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pegylated recombinant human coagulation factor VIII-Fc fusion protein
- Development stage
- Phase 3
- Lead developer
- Jiangsu Gensciences
- Modality
- Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, PEGylated Peptides → Modified Peptides → Peptides
- Administration
- Intravenous
01
Overview
FRSW117 is a next-generation, ultra-long-acting pegylated recombinant human coagulation factor VIII-Fc fusion protein developed for the treatment and prevention of bleeding in patients with hemophilia A. It incorporates both Fc fusion and PEGylation technologies to extend its half-life, enabling once-weekly dosing. This design aims to maintain high trough levels of FVIII activity, reduce annualized bleeding rates, and decrease the frequency of intravenous infusions required by patients. Clinical studies have demonstrated that FRSW117 has a favorable safety profile and effective prophylactic efficacy in severe hemophilia A. The drug is being developed by Jiangsu Gensciences and has received FDA orphan drug designation[1][4][5][7].
- Other names
- PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein
02
Targets
FCGRT (Neonatal crystallizable fragment receptor)FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)F8 (Coagulation Factor VIIIa)
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