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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1800084 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2018-08-01 杭州尚健生物技术有限公司 Hangzhou Shangjian Biotechnology Co Ltd Certificate Issued 2018-10-15 view
CXSB1900009 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products Supplementary Application 2019-04-30 石药集团中奇制药技术(石家庄)有限公司 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd Certificate Issued 2019-06-03 view
CXSL2000032 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2020-02-22 上海昀怡健康科技发展有限公司 Shanghai Yunyi Health Technology Development Co Ltd In Review 2020-02-21 view
CXSL2000352 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2020-12-14 石药集团中奇制药技术(石家庄)有限公司 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd In Review 2020-12-10 view
CXSL2000351 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2020-12-14 石药集团中奇制药技术(石家庄)有限公司 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd In Review 2020-12-10 view
CXSL2101103 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2021-05-31 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2101138 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2021-06-18 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2101280 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2021-08-27 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2101307 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(3.3) New Drug Application 2021-09-03 Dongguan HEC Biopharmaceutical R&D Co Ltd view
CXSL2101378 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2021-10-21 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2101380 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2021-10-26 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2101525 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2021-12-28 Beijing Dongfang Biotech Co Ltd view
CXSL2200347 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2022-08-01 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2200551 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2022-11-01 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2200560 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2022-11-07 Shanghai Yunyi Health Technology Development Co Ltd view
CXSL2200576 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2022-11-16 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2300061 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2023-01-28 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2300389 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2023-06-02 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2300414 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2023-06-14 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXSL2300482 重组抗PD-1全人源单克隆抗体注射液 Recombinant anti-PD-1 humanized monoclonal antibody Injection Biological Products(1) New Drug Application 2023-07-15 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view