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百心安-B(02185.HK):完成Bioheart®全降解支架(BRS)產品臨牀試驗患者入組
格隆匯 02-16 21:57

格隆匯2月16日丨百心安-B(02185.HK)宣佈,於2022年2月16日,公司完成全降解支架(BRS)產品BIOHEART®(一種自主開發可隨時間被人體完全吸收的臨時支架)臨牀試驗患者入組。其為治療冠狀動脈疾病的經皮冠狀動脈介入治療手術中使用的自主研發全降解支架系統。Bioheart®於2017年2月獲國家藥品監督管理局認定為"創新醫療器械",因此合資格進入快速審批程序。

根據弗若斯特沙利文的資料,截至公吿日期,中國僅有兩款已商業化的全降解支架產品,且均為第一代全降解支架產品,支柱厚度超過150微米。我們是中國僅有的四家擁有處於臨牀試驗階段的第二代全降解支架產品的國內公司之一。由於我們較其他競爭者更早於中國完成隨機對照臨牀試驗患者入組,而截至公吿日期,全球市場亦無報吿有全降解支架在研產品已啟動隨機對照臨牀試驗,故預期Bioheart®將成為全球首個基於多中心隨機對照臨牀試驗結果獲得監管批准的第二代全降解支架系統。

展望未來,公司將持續進行其臨牀計劃,並將Bioheart®推向市場。公司將繼續加強其內部研發能力,併為臨牀護理帶來創新。

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