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康希諾(688185.SH):13價肺炎球菌多糖結合疫苗(CRM197,TT載體)進入Ⅲ期臨牀試驗
格隆匯 04-13 16:33

格隆匯 4 月 13日丨康希諾(688185.SH)公佈,公司研發的13價肺炎球菌多糖結合疫苗(CRM197TT載體)(PCV13i)已完成III期臨牀試驗準備工作,正式進入III期臨牀試驗。

肺炎球菌性疾病是全球嚴重的公共衞生問題之一。肺炎鏈球菌是引起兒童肺炎、腦膜炎、菌血症等嚴重疾病的主要病原菌,也是引起急性中耳炎和鼻竇炎等的常見病因。在發達國家和地區,肺炎球菌多糖結合疫苗的引入和廣泛使用有效控制了肺炎球菌導致的嚴重疾病。但在非洲和亞洲地區,5歲以下兒童患病的數量和比例依舊較高。WHO建議全球各國均應將肺炎球菌多糖結合疫苗納入本國的兒童免疫接種規劃,尤其是兒童死亡率高的國家應引進多抗原肺炎球菌多糖結合疫苗作為國家免疫規劃中的高優先級項目。WHO預防和控制肺炎全球行動計劃(GAPP)中提出目標,2025年消滅可預防肺炎導致的兒童死亡引入肺炎球菌多糖結合疫苗是達成這一目標的主要手段。

公司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。

公司於20194月取得PCV13i的臨牀試驗申請批准,2020年年內完成臨牀I 期試驗。

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