邁克生物(300463.SZ)：兩個新冠病毒化學發光檢測產品獲註冊證書
格隆匯5月18日丨邁克生物(300463.SZ)公佈，公司於近日收到國家藥品監督管理局(“NMPA”)頒發的《醫療器械註冊證》，產品名稱為新型冠狀病毒(2019-nCoV)IgM抗體檢測試劑盒(直接化學發光法)、新型冠狀病毒(2019-nCoV)IgG抗體檢測試劑盒(直接化學發光法)。
新冠疫情在國內爆發以來，各行各業均受到巨大沖擊，給人民的生活和財產造成重大影響。當前，我國新冠疫情防控工作仍然艱鉅，各地方政府積極響應中央疫情應對指示，正在加快提升核酸與抗體檢測能力、擴大檢測範圍，做好重點地區、重點人羣應檢盡檢、願檢盡檢工作，為鞏固疫情防控成果、各行復工復產提供有效保障。
目前臨牀常見的新型冠狀病毒檢測試劑包括核酸檢測試劑和抗體檢測試劑兩類，其中，核酸檢測試劑主要用於臨牀確診，抗體檢測試劑主要用於輔助檢測，主要包括膠體金法檢測產品和化學發光法檢測產品。
根據國家藥品監督管理局官方查詢信息，截至公告披露日，國內已有約10個廠家取得新冠抗體檢測產品註冊證書，其中使用化學發光方法的廠家約5家，市場競爭將更加激烈，公司產品的市場份額暫無法預測。
公司此次獲證的新型冠狀病毒(2019-nCoV))IgM抗體、IgG抗體檢測試劑盒(直接化學發光法)為吖啶酯直接化學發光免疫平台下的新產品，主要系配套公司該技術平台下全自動化學發光免疫分析儀i3000與i1000的檢測項目。該產品支持檢測血清、血漿樣本，樣本無需預處理，樣本檢測效率相對較高。新型冠狀病毒IgM、IgG抗體分開檢測更加適用於不同模式的結果判讀，增加優化了重組S蛋白片段，可為預後及康復評估提供重要信息。
上述兩個產品的實際生產銷售情況受到疫情防控形勢變化、各項政策變化、上游原料供應、市場推廣及其他多重因素的影響，目前尚無法預測產品對公司未來營業收入的影響。
自新型冠狀病毒感染肺炎疫情在全國爆發開始，公司積極調集資源開展新冠檢測產品研發，已完成分子診斷、化學發光免疫、快速檢測三個技術平台的新冠檢測產品開發工作，截至公告披露日，公司新型冠狀病毒2019-nCoV核酸檢測試劑盒(熒光PCR法)已取得NMPA註冊證書、CE認證和FDAEUA，新型冠狀病毒(2019-nCoV))IgM抗體、IgG抗體檢測試劑盒(直接化學發光法)已取得NMPA註冊證書、CE認證，新型冠狀病毒(SARS-Cov-2)IgG/IgM抗體檢測試劑盒(膠體金法)已取得CE認證並已向NMPA提交註冊審批申請，目前處於審核過程中。此次產品取得註冊證書後，公司可以同時滿足客户對新冠病毒核酸檢測產品與抗體檢測產品的多種臨牀需求。
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