Brii Bio’s COVID-19 Antibody Cocktail Gets the Greenlight in China

The NMPA has given its blessing to Brii Biosciences’ Covid-19 antibody cocktail, making it the first approved targeted therapy against Covid-19 in China. The drug combines amubarvimab and romlusevimab, formerly known as BRII-196 and BRII-198, to treat Covid-19 in mildly symptomatic patients who are at high risk for progression to severe disease. 

The regulatory nod from China comes as Brii Bio awaits the decision from the US FDA to authorize its drug combo for emergency use. 

“As a startup multi-national biotech company co-located in both China and the U.S., 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,” said Rogers Luo, President of Brii Bio in the Greater China region. 

Reducing Risk of Severe Disease by 80%

Approval is based on results from the Phase 3 Activ-2 trial, which showed that the amubarvimab/ romlusevimab combo reduced risk of hospitalization and death by 80%. Sponsored by the National Institutes of Health (NIH), the Activ-2 trial enrolled 847 patients and took place in the US, Brazil, South Africa, Mexico, Argentina, and the Philippines. 

Brii Bio is analyzing how the antibody cocktail holds up against different Covid-19 variants. The company has said that the combination remains effective against previously identified strains such as the Gamma, Delta, and Delta+ variants. Meanwhile, testing against the Omicron variant is ongoing.   

An Extra Weapon in the Fight against Covid-19

If vaccines are a shield that guards against Covid-19, antibody cocktails work more like a sword. Amubarvimab and romlusevimab, as neutralizing monoclonal antibodies, supplement the body’s immune response against the coronavirus by targeting the viral spike proteins. 

China’s first approval for an antibody combination therapy will certainly not be its last. Another cocktail, co-developed by Junshi Biosciences and the Institute of Microbiology of the Chinese Academy of Sciences, seems likely to get the nod. According to Phase 3 trial data, the regime which consists of etesevimab and bamlanivimab is said to slash severe disease risk by 70%. Just this week, Eli Lilly, Junshi’s global partner, announced that the FDA has expanded emergency use of the combo in the US to include younger patients including newborns. 

Besides antibody cocktails and vaccines, China is also developing its own oral antivirals and other treatments for Covid-19. 

Azvudine, an oral antiviral drug originally designed to treat HIV, may be getting its own first-in-class approval in China this month. Developed by Henan Normal University, the drug acts as a reverse transcriptase inhibitor that blocks viral replication. 

Proxalutamide, an androgen deprivation therapy, is being investigated by Kintor Pharma in Phase 3 trials in Brazil. While it has been authorized for emergency use in Paraguay, the treatment has generated controversy over the ethical violations and results that appear too good to be true in Brazil. 

Author

Joy Lin

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