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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1600092 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2017-03-01 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2017-09-27 view
CXSL1700146 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-01-08 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2018-06-28 view
CXSL1700145 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-01-08 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2018-06-28 view
CXSL1700200 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-01-03 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2018-06-28 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
CXSL1900133 重组抗IL-5人源化单克隆抗体注射液 Recombinant anti-IL-5 Humanized Monoclonal Antibody Injection Biological Products(1) New Drug Application 2019-11-29 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd In Review 2019-11-28 view
CXSL2000159 重组抗IL-4Rα人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2020-07-04 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd In Review 2020-07-02 view
CXSL1900050 重组抗IL-17A人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2019-05-30 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd In Review 2019-05-29 view
CXSL2100086 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(2.2) New Drug Application 2021-03-09 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd In Review 2021-03-08 view
CXSS1900033 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 Injection Biological Products(13) New Drug Application 2019-08-06 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2021-07-05 view
CXSL1700058 注射用重组抗HER2人源化单抗-DM1偶联物 recombinant humanized anti-HER2 mAb-DM1 Lyophilized Biological Products(2) New Drug Application 2017-08-24 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd In Review 2017-08-22 view
CXSS1800023 注射用重组抗HER2人源化单克隆抗体 Recombinant humanized monoclonal antibody against HER2 Lyophilized Biological Products(2) New Drug Application 2018-09-10 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2020-06-22 view
CXSL2100069 注射用SSGJ-612 SSGJ-612 Lyophilized Biological Products(1) New Drug Application 2021-02-25 三生国健药业(上海)股份有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd In Review 2021-02-24 view