Pfizer Inc. (PFE.US) has filed for market approval of a new type of drug and a new indication in China.

On January 22, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration showed that Pfizer Inc. (PFE.US) has applied for a new indication for the type 1 new drug "Marstacimab Injection", with a registration classification of 2.2. Based on public information and clinical trial progress, this new indication may be for inhibiting bleeding tendencies in patients with congenital hemophilia (with clotting factor VIII or IX inhibitors). Marstacimab (PF-6741086) is a monoclonal antibody targeting the K2 domain of tissue factor pathway inhibitor (TFPI) developed by Pfizer Inc., belonging to hemophilia re-balancing therapy. TFPI is a natural anticoagulant protein with the function of preventing blood clot formation and promoting hemostasis. In November 2025, Pfizer Inc. announced that the world's first non-factor innovative drug Yurin (generic name: Marstacimab), which only requires a fixed subcutaneous injection once a week, has been officially approved for marketing by the National Medical Products Administration (NMPA) of China. The drug has been successively approved for marketing in the United States, the European Union, Japan, and China. The approved indications are: for the regular treatment of patients with severe hemophilia A (congenital factor VIII deficiency, FVIII <1%) or severe hemophilia B (congenital factor IX deficiency, FIX <1%) without clotting factor inhibitors, aged 12 and above and weighing not less than 35 kilograms, to reduce the occurrence of bleeding. After approval, it became the world's first subcutaneous injection drug for hemophilia B once a week, as well as the first fixed-dose regimen for A/B type hemophilia. In December 2025, Pfizer Inc. announced the submission of a new indication application for Marstacimab in Japan, intending to add the indication of "inhibiting bleeding tendencies in patients with congenital hemophilia (with clotting factor VIII or IX inhibitors)". This is the same indication formally accepted by the CDE in China.