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艾美疫苗(06660.HK):迭代升級肺炎疫苗產品佈局完成,系列產品研發全面推進
格隆匯 03-04 07:45

格隆匯3月4日丨艾美疫苗(06660.HK)發佈公吿,集團按照既定公司戰略積極推進疫苗產品管線的開發,通過持續的技術創新,快速推進迭代升級肺炎疫苗系列產品的研發,加快實現新質生產力。集團利用多糖結合疫苗技術平台優勢,開發了一系列肺炎疫苗產品,其中:1、13價肺炎結合疫苗已完成III期臨牀試驗的現場工作,並已提交申報上市預申請;2、23價肺炎多糖疫苗也已完成III期臨牀試驗,預計於2024年內申請註冊上市;3、20價肺炎結合疫苗已提交臨牀試驗預申請;4、全球同步首研的24價肺炎結合疫苗已完成臨牀前研究工作。

根據世界衞生組織分級,肺炎鏈球菌性疾病為需“極高度優先”使用疫苗預防的疾病之一。美國獲批的13價肺炎結合疫苗覆蓋全年齡段,而中國獲批的僅覆蓋6週歲以下,6歲以上人羣市場處於空白狀態,行業顧問灼識諮詢預計2030年中國該市場規模有望超過200億元,市場潛力巨大。此外,13價肺炎結合疫苗在中國獲批年齡組的滲透率預估為25.9%,而美國相應年齡組滲透率超過80%,仍然具有較大市場空間。

據推測,全球13價肺炎結合疫苗缺口高達1.8億劑,但目前全球僅三家企業獲批供應,集團13價肺炎結合疫苗上市之後,集團有望成為重要供應商。

集團肺炎系列疫苗GMP車間已分批建設完成,滿足國際化標準,13價肺炎結合疫苗、23價肺炎多糖疫苗的III期臨牀樣品均在上述車間生產。上述迭代肺炎疫苗系列產品上市後,將能充分滿足肺炎疫苗的市場需求,實現行業新質生產力,引領國際產業創新。

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