Pfizer has received China National Medical Products Administration (NMPA) approval for marstacimab as the first TFPI monoclonal antibody (mAb) for routine prophylaxis in severe haemophilia A and B patients without inhibitors, based on the Phase III BASIS trial showing 35% reduction in annualised bleeding rate (ABR) versus on demand factor replacement therapy. The weekly subcutaneous injection offers a simplified administration alternative to intravenous factor concentrates requiring frequent infusions, with minimal preparation time and improved treatment adherence. The global multicentre open label study enrolled 116 patients, demonstrating superior bleeding prevention during the 12-month active treatment period compared to the 6-month observational phase with conventional clotting factor therapy.

The safety profile remained consistent with earlier Phase I/II data, showing manageable adverse events such as injection site reactions, headache, pruritus and hypertension, without new signals observed. Marstacimab's mechanism provides a novel approach targeting TFPI, restoring thrombin generation potential and rebalancing the coagulation cascade in haemophilia patients with or without inhibitors.

According to PharmCube's NextBiopharm® database, marstacimab is the second TFPI mAb to hid the global market, with three more active programs in the clinic. Click here to request a free trial for NextBiopharm®.