The combined treatment scheme of monoclonal neutralizing antibody Ambavamab/Romisvirmab developed by Professor Zhang, professor of Tsinghua University Medical College and director of Tsinghua University Global Center for Health and Infectious Diseases AIDS, was approved by China Drug Administration on February 8th.
It can be used to treat mild and common patients with novel coronavirus infection (coronavirus pneumonia-19) in adults and adolescents (17 years old, weight ≥40kg) accompanied by high-risk factors of progression to severe illness (including hospitalization or death). Among them, adolescents with indications (12-17 years old and weighing ≥40kg) are conditionally approved.
This approval indicates that China has the first self-developed anti-COVID-19 specific drug, which has been proved to be effective through strict randomized, double-blind and placebo-controlled studies.
Professor Zhang said that the approval of the combination therapy of Ambroxumab and Romizumab brought China the first specific drug for COVID-19. This combination therapy has shown excellent safety and protection in international multi-center trials, and it is the only antibody drug in the world to evaluate the therapeutic effect of mutant infected people and obtain the best data so far.
In less than 20 months, Tsinghua University cooperated with Shenzhen Third People's Hospital and Tengshengbo Pharmaceutical Co., Ltd., from the initial isolation and screening of neutralizing antibodies to the completion of international phase III clinical trials, and rapidly promoted the combination treatment of Ambavirumab/Romisimab, and finally obtained the listing license in China.
This achievement is the result of China's joint efforts with world-class scientists and clinical researchers, including the National Institute of Allergy and Infectious Diseases under the National Institutes of Health, which supports the international clinical research of ACTIV-2, and the AIDS clinical trial team leading the clinical research of ACTIV-2.