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沃森生物(300142.SZ):二價HPV疫苗臨牀研究Ⅲ期臨試數據揭盲 進入統計分析與臨牀研究總結階段
格隆匯 01-17 17:20

格隆匯1月17日丨沃森生物(300142.SZ)公佈,公司子公司上海澤潤自主研發的重組人乳頭瘤病毒雙價(16/18型)疫苗(酵母)(下稱“二價HPV疫苗”或“本疫苗”)臨牀研究完成Ⅲ期臨牀試驗數據揭盲工作,並進入臨牀試驗數據統計分析與臨牀研究總結階段。

上海澤潤研發的二價HPV疫苗主要用於適齡女性預防由HPV16、18型感染引起的子宮頸癌。HPV疫苗是全球最暢銷的疫苗之一。目前,全球已上市銷售的HPV疫苗包括GSK的二價HPV疫苗、默沙東公司的四價HPV疫苗和九價HPV疫苗。根據上述兩家公司的年報,2018年HPV系列疫苗全球銷售額合計達33.2億美元。國內僅有一個廠家的二價HPV疫苗於近期獲得藥品註冊批件。

公司立項研發HPV疫苗歷經10餘年。其中,自主研發的二價HPV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》(批件號:2011L01085);自主研發的九價HPV疫苗也於2018年1月獲得了《藥物臨牀試驗批件》(批件號:2017L05282),目前處於臨牀研究階段。

隨着公司該二價HPV疫苗Ⅲ期臨牀試驗揭盲,標誌着其臨牀研究工作已進入最後的總結階段。根據國家藥品註冊管理的相關法規,本疫苗產品臨牀研究工作完成後,申報主體在獲得疫苗臨牀研究總結報告後即可向國家藥品監督管理局申請藥品生產註冊批件。在提交申請藥品生產註冊批件申報材料後,還需在技術審評、臨牀試驗數據現場核查、生產現場檢查等程序通過後,方能獲得藥品註冊批件。

本疫苗臨牀研究工作進入統計分析與臨牀研究總結階段,對公司近期業績尚不會產生重大影響。本疫苗獲得臨牀研究總結報告的進度以及藥品審評審批的時間進度尚存在一定的不確定性。

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