Zepuning® is the commercial brand name of Recombinant human thrombin, a recombinant serine protease developed by Suzhou Zelgen Biopharmaceuticals. It converts fibrinogen into fibrin locally to form stable clots and achieves topical hemostasis.
Main Indications
For topical hemostasis during surgical procedures in adults, when bleeding cannot be controlled by standard surgical techniques such as suture, ligation or electrocautery, to control oozing from surgical wounds, capillary and small venous hemorrhage.
Clinical Research
Pivotal phase III clinical research demonstrated that recombinant human thrombin achieved effective local hemostasis in multiple surgical scenarios. The hemostatic efficacy was non-inferior to plasma-derived thrombin, meeting the primary endpoint with a low incidence of anti-thrombin antibody formation.
Common Side Effects
Allergic reactions: rash, urticaria, pruritus;
Other common reactions: fever, local tissue irritation. Rare serious adverse events include anaphylaxis.
Approval Status in China
Original drug Zepuning® (Recombinant Human Thrombin) was officially approved for marketing in China in January 2024, with the specification of 5000 IU per vial. It is currently a prescription drug.
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