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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1400093 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2014-12-11 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2016-09-26 view
CXSL1600032 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-05-18 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2017-01-11 view
CXSL1600051 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2016-08-11 上海津曼特生物科技有限公司 Shanghai GeneMab Biological Technology Co Ltd Certificate Issued 2017-07-06 view
CXSL1600053 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2016-08-11 上海津曼特生物科技有限公司 Shanghai GeneMab Biological Technology Co Ltd Certificate Issued 2017-03-15 view
CXSL1600131 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2017-02-13 菲洋生物科技(吉林)有限公司 Feiyang Biotechnology (Jilin) Co Ltd Certificate Issued 2017-12-21 view
CXSL1700048 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2017-07-17 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2017-12-21 view
CXSL1700051 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2017-07-25 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2017-12-21 view
CXSL1700211 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2018-01-31 苏州信达生物科技有限公司 Suzhou Xinda Biotechnology Co Ltd Certificate Issued 2018-07-06 view
CXSL2000374 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(3.3) New Drug Application 2020-12-23 广东安普泽生物医药股份有限公司 Annpo Biotechnology Inc In Review 2020-12-22 view
CXSL2101237 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2021-08-05 Shanghai GeneMab Biological Technology Co Ltd view