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和黃醫藥(00013.HK):愛優特®(呋喹替尼)於香港獲批用於治療轉移性結直腸癌
格隆匯 01-30 12:22

格隆匯1月30日丨和黃醫藥(00013.HK)宣佈今日宣佈愛優特®(ELUNATE®,呋喹替尼/fruquintinib)取得香港藥劑業及毒藥管理局批准在香港註冊使用,用於治療經治的成人轉移性結直腸癌患者。愛優特®是血管內皮生長因子受體("VEGFR")1、2和3的選擇性口服抑制劑,VEGFR抑制劑在抑制腫瘤的血管生成中起到了至關重要的作用。

中國香港特區政府去年10月公佈新的新藥審批機制(簡稱"1+"機制),此次呋喹替尼獲批成為該"1+"機制下首個獲批在港註冊使用的藥物。該機制2023年11月1日正式生效,容許用治療嚴重或罕見疾病的新藥,在符合本地臨牀數據支持等要求,並經本地專家認可新藥的適用範圍後,須提交一個(而非原來的兩個)參考藥物監管機構的許可,便可以在香港申請註冊。基中國國家藥監局的批准,以及在香港當地的臨牀數據,和黃醫藥提交了呋喹替尼在香港的註冊申請。此外,呋喹替尼亦已2023年11月取得美國食品藥物管理局("FDA")的批准。

和黃醫藥執行副總裁兼首席運營官安凱倫醫生表示:"香港是和黃醫藥的誕生地,我們竭盡所能把將我們的創新藥物帶向香港患者作為優先要務,並很高興迎來香港的首個藥物獲批。我們欣然看到簡化的新藥註冊流程,彰顯了特區政府對加快患者獲得新療法的效率和決心。隨着我們更多用其他癌症類型和免疫性疾病的候選藥物管線持續推進,我們期待為香港的患者帶來更多新的療法。"

和黃醫藥腫瘤及免疫業務(香港及區域市場)副總裁李嘉雯醫生表示:"結直腸癌是香港第二常見的癌症,現時有效的治療選擇相當有限,尤其是對經治的轉移性結直腸癌患者來説。呋喹替尼作為口服三線治療藥物,在全球臨牀試驗中表現出具有臨牀意義的獲益和一致的安全性。我們很自豪能夠成為「1+」機制下首個獲批的藥物,並期待儘快為香港患者帶來這一重要的治療選擇。"

內科腫瘤科學者及專科醫生陳林醫生表示:"癌症無論對患者及其家人,還是對我們作為醫護人員來説,都依然是一項嚴峻的挑戰,且在過去幾十年來發病率呈上升趨勢。癌症的複雜性令研究人員帶來新的治療進展變得困難重重。本土創新在解決全球未滿足的醫療需求方面發揮越來越積極的作用,着實令人感到鼓舞。我們很期待能為香港的癌症患者帶來像這樣具有意義的治療選擇。"

呋喹替尼將由和黃醫藥以商品名愛優特®在香港上市銷售。在中國內地,呋喹替尼由和黃醫藥與禮來公司合作開發並銷售。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。呋喹替尼由武田以商品名FRUZAQLA™於美國上市銷售。緊隨FDA批准後,呋喹替尼已獲納入到美國國家綜合癌症網絡(NCCN)腫瘤學臨牀實踐指南中。

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