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翰宇藥業(300199.SZ):家用型新型冠狀病毒抗原檢測試劑盒近期通過了中國食品藥品鑑定研究院檢測

格隆匯4月18日丨翰宇藥業(300199.SZ)公佈,基於深圳翰宇藥業股份有限公司此前與乙方深圳國家感染性疾病臨牀醫學研究中心(簡稱“國研中心”)及深圳市第三人民醫院(簡稱“市三院”)2022年2月22日簽署的《戰略合作框架協議》以及2022年3月11日簽署的《約束性意向書》基礎上,公司與國研中心、市三院簽署正式《技術開發合作協議》,擬合作研究開發家用型新型冠狀病毒抗原檢測試劑盒(以下簡稱“試劑盒”),研究基礎包括但不限於已有編號抗體及其專利、及與試劑盒產品開發相關的各類技術、產品、專利等。

項目目標:研究開發家用型新型冠狀病毒抗原檢測試劑盒,研究基礎包括但不限於乙方已有編號P301-F7和P301-H5兩條抗體及其專利(專利申請號:202210276045.6)、及與試劑盒產品開發相關的各類技術、產品、專利等。

該新冠檢測試劑盒已於近期通過了中國食品藥品鑑定研究院檢測,同時公司已與深圳三院簽署臨牀研究合同,將在完成臨牀備案後開展臨牀試驗,未來尚需臨牀試驗、臨牀進度及後續能否獲批上市具有不確定性。

截至公吿披露日,國內已有27家廠家的同類型產品獲批,國際上已有多款試劑盒通過認證並上市銷售,如:九安醫療美國子公司已獲得美國FDAEUA授權,並在美國銷售上市;亞輝龍已獲日本PMDA認證,並已收到訂單將在日本銷售上市;華大基因全資子公司已獲得歐盟CE證書,同時獲得沙特阿拉伯食品藥品管理局批准上市等等。同時,國內尚有多家同類型產品尚在國家藥品監督管理局審批中,公司產品能否上市並獲批尚存在不確定性,對未來業績影響存在較大不確定性。

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