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 |
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 | | In Review | 2021-01-28 | 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 |
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 |
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 | In Review | 2020-06-17 | 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 | In Review | 2020-03-11 | 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 | In Review | 2019-11-04 | 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 | In Review | 2019-08-09 | 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 | 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 | In Review | 2019-03-22 | 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 | In Review | 2018-11-28 | 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 |
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 |
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 |
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 |
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 | In Review | 2018-02-05 | 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 |
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 |