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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1500067 重组抗EGFR人鼠嵌合单克隆抗体注射液 Recombinant anti-EGFR human-mouse chimeric monoclonal antibody Injection Biological Products(2) New Drug Application 2015-10-12 上海中信国健药业股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2016-08-04 view
CXSS1100005 注射用重组抗HER2人源化单克隆抗体 Recombinant humanized monoclonal antibody against HER2 Lyophilized Biological Products(2) New Drug Application 2011-07-18 上海中信国健药业股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2016-08-01 view
CXSL1200048 注射用重组抗HER2人源化单克隆抗体 Recombinant humanized monoclonal antibody against HER2 Lyophilized Biological Products(2) New Drug Application 2012-11-08 上海中信国健药业股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2014-06-05 view
CXSL1600034 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2016-06-15 上海中信国健药业股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2018-01-17 view
CXSS1100021 重组抗CD20人鼠嵌合单克隆抗体注射液 rituximab Injection Biological Products(2) New Drug Application 2012-01-29 上海中信国健药业股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2016-11-09 view
CXSL1600035 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2016-06-15 上海中信国健药业股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2018-01-17 view
CXSL1100026 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 Injection Biological Products(13) New Drug Application 2011-07-20 上海中信国健药业股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2013-07-19 view