SV003

SV003 is a humanized bispecific monoclonal antibody developed by Shanghai Synvida Biotechnology as a Factor VIII (FVIII) mimetic for the treatment of Hemophilia A. It is designed to bridge activated Factor IX (FIXa) and Factor X (FX), thereby mimicking the natural cofactor function of FVIIIa in the coagulation cascade. This mechanism allows for the restoration of thrombin generation in patients with FVIII deficiency, including those who have developed inhibitors against FVIII replacement therapies. SV003 was discovered using Synvida's proprietary EMPRESS yeast library construction system. While some early contexts associated the drug with oncology, its primary clinical development is focused on hematology, with Phase 1 trials evaluating its safety, pharmacokinetics, and pharmacodynamics in healthy participants.