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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1600095 重组抗TNFα全人单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2016-12-12 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2017-04-20 view
CXSL1500131 重组抗EGFR人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2016-02-25 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2016-09-28 view
CXSL1500068 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-07-22 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2016-05-19 view
CXSL1500046 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 2015-06-18 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2016-09-26 view
CXSL1400129 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 2015-03-10 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2016-08-04 view
CXSL1400065 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 2014-07-23 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2016-01-29 view
CXSL1300122 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2014-06-27 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2015-12-30 view
CXSL1300056 重组抗TNFα全人单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2013-12-23 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2016-01-14 view
CXSL1200099 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 2013-04-28 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2015-07-13 view
CXSL1200033 重组人鼠嵌合抗CD20单克隆抗体注射液 rituximab Injection Biological Products(2) New Drug Application 2012-05-23 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2015-04-22 view
CXSL1100086 重组人鼠嵌合抗CD20单克隆抗体注射液 rituximab Injection Biological Products(2) New Drug Application 2012-05-08 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2014-03-28 view