Chinese drugmaker Sinopharm said on Monday it has obtained approval to conduct clinical trials of an inhaled monoclonal antibody against the novel coronavirus, a potentially significant weapon against the dominant Omicron variant.
China National Biotech Group, a subsidiary of Sinopharm, received authorization from the National Medical Products Administration on Friday to test a nasal spray utilizing a monoclonal antibody, F61, as a preventive therapy for personnel at high risk of exposure to the virus, according to a statement released by the company.
F61 has demonstrated wide-spectrum neutralizing activities against the original virus and its major strains, including dominant variants in circulation, such as Omicron BA.1, BA.1 .1, BA.2, BA.3, BA.4/5 and BF.7, it said.
An injection version of F61 was approved for human trials on July 22. The first phase of the trial, initiated in Hangzhou on July 28, is near completion, and results have shown a good safety record.
The F61 inhaled spray is easier to use and is expected to trigger protection along nasal mucosa, the first line of defense against respiratory pathogens like the novel coronavirus.
It added the drug candidate has been shown to be safe and effective in real-world studies, and can reduce the rate of infection among close contacts.