my country's first new coronavirus neutralizing antibody combination therapy drug approved
Science and Technology Daily, Beijing, December 8th (Reporter Fu Lili) The reporter learned from the National Medical Products Administration on the 8th that the bureau urgently approved Tengsheng Huachuang Medical Technology (Beijing) Co., Ltd.'s new coronavirus neutralizing antibody combination therapy drug Amba Application for registration of Virumab injection (BRII-196) and Romisvelumab injection (BRII-198).
This is my country's first approved new coronavirus neutralizing antibody combination therapy drug with independent intellectual property rights.
According to reports, the State Food and Drug Administration, in accordance with the relevant provisions of the Drug Administration Law, conducted emergency review and approval in accordance with the special drug approval procedures, and approved 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 (COVID-19) patients.
Among them, adolescents (12-17 years old, weight ≥40kg) indication population are conditional approval.