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沃森生物(300142.SZ):呼吸道合胞病毒mRNA疫苗臨牀研究申請獲得受理
格隆匯 08-03 16:18

格隆匯8月3日丨沃森生物(300142.SZ)公吿,由雲南沃森生物技術股份有限公司(以下簡稱“公司”或沃森生物)、復旦大學、上海藍鵲生物醫藥有限公司(以下簡稱“藍鵲生物”)及公司子公司玉溪沃森生物技術有限公司、北京沃森創新生物技術有限公司聯合研發的呼吸道合胞病毒mRNA疫苗(以下簡稱“本疫苗”)向國家藥品監督管理局申請臨牀試驗,並於近日獲得《受理通知書》。

目前,國外已有3款呼吸道合胞病毒疫苗獲批上市,分別為GSK的Arexvy(重組蛋白疫苗)、輝瑞的Abrysvo(重組蛋白疫苗)和Moderna的mRESVIA(mRNA1345,mRNA疫苗),國內尚無呼吸道合胞病毒疫苗批准上市。2023-2024年度,RSV疫苗全球銷售額約為40億美元。

根據國家藥品註冊的相關法規,本疫苗申請臨牀試驗獲得受理後,將由國家藥品監督管理局藥品審評單位進行技術審評,需經批准後方可開展臨牀試驗,期間審評和審批的結果具有一定的不確定性。本疫苗申請臨牀試驗獲得受理對公司本年度的經營業績不會產生重大影響。敬請廣大投資者謹慎決策,注意投資風險。

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