(Reporter Zhang Hang) A reporter learned from the Municipal Science and Technology Commission yesterday that a new human coronavirus monoclonal antibody developed by Yan Jinghua, a researcher of the Institute of Microbiology, Chinese Academy of Sciences, has been approved by the State Food and Drug Administration for clinical trials. Phase I clinical trials will conduct dose exploration and safety verification in healthy people. This is the first therapeutic antibody drug approved for clinical trials of new coronary pneumonia in China. It is also the world's first clinical trial of therapeutic antibodies for new coronary pneumonia in healthy people after the completion of non-human primate experiments.
According to reports, since the outbreak of the New Coronary Pneumonia, the Institute of Microbiology of the Chinese Academy of Sciences has established a number of anti-epidemic research teams to overcome difficulties. At the same time, the Beijing Municipal Science and Technology Commission actively coordinated resources and set up rapid scientific research projects. Relying on the animal model platform of the Laboratory Animal Institute of the Chinese Academy of Medical Sciences, it supported and promoted the animal experiments of the Institute of Microbiology.
The team of Yan Jinghua isolated and identified dozens of fully human antibody genes from patients with new coronary pneumonia who were discharged from hospital. After repeated trials and comparisons, two antibodies with high efficiency of neutralizing new coronavirus were screened in late February. The new monkey coronavirus infection model evaluated the effectiveness of the antibody. The results showed that the neutralizing antibody effectively blocked the infection of the new coronavirus, significantly reduced the load of the new coronavirus in the respiratory tract of rhesus monkeys, and protected the virus infection Caused lung damage. The results of animal experiments provide a positive prospect for the further development of new coronary pneumonia therapeutic antibody drugs.
The approval of the antibody drug for clinical trials indicates that antibody drugs with independent intellectual property rights have taken a key step in curbing the further spread of new coronaviruses, and provided a Chinese plan for maintaining global public health safety. However, there is still a long way to go from entering human clinical trials to the final listing of antibody drugs.
According to the introduction of the Municipal Science and Technology Commission, Beijing has deployed 21 scientific and technological breakthrough projects for the first time since the outbreak. At present, 4 new coronary pneumonia diagnostic reagents have been approved for marketing in Beijing, and 3 new coronary pneumonia vaccines have entered the phase II clinical trial.