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基石藥業-B(02616.HK):普吉華®在中國獲批治療晚期或轉移性RET突變甲狀腺髓樣癌及RET融合陽性甲狀腺癌
格隆匯 03-14 08:13

格隆匯3月14日丨基石藥業-B(02616.HK)發佈公吿,選擇性轉染重排(“RET”)抑制劑普吉®(普拉替尼膠囊)的擴展適應症申請已經獲得中國國家藥品監督管理局(“NMPA”)批准。該項在中國的擴展適應症包括需要系統性治療的晚期或轉移性RET突變型甲狀腺髓樣癌(“MTC”)成人和12歲及以上兒童患者的治療,以及需要系統性治療且放射性碘難治(如果放射性碘適用)的晚期或轉移性RET融合陽性甲狀腺癌(“TC”)成人和12歲及以上兒童患者的治療。

基石藥業董事長兼首席執行官江寧軍博士表示:“我們很高興普吉華®擴展適應症獲批,為中國RET突變MTC及RET融合陽性TC患者帶來新的治療選擇,也特別感謝NMPA的優先審評。基石藥業始終致力於開發創新藥物,滿足癌症患者未解決的醫療需求。我們將持續增強管線開發的臨牀價值和市場潛力,加速為全球患者帶來更多高品質的新藥。”

普吉華®ARROW研究主要研究者、天津市人民醫院院長高明教授表示:“近年來,TC發病率持續上升。臨牀上對MTC治療手段有限,亟待精準靶向尤其是針對RET突變MTC患者的治療方案。普吉華®在晚期或轉移性RET突變MTC中國患者中顯示出了優越和持久的抗腫瘤活性,整體安全性與全球人羣相似。隨着普吉華®擴展適應症的獲批,我們期待能夠解決更多TC患者亟待滿足的臨牀需求。”

基石藥業首席醫學官楊建新博士表示:“普吉華®擴展適應症的獲批是繼其獲批用於RET基因融合陽性的局部晚期或轉移性NSCLC之後的又一重要里程碑。我們感謝所有為普吉華®擴展適應症的臨牀開發做出貢獻的患者和研究者們。我們還將繼續推進普吉華®在其他多種腫瘤中的臨牀研究,早日將更多的創新療法惠及更多患者。”

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