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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1700058 注射用重组抗HER2人源化单抗-DM1偶联物 recombinant humanized anti-HER2 mAb-DM1 Lyophilized Biological Products(2) New Drug Application 2017-08-24 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd In Review 2017-08-22 view
CXSL1600103 注射用重组抗HER2人源化单克隆抗体-DM1 recombinant humanized anti-HER2 mAb-DM1 Lyophilized Biological Products(1) New Drug Application 2017-01-05 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd Certificate Issued 2017-09-27 view