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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1900113 SHR-1316注射液 Adebrelimab Injection Biological Products(1) New Drug Application 2019-10-24 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2019-10-23 view
CXSB2000116 SHR-1314注射液 vunakizumab Injection Biological Products(1) Supplementary Application 2020-12-02 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-12-01 view
CXSL2000040 SHR-1316注射液 Adebrelimab Injection Biological Products(1) New Drug Application 2020-03-07 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-03-06 view
CXSL1900030 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2019-03-26 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2019-03-25 view
CXSL2100079 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(2.2) New Drug Application 2021-03-03 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2021-03-02 view
CXSB2000023 SHR-1314注射液 vunakizumab Injection Biological Products Supplementary Application 2020-06-30 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-11-11 view
CXSB1900021 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products Supplementary Application 2019-09-12 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd Certificate Issued 2019-11-28 view
CXSL2000298 贝伐珠单抗注射液 bevacizumab Injection Biological Products(2.2) New Drug Application 2020-10-27 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-10-26 view
CXSL2000006 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2020-01-16 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-01-15 view
CXSL1700113 注射用SHR-1501 SHR-1501 Lyophilized Biological Products(1) New Drug Application 2017-12-18 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd Certificate Issued 2018-05-17 view
CXSL2100017 SHR-1701注射液 retlirafusp alfa Injection Biological Products(1) New Drug Application 2021-01-19 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2021-01-19 view
CXSS2000012 贝伐珠单抗注射液 bevacizumab Injection Biological Products(2) New Drug Application 2020-04-15 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-04-14 view
CXSL1900054 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2019-06-21 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2019-06-20 view
CXSS2100031 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(2.2) New Drug Application 2021-03-26 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd Certificate Completed-Pending Issued 2021-12-10 view
CXSL2000253 SHR-1314注射液 vunakizumab Injection Biological Products(1) New Drug Application 2020-09-01 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-08-31 view
CXSS2000055 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(2.2) New Drug Application 2020-11-12 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-11-11 view
CXSL2000033 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2020-02-21 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-02-20 view
CXSL1900009 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2019-02-03 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2019-02-02 view
CXSL2100080 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(2.2) New Drug Application 2021-03-03 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2021-03-02 view
CXSL2000099 SHR-1316注射液 Adebrelimab Injection Biological Products(1) New Drug Application 2020-05-15 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-05-14 view