艾美疫苗(06660.HK):mRNA呼吸道合胞病毒疫苗獲美國FDA批准開展臨牀其體液免疫、細胞免疫顯著高於國際上市產品
格隆匯2月26日丨艾美疫苗(06660.HK)公吿,集團按照既定公司戰略積極推進疫苗產品管線的開發,利用mRNA技術平台優勢,通過持續的技術創新,快速推進mRNA疫苗系列產品的研發,mRNA呼吸道合胞病毒疫苗已於近日獲得美國食品和藥品監督管理局(FDA)臨牀試驗許可。這也是集團的產品首次獲得美國FDA批准臨牀,標誌着集團的國際化戰略又邁出了重要一步。
臨牀前動物試驗中,第三方檢測單位的檢測結果顯示:集團mRNA呼吸道合胞病毒疫苗特異性IgG抗體滴度、真病毒中和抗體效價、特異性T細胞免疫,均顯著高於國際上市的mRNA呼吸道合胞病毒對照疫苗。
呼吸道合胞病毒是常見的呼吸道感染病原體,具有高度傳染性,在全球範圍內廣泛流行,呼吸道合胞病毒感染是導致一週歲以內嬰兒死亡的重要原因,也是造成老年人呼吸道感染死亡的重要因素。同時感染過呼吸道合胞病毒的人羣仍存在再次感染呼吸道合胞病毒的可能性。目前,全球尚無獲批的針對呼吸道合胞病毒可用於臨牀的抗病毒特效藥,接種疫苗進行主動免疫預防是避免呼吸道合胞病毒重症感染的有效手段。
集團是中國最早開發mRNA疫苗產品的企業之一,也是國內第一批取得mRNA技術自主專利的疫苗企業,具有成熟的mRNA疫苗研發體系。同時,集團已建立完善的mRNA疫苗質量管理體系和符合GMP標準的商業化規模生產車間,該mRNA技術平台上已經過上萬例mRNA疫苗產品的人體臨牀試驗數據驗證。集團現已打通mRNA疫苗研發、生產等全生命週期的流程,在完成臨牀後可迅速實現mRNA疫苗產品的產業化,加快疫苗產品的商業化進程。作為全球疫苗市場新的重磅大單品,該款產品上市後有望成為集團新的業績增長點。
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