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China Expected to Approve Brii Bio COVID-19 Therapy Next Month
Following announcement of the Phase III trial results for BRII-196/BRII-198, Brii also filed for approval in the
Brii said the therapy consists of two non-competing SARS-CoV-2 mAbs derived from convalesced COVID-19 patients. The Phase III trial was conducted in the
In September Brii announced it had allocated $100 million for global filings and commercialization of the therapy. The combination therapy was co-developed by
In the Phase III trial, there were no deaths in the active drug cohort versus 8 deaths in the placebo group. In subjects who received treatment with BRII-196/BRII-198 within five days of symptom onset, 2% (4/196) progressed to hospitalization or death, compared with 11% (21/197) in the placebo arm. The arm of the trial that contained subjects who were treated 6-10 days after symptom onset produced similar results. A total of 837 people were enrolled in the trial.
"Human bodies produce a great amount of antibodies, but not all of them have antiviral efficacy. The goal of our research is to pick out the strongest ones that can be used as antibody drugs to treat infected patients," said Zhang Linqi, a professor at the
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