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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CXSL1800018 注射用SHR-1209 recaticimab Lyophilized Biological Products(1) New Drug Application 2018-03-05 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd Certificate Issued 2018-06-28 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
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
CXSL1900036 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2019-04-24 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2019-04-22 view
CXSL1900037 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2019-04-24 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2019-04-22 view
CXSS1800009 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2018-04-23 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd Certificate Issued 2019-06-03 view
CXSL1900055 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
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
CXSL1900063 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2019-07-01 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2019-06-28 view
CXSB1900013 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products Supplementary Application 2019-06-21 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd Certificate Issued 2019-07-08 view
CXSL1900106 SHR-1316注射液 Adebrelimab Injection Biological Products(1) New Drug Application 2019-09-25 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2019-09-24 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
CXSL1900123 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2019-11-05 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2019-11-04 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
CXSL1900148 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products(1) New Drug Application 2019-12-24 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2019-12-23 view
CXSL2000007 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
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
CXSL2000003 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
CXSB2000002 注射用卡瑞利珠单抗 camrelizumab Lyophilized Biological Products Supplementary Application 2020-01-17 苏州盛迪亚生物医药有限公司 Suzhou Suncadia Biopharmaceuticals Co Ltd In Review 2020-01-16 view