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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
CXSL1600070 注射用重组抗HER2人源化单克隆抗体组合物 B-002 Lyophilized Biological Products(1) New Drug Application 2017-02-13 上海医药集团股份有限公司 Shanghai Pharmaceuticals Holding Co Ltd Certificate Issued 2017-09-27 view
CXSL1700022 注射用重组抗HER2人源化单克隆抗体偶联美登素衍生物DM1 HS-630 Lyophilized Biological Products(2) New Drug Application 2017-05-25 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2018-05-08 view
CXSL1700072 注射用重组抗HER2人源化单克隆抗体-MCC-DM1偶联剂 B-003 Lyophilized Biological Products(2) New Drug Application 2017-07-31 上海交联药物研发有限公司 Shanghai Shangyao Cross Linked Pharmaceutical Technology Co Ltd Certificate Issued 2018-02-25 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
X0302917 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 2004-04-02 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2004-07-12 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
CXSL1700045 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 2017-08-15 上海生物制品研究所有限责任公司 Shanghai Institute of Biological Products Co Ltd Certificate Issued 2018-08-13 view
CXSL1100036 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 2011-07-21 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd Certificate Issued 2013-07-19 view
CXSS1800023 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 2018-09-10 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2020-06-22 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
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
CXSL1400092 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 2014-11-25 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2016-02-19 view
CXSR1100006 注射用重组抗HER2人源化单克隆抗体 Recombinant humanized monoclonal antibody against HER2 Lyophilized Biological Products State Standards 2011-09-27 哈药集团生物工程有限公司 Harbin Pharmaceutical Group Bioengineering Co Ltd Certificate Issued 2012-07-03 view
CXSL1000002 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 2010-03-25 哈药集团生物工程有限公司 Harbin Pharmaceutical Group Bioengineering Co Ltd Certificate Issued 2011-08-03 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
CXSL1800072 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 2018-06-29 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd In Review 2018-06-28 view
CXSB2000040 注射用重组抗HER2人源化单克隆抗体 Recombinant humanized monoclonal antibody against HER2 Lyophilized Biological Products(原2) Supplementary Application 2020-08-12 海正药业(杭州)有限公司 Hisun Pharmaceutical (Hangzhou) Co Ltd Certificate Issued 2020-12-09 view
CXSS0700053 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 2007-08-22 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2008-10-29 view
CXSL1400053 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 2014-07-14 深圳万乐药业有限公司 Shenzhen Main Luck Pharmaceuticals INC Certificate Issued 2016-02-18 view