百克生物(688276.SH):帶狀皰疹減毒活疫苗上市許可申請獲批准
格隆匯1月31日丨百克生物(688276.SH)公佈,公司近日收到國家藥品監督管理局下發的帶狀皰疹減毒活疫苗的《藥品註冊證書》。規格:復溶後每瓶0.5ml。每1次人用劑量為0.5ml,含水痘-帶狀皰疹活病毒應不低於4.3lgPFU。
目前全球範圍內共有兩款帶狀皰疹疫苗上市,分別為默沙東的Zostavax以及葛蘭素史克的Shingrix。Zostavax由默沙東研製並於2006年5月獲FDA批准上市,是第一種常規推薦給老年人的帶狀皰疹減毒活疫苗;Shingrix由葛蘭素史克研發並於2017年10月獲FDA批准上市,是基因重組亞單位疫苗。中國地區僅有葛蘭素史克生產的Shingrix已上市銷售,該疫苗於2020年6月28日正式在中國上市銷售。
公司本次獲批的帶狀皰疹減毒活疫苗適用於40歲及以上成人。
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