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石藥集團(01093.HK):呼吸道合胞病毒mRNA疫苗(SYS6016)獲臨牀試驗批准
格隆匯 07-11 17:23

格隆匯7月11日丨石藥集團(01093.HK)發佈公吿,集團開發的呼吸道合胞病毒(RSV)mRNA疫苗(SYS6016)(“該產品”)已獲得中國國家藥品監督管理局批准,可以在中國開展臨牀試驗。

根據披露,該產品由編碼呼吸道合胞病毒全長融合糖蛋白(F蛋白)融合前構象的mRNA分子包裹於脂質納米顆粒所構成,適用於預防由RSV感染引起的下呼吸道疾病。臨牀前研究顯示,該產品在體內翻譯為融合前構象F蛋白並誘導高滴度且持久的中和抗體,對RSV-A和RSV-B亞型病毒株均具有較好的保護作用,且具有良好的安全性。

RSV可以引起全年齡段人羣的呼吸道感染,尤其是對於兒童、老年人,以及存在免疫缺陷或者合併基礎疾病的成年人,更可能出現重症感染,以及呼吸系統後遺症,甚至死亡等嚴重影響,對人類生命健康和社會造成巨大負擔。目前國內尚無針對RSV感染的疫苗上市,該產品的研發進展在國內屬於第一梯隊。集團將全力以赴推進該產品的臨牀研究工作,力爭該產品儘快上市,為社會和股東創造出價值。

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