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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1600075 重组抗PD-L1全人单克隆抗体注射液 Recombinant anti-PD-L1 human monoclonal antibody Injection Biological Products(1) New Drug Application 2016-10-11 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2017-07-17 view
CXSB1800001 重组抗PD-L1全人单克隆抗体注射液 Recombinant anti-PD-L1 human monoclonal antibody Injection Biological Products Supplementary Application 2018-01-26 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2018-06-28 view
CXSL1700212 CS1002注射液 Ipilimumab Injection Biological Products(2) New Drug Application 2018-03-01 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2018-08-13 view
CXSL1800027 CS1003注射液 CS1003 Injection Biological Products(1) New Drug Application 2018-03-13 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2018-07-06 view
CXHL1800064 CS3006片 CS3006 Tablet Chemical Drugs(1) New Drug Application 2018-04-25 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2018-07-13 view
CXHL1800063 CS3006片 CS3006 Tablet Chemical Drugs(1) New Drug Application 2018-04-25 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2018-07-13 view
CXHL1800062 CS3006 CS3006 Active ingredient Chemical Drugs(1) New Drug Application 2018-04-25 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2018-04-23 view
CXHL1700361 CS3001 CS3001 Active ingredient Chemical Drugs(1) New Drug Application 2018-06-06 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2018-06-04 view
CXHL1700363 CS3001片 CS3001 Tablet Chemical Drugs(1) New Drug Application 2018-06-06 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2018-10-15 view
CXHL1700362 CS3001片 CS3001 Tablet Chemical Drugs(1) New Drug Application 2018-06-06 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2018-10-15 view
JXHL1800152 BLU-554胶囊 BLU-554 Capsule Chemical Drugs(1) Import Drug Application 2018-11-02 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2018-11-01 view
JXHL1800162 avapritinib片 avapritinib Tablet Chemical Drugs(1) Import Drug Application 2018-11-26 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2018-11-23 view
JXHL1900001 BLU-667胶囊 BLU-667 Capsule Chemical Drugs(1) Import Drug Application 2019-01-09 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-01-08 view
CXHL1900010 CS3003 CS3003 Active ingredient Chemical Drugs(1) New Drug Application 2019-01-11 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-01-10 view
CXHL1900013 CS3003片 CS3003 Tablet Chemical Drugs(1) New Drug Application 2019-01-11 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-01-10 view
CXHL1900011 CS3003片 CS3003 Tablet Chemical Drugs(1) New Drug Application 2019-01-11 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-01-10 view
JXHL1900014 avapritinib片 avapritinib Tablet Chemical Drugs(1) Import Drug Application 2019-01-26 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-01-24 view
CXSL1900011 重组抗PD-L1全人单克隆抗体注射液 Recombinant anti-PD-L1 human monoclonal antibody Injection Biological Products(1) New Drug Application 2019-02-12 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-02-11 view
CXSL1900017 重组抗PD-L1全人单克隆抗体注射液 Recombinant anti-PD-L1 human monoclonal antibody Injection Biological Products(1) New Drug Application 2019-03-07 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-03-06 view
JXHL1900045 BLU-554胶囊 BLU-554 Capsule Chemical Drugs(1) Import Drug Application 2019-03-08 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-03-07 view