China approves first covid-19 neutralizing antibody combination therapy
(ECNS) -- Two medications of covid-19 neutralizing antibody combination therapy manufactured by Brii Biosciences Limited (Brii Bio) were approved by the National Medical Products Administration (NMPA) on Wednesday, according to an announcement by the NMPA.
Brii Bio’s monoclonal neutralizing antibody (mAb) therapy refers to the amubarvimab/romlusevimab combination (previously BRII-196/BRII-198 combination).
The approval aims to treat adults and pediatric patients (aged 12-17, weighing at least 40kg) with a mild and normal type of covid-19 at high risk for progression to severe disease, including hospitalization or death, said Bri Bio.
In less than 20 months, Brii Bio progressed the amubarvimab/romlusevimab combination from discovery to completion of Phase 3 development, leading to a rapid approval by the NMPA.
According to data from the Phase 3 clinical trial with 847 outpatients released by Brii Bio, there is a statistically significant 80 percent (78 percent in interim results) reduction of hospitalization and death, with fewer deaths through 28 days in the treatment arm (0) relative to placebo (9), as well as an improved safety outcome over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease.
"As the first COVID-19 treatment in China, the amubarvimab/romlusevimab combination demonstrates positive clinical outcomes and favorable safety in global, multicenter trials," said Zhang Linqi, director of the Global Health and Infectious Diseases Research Center and Comprehensive AIDS Research Center at Tsinghua University’s School of Medicine.
“Compared to convalescent plasma therapy, the neutralizing antibody combination therapy is a type of cellular expression via gene modification,” said Yan Li, Chief Medical Officer of Brii Bio, “So it has a higher neutralizing antibody titer and single ingredient, and is suitable for mass production.”
The neutralizing antibody has its limitations, Yan added, saying that it may reduce some neutralizing effect when there is a new variant.