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康希諾生物(06185.HK)13價肺炎疫苗達到臨床終點
阿思達克 01-31 09:02
康希諾生物(06185.HK)公布,公司開發的13價肺炎球菌多糖結合疫苗(CRM197,TT載體)(PCV13i)於近日獲得III期臨床試驗總結報告。 報告顯示,根據目前已獲得的數據,該疫苗具有良好的安全性和免疫原性,臨床研究在目標人群中已達到預設的臨床終點。是次臨床試驗總結報告的取得表明PCV13i具備了向國家藥品監督管理局(NMPA)遞交藥品生產註冊申請的必要條件,此後還需經過技術審評、臨床試驗現場核查、生產現場檢查等程序,待獲得藥品註冊批件且產品獲得批簽發後方可上市銷售。
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