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New drug for prevention! Chinese biologic anti-neocon monoclonal antibody F61 nasal spray approved for clinical use, effective in reducing the positive switch rate in the close contact population

2022/11/29 17:10:18 Views:677

Original from: Genomeweb


On November 28th China Biologics public release said that the company's anti-neoconazole monoclonal antibody F61 nasal spray developed by the company was approved for clinical use.


It is reported that on November 25, the recombinant fully human-derived anti-neoconavirus monoclonal antibody nasal spray (F61 nasal spray) from Wuhan Institute of Biological Products of China National Pharmaceutical Group was approved by the State Drug Administration for clinical trials for the prevention of people with high risk of exposure to neoconavirus.


The recombinant fully human-derived broad-spectrum neocoronavirus monoclonal antibody ("monoclonal antibody F61") was developed by Yang Xiaoming's team and Liang Mi Fang's team at the Institute of Prevention and Control of Viral Diseases of the Chinese Center for Disease Control and Prevention, using peripheral blood mononuclear cells (PBMC) from patients recovered from neocoronavirus as raw material. The F61 monoclonal antibody has a broad spectrum of neutralizing activity against SARS-CoV-2 prototype strain and major variants, especially against Omicron BA.1, BA.1 .1, BA.2, BA.3, BA.4/5 and BF.7, which are the main variants of the current epidemic.


On July 22, the recombinant fully human-derived broad-spectrum neo-coronavirus monoclonal antibody injection (F61) declared by Wuhan Institute of Biological Products of Sinopharm Group was granted clinical trial approval by the State Drug Administration, and the study of F61 nasal spray was promoted simultaneously.


The phase I clinical trial of F61 injection was started on July 29, 2022 at Shulan Hospital (Hangzhou) and has been basically completed. The results show that F61 injection has good safety and the maximum tolerated dose (MTD) can reach 3000mg/person, and the phase II clinical trial has been successfully started.


F61 nasal spray adopts the same production process and formulation prescription as F61 injection, and has broad spectrum and high neutralizing activity against all variants of New Coronavirus.


F61 nasal spray is easy to use and acts directly on the upper respiratory tract of the nasopharynx, forming a protective film on the nasal mucosa.


This protective film prevents the neo-coronavirus from binding to host cells when it invades, specifically blocking neo-coronavirus invasion.


In previous real-world studies, it was safe and effective after use in post-neoconavirus exposure populations in many parts of the country, and could effectively reduce the positive turnover rate in the close-knit population.


Currently, the epidemiological situation of NCCV is still severe at home and abroad, and there is an urgent need for effective epidemic prevention and control products.


The F61 nasal spray is a product with independent intellectual property rights that can be used for the prevention of people with high risk of exposure to the new coronavirus and protect people's life and health.


Source: New drug for prevention! Chinese biologic anti-neocon monoclonal antibody F61 nasal spray approved for clinical use, effective in reducing the positive switch rate in the close contact population