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萬泰生物(603392.SH):子公司雙價人乳頭瘤病毒疫苗獲藥品補充申請批准通知書
格隆匯 07-23 17:47

格隆匯7月23日丨萬泰生物(603392.SH)公佈,近日,公司全資子公司廈門萬泰滄海生物技術有限公司(“萬泰滄海”)收到國家藥品監督管理局頒發的雙價人乳頭瘤病毒疫苗(大腸桿菌)(英文名稱:Recombinant Human Papillomavirus Bivalent (Types16,18)Vaccine (Escherichia coli))(商品名稱:馨可寧®)的《藥品補充申請批准通知書》(通知書編號:2021B02273)。

本次國家藥品監督管理局對該藥品已批准的西林瓶包裝形式的製劑生產規模進行放大,單價吸附原液單批次最大配置規模由20L增加到50L,半成品單批次最大配置規模由40L增加至100L,由此對制檢規程中相關內容進行修訂。

此次藥品補充獲批事項,理論上可使公司二價宮頸癌疫苗西林瓶和預灌封注射器兩種包裝形式的總產能達到3000萬支/年,其中西林瓶包裝形式的產能2000萬支/年,預灌封注射器包裝形式的產能1000萬支/年。實際生產量視包材供應、生產計劃、市場銷售情況確定。

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