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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYHB1901375 BLU-667胶囊 BLU-667 Capsule Chemical Drugs(1) Supplementary Application 2019-11-28 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2020-01-20 view
JYHB1900973 BLU-667胶囊 BLU-667 Capsule Chemical Drugs Supplementary Application 2019-08-15 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-08-16 view
JXHS2000131 普拉替尼胶囊 pralsetinib Capsule Chemical Drugs(1) Import Drug Application 2020-09-08 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2021-03-25 view
JXHS2000052 阿泊替尼片 avapritinib Tablet Chemical Drugs(5.1) Import Drug Application 2020-04-29 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2021-03-31 view
JXHS2000051 阿泊替尼片 avapritinib Tablet Chemical Drugs(5.1) Import Drug Application 2020-04-29 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2021-03-31 view
JXHS2000050 阿泊替尼片 avapritinib Tablet Chemical Drugs(5.1) Import Drug Application 2020-04-29 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd Certificate Issued 2021-03-31 view
JXHL2000020 Pralsetinib胶囊 pralsetinib Capsule Chemical Drugs(1) Import Drug Application 2020-02-19 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2020-02-18 view
JXHL1900152 avapritinib片 avapritinib Tablet Chemical Drugs(1) Import Drug Application 2019-07-08 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-07-05 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
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
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
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
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
CXSS2000056 舒格利单抗注射液 Sugemalimab Injection Biological Products(1) New Drug Application 2020-11-13 基石药业(苏州)有限公司,无锡药明生物技术股份有限公司 Approval Completed-Pending Certificated 2021-12-20 view
CXSL2000357 CS1002注射液 Ipilimumab Injection Biological Products(2.2) New Drug Application 2020-12-18 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2020-12-16 view
CXSL2000356 CS1003注射液 CS1003 Injection Biological Products(1) New Drug Application 2020-12-16 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2020-12-15 view
CXSL2000015 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 2020-02-10 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2020-02-07 view
CXSL1900143 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 2019-12-20 基石药业(苏州)有限公司 Cornerstone Pharmaceutical (Suzhou) Co Ltd In Review 2019-12-18 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
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