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康泰生物(300601.SZ):二價腸道病毒滅活疫苗(Vero細胞)、四價腸道病毒滅活疫苗(Vero細胞)獲批臨牀試驗
格隆匯 02-07 16:22

格隆匯2月7日丨康泰生物(300601.SZ)公佈,公司全資子公司北京民海生物科技有限公司(以下簡稱“民海生物”)研發的二價腸道病毒滅活疫苗(Vero細胞)、四價腸道病毒滅活疫苗(Vero細胞)近日獲得國家藥品監督管理局出具的《藥物臨牀試驗批准通知書》,根據《中華人民共和國藥品管理法》《中華人民共和國疫苗管理法》及有關規定,經審查,上述兩種疫苗均符合藥品註冊的有關要求,同意進行臨牀試驗。

二價腸道病毒滅活疫苗(Vero細胞)適用於6月齡至71月齡EV-A71、CV-A16易感者,可刺激機體產生抗EV-A71、CV-A16的免疫力,用於預防腸道病毒EV-A71、CV-A16感染所致的手足口病等傳染病;四價腸道病毒滅活疫苗(Vero細胞)適用於6月齡至71月齡EV-A71、CV-A6、CV-A10、CV-A16易感者,可刺激機體產生抗EVA71、CV-A6、CV-A10、CV-A16的免疫力,用於預防腸道病毒EV-A71、CV-A6、CVA10、CV-A16感染所致的手足口病等傳染病。手足口病是由多種腸道病毒感染引起的一種兒童常見傳染病,目前尚無針對腸道病毒感染的特效藥物,接種疫苗是預防手足口病及其大爆發最有效和最經濟的措施。

目前全球尚無二價腸道病毒滅活疫苗(Vero細胞)、四價腸道病毒滅活疫苗(Vero細胞)獲批上市。

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