index.html
4. Internal information