The Institute of Microbiology at the Chinese Academy of Sciences announced on Saturday that its application for fully human monoclonal antibody clinical trials for COVID-19 has been approved by the National Medical Products Administration, marking China's domestically produced COVID-19 antibody medicine entering into a clinical evaluation phase.
The phase I clinical trial will test the safety and dosage of the neutralizing antibody among healthy people, and this is a clinical trial for the world-first neutralizing antibody treatment against COVID-19 among healthy people after non-human primate experiments.
A Beijing-based immunologist, who requested anonymity, told the Global Times that the trial marks a breakthrough in the treatment of COVID-19 around the world.
"Monoclonal antibodies are generally very rarely used in the treatment of infectious diseases. Antibodies are sometimes used in the treatment of diphtheria, tetanus, even Ebola, but they either are antiserum or the plasma from recovered patients, not monoclonal."
Many research teams in other countries have also been working on monoclonal antibodies of novel coronavirus, but few of them have entered into trials, he said.
The anonymous expert explained that monoclonal antibodies, unlike polyclonal antibodies, have their own unique structure and sequence in which the antibody binds to the antigen, and that uniqueness represents its intellectual property right.
"It is worth mentioning that this antibody drug has our own independent intellectual property rights of China as it indicates the monoclonal antibody is only unique to the research teams," he said.
On May 26, the Nature released research on antibodies of COVID-19 led by teams of experts from the Institute of Microbiology at the Chinese Academy of Sciences, Wuhan Virology Institute, some top hospitals in Beijing, pharmacy companies and China's Center for Disease Control and Prevention.
The Institute of Microbiology at the Chinese Academy of Sciences also said that the neutralizing antibodies have a promising future in clinical application and so far the process to industrializing it is smooth. "Once successfully being put into the market, it will make contributions to the global COVID-19 prevention."
However, the institute also stressed that there is still a long way to go between entering into clinical trials to finally making the antibodies a usable medicine.