China’s first specific anti-coronavirus drug developed by Tsinghua University has been approved for marketing.
The new coronavirus monoclonal neutralizing antibody ambavir/romisvir was developed by Professor Zhang Linqi, professor of Tsinghua University School of Medicine and director of Tsinghua University Global Health and Infectious Disease Research Center and AIDS Comprehensive Research Center. The monoclonal antibody combination therapy received marketing approval from the China Food and Drug Administration on December 8.
Indicated for the treatment of novel coronavirus infection (COVID-19) in adults and adolescents (12-17 years old, weighing ≥40kg) with mild and common forms and high risk factors for progression to severe disease (including hospitalization or death). 19) patients. Among them, the indication group for adolescents (12-17 years old, weight ≥40kg) is subject to conditional approval.
This approval marks China’s first fully independently developed anti-COVID-19 drug that has been proven effective through rigorous randomized, double-blind, placebo-controlled studies.
Professor Zhang Linqi said that the approval of the ambavirumab/romisevirumab combination therapy has brought China the first specific drug for the treatment of COVID-19. This combination therapy has demonstrated excellent safety and protection in international multi-center trials. It is the only antibody drug in the world that has evaluated the therapeutic effect of patients infected with variant strains and obtained optimal data.
In less than 20 months, Tsinghua University cooperated with Shenzhen Third People’s Hospital and Tengsheng Biopharmaceuticals to develop ambavirumab/romisevirumab combination therapy from the initial stage. The isolation and screening of neutralizing antibodies were rapidly advanced to the completion of international phase 3 clinical trials and finally obtained marketing approval in China.
This achievement is the result of joint efforts between China and world-class scientists and clinical researchers, including the U.S. National Institute of Allergy and Infectious Diseases under the National Institutes of Health, which supports the international clinical study of ACTIV-2. Institute of Disease Research and the AIDS Clinical Trials Group leading the ACTIV-2 clinical study.