華大基因(300676.SZ)全資子公司產品列入WHO應急使用清單
格隆匯5月10日丨華大基因(300676.SZ)發佈公告，公司全資子公司BGI EuropeA/S(以下簡稱“歐洲醫學”)的新型冠狀病毒核酸檢測產品於近日被列入為世界衞生組織(以下簡稱“WHO”)應急使用清單(以下簡稱“EUL”)。
根據披露，新型冠狀病毒的核酸檢測是新型冠狀病毒肺炎感染確診的重要手段之一，新型冠狀病毒核酸檢測試劑盒是目前各國進行體外定性檢測新型冠狀病毒感染的肺炎疑似病例和其他需要進行新型冠狀病毒感染鑑別診斷者的主要方法。公司研發的新型冠狀病毒核酸檢測試劑盒可實現病毒的快速檢測，協助各國當局和醫療機構等採取及時有效的防控措施，較好地滿足各國疫情防控的市場需求。
2020年1月30日，WHO宣佈新型冠狀病毒肺炎疫情的暴發構成國際關注的突發公共衞生事件，並啟動檢測新型冠狀病毒的體外診斷試劑EUL。截至該公告披露日，根據WHO官網信息顯示，共計5家國內外企業的新型冠狀病毒檢測產品在WHO應急使用清單之列，其中公司上述檢測試劑盒是率先入圍WHO EUL的中國企業產品。
截至目前，公司該檢測產品獲得的批准情況如下：在國內市場，已取得了中國國家藥品監督管理局頒發的醫療器械註冊證；在歐洲市場，完成了歐盟CE認證，並獲得了歐盟自由銷售證書；在美國市場，已獲得了美國食品藥品監督管理局(以下簡稱“FDA”)簽發的緊急使用授權(EUA)；在日本市場，已通過了日本PMDA認證；在澳大利亞市場，已獲得了澳大利亞TGA註冊；在新加坡市場，已獲得新加坡衞生科學局的臨時授權；在加拿大市場，已通過了加拿大衞生部認證。
公司表示，此次公司產品被列入到WHO EUL，意味着WHO對公司產品質量的認可和肯定，可為WHO成員國和各意向採購方提供採購依據，有利於進一步提升公司產品的國際競爭力，在全球範圍內助力新型冠狀病毒感染的肺炎疫情防控工作。
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