A strong antibodies combination !
China has the first fully self-developed anti-new coronavirus specific drug that has been proven to be effective through a strictly randomized, double-blind, placebo-controlled study. Last month, non-competing SARS-CoV-2 monoclonal neutralizing antibodies amubarvimab and romlusevimab (so BRII-196 and BRII-198 ) were developed by Professor Zhang Linqi, a professor of Tsinghua University School of Medicine and director of the Center for Global Health and Infectious Disease Research and AIDS Comprehensive Research Center of Tsinghua University.
Combination therapy (previously known as BRII-196BRII-198 combination therapy) received marketing approval from the China National Medical Products Administration (NMPA) for the treatment of novel coronavirus (SARS-CoV-2) with a positive test result accompanied by progression to severe Adult and pediatric (≥12 years old, weight ≥40 kg) patients with risk factors for COVID-19.
According to reports, the approval is based on the Phase 3 clinical trial of ACTIV-2 supported by the National Institutes of Health (NIH, in USA), including positive interim and final results of 847 enrolled patients.
The final results showed a statistically significant 80% (interim 78%) reduction in the risk of hospitalization and death among high-risk COVID-19 outpatients with the combination of amubarvimab and romlusevimab compared to placebo.
As of the 28-day clinical endpoint, there were zero deaths in the treatment group and 9 deaths in the placebo group, and its clinical safety profile was superior to that of the placebo group. At the same time, subjects who started treatment early (within 5 days after onset of symptoms) or late (within 6 to 10 days after onset of symptoms) had significantly lower hospitalizations and lower mortality rates, which provided new covid-19 patients with longer treatment window.
This achievement is the result of the joint efforts of China and the world’s leading scientists and clinical researchers, including the National Institute of Allergy and Infectious Diseases (NIAID, USA) under the National Institutes of Health (NIH, USA), which support the ACTIV-2 ( Accelerating COVID-19 Therapeutic Interventions and Vaccines-2) international clinical study, and the AIDS Clinical Trials Group (ACTG), which leads clinical research on ACTIV-2.
In October 2021, the R&D team has completed the submission to the U.S. Food and Drug Administration (FDA) of an Emergency Use Authorization (EUA) application for the combination therapy of amubarvimab and romlusevimab.
How did Chinese scientists discover it?
“We isolated hundreds of antibodies from patients who had recovered from COVID-19, and selected the best two against COVID-19,” Zhang Linqi, a professor at Tsinghua’s School of Medicine and the leader of the research team, said at a press conference following the treatment’s approval.
“We have very sophisticated and complex industrial systems that take the antibodies we select and reproduce them in vitro hundreds of millions of times ” Zhang said.
There are at least seven countries currently researching cocktail therapy treatment for COVID-19, but Professor Zhang is still confident the treatment developed by his team has advantages over the competition.
Zhang said that their cocktail uses broadly neutralizing antibodies that can target different sites of the virus, sothat the treatment can protect against a wide range of mutant strains.
“During our research and development, we have basically overcome the changes of Alpha, Beta, Gamma, Delta and Omicron. We’ve found that our antibodies combination was able to bind and neutralize these mutations,” said Zhang.
He also said it could be used on a wide range of patients, including people with chronic diseases, such as cardiovascular disease and diabetes.
The results on how the Omicron variant would affect the antibody cocktail are expected to come out after about two weeks, according to Brii Chief Financial Officer Li Ankang.
Sources: CGTN, People’s Daily Online, Reuters.
