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基石藥業(02616.HK)合作夥伴Blueprint之治療甲狀腺癌藥物獲美批准
阿思達克 12-10 08:33
基石藥業(02616.HK)公布,合作夥伴 Blueprint Medicines於近期宣佈,美國食品和藥物管理局已批准GAVRETO(普拉替尼),用於治療在轉染過程中重新排列(「RET」)變異的甲狀腺癌患者。

這項加速批准擴展了GAVRETO的適應症,包括需要系統治療的晚期或轉移性RET突變甲狀腺髓樣癌成人和12歲及以上兒童患者,以及需要系統治療且放射性碘難治的晚期或轉移性RET融合陽性甲狀腺癌成人和12歲及以上兒童患者。對該適應症的繼續批准可能取決於確證性試驗中對臨床獲益的驗證和描述。

基石藥業與 Blueprint Medicines達成獨家合作和授權協議,獲得了包括普拉替尼在內的多款藥物在大中華區地區,包括內地、香港、澳門和台灣地區的獨家開發和商業化授權。

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