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HFB30132A (enzuvomab) is a fully human monoclonal antibody developed as an anti-SARS-CoV-2 agent. It targets the spike (S) protein receptor binding domain (RBD) of the virus and was identified from a convalescent COVID-19 patient. The antibody is engineered as an IgG4 subclass with specific mutations (S228P to prevent half-antibody formation and M252Y/S254T/T256E [YTE] for extended half-life). These modifications increase its binding to FcRn for longer systemic persistence and reduce FcγR binding to minimize the risk of antibody-dependent enhancement. Preclinical studies demonstrated potent neutralization against live SARS-CoV-2 virus and multiple variants in vitro and in vivo. Clinical trials have shown that it is well tolerated, non-immunogenic at tested doses, exhibits low clearance, long terminal elimination half-life (~89–107 days), and distributes efficiently to respiratory mucosa[1][3][5][7].
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