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
Download prescribing information
When will Sepucapane be approved?
Approved on July 21, 2026.
Is Spicpan a innovative drug?
CountryClass 1 innovative drugs.
What are the indications of Spicpan?
Used to treat paroxysmal nocturnal hemoglobinuria that has not been treated with complement inhibitors before.PNH) adult patients.
What is the pharmacological effect of Spicpan?
selective complement factors Small molecule inhibitors of B (FB).
Which of the following complement activation pathways is primarily involved by the B factor of complement?
Bypass pathway.
For which type of PNH is Sepucapane used?
Prototypical.
What is the main advantage of targeting complement factor B?
Control both intravascular and extravascular hemolysis simultaneously.
What is the recommended dose of Spironolactone?
200 mg, once a day.
How to take Siprocapane?
Can be taken with or without food.
What modification was applied to the original Ipocapane to obtain Spocapane?
Tertiary ring modification and deuteration.
What improvements has Spicpan achieved compared to Ipcanpan?
The permeability is enhanced, leading to improved oral bioavailability.
Sippokpan metabolism pathway?
Feces excretion is the main excretion route (72.2±4.27%), and renal excretion via urine is a secondary excretion pathway (21.7±2.61%).
The compliance rate of sapipant in Study 301 Phase III 301 compared to the control group is?
59.5%。
The compliance rate of sapipant in Study 302 phase III compared to the control group is?
52.8%。
Advantages of Spicpan over current competing drugs on the market
Oral administration, once a day; no dose adjustment required for patients with mild, moderate, or severe liver dysfunction; no reproductive toxicity.