The world's first EV71 vaccine of HFMD independently developed has obtained new drug certificate

Source: Beijing Municipal Commission of science and technology, 2016-1-12 recently, the application for the production registration of enterovirus 71 inactivated vaccine, a class 1 new biological product for prevention independently developed by Beijing Kexing Biological Products Co., Ltd., was approved by the State Food and drug administration, and obtained the new drug certificate and production approval Hand, foot and mouth disease (HFMD) is an acute infectious disease that seriously endangers children under 5 years old in China Since it was incorporated into the national epidemic reporting system in 2008, more than 1 million HFMD cases have been reported every year By the end of 2015, nearly 14 million HFMD cases have been reported in China, and 3300 infant deaths have been reported In many cases, the incidence rate ranks first in the notifiable infectious diseases The fatality rate ranks the first five, which has a great impact on social stability and economic development The protection rate of the vaccine for HFMD caused by EV71 is 94.6%, and for HFMD caused by EV71 is 100% The clinical results show that the vaccine is safe, effective, mature in production process, stable in product quality, and is at the international leading level At present, Beijing Kexing new vaccine industrial base has been built in Changping Science and Technology Park, with an annual design capacity of 20 million pieces (10 million people) The successful development and industrialization of EV71 vaccine will greatly alleviate the epidemic situation of HFMD in China After 2009 influenza A (H1N1) vaccine, EV71 vaccine has become another vaccine product that is the first to be listed in the world and to respond to major new infectious diseases, creating conditions for the vaccine to enter the international market.