康泰生物(300601.SZ):三價流感病毒裂解疫苗(MDCK細胞)臨牀試驗申請獲得受理
格隆匯5月28日丨康泰生物(300601.SZ)公佈,公司今日收到國家藥品監督管理局簽發的受理通知書,同意受理公司和蘭州百靈生物技術有限公司研發的三價流感病毒裂解疫苗(MDCK細胞)的臨牀試驗申請。
本次申請臨牀試驗獲得受理的三價流感病毒裂解疫苗(MDCK細胞)適用於3週歲及以上人羣,可刺激機體產生抗流感病毒的免疫力,用於預防疫苗相關型別的流感病毒引起的流行性感冒。MDCK細胞具有易培養、增殖快、流感病毒易感等特徵,細胞基質流感疫苗通過在MDCK細胞中大規模培養流感病毒,可以實現生產產量更高、產品質量更穩定、生產成本更低的效果。
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