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艾德生物(300685.SZ):公司產品進入創新醫療器械特別審查程序

格隆匯10月9日丨艾德生物(300685.SZ)公佈,廈門艾德生物醫藥科技股份有限公司(以下簡稱"公司")自主研發的產品於近日進入國家藥品監督管理局醫療器械技術審評中心創新醫療器械特別審查程序。

HRD試劑盒是PARPi(靶向多聚ADP-核糖聚合酶抑制劑)新藥治療的伴隨診斷產品。PARPi新藥是一類用於以BRCA基因為核心的多基因多位點變異腫瘤的靶向藥物,覆蓋卵巢癌、前列腺癌、乳腺癌、胰腺癌等多癌種,使用前需要檢測HRD狀態。公司HRD試劑盒是國內首款進入"創新醫療器械"程序的HRD試劑盒。在PARPi新藥伴隨診斷領域,公司從國內首個且目前唯一獲批的人類BRCA1基因和BRCA2基因突變檢測試劑盒到"創新醫療器械"HRD試劑盒,全面覆蓋了卵巢癌、前列腺癌、乳腺癌、胰腺癌等癌種,滿足PARPi新藥治療的臨牀檢測需求。

HRD試劑盒採用自主專利的ADx-GSS®智能算法,在提高準確性的同時,涵蓋了更適合我國患者的位點,全面滿足國內外臨牀需求。此外,該試劑盒還運用了公司自主創新的ADx-HANDLE®專利建庫技術,化繁為簡、減少操作步驟,縮短患者等待檢測結果的時間,解決了操作複雜、報吿週期長等臨牀痛點,已成為阿斯利康PARPi奧拉帕利的"伴隨診斷試劑"。

進入創新醫療器械特別審查程序的創新醫療器械產品,註冊申報時可享受優先辦理,可有效縮短產品註冊週期,加快產品的上市速度,對公司未來的發展將產生積極影響。

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