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四環醫藥(00460.HK):軒竹生物1類新藥吡羅西尼臨牀III期試驗達到主要終點
格隆匯 04-26 18:52

格隆匯4月26日丨四環醫藥(00460.HK)發佈公吿,集團旗下非全資附屬公司軒竹生物科技股份有限公司在研1類新藥吡羅西尼(Birociclib,XZP-3287 CDK4/6(細胞週期依賴性激酶4和6)抑制劑)聯合氟維司羣治療既往內分泌治療後進展的HR+/HER2-晚期乳腺癌III期臨牀試驗達到主要終點。此外,吡羅西尼聯合醋酸阿比特龍和潑尼松治療晚期或轉移性前列腺癌的II期臨牀試驗申請已被中國國家藥品監督管理局藥品審評中心受理。

軒竹生物近期召開了獨立數據監查委員會(IDMC)會議對吡羅西尼聯合氟維司羣的III期臨牀試驗期中分析數據進行了審閲,IDMC專家一致同意期中分析結果顯示試驗已達到期中分析預設的界值,與對照組相比,具有顯著的統計學差異和臨牀意義,建議提前遞交上市申請。此外,吡羅西尼也是國內自主研發的CDK4/6抑制劑中首個計劃開展治療晚期前列腺癌臨牀研究的產品。

臨牀I期研究結果表明,作為一個全新結構的CDK4/6抑制劑,吡羅西尼有望克服激素受體陽性(HR+)乳腺癌患者內分泌治療的耐藥問題;同時亦觀察到吡羅西尼單藥針對多線治療失敗的晚期乳腺癌患者有明顯療效。臨牀前研究結果表明,吡羅西尼具有獨特的藥代動力學特徵,能夠有效通過血腦屏障,對乳腺癌腦轉移的患者和腦癌患者預期會產生良好療效。此外,由於CDK4/6新穎的靶點作用機制,吡羅西尼可以和多個靶點藥物聯用,具有重要的臨牀意義和廣闊的市場前景。

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