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艾美疫苗(06660.HK)完成迭代升級肺炎及狂犬疫苗產品佈局 3款疫苗料今年申報上市
阿思達克 03-04 09:00
艾美疫苗(06660.HK)公布,集團研發的13價肺炎結合疫苗、無血清迭代狂犬疫苗、23價肺炎多糖疫苗,均已完成III期臨床試驗的現場工作,正在開展新藥申報上市前的各項準備工作,計劃今年完成申報上市。集團已完成上述三款疫苗的生產車間建設,並在已建成的生產車間內完成III期臨床試驗樣品的生產。 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,開發一系列肺炎疫苗產品,其中13價肺炎結合疫苗已完成III期臨床試驗的現場工作,並已提交申報上市預申請;23價肺炎多糖疫苗也已完成III期臨床試驗,預計於今年內申請註冊上市;20價肺炎結合疫苗已提交臨床試驗預申請;全球同步首研的24價肺炎結合疫苗已完成臨床前研究工作。 同時,集團亦加速開發迭代升級狂犬疫苗系列產品,其中無血清迭代狂犬疫苗III期臨床試驗的現場工作已完成,正在開展新藥申報上市前的各項準備工作,計劃於今年完成申報上市;新型工藝人二倍體狂犬疫苗預計將於今年上半年提交臨床試驗預申請;mRNA迭代狂犬疫苗是國內受理的第一款非新冠mRNA疫苗產品。集團已建設完成具備生產能力且滿足國際化標準的無血清迭代狂犬病疫苗車間和新型工藝人二倍體狂犬病疫苗車間,並正在進行設備調試和驗證工作。
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