China approves country's first COVID-19 antibody drug, developed by Tsinghua research team
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A Chinese research team has developed an "antibody cocktail therapy" that can fight SARS-CoV-2.

The antibody cocktail made of two monoclonal antibodies Brii-196 and Brii-198 has shown an efficacy of 80 percent in cutting hospitalizations and deaths among high-risk groups in multicenter randomized clinical trials.

The treatment was jointly developed by a research team led by Zhang Linqi, a professor at School of Medicine of Tsinghua University, the Third People's Hospital of Shenzhen, Guangdong province, and Brii Biosciences.

Zhang has devoted 30 years to studying HIV-1 pathogenesis and vaccine development, and also emerging and re-emerging human viral pathogens such as Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV-1, and SARS-CoV-2.

Zhang said “at the beginning of the outbreak, we isolated hundreds of antibodies from patients who had recovered from COVID-19. In a joint effort with Shenzhen No.3 People’s hospital and Brii Biosciences, we have obtained 206 monoclonal antibodies and selected the best two (Brii-196 and Brii-198) as the cocktail therapy against SARS-CoV-2. They have shown a strong antiviral activity and work well together. Multicenter randomized clinical trials have also suggested that this cocktail therapy could reduce hospitalizations and mortality by 80 percent.”

In October, the research team submitted a formal application for conditional approval to China's National Medical Products Administration (NMPA) and for emergency use approval to the US Food and Drug Administration.

During the pandemic, NMPA's Center for Drug Evaluation initiated a special rolling submission channel, which expedites the review and approval process of the latest and most promising medical breakthroughs such as the antibody cocktail therapy Prof. Zhang’s team developed.

The clinical team conducted very effective clinical trials at home and abroad in strict accordance with international standards. And the data for the reduction of hospitalizations and deaths was generated from a randomized, double-blind, placebo-controlled clinical trial.

“In fact, while being reviewed by Chinese regulators, our antibody drugs have already played a huge role in treatment for those suffering from the sporadic outbreaks of COVID-19. They were used in emergency and compassionate situations in a dozen provinces and autonomous regions that were experiencing outbreaks,” Zhang said.

The impressive safety and efficacy profile from clinical trials has supported application to and approval by the National Health Commission and the Ministry of Science and Technology.

The antibody cocktail treatment has competitive advantages, according to Zhang. First, it is very potent in inhibiting the virus from infecting cells. The antibody cocktail can target different sites of the virus, even it is mutated. They are broadly neutralizing antibodies. The team also modified the antibodies to extend their half-lives. With one shot, the antibody cocktail can stay in the human body for about nine to 12 months. Besides the therapeutic efficacy in current clinical trials, they can also be used for prevention measures

“Antibody drugs and vaccines are complementing each other. Current vaccines have good efficacy, but are not 100 percent effective,” Zhang added.

For superinfection cases, this treatment would be particularly useful. In this regard, our antibody drugs, given their high safety and efficacy profile, can make a significant impact in the fight against the pandemic.

“Our antibody cocktail therapy has been leading the way in both clinical progress and efficacy,” Zhang said.