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沃森生物(300142.SZ):子公司雙價HPV疫苗獲得藥品註冊證書
格隆匯 03-28 17:18

格隆匯3月28日丨沃森生物(300142.SZ)公佈,公司於2022年3月28日收到控股子公司上海澤潤生物科技有限公司的全資子公司澤潤生物的通知,澤潤生物於近日收到由國家藥品監督管理局批准頒發的雙價人乳頭瘤病毒疫苗(畢赤酵母)(以下簡稱“雙價HPV疫苗”)的《藥品註冊證書》。經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。

澤潤生物雙價HPV疫苗的開發歷經十七年。該疫苗於2011年6月獲得國家食品藥品監督管理總局頒發的《藥物臨牀試驗批件》。臨牀試驗工作歷時九年,該疫苗通過了樣本量為12000例的隨機、雙盲、多中心的保護效力臨牀試驗的確證,2020年6月申請新藥上市許可獲得《受理通知書》,2021年7月正式納入優先審評審批品種,2022年3月22日獲得國家藥品監督管理局簽發的《藥品註冊證書》。

澤潤生物的雙價HPV疫苗研發過程中多次獲得國家科技部“重大新藥創制”專項支持、上海市科委“科技創新行動計劃”重點項目支持;2015年,該項目還獲得比爾及梅琳達·蓋茨基金會專項資金資助。

澤潤生物研發的雙價HPV疫苗適用於預防女性因高危型HPV16、18型所致的宮頸癌等疾病。目前,全球已上市銷售的HPV疫苗包括美國默沙東的四價HPV疫苗和九價HPV疫苗、英國葛蘭素史克的雙價HPV疫苗以及廈門萬泰的雙價HPV疫苗。根據上述公司的年報,2021年上述HPV疫苗全球銷售額合計約63億美元。

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