China has granted emergency approval to its first-ever antibody cocktail therapy against Covid-19, which has shown to be effective in reducing the risk of hospitalisation or death among high-risk Covid-19 patients by 80 per cent, the media reported.
The company in October submitted an application to the National Medical Products Administration and received emergency approval from China’s top medicine regulator this week, Global Times reported.
The combination therapy, co-developed by Tsinghua University, the Third People’s Hospital of Shenzhen and Brii Biosciences, headquartered in China and the US, also retains its neutralising activity against the Omicron variant, the report said.
The SARS-CoV-2 therapy BRII-196/BRII-198 has shown excellent safety and protection effects in international multi-centre trials, and is the only antibody drug in the world to have evaluated the efficacy of the treatment of patients with mutant strains and obtained the best results, Zhang Linqi, the professor who leads the research and development of the drug at Tsinghua’s School of Medicine, was quoted as saying.
Brii Biosciences had, in late August, announced that its cocktail therapy demonstrated a statistically significant reduction of 78 per cent in the hospitalisation and death in phase III clinical trials conducted in the US, Brazil, South Africa, Mexico, Argentina and the Philippines.
It has also been used among more than 700 patients infected in the recent epidemic flare-ups in China, caused by the Delta variant.
The therapy has also proven effective against major coronavirus variants, including the Delta, Lambda and MU variants, according to a report by the Beijing Daily.
With one shot, the antibody cocktail can persist in the human body for about nine to 12 months. Besides the therapeutic efficacy shown in the clinical trials, it can also be used for epidemic prevention.
“Antibody drugs and vaccines complement each other. If people who have underlying or immune diseases cannot take vaccines, they could choose to take this drug instead to get antibodies against Covid-19,” Linqi said.
In the next step, the team will investigate the preventive effect of this “antibody cocktail therapy” among high-risk and immunocompromised people, Linqi said.
The main mechanism of the drug neutralises the novel coronavirus, preventing the virus from being absorbed to susceptible cells and thus preventing the virus or its genetic materials from entering cells to proliferate.
Brii Biosciences has also submitted an application for the emergency use approval to the US Food and Drug Administration in October, but it is yet to be approved.