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復星醫藥(600196.SH)控股子公司注射用曲妥珠單抗獲註冊批准
格隆匯 08-14 18:23

格隆匯8月14日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海復宏漢霖生物技術股份有限公司的注射用曲妥珠單抗(即注射用重組抗HER2人源化單克隆抗體,商品名稱:漢曲優®)用於HER2陽性的轉移性乳腺癌、HER2陽性的早期乳腺癌、HER2陽性的轉移性胃腺癌或胃食管交界處腺癌治療的上市註冊申請獲國家藥品監督管理局批准。

該新藥為本集團(即本公司及控股子公司/單位,下同)自主研發的單克隆抗體生物類似藥,主要用於HER2陽性的轉移性乳腺癌、HER2陽性的早期乳腺癌及HER2陽性的轉移性胃腺癌或胃食管交界處腺癌治療等。該新藥的場地及生產設施已通過上海市藥品監督管理局的GMP現場檢查。截至2020年7月,集團現階段針對該新藥累計研發投入約為人民幣8.04億元(未經審計)。

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