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藥捷安康-B(02617.HK):替恩戈替尼(TT-00420)被授予治療MCRPC快速通道認證
格隆匯 06-24 06:33

格隆匯6月24日丨藥捷安康-B(02617.HK)發佈公告,美國食品藥物管理局(“FDA”)授予替恩戈替尼(tinengotinib, TT-00420)治療轉移性去勢抵抗性前列腺癌(“mCRPC”)患者的快速通道認證(fast track designation)。

mCRPC是一種晚期前列腺癌,指對去勢治療產生耐藥,及╱或出現新轉移的前列腺癌。前列腺癌是全球男性死亡率第二高的腫瘤。mCRPC是導致前列腺癌患者死亡的主要因素。隨着人口老齡化,全球mCRPC的發病率從2019年的180,500例上升至2024年的209,300例。

替恩戈替尼是一款自主研發、處於全球III期註冊實驗的多靶點激酶抑制劑,靶向FGFR/VEGFR、JAK和Aurora激酶發揮抗腫瘤作用。目前正在美國與中國進行的臨牀試驗顯示,替恩戈替尼在多種實體瘤治療中具有療效潛力。替恩戈替尼就治療CCA獲FDA授予孤兒藥(ODD)及快速通道認證(FTD),於中國獲國家藥品監督管理局突破性療法認證(BTD),就治療膽道癌獲EMA孤兒藥認證。

替恩戈替尼是全球首個和唯一一個有潛力同時抑制FGFR/JAK通路,且針對mCRPC有臨牀療效證據的研究藥物。於替恩戈替尼單一療法I期 ╱II期臨牀試驗中,共有13名患者有可測量病竈。整體緩解率(ORR)爲46%及疾病控制率(DCR) 爲85%。超過90%的患者的腫瘤體積縮小,超過60%的患者腫瘤體積縮小超過 30%。主要結果於2024年ASCO GU公佈。

作爲集團繼CCA適應症後獲得的第二個快速通道認證,此凸顯集團臨牀與註冊團隊一貫高效的執行能力,替恩戈替尼的良好療效數據將支持此藥物在mCRPC領域的進一步開發。

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