康泰生物(300601.SZ):收到Sabin株脊髓灰質炎滅活疫苗(Vero細胞)Ⅲ期臨牀試驗總結報吿
格隆匯11月22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(簡稱“民海生物”)近日收到《Sabin株脊髓灰質炎滅活疫苗(Vero細胞)Ⅲ期臨牀試驗總結報吿》,民海生物研發的Sabin株脊髓灰質炎滅活疫苗(Vero細胞)臨牀研究階段工作順利完成。
研究結果顯示,民海生物研製的Sabin株脊髓灰質炎滅活疫苗(Vero細胞)具有良好的安全性和免疫原性。該次臨牀試驗總結報吿的取得表明Sabin株脊髓灰質炎滅活疫苗(Vero細胞)具備了申報生產的必備條件,對公司的發展具有重要的意義。
Sabin株脊髓灰質炎滅活疫苗(Vero細胞)用於預防脊髓灰質炎病毒所引起的急性傳染病,接種Sabin株脊髓灰質炎滅活疫苗(Vero細胞)後,可刺激機體產生抗脊髓灰質炎病毒的免疫力,用於預防由脊髓灰質炎Ⅰ型、Ⅱ型和Ⅲ型病毒感染導致的脊髓灰質炎。
經查詢國家藥監局網站,目前國內已上市Sabin株脊髓灰質炎滅活疫苗(Vero細胞)的廠家包括北京科興生物製品有限公司、北京生物製品研究所有限責任公司、中國醫學科學院醫學生物學研究所。
公司表示,該次臨牀試驗總結報吿的取得表明Sabin株脊髓灰質炎滅活疫苗(Vero細胞)具備了申報生產的必備條件。若該產品註冊成功,將進一步豐富公司的產品梯隊,增強公司的核心競爭力,強化公司的市場地位。
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