智飛生物(300122.SZ):23價肺炎球菌多糖疫苗申請生產註冊獲得受理
格隆匯3月16日丨智飛生物(300122.SZ)公佈,公司近日獲悉由公司全資子公司北京智飛綠竹生物製藥有限公司(“智飛綠竹”)研發的23價肺炎球菌多糖疫苗申請生產註冊獲得國家藥品監督管理局出具的《受理通知書》(受理號:CXSS2200028 國)。
肺炎鏈球菌是導致各年齡組人羣社區獲得性肺炎的最重要病原菌,同時也是引起中耳炎、肺炎、腦膜炎和菌血症的主要病原菌。據世界衞生組織統計,全球每年有超過120萬人死於肺炎鏈球菌感染,其中大多數發生在發展中國家。預防肺炎球菌感染的疫苗分為多糖疫苗和結合疫苗2種,其中23價肺炎球菌多糖疫苗用於2歲以上適宜人羣預防肺炎球菌引起的感染性疾病,是國內外預防肺炎球菌感染的最主要產品之一。
目前國內外已有23價肺炎球菌多糖疫苗產品上市,若項目進展順利,將進一步發揮公司肺炎疫苗矩陣優勢,完善產品梯隊,對未來經營、研發創新、長期可持續發展產生一定積極影響。
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