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Recombinant coagulation factor XI is a biosynthetic form of the human coagulation factor XI (FXI) protein, produced using recombinant DNA technology. Factor XI is a serine protease zymogen that plays a critical role in the intrinsic pathway of the blood coagulation cascade. Upon activation to factor XIa (typically by thrombin or factor XIIa), it catalyzes the conversion of factor IX to factor IXa, which subsequently facilitates the amplification of thrombin generation and the formation of a stable fibrin clot. This agent is primarily utilized as a replacement therapy for patients with factor XI deficiency, also known as Hemophilia C or Rosenthal syndrome, to prevent or control bleeding episodes, particularly during surgical procedures or following trauma. In clinical research, such as the ChiCTR2100044838 trial, it is evaluated for pharmacokinetic-guided precision replacement to optimize perioperative safety and factor utilization in patients with hemophilia.
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