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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1900083 注射用重组人源化抗HER2单克隆抗体 Recombinant humanized monoclonal antibody against HER2 Lyophilized Biological Products(2) New Drug Application 2019-08-06 喜康(武汉)生物医药有限公司 Xikang(Wuhan)Biopharmaceutical Co Ltd In Review 2019-08-05 view
CXSL1500047 注射用重组人源化抗HER2单克隆抗体-美登素偶联物 BAT-8001 Lyophilized Biological Products(1) New Drug Application 2015-07-09 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2016-10-11 view
CXSL1800121 注射用重组人源化抗HER2单克隆抗体-美登素偶联物 BAT-8001 Lyophilized Biological Products(1) New Drug Application 2018-12-25 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2018-12-24 view