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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1200088 重组人-鼠嵌合抗CD20单克隆抗体注射液 rituximab Injection Biological Products(2) New Drug Application 2013-02-04 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2014-09-24 view
CXSL1400005 重组人抗肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2014-02-19 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2016-01-13 view
CXSL1400002 重组人抗肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2014-02-17 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2016-01-13 view
CXSL1500010 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-04-21 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2016-05-19 view
CXSL1500044 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-05-25 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2016-05-19 view
CXSL1500136 IBI308 sintilimab Injection Biological Products(1) New Drug Application 2016-01-25 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2016-09-04 view
CXSL1500009 重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白注射液 Injection Biological Products(1) New Drug Application 2015-04-21 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2016-12-22 view
CXSL1500008 重组人血管内皮生长因子受体-抗体-人补体受体1融合蛋白注射液 Injection Biological Products(1) New Drug Application 2015-04-21 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2016-12-22 view
CXSL1600128 重组全人源抗前蛋白转化酶枯草溶菌素9(PCSK-9)单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2017-02-13 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2017-09-27 view
CXSB1700005 重组人抗肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products Supplementary Application 2017-08-18 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2018-01-17 view
CXSS1700038 信迪单抗注射液 sintilimab Injection Biological Products(1) New Drug Application 2017-12-13 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2018-03-26 view
CXSL1800012 注射用重组全人源抗肿瘤坏死因子受体超家族成员4(OX40)单克隆抗体 Lyophilized Biological Products(1) New Drug Application 2018-02-09 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2018-07-06 view
CXSL1800074 IBI188 letaplimab Injection Biological Products(1) New Drug Application 2018-07-04 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2018-09-03 view
CXSL1800082 信迪利单抗注射液 sintilimab Injection Biological Products(1) New Drug Application 2018-07-30 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2018-10-08 view
CXSL1800081 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-07-30 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2018-10-08 view
CXSL1800119 IBI318 IBI318 Injection Biological Products(1) New Drug Application 2018-12-10 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd In Review 2018-12-07 view
CXSS1800008 信迪利单抗注射液 sintilimab Injection Biological Products(1) New Drug Application 2018-04-19 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2019-01-03 view
CXSL1900025 信迪利单抗注射液 sintilimab Injection Biological Products(1) New Drug Application 2019-03-14 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd In Review 2019-03-13 view
CXSL1900040 IBI110 IBI110 Other Biological Products(1) New Drug Application 2019-04-26 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd In Review 2019-04-25 view
CXSB1900010 信迪利单抗注射液 sintilimab Injection Biological Products Supplementary Application 2019-05-16 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2019-06-05 view