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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
CXSL1300093 注射用重组人胰高血糖素样肽-1类似物融合蛋白(酵母) MW-04 Lyophilized Biological Products(1) New Drug Application 2013-12-17 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2016-11-23 view
CXSL1200071 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2012-10-23 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2014-10-24 view
CXSL1000048 注射用重组(酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(I)融合蛋白 Lyophilized Biological Products(1) New Drug Application 2010-12-23 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2012-12-25 view
CXSL1000047 注射用重组(酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(I)融合蛋白 Lyophilized Biological Products(1) New Drug Application 2010-12-23 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2012-12-25 view
CXSB1900019 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products Supplementary Application 2019-08-13 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2020-03-06 view
CXSB1900017 注射用重组(酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(I)融合蛋白 Lyophilized Biological Products Supplementary Application 2019-08-06 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd In Review 2019-08-05 view
CXSB1700001 注射用重组(酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(I)融合蛋白 Lyophilized Biological Products Supplementary Application 2017-06-08 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2018-03-06 view