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康哲藥業(00867.HK)創新藥亞甲藍腸溶緩釋片中國橋接試驗完成首例受試者給藥
格隆匯 01-10 19:46

1月10日,康哲藥業控股有限公司(00867.HK)創新藥亞甲藍腸溶緩釋片中國橋接試驗完成首例受試者給藥,這是繼該產品2021年8月中國IND獲批後的又一重大進展。

該研究為隨機、雙盲、安慰劑對照、多中心的III期臨牀試驗,旨在評價與安慰劑相比,亞甲藍腸溶緩釋片在接受結直腸腫瘤結腸鏡篩查或結腸鏡監測的受試者中輔助提高組織學證實的非息肉樣結直腸病變檢出率的有效性。該研究擬入組1,800例受試者,由首都醫科大學附屬北京友誼醫院牽頭,將在全國約20家中心進行。其主要研究者包括中華醫學會消化內鏡學分會前主任委員、中國醫師協會消化醫師分會會長張澍田教授,中華醫學會消化病學分會常委兼祕書長、中華老年醫學學會消化分會會長劉玉蘭教授等消化領域權威專家。

亞甲藍腸溶緩釋片

亞甲藍腸溶緩釋片是現有液體結腸染色染料亞甲藍的新型口服緩釋製劑,由康哲藥業合作伙伴Cosmo的專有MMX緩釋控釋技術配製而成,通過增強接受篩查或監測結腸鏡檢查的成年患者結直腸病變的可視化,從而幫助提高結直腸癌或癌前病變的檢出率。該產品於2020年8月獲歐洲藥品管理局批准以LumeblueTM商品名上市。

結直腸癌是最常見的消化系統惡性腫瘤之一,世界衞生組織國際癌症研究機構(IARC)數據顯示,中國2020年結直腸癌的新發病例數為56萬例,死亡病例達29萬例。在結直腸癌擴散和發展前,及早診斷癌症病灶並予以清除,可顯著提高患者生存率。結腸鏡檢查被視為結直腸癌篩查金標準,然而由於固有的檢測敏感性問題,具有臨牀意義的癌前病變在實踐中常常被忽略。在常規結腸鏡檢查步驟中添加亞甲藍腸溶緩釋片可提高診斷敏感性,為廣大患者帶來潛在益處,產品市場前景可期。

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