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基石藥業-B(02616.HK)在新加坡成功遞交口服IDH1抑制劑ivosidenib的新藥上市申請
格隆匯 11-10 08:10

格隆匯 11 月 10日丨基石藥業-B(02616.HK)發佈公告,公司已向新加坡衞生科學局遞交ivosidenib的新藥上市申請(“NDA”),用於治療攜帶易感異檸檬酸脱氫酶-1(“IDH1”)突變的成人復發或難治性(“R/R”)急性髓系白血病(“AML”)患者。Ivosidenib是一種強效、高選擇性同類首創口服IDH1抑制劑,由基石藥業的合作伙伴Agios Pharmaceuticals(納斯達克股份交易代碼:AGIO)開發,且已於2018年7月獲得美國食品藥品監督管理局(“FDA”)批准,用於治療經美國FDA批准的伴隨診斷檢測的攜帶易感IDH1基因突變的AML成人患者。2019年5月,美國FDA批准了ivosidenib的補充新藥申請,用於治療75歲及以上或因合併症而無法使用強化化療(“IC”)的新診斷IDH1基因突變的AML患者。

根據披露,AML是成人白血病中最常見的類型,且疾病進展迅速,絕大多數患者為老年患者。在美國,每年約有20,000新發病例,患者五年生存率約29%。在新加坡,每年發病率呈上升趨勢老年和R/R AML患者預後較差,大約6%至10%的AML患者攜帶IDH1突變。

目前,針對新診斷AML患者的標準治療主要為IC的誘導治療,約35%至40%的年輕患者可以達到完全緩解,但僅有約10%的老年患者能實現三年或以上生存。大部分AML患者最終會對治療產生耐藥或復發,發展為R/RAML,後續臨牀治療難度極大,且國際上尚無統一的標準治療方案。隨着基因測序的出現,突變分析為AML治療帶來了新的機遇與挑戰。

Ivosidenib是一種針對IDH1酶的口服靶向抑制劑,也是全球首個唯一獲得美國FDA批准治療IDH1突變R/RAML的藥物。該藥物由Agios開發,基石藥業於2019年與Agios達成獨家合作與授權合約,推進ivosidenib在中國大陸、香港特別行政區、澳門特別行政區及中國台灣的臨牀開發與商業化。2020年3月,基石藥業與Agios對該協議進行修訂,將其臨牀開發和商業化授權區域從大中華區擴展至新加坡。

基石藥業董事長兼首席執行官江寧軍博士表示:“我們很高興地看到公司在新加坡成功遞交ivosidenib新藥上市申請,用於治療IDH1基因突變的復發/難治性急性髓系白血病。這是基石藥業首次在大中華以外地區遞交新藥上市申請,對公司全球商業化進程意義重大。我們將繼續致力於讓更多的腫瘤患者從抗腫瘤創新療法中獲益。”

基石藥業首席醫學官楊建新博士表示:“AML的治療領域正面臨急迫的藥物開發需求,尤其是缺乏有效藥物的IDH1基因突變R/RAML患者。Ivosidenib是目前唯一一款獲得美國FDA批准上市的針對IDH1突變的AML靶向藥物。我們殷切地希望ivosidenib早日在新加坡獲批,造福這部分患者。”

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