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沃森生物(300142.SZ):13價肺炎球菌多糖結合疫苗獲批上市
格隆匯 12-31 18:15

格隆匯12月31日丨沃森生物(300142.SZ)公佈,2019年12月31日,國家藥品監督管理局官網藥品監管要聞欄目發佈:國家藥品監督管理局已於近日批准公司子公司玉溪沃森生物技術有限公司申報的13價肺炎球菌多糖結合疫苗上市註冊申請。要聞內容如下:

“近日,國家藥品監督管理局批准玉溪沃森生物技術有限公司申報的13價肺炎球菌多糖結合疫苗(以下簡稱13價肺炎結合疫苗)上市註冊申請。該疫苗主要用於6周齡至5歲(6週歲生日前)嬰幼兒和兒童,預防肺炎球菌1型、3型等13種血清型肺炎球菌引起的侵襲性疾病。

肺炎球菌疾病是導致5歲以下兒童發病和死亡的主要原因。世界衞生組織將兒童肺炎球菌疾病列為需高度優先使用疫苗預防的疾病,並推薦使用13價肺炎結合疫苗進行接種。2018年,我國新生兒數量超過1500萬,對該疫苗有着巨大的臨牀需求。

目前,全球已上市的13價肺炎球菌結合疫苗僅美國輝瑞(惠氏)公司生產。2016年該疫苗獲批進入我國,是之前國內預防小年齡羣嬰幼兒肺炎的唯一疫苗。此次批准的13價肺炎球菌多糖結合疫苗是我國首個自主研發生產的國產疫苗,同時也是全球第二個產品。

國家藥監局深入貫徹落實國務院常務會議精神,在加快臨牀急需境外新藥進口審批的同時,積極鼓勵和支持國產企業研發申報,並通過採取早期介入、全程指導、優化程序、及時跟進等方式,加快推進國產疫苗註冊上市。此次13價肺炎結合疫苗的上市,將提高該類疫苗的可及性,更好地滿足公眾需求,為保護嬰幼兒健康、預防相應血清型肺炎球菌引起的侵襲性疾病發揮重要作用。”

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