復星醫藥(02196.HK):用於晚期實體瘤治療新藥獲准臨牀試驗
格隆匯1月15日丨復星醫藥(02196.HK)公告,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司復星弘創(蘇州)醫藥科技有限公司(以下簡稱“復星弘創”)收到國家藥品監督管理局關於同意ORIN1001片(以下簡稱“該新藥”)用於晚期實體瘤治療開展臨牀試驗的通知書。復星弘創擬於近期條件具備後於中國境內(不包括港澳台地區,下同)開展該新藥的I期臨牀試驗。
該新藥為集團(即本公司及控股子公司/單位,下同)自主研發的具有新酶型靶點、新作用機制和新化學結構類型的首創(First-in-Class)小分子藥物,用於晚期實體瘤治療。截至本公告日,該新藥用於晚期實體瘤治療於美國處於I期臨牀試驗中,其用於複發性、難治性、轉移性乳腺癌(包括三陰乳腺癌)已獲美國食品藥品監督管理局FastTrackDevelopmentProgram(即快速通道審評)認證。
截至本公告日,在全球範圍內尚無與該新藥同類型產品上市。
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