A neutralizing monoclonal antibody combination therapy for COVID-19, BRII-196/BRII-198, which is jointly developed by Tsinghua University, the Third People’s Hospital of Shenzhen and Brii Biosciences, a biotechnology company based in China and the U. S., is expected to enter the market soon.
The therapy is currently making the most progress as an antibody treatment for COVID-19, with Phase III international clinical trials already completed and clinical trial data submitted to both Chinese and U.S. drug regulators.
BRII-196/BRII-198 is expected to become China’s first neutralizing treatment for COVID-19 to get approval for market use in December. It will likewise be the first to receive emergency use authorization in developed countries like the U.S.
During the 28-day primary endpoint, data from Brii Biosciences demonstrated a 78-percent reduction in hospitalization or death risks in patients receiving single dose treatments of BRII-196/BRII-198 with zero deaths, versus eight via placebo.
The therapy’s Phase III trials were conducted at clinical sites around the world, including the U.S., Brazil, South Africa, Mexico, Argentina and the Philippines, enrolling patients between January and July 2021 – a period in which COVID-19 variants rapidly emerged globally.
Liu Lei, Party chief of the Third People’s Hospital of Shenzhen, said that Tsinghua University and the hospital were primarily responsible for research work such as test screening and virology tests during the drug research and development process, while Brii Biosciences was in charge of genetically modifying the antibodies.
“Our hospital has provided a large number of antibodies from recovered COVID-19 patients in the research process,” Liu said.
The research team extracted 206 antibodies from blood samples of recovered COVID-19 patients and eventually screened two antibodies with high activity, strong complementarity and the best effect for clinical research, according to Liu.
“It is encouraging that the team also found that the neutralizing antibody combination therapy can be used not only to treat patients, but also have preventive and protective effects on uninfected high-risk groups,” Liu said, adding that the drug can be used as a supplement to COVID vaccines.
In September this year, Brii Biosciences announced to commit an additional US$100 million to advance global regulatory filings and commercial efforts for its investigative BRII-196/BRII-198 antibody therapy.
More than a dozen neutralizing antibody projects in China have passed the special approval procedures and been approved to carry out clinical trials, said Xinhua News Agency, citing information released by the drug evaluation center of the National Medical Products Administration.