Pharmacokinetics, Safety and Preliminary Efficacy of Multiple Doses of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW117) in Previously Treated Adult and Adolescent Subjects with Severe Hemophilia a: Results from an Open-Label, Multicenter, Phase 2 Study

Introduction ：Prophylaxis of severe hemophilia A (HA) with standard half-life Factor VIII (FVIII) products necessitates frequent administration, and low trough FVIII activity levels lead to higher risk of bleeds. FRSW117 is a PEGylated recombinant human coagulation factor VIII Fc fusion protein (PEGylated rhFVIII-Fc), in a phase 1 study, single-dose FRSW117 was well tolerated and provided a prominently longer t1/2 with FVIII activity maintaining at ≥ 1% for more than 7 days. This open-label, multicenter phase 2 study (NCT05265286) aimed to evaluate the PK, safety, and preliminary efficacy of multiple 4 doses of FRSW117 in previously treated subjects with severe HA. Methods ：Severe HA (FVIII:C