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康希諾(688185.SH):13價肺炎球菌多糖結合疫苗(CRM197/破傷風類毒素)獲得藥品註冊證書
格隆匯 06-20 16:04

格隆匯6月20日丨康希諾(688185.SH)公佈,公司已獲得國家藥品監督管理局下發的13價肺炎球菌多糖結合疫苗(CRM197/破傷風類毒素)(簡稱“PCV13i”)《藥品註冊證書》,公司的PCV13i採用多糖抗原與蛋白載體共價結合的方式,多糖抗原連接載體蛋白後,多糖可以轉化為T細胞依賴性抗原,不僅可以在2歲以下嬰幼兒體內誘導出很高的特異性抗體水平,還可以產生記憶性B細胞,產生免疫記憶。同時,公司採用雙載體技術,可減少與其他疫苗共注射時對免疫原性造成的免疫抑制。

在生產工藝上,公司採用了更加安全的生產工藝,發酵培養基採用無動物來源培養基,降低了動物源生物因子造成的風險,且避免了傳統純化工藝採用苯酚方法帶來的毒性殘留。

PCV13i為公司肺炎產品組合中首個獲得藥品註冊證書的產品,為公司更高價肺炎結合疫苗的研發奠定基礎。同時,因與公司目前的主要商業化產品四價流腦結合疫苗曼海欣®同樣定位為高端自費疫苗,目標消費人羣重合,該產品的上市有利於公司豐富商業化產品品種,並提升營銷效率。待後續形成銷售訂單,將對公司業績產生積極影響。

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