成大生物(688739.SH):十五價HPV疫苗獲批開展臨牀試驗
格隆匯3月15日丨成大生物(688739.SH)公佈,近日,公司合作開發的重組十五價人乳頭瘤病毒疫苗(大腸埃希菌)收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》(通知書編號:2022LP00449),批准重組十五價人乳頭瘤病毒疫苗(大腸埃希菌)(“十五價HPV疫苗”)開展臨牀試驗。
公司合作研發的十五價HPV疫苗經過篩選目標血清型優勢基因序列,構建目標血清型的工程菌株,開發檢測試劑盒並優化蛋白純化工藝,可以預防全部高危型HPV病毒和與尖鋭濕疣高相關的HPV6/11型的疫苗。用於預防相應型別的持續感染及由此引起的宮頸癌、外陰癌、陰道癌、肛門癌和尖鋭濕疣以及CIN1/2/3、宮頸原位腺癌、VIN2/3、VaIN2/3、AIN1/2/3等相關疾病,對宮頸癌的預防效果達到96%以上。
宮頸癌是女性第二大惡性腫瘤,人乳頭瘤病毒(HPV)與宮頸癌具有直接的相關性。此次獲得重組十五價人乳頭瘤病毒疫苗(大腸埃希菌)的臨牀試驗批准通知書,表明公司在十五價HPV疫苗領域的研發取得新進展。
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