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艾美疫苗(06660.HK):mRNA呼吸道合胞病毒(RSV)疫苗獲得臨牀試驗許可
格隆匯 10-30 06:21

格隆匯10月30日丨艾美疫苗(06660.HK)發佈公吿,集團控股子公司珠海麗凡達生物技術有限公司研發的mRNA呼吸道合胞病毒(RSV)疫苗已於近日獲得國家藥品監督管理局出具的《藥物臨牀試驗批准通知書》,標誌着該疫苗的研發進入了新的階段。

RSV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,RSV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RSV的人羣仍存在再次感染RSV的可能性。目前,全球尚無獲批的針對RSV可用於臨牀的抗病毒特效藥,對RSV的預防成為抵禦其健康威脅的重要策略,接種疫苗進行主動免疫預防是避免RSV重症感染的有效手段,中國尚無RSV疫苗獲批上市,全球現有葛蘭素史克和輝瑞兩家公司的RSV疫苗上市銷售。2023年度,RSV疫苗的全球銷售額為24.6億美元。根據行業顧問灼識諮詢預測,預計到2030年,RSV疫苗在全球的市場規模將達到約167億美元,市場空間極其廣闊。

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,已開發了數款mRNA候選疫苗(包括但不限於mRNA狂犬疫苗、mRNARSV疫苗、mRNA帶狀皰疹疫苗等),並已建立了完善的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,在mRNA技術平台上生產的疫苗也已經過臨牀試驗驗證。集團現已打通mRNA疫苗研發、生產等全生命週期的流程,在完成臨牀試驗後可以迅速實現mRNA疫苗產品的產業化,加快疫苗產品的商業化進程。集團將加速推進mRNA呼吸道合胞病毒(RSV)疫苗的臨牀試驗。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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