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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1400049 Exendin-4 Fc融合蛋白注射液 JY-09 Injection Biological Products(1) New Drug Application 2014-08-14 北京东方百泰生物科技有限公司 Beijing Dongfang Biotech Co Ltd Certificate Issued 2016-04-21 view
CXSL1600061 重组人源化抗VEGF单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2016-10-20 北京东方百泰生物科技有限公司 Beijing Dongfang Biotech Co Ltd Certificate Issued 2017-05-22 view
CXSL1500087 重组人源化抗VEGF单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-11-19 北京东方百泰生物科技有限公司 Beijing Dongfang Biotech Co Ltd Certificate Issued 2017-01-23 view
CXSL1800023 重组抗VEGFR2全人源单克隆抗体(JY025)注射液 Recombinant anti-VEGFR2 human monoclonal antibody Injection Biological Products(1) New Drug Application 2018-03-05 北京东方百泰生物科技有限公司 Beijing Dongfang Biotech Co Ltd Certificate Issued 2018-07-24 view
CXSL1500023 重组抗肿瘤坏死因子-α全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2015-05-08 北京东方百泰生物科技有限公司 Beijing Dongfang Biotech Co Ltd Certificate Issued 2017-02-13 view