和黃醫藥(00013.HK)宣佈武田獲得FRUZAQLA®(呋喹替尼/fruquintinib)在日本的上市批准
格隆匯9月24日丨和黃醫藥(00013.HK)今日宣佈其合作夥伴武田(TSE：4502/ NYSE：TAK)取得日本厚生勞動省(MHLW)批准生產及銷售FRUZAQLA® (呋喹替尼，fruquintinib)用於治療經治的轉移性結直腸癌患者。FRUZAQLA®成為日本超過十年來首個獲批用於治療轉移性結直腸癌的創新靶向療法，無論患者的生物標誌物狀態如何。根據日本國立癌症研究中心的統計數據，結直腸癌是日本最常見的癌症類型，估計 2023 年有 16.1 萬例新增病例，並造成 5.4 萬人死亡。
FRUZAQLA®獲批用於治療無法徹底治癒及無法切除，且化療後病情進展的晚期或複發性結直腸癌。
和黃醫藥首席執行官兼首席科學官蘇慰國博士表示：「現在，武田已在日本取得 FRUZAQLA 批准，這證明了我們全球數據包的實力以及這種新藥為轉移性結直腸癌患者提供急需的治療選擇的潛力。在過去的十幾年來，武田一直是日本的轉移性結直腸癌治療領域的領導者，我們有信心武田能夠將 FRUZAQLA®帶向日本患者。」
日本柏市國立癌症研究中心東醫院副院長、藥物和診斷開發促進部主任兼胃腸腫瘤科主任吉野孝之醫生表示：「FRUZAQLA® 的日本獲批對於轉移性結直腸癌患者來説是一個重大的消息，他們長期以來都在翹首期盼新的有效治療選擇。FRESCO-2 全球研究展示了這種療法在臨牀中為患者帶來的積極影響。在日本，篩查和有效療法的出現和普及令結直腸癌患者的治療結果不斷改善，我們期待 FRUZAQLA®的出現將為此類疾病的患者帶來新的希望。」
日本厚生勞動省的批准主要基於在美國、歐洲、日本和澳洲開展的 FRESCO-2 III 期研究的結果。FRESCO-2 研究的數據已於 2023 年 6 月在《柳葉刀(The Lancet)》上發表。 武田擁有在中國內地、香港和澳門以外進一步開發、商業化和生產呋喹替尼的全球獨家許可。FRUZAQLA®於 2023 年 11 月在美國獲得批准，並於 2024 年 6 月在歐洲獲得批准。
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