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2022-07-07| ChinaCOVID-19

Brii Biosciences Begins Marketing COVID-19 Antibody Cocktail Therapy in China

by Fujie Tham
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China and US-headquartered Brii Biosciences announced the commercial marketing of the amubarvimab/romlusevimab combination therapy for COVID-19 in China. The company announced the release of the first commercial antibodies batch on July 7 after the initial December 2021 conditional approval by China’s National Medical Products Administration (NMPA).

In March 2022, National Health Commission of China added Brii’s antibody combination to its COVID-19 treatment guideline, officially recommending the drug for treatments. At the same time, China’s regulator has rubber-stamped AstraZeneca’s Evusheld antibody combination for use in a special medical tourism zone in Qionghai. 

Related article: Brii Bio’s Covid-19 Antibody Cocktail Gets the Greenlight in China 

 

Brii’s Combination Demonstrated Efficacy in ACTIV-2 Phase 3 Study

 

The amubarvimab plus romlusevimab combination are neutralizing antibodies derived and engineered from recovered COVID-19 patients from Shenzhen’s 3rd People’s Hospital, Brii said the combination is enhanced to “more durable treatment effect”.

In the ACTIV-2 Phase 3 clinical trial, the US National Institute of Allergy and Infectious Diseases (NIAID) found the company’s antibody combination showed an 80% reduction in hospitalizations and deaths, and improved safety outcomes in high-risk non-hospitalized patients. The therapy works for patients that are treated early or late with similar efficacy rates, making it a good asset for mild and moderate COVID-19 patients at risk of developing severe conditions. 

Brii’s therapy fared well against all major COVID-19 variants of concern, including Omicron subvariants BA.1.1 and BA.2.

While in the US, Brii Biosciences’ Emergency Use Authorization (EUA) application for the amubarvimab/romlusevimab combination is under review by the FDA and is pending satisfactory completion of FDA inspection of its manufacturing partners.

“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,”said Rogers Luo, President of Brii Bio Greater China.

 

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