FT-004 (Frontera Therapeutics)

FT-004 is an investigational adeno-associated virus (AAV) gene therapy being developed by Frontera Therapeutics (Fangtuo Biotechnology) for the treatment of hemophilia B. The therapy utilizes a liver-tropic AAV vector to deliver a functional copy of the human Factor IX (FIX) gene into the hepatocytes of patients. This approach is intended to provide long-term, stable expression of the FIX protein, thereby restoring blood clotting function and reducing or eliminating the requirement for exogenous factor replacement therapy. FT-004 is administered as a single-dose intravenous infusion and has received Investigational New Drug (IND) clearance from both the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA).