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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2200069 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2022-02-07 SinoCelltech Ltd view
CXSL2101434 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2021-11-22 SinoCelltech Ltd view
CXSL2101400 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2021-11-01 Shandong New Time Pharmaceutical Co Ltd view
CXSL2101395 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2021-11-01 Taizhou Hanzhong Biomedical Co Ltd view
CXSL2101342 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2021-09-26 Taizhou Hanzhong Biomedical Co Ltd view
CXSL2101076 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2021-05-14 Taizhou Hanzhong Biomedical Co Ltd view
CXSL2101051 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2021-04-30 Shandong New Time Pharmaceutical Co Ltd view
CXSL2000144 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2020-07-04 山西威奇达光明制药有限公司 Shanxi Weiqidaguangming Pharmaceutical Co Ltd In Review 2020-07-03 view
CXSL2000118 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2020-05-29 神州细胞工程有限公司 SinoCelltech Ltd In Review 2020-05-28 view
CXSL2000022 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2020-02-14 泰州翰中生物医药有限公司 Taizhou Hanzhong Biomedical Co Ltd In Review 2020-02-13 view
CXSL2000011 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2020-01-18 泰州翰中生物医药有限公司 Taizhou Hanzhong Biomedical Co Ltd In Review 2020-01-17 view
CXSL1800130 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2019-01-07 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2019-01-04 view
CXSL1800123 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2018-12-25 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2018-12-24 view
CXSL1800122 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2018-12-25 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2018-12-24 view
CXSL1800032 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2018-04-11 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2018-07-24 view
CXSL1800025 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2018-03-06 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2018-07-06 view
CXSL1600107 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2017-02-22 泰州翰中生物医药有限公司 Taizhou Hanzhong Biomedical Co Ltd Certificate Issued 2017-09-14 view
CXSL1600102 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2017-01-12 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2017-09-14 view
CXSL1400138 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2015-01-21 泰州君实生物医药科技有限公司 Taizhou Junshi Biomedical Technology Co Ltd Certificate Issued 2016-01-14 view