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石藥集團(01093.HK):新型冠狀病毒mRNA疫苗“SYS6006”獲臨牀許可
格隆匯 04-03 19:21

格隆匯4月3日丨石藥集團(01093.HK)發佈公吿,集團開發的新型冠狀病毒mRNA疫苗“SYS6006”已獲中國家藥品監督管理局批准,可開展於中國的臨牀研究。SYS6006為集團針對新型冠狀病毒變異毒株自主研發的mRNA疫苗。

該產品根據毒株的流行情況進行鍼對性的抗原突變設計,臨牀前研究表明,該產品對包含Omicron和Delta在內的當前主流突變毒株具有良好的免疫保護效力;通過體液免疫和細胞免疫對機體提供免疫保護,並可產生記憶性B細胞,提供長效保護效力。此外,臨牀前安全性評價數據也充分證明了該產品的安全性。該產品使用先進的生產技術 ,工藝過程高度可控,批間一致性好,容易實現放大和產業化;而且穩定性好,可在2-8℃長期儲藏。集團對mRNA技術的關鍵生產原料和輔料實現了內化生產和國產化替代,可滿足大規模產能供應需求。

基於在安全性、有效性以及產業化方面的優勢,並根據疫情防控的需要,該產品被國家藥品監督管理局列入特別審批程序,快速批准進入臨牀。集團將全力以赴推進該產品的國內及國際多中心臨牀研究工作,力爭該產品儘快上市,為解決全球新冠疫情作出貢獻。

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