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迪哲醫藥(688192.SH):DZD9008獲美國FDA突破性療法認定
格隆匯 01-27 17:36

格隆匯1月27日丨迪哲醫藥(688192.SH)公佈,近日,公司產品DZD9008用於治療EGFR 20號外顯子插入突變的非小細胞肺癌獲得美國食品藥品監督管理局(FDA)突破性療法認定(Breakthrough Therapy Designation)這是繼 202012DZD9008獲得中國國家藥品監督管理局藥品審評中心破性治療藥物品種”認定資格後又一重大進展。

DZD9008 是公司自主研發的針對 EGFR/HER2 20 號外顯子插入突變設計的全球首創小分子化合物,首選適應症為治療 EGFR 20 號外顯子插入突變非小細胞肺癌,目前處於國際多中心 II 期單臂關鍵性臨牀試驗階段,正在中國、美國、韓國、澳大利亞、日本、法國等國家和地區開展臨牀試驗

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