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On July 13, Sanofi's recombinant human coagulation factor VIII Fc-von Willebrand factor-XTEN fusion protein (efanesoctocog alfa, rFVIIIFc-VWF-XTEN, BIVV001) for injection was awarded CDE's proposed breakthrough therapy and its proposed indications It is used for adults and children with hemophilia A: (1) Routine preventive treatment to reduce the frequency of bleeding; (2) On-demand treatment of bleeding; (3) Treatment of perioperative bleeding

Hemophilia is a genetic disorder of blood clotting

Von Willebrand Factor (vWF) can form a complex with FVIII to stabilize and protect FVIII from degradation and clearance, but FVIII is also degraded when VWF is degraded, resulting in the upper limit of FVIII's half-life being only 15-19 hours

BIVV001 is a new type of coagulation factor VIII replacement therapy under development.

A Phase I/IIa clinical trial code-named EXTEN-A evaluated BIVV001 doses of 25 IUkg (n=6) and 65 IU/kg (n=8) in subjects 19-63 years of age with severe hemophilia A.

The test results showed that BIWV001 was well tolerated, and no allergic reactions or clinically significant treatment-related adverse events were found during the study

In the 25 IU/kg cohort, a single administration of BIVV001 reached a half-life of 38 hours for FVIII, which was a 4-fold increase from the 9-hour half-life of rFVIII injection.

On February 18 this year, the FDA granted the therapy Fast Track Qualification (FTD) for the treatment of patients with type A blood diseases

BIVV001 was originally developed based on Amunix’s XTEN technology.