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Byclot (MC710) is a plasma-derived bypassing agent developed by KM Biologics for the management of bleeding episodes in patients with congenital hemophilia A or B who have developed inhibitors to factor VIII or factor IX. It is a combination product consisting of human plasma-derived activated factor VII (FVIIa) and factor X (FX). The therapeutic rationale for this combination is the synergistic effect between FVIIa and FX, which significantly enhances thrombin generation on the surface of activated platelets compared to FVIIa alone. This mechanism effectively bypasses the deficiency of factor VIII or IX in the intrinsic pathway of the coagulation cascade. Byclot was first approved in Japan in 2016 for on-demand treatment and has since been evaluated in Phase II/III studies for prophylactic use to reduce the frequency of bleeding episodes in the same patient population.
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