BEIJING: China’s first home-developed anti-COVID-19 drug-using antibody cocktail therapy has been approved for marketing, after being found to be effective in reducing the risk of hospitalization or death among high-risk COVID-19 patients by 80 percent.
It also retains its neutralizing activity against the Omicron variant. The drug shows excellent safety and protection effects in international multi-center trials, and it 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 University’s School of Medicine, told the Global Times on Thursday at the university.
Studies showed that the drug could retain neutralizing activity against numerous variants including Alpha, Delta, and Omicron. In the next step, Zhang’s team will investigate the preventive effect of this antibody cocktail therapy among high-risk and immune compromised people, said the professor.
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, Zhang said.
The antibody cocktail contains two monoclonal antibodies – Brii-196 and Brii-198 which received emergency approval from China’s top medicine regulator, the National Medical Products Administration, on Wednesday. Its approval signifies that China has the first fully domestically developed and proven anti-COVID-19 drug that has undergone strict randomized, double-blind, and placebo-controlled trials.
The therapy was jointly developed by Tsinghua University, the Third People’s Hospital of Shenzhen, and Brii Bio-sciences. The main mechanism of the drug neutralizes 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.
The study was conducted at multiple clinical trial centers around the world, including the US, Brazil, South Africa, Mexico, Argentina, and the Philippines. The clinical trial results showed that the antibody cocktail therapy reduces the risk of hospitalization and death among high-risk COVID-19 patients by 80 percent.
Nine deaths were seen in the placebo group while there were zero deaths in the treatment group. Since June, Brii Biosciences has been working with government agencies and hospitals to donate about 3,000 doses, which helped treat about 900 COVID-19 patients across the country, including those from Guangdong, Yunnan, and Inner Mongolia. The team submitted an application for emergency use approval to the US Food and Drug Administration in October, which means that it is likely to be the first medication to receive emergency use authorization in a developed country.