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東方生物(688298.SH):三款新型冠狀病毒系列檢測試劑產品可視為已經備案獲得歐盟市場準入
格隆匯 02-23 19:32

格隆匯2月23日丨東方生物(688298.SH)公佈,公司於2020 年2月24日披露了《浙江東方基因生物製品股份有限公司關於媒體報道的澄清公告》,由於工作人員的表述失誤,現對澄清公告內容補充如下:

東方生物近期開發的三款新型冠狀病毒(2019-nCoV)系列檢測試劑產品。該系列產品包括基於膠體金免疫層析法的2019-nCoV新型冠狀病毒抗原快速檢測試紙、以及基於熒光PCR平台的2019-nCoV新型冠狀病毒核酸檢測試劑盒、新型冠狀病毒抗體檢測試劑(膠體金法)。已經根據歐盟法規由歐盟代表提交備案註冊,在備案號獲得前,根據歐盟法規,可視為已經備案獲得了市場準入,中國的相關產品註冊在進行中。該系列新型冠狀病毒(2019-nCoV)檢測試劑產品在法規允許的情況下,既可以國外銷售,也可以國內銷售,而不是隻打算主要銷往國外。

由於公司澄清公告內容有誤,對於此次補充給廣大投資者帶來的不便,公司深表歉意,敬請諒解。公司將進一步加強公告文件在編制過程中的審核工作,提高信息披露質量。

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