New coronavirus neutralizing antibody combined therapy drugs Ambavirimab injection (BRII-196) and Romisvirimab injection (BRII-198)
2022/01/11
entral Commission for Discipline Inspection and State Supervision Commission website
On the afternoon of December 9, the Tsinghua University Anti-epidemic Drug Achievement Conference and the first domestically produced new crown specific drug release conference were held at Tsinghua University School of Medicine and Shenzhen Third People`s Hospital respectively to introduce China`s first anti-epidemic drug approved for marketing the day before. The specific situation and application prospects of new coronavirus specific drugs.
On December 8, the official website of the State Food and Drug Administration issued a message to urgently approve the registration of the new coronavirus neutralizing antibody combined therapy drug Ambavirimab Injection (BRII-196) and Romisvirimab Injection (BRII-198) Application and approval of the combination of the above two drugs for the treatment of adults and children (≥12 years old, weight ≥40 kg) patients who have a positive test result for the new coronavirus and who have progressed to severe COVID-19 risk factors.
Zhang Linqi, a professor at the School of Medicine of Tsinghua University, said that ambasavirumab and romisvirumab are a pair of non-competitive non-competitive products obtained from patients recovering from the new coronavirus pneumonia in cooperation with Tsinghua University, Shenzhen Third People`s Hospital and Tengsheng Biopharmaceuticals. The new type of severe acute respiratory syndrome virus 2 monoclonal neutralizing antibody. In particular, bioengineering technology is used to reduce the risk of antibody-mediated dependent enhancement, and to extend the plasma half-life to obtain a longer-lasting therapeutic effect.
"Our research team successfully extracted a pair of highly active neutralizing antibodies from the peripheral B cells of patients with COVID-19, which laid a solid foundation for the subsequent development of this anti-coronavirus drug." Shenzhen Third People's Hospital Liver Disease Research Zhang Zheng, director of the institute, said that his team used the single cell isolation and antibody development platform established in the early stage to successfully isolate 206 anti-neovirus monoclonal antibodies and sequences from the B cells of 8 COVID-19 patients, and dozens of them were displayed. It has a super high neutralizing activity against the new coronavirus. In particular, on January 29 and February 3, 2020, the two best antibody strains were screened out, and after multiple technical identification, evaluation, optimization and modification, they became BRII-196 and BRII-198.
According to Zhang Linqi, clinical trial data showed that whether patients 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), the hospitalization and mortality rate were significantly reduced. Provides a longer treatment window for patients with new crowns.
Within 20 months, the therapy quickly advanced from the initial laboratory study to the completion of the international phase 3 clinical trial, and finally received China`s marketing approval. This "China speed" relies on the joint efforts of China and world-class scientists and clinical researchers, including the National Institute of Allergy and Infectious Diseases under the National Institutes of Health, which supports ACTIV-2 international clinical research, and its leadership The AIDS clinical trial group of ACTIV-2 clinical research.
The approval of the ambavirumab/romisvirimab combination therapy marks China's first fully independently developed and proven effective anti-coronavirus specific drug that has undergone a rigorous randomized, double-blind, placebo-controlled study. 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.
