Brii Bio's COVID-19 MAb first conditionally approved treatment by NMPA in China

China’s National Medical Products Administration (NMPA) has granted approval of Sino-American firm Brii Biosciences’ (HK: 2137) monoclonal neutralizing antibody (MAb) therapy, the amubarvimab/romlusevimab combination (previously BRII-196/BRII-198 combination), for the treatment in adults and pediatric 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 hospitalization or death.

The indication of pediatric patients (age 12-17 weighing at least 40 kg) is under a conditional approval

In October 2021, Brii Bio initiated and subsequently completed the rolling submission of an emergency use authorization (EUA) application with the US Food and Drug Administration. In addition, the company is pursuing additional efforts and regulatory filings for the amubarvimab/romlusevimab combination in established and emerging markets with an initial focus on securing access in countries where clinical trials were conducted and where significant gaps in access to highly effective treatments have been identified. The company is planning further studies in China, to evaluate the use of the amubarvimab/romlusevimab combination among immunocompromised population as an additional measure of prophylaxis.