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萬泰生物(603392.SH):九價HPV疫苗Ⅲ期主臨牀試驗V8期訪視的現場工作已完成,正在進行標本檢測工作
格隆匯 12-19 18:41

格隆匯12月19日丨萬泰生物(603392.SH)公佈股票交易異常波動公吿,經公司核實,公司九價HPV疫苗Ⅲ期主臨牀試驗V8期訪視的現場工作已完成,正在進行標本檢測工作。標本檢測種類較多且檢測流程複雜,檢測完成後還需要對數據進行質控,具體時間需要依據各環節的進度,公司已制定相應的推進計劃,目前按計劃執行中。當前風險包括但不限於如下幾點:在V8訪視期內發現的持續感染病例不足,未能滿足臨牀終點病例數要求,需在下次訪視中繼續收集病例;商業化工藝驗證無法按計劃完成,導致具備商業化生產條件的時間延後;上述多種情況均可能導致產品上市的時間延後。

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