Boya biological declared clinical class 1 biological products for treatment of HFMD (EV71) human immunoglobulin accepted

According to the information on July 2 on the website of the State Food and Drug Administration (CFDA), the human immunoglobulin of class 1 therapeutic biological product hand foot mouth disease (EV71) declared by Boya biology has been accepted At present, there is no such product on the market in China HFMD is a worldwide infectious disease, which occurs in most parts of the world EV71 is the abbreviation of enterovirus 71, which is one of the main pathogens of HFMD in infants In recent years, the epidemic mostly occurred in Asia, so far, there is no effective vaccine on the market, but anti EV71 high-efficient plasma can be directly screened from the blood plasma donors of HFMD infected naturally to prepare human immunoglobulin In China, the particularity of the source and the national supervision result in the scarcity of human immunoglobulin raw materials for HFMD (EV71); limited by the high-efficient plasma source, it is difficult to carry out large-scale production and clinical application in a short period of time At present, there is no domestic enterprise to produce the product, and Boya biology is the first one to declare in China In the field of HFMD, domestic manufacturers have begun to layout, but all focus on vaccines, including Vero cell, which was declared by Hualan biology in February last year, and the HFMD (enterovirus 71, EV71) inactivated vaccine approved by Beijing Weigu biomedical Co., Ltd., which is controlled by China Life Group and invested by Tiantan biology, by the end of 2010.