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Human coagulation factor IX is a plasma-derived protein injection developed by Tiantan Bio for the treatment of hemophilia B. As a replacement therapy, it provides the essential coagulation factor IX that is deficient or absent in patients with this rare bleeding disorder. Factor IX is a vitamin K-dependent serine protease that plays a critical role in the intrinsic pathway of the blood coagulation cascade. Once activated to factor IXa, it forms a complex with activated factor VIII, calcium ions, and phospholipids to activate factor X, which eventually leads to thrombin generation and stable fibrin clot formation. The drug is currently in the IND-enabling phase of development and is extracted directly from human plasma to ensure biological activity.
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