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美康生物(300439.SZ):研發的新型冠狀病毒核酸檢測試劑盒尚處於臨牀驗證階段
格隆匯 02-04 18:28

格隆匯2月4日丨美康生物(300439.SZ)公佈,公司股票於2020年2月3日、2月4日連續兩個交易日收盤價格漲幅偏離值累計超過20%,根據深圳證券交易所的有關規定,屬於股票交易異常波動的情況。

公司關注到近日相關媒體和投資者對公司目前已研製出的新型冠狀病毒核酸檢測試劑盒(多重熒光PCR法)和新型冠狀病毒蛋白快速檢測試劑盒給予了關注,現對相關情況進行説明並風險提示如下:

公司研發的新型冠狀病毒核酸檢測試劑盒,採用實時熒光定量PCR技術可實現對2019-nCoV新型冠狀病毒RNA的檢測;公司研發的新型冠狀病毒蛋白快速檢測試劑盒採用免疫層析法,是一種POCT快速檢測方式,可用於醫療機構對新型冠狀病毒的初步快速篩查。公司研發的上述產品尚處於臨牀驗證階段,臨牀驗證的結果符合相關檢測標準,公司將提交樣品及相關資料向國家藥品監督管理局進行註冊申請,能否取得醫療器械註冊證書及取得註冊證書的時間具有不確定性。

鑑於上述產品註冊時間的不確定性及市場需求的變化等因素的影響,上述產品的成功研製對公司短期業績產生實質性的影響有限,對公司未來業績的有利影響存在較大的不確定性。

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