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沃森生物(300142.SZ):九價HPV疫苗啟動III期臨牀試驗
格隆匯 09-07 18:50

格隆匯9月7日丨沃森生物(300142.SZ)公佈,由公司控股子公司上海澤潤生物科技有限公司(“上海澤潤”)自主研發的“重組人乳頭瘤病毒九價病毒樣顆粒疫苗(6、11、16、18、31、33、45、52、58型L1蛋白)(畢赤酵母)”(“九價HPV疫苗”),於近日正式啟動“重組人乳頭瘤病毒九價疫苗與Gardasil9免疫原性比較III期臨牀試驗”首例受試者入組,標誌着本疫苗正式進入III期臨牀研究階段。

本疫苗主要用於適齡女性預防由HPV16、18、31、33、45、52、58型感染引起的子宮頸癌、外陰癌、陰道癌、肛門癌和由HPV6、11型感染引起的生殖器疣,同時用於適齡男性預防由HPV16、18、31、33、45、52、58型感染導致的肛門癌和由HPV6、11型感染導致的生殖器疣。

上海澤潤研發的九價HPV疫苗於2016年11月申請臨牀試驗獲得受理,並於2018年1月獲得臨牀批件進入臨牀研究。本疫苗已完成了I期臨牀試驗,研究結果顯示具有良好的安全性和免疫原性。

目前,九價HPV疫苗全球僅有美國默沙東公司生產上市銷售。其他上市銷售的HPV疫苗產品還有雙價HPV疫苗和四價HPV疫苗。據公開數據顯示,2021年HPV疫苗全球銷售額合計已達到63億美元。

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