和黃醫藥(00013.HK)旗下結直腸癌新藥於日本提交上市申請
和黃醫藥(00013.HK)公佈,合作夥伴武田(Takeda)已向日本厚生勞動省,提交(口夫)(口奎)替尼用於經治轉移性結直腸癌成人患者的新藥上市申請。
(口夫)(口奎)替尼是一種選擇性的口服血管內皮生長因子受體(VEGFR)-1、-2及-3抑制劑,VEGFR對於阻斷腫瘤血管生成起到關鍵作用。(口夫)(口奎)替尼的新藥上市申請是基於FRESCO-2全球研究(一項在美國、歐洲、日本及澳洲開展的III期國際多中心臨牀試驗),以及FRESCO中國III期研究的結果。
FRESCO-2及FRESCO研究探索了(口夫)(口奎)替尼聯合最佳支持治療,兩項研究均達到主要終點及關鍵次要終點,研究顯示(口夫)(口奎)替尼治療在總生存期和無進展生存期,均達到具有統計學意義和臨牀意義的顯着改善。(口夫)(口奎)替尼在患者中的耐受性普遍良好。
和黃醫藥研發負責人及首席醫學官石明表示,在強大臨牀數據及在中國取得成功所支持下,相信(口夫)(口奎)替尼對於患者是一個重要的選擇,對其在日本獲得批準後所產生的影響感到樂觀。
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