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雙鷺藥業(002038.SZ):創新藥DT678片獲批臨牀試驗
格隆匯 12-07 16:39

格隆匯12月7日丨雙鷺藥業(002038.SZ)公佈,公司於近日收到國家藥品監督管理局簽發的關於DT678片的《藥物臨牀試驗批准通知書》(通知書編號:2021LP01938)。DT678片為P2Y12受體拮抗劑,通過抑制ADP與血小板P2Y12受體的結合,從而抑制血小板聚集,預防血栓形成。

DT678片是全球首創的抗血小板聚集用藥領域的創新藥,由美國密歇根大學參股的DT公司(雙鷺藥業持有30%股權)與我公司共同開發,公司擁有該專利化合物在中國的獨家開發使用權。

目前臨牀上預防和治療因血小板高聚集而引起的心腦血管和其它動脈循環障礙疾病的藥物主要以氯吡格雷為主,約佔市場總份額的 81%,2020年氯吡格雷全國銷售額超過50億。但氯吡格雷需要通過肝細胞色素p450酶(CYP)轉化才具有活性,故在攜帶CYP2C19失活等位基因的人羣中,氯吡格雷的二級預防效果較差,且CYP2C19失活等位基因在不同族裔人羣中的攜帶比例有明顯差別,在白人患者和亞洲患者中分別約25%和60%。

公司研發的DT678片無需通過肝細胞色素p450酶(CYP)轉化,僅需在內源性谷胱甘肽的存在的前體下,即可轉化成藥效活性成分,藥效是氯吡格雷的20倍以上。DT678片不僅繞過了細胞色素p450酶(CYP)生物催化轉化過程,而且還規避了許多與噻吩吡啶藥物相關的缺點,具有藥效好、起效快、副反應小和穩定性更強的特點,是更適合所有亞洲人的抗血小板高聚集治療用藥,也是公司近年來開發的重點產品。

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