東方生物(688298.SH):尚未取得歐盟給予的新冠病毒診斷系列產品的備案登記號
格隆匯2月23日丨東方生物(688298.SH)公佈,2020年2月22日,公司關注到有相關媒體對公司研發的新型冠狀病毒檢測產品進行報道稱:“目前,新型冠狀病毒核酸檢測試劑盒(免提取熒光PCR法)、新型冠狀病毒膠體金檢測試劑,已經在歐盟註冊備案。”現就有關事項澄清説明如下:
公司於今年二月初完成了新型冠狀病毒(2019-nCoV)系列檢測試劑新品的研發。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,並於2020年2月5日發佈了風險提示公告(公告編號:2020-001)。近日,公司開發了第三款新型冠狀病毒抗體檢測試劑(膠體金法)。公司產品以海外銷售為主,因此根據公司計劃,上述三款檢測產品也將以海外銷售為主。目前,公司已向歐盟提交了註冊備案申請,並將陸續向國家藥監局提交醫療器械註冊證申請。根據歐盟相關法律規定,上述三款檢測產品在進入歐盟市場銷售前,需由歐盟代表提交歐盟備案,備案即獲得市場準入資格,獲得相應的備案登記號。截止到公告發布日,公司尚未取得歐盟給予的新冠病毒診斷系列產品的備案登記號,國內註冊證申請工作也仍在進行中。公司將密切關注上述事項進展,及時履行必要的信息披露義務。
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