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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2400386 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(3.3) New Drug Application 2024-06-14 view
CXSL2300579 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(3.3) New Drug Application 2023-08-29 Shanghai Henlius Biotech Co Ltd view
CXSL2101329 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 2021-09-16 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd view
CXSL2101270 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 2021-08-23 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd view
CXSL2101225 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 2021-08-03 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd view
CXSL2101226 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 2021-07-30 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd view
CXSL2101221 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 2021-07-28 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd view
CXSB2101026 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) Supplementary Application 2021-07-08 Shanghai Henlius Biotech Co Ltd view
CXSL1900059 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 2019-06-26 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd In Review 2019-06-25 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
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
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