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Omfiloctocog alfa (SCT800) is a third-generation, B-domain-deleted recombinant human coagulation factor VIII (rFVIII) developed by Sinocelltech Ltd. for the treatment and prophylaxis of hemophilia A. As a replacement therapy, it supplies the missing or deficient coagulation factor VIII, which is a critical cofactor in the intrinsic pathway of the blood coagulation cascade. By restoring factor VIII levels, omfiloctocog alfa facilitates the activation of factor X and the subsequent generation of thrombin and fibrin clots, thereby preventing or controlling bleeding episodes. It is the first recombinant factor VIII product developed and manufactured in China, and it has demonstrated efficacy and safety in clinical trials involving both adult and pediatric previously treated patients (PTPs) with severe hemophilia A.
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