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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
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
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
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
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
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
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
CXSL1900083 注射用重组人源化抗HER2单克隆抗体 Recombinant humanized monoclonal antibody against HER2 Lyophilized Biological Products(2) New Drug Application 2019-08-06 喜康(武汉)生物医药有限公司 Xikang(Wuhan)Biopharmaceutical Co Ltd In Review 2019-08-05 view
CXSL1100032 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 2011-08-26 嘉和生物药业有限公司 Genor Biopharma Co Ltd Certificate Issued 2013-07-19 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
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
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
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
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