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    Home > Medical News > Medical Research Articles > Kexing biological products class 1 new drug obtained new drug certificate

    Kexing biological products class 1 new drug obtained new drug certificate

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    Recently, Beijing Kexing Biological Products Co., Ltd independently developed a new class 1 preventive biological product, enterovirus 71 inactivated vaccine The production registration application was approved by the State Food and drug administration, and the new drug certificate and drug registration approval were obtained Hand foot mouth disease (HFMD) is an infectious disease caused by a variety of enteroviruses It is usually found in infants under 5 years old Since 2008, more than one million cases of HFMD have been reported every year in China, and more than 3000 deaths have been reported According to the Research Report of China CDC, the severe and death cases are mainly concentrated in children aged 6 months to 2 years, among which enterovirus 71 (EV71) is the main cause of severe and death cases of HFMD in China Therefore, Beijing Kexing Biological Products Co., Ltd began to develop EV71 vaccine since 2008 The preclinical study was completed in December 2009, and the clinical trial was approved in December 2010, becoming one of the first EV71 vaccines approved for clinical study in mainland China The phase III clinical trial was opened in March 2013 The clinical trial results of more than 10000 people showed that the protection rate of the vaccine against HFMD caused by EV71 could reach 94.6%, and the protection rate against HFMD caused by EV71 could reach 100% It is the only vaccine with the effect of severe protection observed In addition, the clinical results show that the vaccine is safe and effective, the production process is mature, and the product quality is stable Relevant research results have been published in the New England Journal of medicine, vaccine, infectious diseases and other international authoritative academic journals "The approval of yierlaifu from Beijing Kexing is an important milestone of the company's development After eight years of struggle, yierlaifu can finally be put into the market " Yin Weidong, managing director of Beijing Kexing Biological Products Co., Ltd., said excitedly and expressed heartfelt thanks for the support of relevant personnel and national institutions "Yierlaifu is the first innovative vaccine product developed and successfully approved by Beijing Kexing." Yin Weidong said that next, the company will cooperate with CDCs at all levels to observe the safety and immune effect of the vaccine in a larger population, so as to provide a scientific basis for promoting the wider use of the vaccine "Beijing Kexing will work closely with the government to contribute to the control and elimination of HFMD caused by EV71 virus." Yin Weidong said According to reports, yierlaifu is suitable for infants and young children aged 6-35 months The vaccination procedure is two injections with an interval of one month After obtaining the new drug certificate and production approval, it is expected to obtain the GMP certificate in early 2016 Once the GMP certificate is obtained, the company will immediately start production to provide high-quality vaccines to China and other countries in need as soon as possible.
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