On November 25, 2022, Sinopharm Group's China Biologics Wuhan Institute of Biological Products Recombinant full-human anti-new coronavirus monoclonal antibody nasal spray (F61 nasal spray) was obtained from the National Drug Administration's clinical trial approval document for the prevention of people with high exposure to the new coronavirus.
The clinical approval of this F61 nasal spray is of great significance and is an important weapon in dealing with the Omickron epidemic.
■ Monoantab F61
recombinant full-human broad-spectrum novel coronavirus monoclonal antibody (referred to as "monoantab F61") was developed by the team of researcher Yang Xiaoming of China Biologics and the team of researcher Liang Mifang of Viral Disease Prevention and Control Institute of Chinese Center for Disease Control and Prevention. It uses peripheral blood mononuclear cells (PBMCs) of patients recovered from COVID-19 as raw material, and uses phage display technology screening. F61 monoantab has broad-spectrum anti-coronavirus neutralization activity against SARS-CoV-2 prototype strain and main variant strains, especially for the currently prevalent major variant strains Omicron BA.1, BA.1.1, BA.2, BA.3, BA.4/5, BF.7, etc., all maintain high school and activity.
On July 22 this year, the recombinant full-human broad-spectrum novel coronavirus monoclonal antibody injection (F61) submitted by Sinopharm Group China Biologics Wuhan Institute of Biology and Technology obtained the approval of the clinical trial of the State Drug Administration, and the research on F61 nasal spray was simultaneously promoted. The Phase I clinical trial of
F61 injection was launched at Shulan Hospital (Hangzhou) on July 29, 2022. It has been basically completed. The results show that the Phase II clinical trial is good, with a maximum tolerant metering (MTD) of 3000mg/person.
■ F61 nasal spray
F61 nasal spray adopts a stock solution production process and preparation prescription consistent with F61 injection, and has broad spectrum, high school and activity for all variant strains of the new coronavirus. F61 nasal spray is easy to use and can directly act on the upper respiratory tract of the nasopharyngeal area, forming a protective film on the nasal mucosa . When the new coronavirus invades, this protective film can prevent it from binding to the host cell and specifically block the invasion of the new coronavirus. In previous studies, it was safe and effective for people who were exposed to the new coronavirus in many places across the country after it was exposed, which can effectively reduce the positive rate of close contacts.
At present, the epidemic situation of the new crown epidemic at home and abroad is still severe, and there is an urgent need for effective epidemic prevention and control products. The F61 nasal spray for preventive purposes is , which has independent intellectual property rights in my country and can be used for prevention of people with high exposure risks to the new coronavirus, and protects people's lives and health.
Source: China Biologics
