Beijing Brii Biosciences (HK: 2137) reported China has approved its combination therapy for patients with mild COVID-19 who are at risk for disease progression. The amubarvimab/romlusevimab combination was based on non-competing Covid-19 monoclonal neutralizing antibodies (mAbs) obtained from convalesced COVID-19 patients. For its NDA, Brii submitted positive data from US Phase III trial that enrolled 847 infected outpatients. The active drug cohort showed an 80% decline in mortality and hospital admission. The US is also reviewing the Brii therapy for approval under Emergency Use rules.

Brii has announced it would allocate an additional $100 million for global regulatory filings and commercialization of the therapy.

In the trial, there were no deaths over the 28 days of the follow-up in subjects who received the treatment versus nine in the placebo arm. The results were surprisingly similar in two groups of the active cohort: patients who received the therapy in up to five days after showing symptoms and patients who were treated six to ten days after becoming symptomatic.

Brii's drug was developed in partnership with the 3rd People’s Hospital of Shenzhen and Tsinghua University.

Brii Bio Greater China president and general manager Rogers Luo said: “This accomplishment is a testament to our steadfast commitment to accelerating innovation in infectious diseases and our ability to fulfill global unmet needs with speed, scientific rigor and impressive results."

He continued, "As a startup multi-national biotech company co-located in both China and the US, we are working to advance access to this treatment for a broad range of Covid-19 patients in China while also scaling its effort to match the need for Covid-19 treatment options to combat the pandemic.”

Brii is a China-US company that is developing therapies for infectious diseases such as hepatitis B virus (HBV), human immunodeficiency virus (HIV), multi-drug resistant (MDR) or extensive drug resistant (XDR) gram-negative infections, along with other conditions that include central nervous system (CNS) diseases.

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Disclosure: none.