BEIJING (Reuters) - China's medical products regulator said on Wednesday it had approved the use of Brii Biosciences' neutralising antibody cocktail for COVID-19, the first treatment of its type against the virus given the go-ahead in the country.
The combination of BRII-196/BRII-198 showed a 80% reduction of hospitalisation and deaths in non-hospitalised COVID-19 patients at high risk of developing severe disease, based on final results from a Phase III clinical trial, Brii said in a statement on Thursday.
The medicine from a Brii subsidiary was approved to treat mild COVID-19 and the disease of "normal type" with high risk of progressing to hospitalisation or death in adults and minors aged 12-17, the National Medical Products Administration said.
The results on how the Omicron variant would affect the antibody cocktail was expected to come out after about two weeks, Brii Chief Financial Officer Li Ankang said.
Brii's shares jumped as much as 13.7% to HK$48.75 ($6.25) before retreating to end 0.5% down on Thursday.
The company has filed emergency use application for the treatment in the U.S. where similar products from Regeneron Pharmaceuticals and Eli Lilly have been approved.
Brii will work with potential partners to seek regulatory clearance for the treatment in areas outside China and the United States, with priority given to countries where Phase III trial for the product had already started, such as South Africa, Brazil and Mexico, Li said at a news briefing.
Brii was also studying using the medicine as a prevention of COVID-19, Li said.
Before the approval, Brii's treatment had already been used in nearly 900 patients in China amid local outbreaks, the company said.
($1 = 7.7971 Hong Kong dollars)
(Reporting by Roxanne Liu and Ryan Woo; editing by Alexander Smith and Jason Neely)