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正海生物(300653.SZ):“活性生物骨”已進入到“主審審評”狀態
格隆匯 11-29 16:06

格隆匯11月29日丨正海生物(300653.SZ)公佈,公司產品活性生物骨已於近日按照家藥品監督管理局(“國家藥監局”)醫療器械技術審評中心對於該產品技術審評階段“資料補充通知單”的相關要求完成了該產品“補充資料”的遞交,並進入到“主審審評”狀態。

活性生物骨屬於“以醫療器械作用為主的藥械組合產品”,預期用於“各種原因造成的骨缺損、骨不連等病症的治療”(具體適用範圍以最終批覆為準)。通過將具有誘導活性的BMP-2與具有天然骨組織孔隙結構的骨支架材料相結合,形成了具有誘導活性的骨支架材料,相比同類或類似產品,活性生物骨具有天然的結構、適宜的孔徑和孔隙率,利於細胞和血管長入;BMP-2所具有的與膠原特異性結合的能力,可以保持其在損傷部位的高濃度而不隨體液擴散。

活性生物骨在臨牀應用上屬於骨科植入物的一個細分方向,其具體用途體現在骨科相關臨牀用途中的“骨缺損”方面。

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