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迪哲醫藥(688192.SH):DZD9008在法國開展II期單臂關鍵性臨牀試驗獲批
格隆匯 01-19 16:29

格隆匯1月19日丨迪哲醫藥(688192.SH)公佈,近日,迪哲(江蘇)醫藥股份有限公司收到法國藥品和保健品安全局(簡稱“ANSM”)關於DZD9008開展II期單臂關鍵性臨牀試驗的批准通知書,批准DZD9008在法國開展針對EGFR20號外顯子插入突變非小細胞肺癌的II期單臂關鍵性臨牀試驗。

DZD9008是公司自主研發的針對EGFR/HER220號外顯子插入突變設計的全球首創小分子化合物,首選適應症為針對EGFR20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、日本等國家和地區開展臨牀試驗,患者入組正常推進中。

公司獲得ANSM批准在法國開展針對EGFR20號外顯子插入突變非小細胞肺癌的II期單臂關鍵性臨牀試驗後,DZD9008的國際多中心II期單臂關鍵性臨牀試驗也將同步在法國開展,這是DZD9008在歐洲獲批的首個臨牀試驗通知書,對公司近期業務沒有重大影響。公司未來將根據II期單臂關鍵性臨牀進展及有效數據,向藥監主管部門提交產品上市申請。

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