A domestically developed COVID-19 drug was approved for use by Chinese authorities Wednesday, making it the first treatment for the novel coronavirus to receive regulatory approval in the country.
The antibody therapy — known as BRII-196/BRII-198 — was developed by the Chinese pharmaceutical firm Brii Biosciences in partnership with scientists at Beijing’s Tsinghua University and the Third People’s Hospital of Shenzhen.
The drug, which is administered by intravenous injection, has been approved to treat adults and minors aged 12 to 17 with mild or moderate symptoms of COVID-19, according to China’s National Medical Products Administration.
During an international trial involving more than 800 patients from countries including the United States, Brazil, South Africa, and the Philippines, BRII-196/BRII-198 was found to reduce COVID-19 patients’ risk of hospitalization and death by 78%, according to Brii Biosciences. Peer-reviewed data has yet to be published.
The drug uses monoclonal antibodies — lab-made molecules that bind to specific spots on the coronavirus’ spike proteins — to impair the virus’ ability to invade human cells, slowing down infection. Brii Biosciences said trials indicated BRII-196/BRII-198 was effective against the Delta variant.
Global pharmaceutical giants GlaxoSmithKline and Vir Biotechnology have developed a similar antibody treatment known as GSK-Vir, which early-stage trial data suggests is effective against all Omicron mutations. The drug was approved for use in the United States in May. To date, China has announced no plans to import COVID-19 treatments.