京新藥業(002020.SZ):“靜脈橋外支架”產品通過創新醫療器械特別審查程序
格隆匯 9 月 28日丨京新藥業(002020.SZ)公佈,經公司近日在國家藥品監督管理局醫療器械技術審評中心網站(https://www.cmde.org.cn/)查詢,獲悉參股公司以色列Vascular Graft Solutions Ltd.(“VGS”)的“靜脈橋外支架”產品被國家藥品監督管理局醫療器械審評中心同意進入特別審查程序。
受理號:CQTS2000101;申請品種:靜脈橋外支架;申請人:Vascular Graft Solutions Ltd.;產品管理類別:第三類;評審結論:同意按照《創新醫療器械特別審查程序》進行審查。
“靜脈橋外支架”為心臟搭橋用血管外支架,由生物相容性纖維和鈷鉻合金編織而成,套在橋血管(移植血管)外面,起塑型和抵抗胸腔壓力的作用。該產品具有生物力學,可幫助橋血管抵抗胸腔壓力,減少內膜增生,降低橋血管的閉塞率,且使用方便,不改變原有操作流程,可自貼合到橋血管上。目前國內尚無同類產品上市,該產品上市後將填補國內該領域產品的空白,具有較大的臨牀價值和市場潛力。
“靜脈橋外支架”是由以色列VGS開發,並已在歐洲上市。公司通過參股VGS,獲得了該產品在中國開發和商業化的獨家許可權利。此次該產品通過創新醫療器械特別審查程序,在註冊申報時將獲得優先辦理的權益,將有效縮短產品註冊週期,加快產品的上市速度。該產品在國內將進行臨牀試驗,如獲批上市,將進一步豐富公司的產品管線,對公司的業務產生積極影響。
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