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SIM0107 (S0812) is a recombinant humanized staphylokinase variant developed by Simcere Pharmaceutical for the treatment of acute ischemic stroke (AIS). As a third-generation thrombolytic agent, it functions by forming a 1:1 stoichiometric complex with plasminogen, which subsequently converts other plasminogen molecules into plasmin, the enzyme responsible for fibrin degradation. Unlike earlier thrombolytics such as streptokinase, SIM0107 is highly fibrin-specific; it preferentially activates plasminogen at the surface of a thrombus, thereby minimizing systemic fibrinolysis and reducing the risk of major bleeding complications, including intracranial hemorrhage. The drug is currently being evaluated in a pivotal Phase 3 clinical trial in China to assess its efficacy and safety in patients with AIS within a broad therapeutic window (4.5 to 24 hours from onset).
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