Posted by Michael Wonder on 09 Dec 2021
Brii Bio announces amubarvimab/romlusevimab combination received approval from NMPA as first COVID-19 neutralising antibody combination therapy in China
8 December 2021 - The approval marks the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomised, double-blind and placebo-controlled trial.
Brii Biosciences today announced that the National Medical Products Administration of China has granted approval of the company's monoclonal neutralising antibody therapy, the amubarvimab/romlusevimab combination (previously BRII-196/BRII-198 combination), for the treatment in adults and paediatric patients (age 12-17 weighing at least 40 kg) with mild and normal type of COVID-19 at high risk for progression to severe disease, including hospitalisation or death.
The indication of paediatric patients (age 12-17 weighing at least 40 kg) is under a conditional approval.
