The first domestically produced COVID-19 neutralizing antibody combination therapy was approved by the National Food and Drug Administration

On December 8, the State Food and Drug Administration urgently approved Tengsheng Huachuang Medical Technology (Beijing) Co.
, Ltd.
's new coronavirus neutralizing antibody combined therapy drug Ambavirimab injection (BRII-196) and Romisvirimab injection Liquid (BRII-198) registration application
.
This is China's first approved new coronavirus neutralizing antibody combination therapy with independent intellectual property rights
.
It is reported that the State Food and Drug Administration, in accordance with the relevant provisions of the Drug Administration Law, in accordance with the special drug approval procedures, conducts emergency review and approval, and approves the above two drugs to be used in combination to treat mild and common types with progress to severe (including hospitalization or Death) Adults and adolescents (12-17 years old, weight ≥40kg) with high-risk factors, patients with novel coronavirus infection (COVID-19)
.
Among them, adolescents (12-17 years old, weight ≥40kg) indication population are conditional approval
.