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和黃醫藥治療細胞肺癌新藥上市申請獲中國國家藥監局受理
阿思達克 05-29 15:57
和黃醫藥公布,中國國家藥監局已受理沃利替尼(savolitinib)用於治療間充質上皮轉化因子外顯子14跳變的非小細胞肺癌的新藥上市申請。

集團指,此次新藥上市申請是基於一項開放標籤的II期註冊研究數據支持。該研究首50名患者的中期數據已於去年9月舉行的中國臨床腫瘤學會年會上發表,並將於美國臨床腫瘤學會今年線上年會發表該研究70名患者的更新分析數據。

和黃醫藥於2011年與阿斯利康就沃利替尼簽訂了全球專利許可、合作開發及商業化協議。沃利替尼的全球開發計劃包括非小細胞肺癌、腎癌,並正在探索其他MET驅動的腫瘤。

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