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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CXHL2100071 IBI362注射液 mazdutide Injection Chemical Drugs(1) New Drug Application 2021-01-29 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd In Review 2021-01-28 view
CXSL2000234 信迪利单抗注射液 sintilimab Injection Biological Products(2.2) New Drug Application 2020-08-12 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd In Review 2020-08-11 view
JXHL1900231 Pemigatinib片 pemigatinib Tablet Chemical Drugs(1) Import Drug Application 2019-09-20 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd;Incyte Biosciences International Sàrl In Review 2019-09-19 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
CYSB2000225 阿达木单抗注射液 adalimumab Injection Biological Products(原2) Supplementary Application 2020-10-13 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2020-12-28 view
JXHL2000015 注射用IBI362 mazdutide Lyophilized Chemical Drugs(1) Import Drug Application 2020-02-15 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd In Review 2020-02-14 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
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
CXSS2100008 贝伐珠单抗注射液 bevacizumab Injection Biological Products(2.2) New Drug Application 2021-01-13 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd In Review 2021-01-12 view
CYSB2000189 贝伐珠单抗注射液 bevacizumab Injection Biological Products(原2) Supplementary Application 2020-08-06 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Approval Completed-Pending Certificated 2021-11-01 view
JXHL1900219 Pemigatinib片 pemigatinib Tablet Chemical Drugs(1) Import Drug Application 2019-08-23 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd;Incyte Biosciences International Sàrl In Review 2019-08-22 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
CXSL2000263 IBI188 letaplimab Injection Biological Products(1) New Drug Application 2020-09-12 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd In Review 2020-09-11 view
CXSL2000008 信迪利单抗注射液 sintilimab Injection Biological Products(1) New Drug Application 2020-01-21 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd In Review 2020-01-20 view
CXSS1800027 阿达木单抗注射液 adalimumab Injection Biological Products(2) New Drug Application 2018-11-15 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2020-09-08 view
JXHL2000323 Parsaclisib片 parsaclisib Tablet Chemical Drugs(1) Import Drug Application 2020-12-14 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd;Incyte Biosciences International Sàrl In Review 2020-12-10 view
CXSL2000180 信迪利单抗注射液 sintilimab Injection Biological Products(1) New Drug Application 2020-07-04 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd In Review 2020-07-02 view
JXHL1900199 Parsaclisib片 parsaclisib Tablet Chemical Drugs(1) Import Drug Application 2019-08-17 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd;Incyte Biosciences International Sàrl In Review 2019-08-16 view
JXHL1900230 Pemigatinib片 pemigatinib Tablet Chemical Drugs(1) Import Drug Application 2019-09-20 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd;Incyte Biosciences International Sàrl In Review 2019-09-19 view