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和黃醫藥(00013.HK):武田獲得歐盟委員會批准FRUZAQLA®(呋喹替尼)
格隆匯 06-24 08:03

格隆匯6月24日丨和黃醫藥(00013.HK)發佈公吿,其合作伙伴武田 (TSE :4502/ NYSE :TAK)取得歐盟委員會(European Commission)批准 FRUZAQLA®(呋喹替尼,fruquintinib)作為單藥療法用於治療既往接受過包括氟尿嘧啶類 (fluoropyrimidine) 、奧沙利鉑 (oxaliplatin)和伊立替康 (irinotecan)為基礎的化療、抗血管內皮生長因子(“VEGF”)治療以及抗表皮生長因子受體(EGFR)治療在內的現有標準治療,以及曲氟尿苷替匹嘧啶 (trifluridine-tipiracil)或瑞戈非尼(regorafenib)治療後疾病進展或不耐受的成人轉移性結直腸癌患者。

西班牙巴塞羅那 Vall d′Hebron 腫瘤研究所(VHIO)所長 Josep Tabernero 博士表示:“呋喹替尼成為第一個也是唯一一個在歐盟獲得批准用於治療結直腸癌的針對所有三種 VEGFR 亞型的選擇性抑制劑,這一決定標誌着歐洲腫瘤學的一個重要里程碑。在歐洲,經治的轉移性結直腸癌患者及他們的臨牀醫生亟需新的治療選擇。我們很高興向前邁出了重要的一步,可以為患者開出這種新的、具有差異性的藥物。”

武田全球抗腫瘤事業部總裁 Teresa Bitetti 表示:“很高興 FRUZAQLA®取得歐盟委員會批准,我們現在可以為經治的轉移性結直腸癌患者提供新的治療選擇,無論他們的生物標誌物狀態如何。長期以來,歐洲的轉移性結直腸癌患者一直在等待新的治療選擇,我們很榮幸通過與和黃醫藥的合作能夠滿足這一需求。”

和黃醫藥首席執行官兼首席科學官蘇慰國博士表示:“對於和黃醫藥來説,這是一個重要的里程碑。這是我們的研發引擎在歐洲首個獲批的產品,並且通過與武田的合作,在如此短的時間內實現了這一目標。目前,這款創新的抗腫瘤藥物正在美國和中國改善該疾病的治療前景,我們也期待將其影響力帶向歐洲的患者。”

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