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2013年10月9日,世界卫生组织(WHO)在日内瓦正式宣布:由国药集团中国生物技术股份有限公司(以下简称国药中生)所属成都生物制品研究所有限责任公司(以下简称成都公司)生产的乙型脑炎减毒活疫苗(SA14-14-2)(以下简称乙脑活疫苗)通过WHO预认证。这是中国自主研发的疫苗首次通过WHO预认证,进入联合国采购机构的药品采购清单,实现了零的突破,在中国疫苗发展史上具有里程碑意义。《中国新药杂志》为此特别采访了国药中生杨晓明总裁、吴永林副总裁和成都公司葛永红总经理,请他们介绍了此次乙脑活疫苗通过WHO预认证的相关历程,以及对我国疫苗生产企业国际化进程带来的重要影响和重大意义。
On October 9, 2013, the World Health Organization (WHO) officially announced in Geneva that it was produced by Chengdu Institute of Biological Products Co., Ltd. (hereinafter referred to as Chengdu Company) affiliated to Sinopharm Group China Biotechnology Co., Ltd. (hereinafter referred to as Sinopharm) Of live attenuated JE vaccine (SA14-14-2) (hereinafter referred to as JE live vaccine) by WHO pre-certification. This is the first time that a vaccine researched and developed by China has passed pre-certification by WHO and entered into the drug purchasing list of the UN procurement agencies, achieving a zero breakthrough and a milestone in the history of vaccine development in China. For this reason, China New Drug Magazine specially interviewed the president of Sinopharm Yang Xiaoming, Vice President Wu Yonglin and General Manager Ge Yonghong of Chengdu Company and asked them about the relevant course of the pre-certification of Japanese encephalitis live vaccine through WHO as well as to the Chinese vaccine manufacturers The important influence and significance of the internationalization process.