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凱普生物(300639.SZ):潮州凱普生物變更醫療器械註冊證 暨產品首次獲批宮頸癌篩查預期用途
格隆匯 06-20 16:29

格隆匯6月20日丨凱普生物(300639.SZ)公佈,近日,廣東凱普生物科技股份有限公司的全資子公司潮州凱普生物化學有限公司取得國家藥品監督管理局批准的《中華人民共和國醫療器械變更註冊(備案)文件(體外診斷試劑)》。公司“高危型人乳頭瘤病毒核酸檢測試劑盒(熒光PCR法)”率先獲批增加宮頸癌初篩、宮頸癌聯合篩查和ASC-US人羣分流預期用途,本次預期用途的變更屬於同品種首個產品首次申報,為國家藥監局批准的第一個用於宮頸癌篩查預期用途的產品。

2015年4月,國家藥監局發佈《人乳頭瘤病毒(HPV)核酸檢測及基因分型試劑技術審查指導原則》(2015年第93號)(下稱“《指導原則》”),針對宮頸癌聯合篩查或宮頸癌初篩用途,要求根據預期用途隨機選取符合條件的女性作為受試者,根據基礎檢查數據進行隨訪研究,隨訪時間至少持續三年。公司經過調查研討,按照《指導原則》設計臨牀試驗方案,於2016年啟動大規模前瞻性臨牀研究,招募上萬名受試者完成三年跟蹤隨訪研究。

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