China News Service, Beijing, December 9th (Reporter Gao Kai) On the afternoon of December 9th, Tsinghua University held a press conference to announce that Professor Zhang Linqi of Tsinghua University led the research and development of China's first anti-coronavirus drug and was approved for listing, which marked China Possess the first fully self-developed and effective anti-coronavirus specific drug that has undergone rigorous randomized, double-blind, and placebo-controlled studies.
According to reports, on December 8, 2021, Professor Zhang Linqi, a professor at Tsinghua University School of Medicine and director of Tsinghua University’s Global Health and Infectious Diseases Research Center and AIDS Comprehensive Research Center, led the research and development of the new crown monoclonal neutralizing antibody ambavirimab/ Romisvirimab combination therapy (previously known as BRII-196/BRII-198 combination therapy) was approved by the China National Medical Products Administration (NMPA) for the treatment of new coronavirus (SARS-CoV-2). The test result is Adults and children (≥12 years old, weight ≥40 kg) patients who are positive and are accompanied by risk factors for progression to severe COVID-19.
This approval signifies that China has the first fully independently developed and proven effective anti-coronavirus specific drug that has undergone rigorous randomized, double-blind, and placebo-controlled studies.
Professor Zhang Linqi said that this combination therapy has demonstrated excellent safety and protection in international multi-center trials, and is the only antibody drug that has carried out the evaluation of the treatment effect of variant infections and obtained the best data in the world so far. .
The antibody combination therapy provides a world-class treatment for my country's fight against the new crown epidemic.
The next step will continue to study the preventive effect of monoclonal antibody combination therapy in high-risk and immunodeficiency populations.
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This approval is based on the Phase 3 clinical trial of ACTIV-2 supported by the National Institutes of Health (NIH), including the positive interim and final results of 847 enrolled patients.
The final result showed that compared with placebo, the combination therapy of ambavirumab/romisvirimab can reduce the risk of hospitalization and death of high-risk new crown outpatients by 80% (interim result is 78%), which is statistically significant .
As of the 28-day clinical endpoint, there were zero deaths in the treatment group and 9 deaths in the placebo group, and its clinical safety was better than that of the placebo group.
At the same time, subjects who started treatment at an early stage (within 5 days after the onset of symptoms) or at a late stage (within 6 to 10 days after the onset of symptoms) had a significant reduction in hospitalization and mortality, which provided new coronavirus patients with Longer treatment window.
It is understood that in less than 20 months, Tsinghua University has cooperated with Shenzhen Third People’s Hospital and Tengsheng Biopharmaceuticals to separate the ambavirumab/romisvirumab combination therapy from the original neutralizing antibody And the screening quickly advanced to the completion of the international phase 3 clinical trial, and finally obtained the marketing approval in China.
According to reports, during the drug development process, Academician Zhong Nanshan led the Guangzhou laboratory team to make outstanding contributions.
Academician Zhong Nanshan presided over the phase 2 clinical studies of ambavirumab (BRII-196) and romisvirimab (BRII-198) in China, and led the demonstration and promotion of the emergency treatment of drugs in my country, and further The safety and effectiveness of the drug in Chinese patients are verified.
It is reported that the Guangzhou laboratory team led by Academician Zhong Nanshan is presiding over the research work on the use of ambavirumab (BRII-196) and romisvirimab (BRII-198) for prevention, and promotes the use of vaccines in people with poor response. Preventive use.
Ambavirimab and Romisvirimab are a pair of non-competitive new severe cases obtained by Tsinghua University, Shenzhen Third People's Hospital and Tengsheng Bo Pharmaceutical from patients in the recovery period of new coronavirus pneumonia (COVID-19). Acute Respiratory Syndrome Virus 2 (SARS-CoV-2) monoclonal neutralizing antibody, especially the application of bioengineering technology to reduce the risk of antibody-mediated dependent enhancement, and prolong the plasma half-life to obtain a more lasting therapeutic effect.
It is reported that in October 2021, the R&D team has completed the submission of an emergency use authorization (EUA) application for ambavirumab/romisvirimab combination therapy to the U.S. Food and Drug Administration (FDA).
In addition, the R&D team is actively advancing the registration application of ambavirumab/romisvirimab combination therapy in other mature and emerging markets around the world, first to ensure that there is a huge gap in the countries where clinical trials have been conducted and the availability of effective treatments. Countries promote market access.
The R&D team will also carry out further research in China to evaluate the preventive immune enhancement effect of ambavirumab/romisvirimab combination therapy in immunosuppressed populations.
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