Brii Bio Initiates Submission of Emergency Use Authorization Filing to U.S. FDA for BRII-196/BRII-198

Brii Bio Initiates Submission of Emergency Use Authorization Filing to U.S. FDA for BRII-196/BRII-198

 Brii Biosciences Limited (“Brii Bio” or the “Company,” stock code: 2137.HK), a multi-national company headquartered in China and developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced the filing of an emergency use authorization (EUA) application for its investigational SARS-CoV-2 (virus that causes COVID-19) combination therapy, BRII-196/BRII-198 (“combination BRII-196/BRII-198”) with the U.S. Food and Drug Administration (FDA). Data to support the EUA filing will be submitted by the Company to the U.S. FDA on a rolling basis.

The Evidence

The EUA filing is based on positive results from the National Institutes of Health (NIH)-sponsored Phase 3 clinical trial, ACTIV-2, in which the BRII-196/BRII-198 combination demonstrated a statistically significant 78% reduction of hospitalization and death and improved safety over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease.  Similar efficacy rates were observed in participants initiating therapy early (0-5 days) and late (6-10 days), following symptom onset. This analysis also showed zero deaths in ...

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