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智飛生物(300122.SZ):收到凍乾重組結核疫苗Ⅰa期臨牀試驗總結報告
格隆匯 12-26 21:36

格隆匯12月26日丨智飛生物(300122.SZ)公佈,公司近日接到公司全資子公司安徽智飛龍科馬生物製藥有限公司的上報,獲悉其研發的凍乾重組結核疫苗(AEC/BC02)獲得了Ⅰa期臨牀人體耐受性臨牀試驗報告。

疫苗名稱:凍乾重組結核疫苗(AEC/BC02);註冊分類:預防用生物製品1類(未在國內外上市銷售的疫苗);劑型:注射劑;適應症:用於預防結核分枝桿菌潛伏感染人羣結核病發病;臨牀批件號:2015L00704;研究方法:單中心、開放性研究設計;研究參與單位:上海市公共衞生臨牀中心。

凍乾重組結核疫苗(AEC/BC02)擬用於結核桿菌潛伏感染人羣預防發生結核病,屬於預防用生物製品1類。經查詢,截至公告披露日,國內外尚無同類產品上市。

已完成的結果表明,“凍乾重組結核疫苗(AEC/BC02)”在符合該臨牀試驗方案的人羣中安全性和耐受性良好,可繼續開展下一步臨牀試驗。公司目前正積極籌備該品後續的臨牀研究工作,將根據進展情況及時履行信息披露義務。

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