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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1700064 重组抗VEGFR2全人单克隆抗体注射液 Recombinant anti-VEGFR2 human monoclonal antibody Injection Biological Products(1) New Drug Application 2017-07-13 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2018-01-17 view
CXSL1700073 重组抗PD-1人源化单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2017-08-07 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2018-03-20 view
CXSL1700205 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-02-06 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd In Review 2018-02-05 view
CXSL1700206 重组抗PD-L1全人单克隆抗体注射液 Recombinant anti-PD-L1 human monoclonal antibody Injection Biological Products(1) New Drug Application 2018-02-13 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2018-07-13 view
CXSL1800070 重组抗PD-1人源化单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2018-07-20 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2018-09-03 view
CXSL1800071 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-07-20 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2018-09-25 view
CXSL1800089 重组抗VEGFR2结构域II-III全人单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-08-14 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2018-10-22 view
CXSL1800118 HLX22单抗注射液 HLX22 Injection Biological Products(1) New Drug Application 2018-11-29 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd In Review 2018-11-28 view
CXSL1900026 重组抗EGFR人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2019-03-25 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd In Review 2019-03-22 view
CXSL1900027 重组抗PD-1人源化单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2019-03-25 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd In Review 2019-03-22 view
CXSL1900085 注射用HLX55单抗 HLX55 Lyophilized Biological Products(1) New Drug Application 2019-08-10 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd In Review 2019-08-09 view
CXSL1900122 重组抗HER2结构域II人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2019-11-05 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd In Review 2019-11-04 view
CXSL2000043 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2020-03-12 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd In Review 2020-03-11 view
CXSB2000019 重组抗HER2结构域II人源化单克隆抗体注射液 Injection Biological Products Supplementary Application 2020-06-18 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd In Review 2020-06-17 view
CXSB2000028 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 Supplementary Application 2020-07-04 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd In Review 2020-07-02 view
CXSL2000321 重组抗CD38全人单克隆抗体注射液 Recombinant Anti-CD38 Humanized Monoclonal Antibody Injection Biological Products(3.3) New Drug Application 2020-11-12 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd In Review 2020-11-11 view
CXSB2100008 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(1) Supplementary Application 2021-01-29 上海复宏汉霖生物技术股份有限公司;上海复宏汉霖生物制药有限公司 Shanghai Henlius Biopharmaceutical Co Ltd;Shanghai Henlius Biotech Co Ltd In Review 2021-01-28 view
CXSL2100041 HLX26单抗注射液 HLX26 Injection Biological Products(1) New Drug Application 2021-02-03 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd In Review 2021-02-02 view