The first domestically produced new crown neutralizing antibody combination therapy has been approved by the State Food and Drug Administration

2021-12-08 17:14:01

On December 8, the State Food and Drug Administration approved the registration application for Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd.'s new coronavirus neutralizing antibody combination therapy drug Ambavizumab injection (BRII-196) and Romisvizumab injection (BRII-198). This is the first approved independent intellectual property combination treatment drug for new coronavirus neutralizing antibodies in my country.

It is reported that the State Food and Drug Administration, in accordance with the relevant provisions of the Drug Administration Law, conducts emergency review and approval in accordance with the special drug approval procedures, and approves the combination of the above two drugs to treat adults and adolescents (12-17 years old, weigh ≥40kg) new coronavirus infection (COVID-19) patients with mild and ordinary types and accompanied by high-risk factors for progression to severe (including hospitalization or death). Among them, the adolescents (12-17 years old, with a weight ≥40kg) are conditionally approved.