| 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 | albipagrastim alfa | 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 | albipagrastim alfa | 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 | albipagrastim alfa | 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;Taizhou Beijin Biotechnology 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 | albipagrastim alfa | 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;Taizhou Beijin Biotechnology Co Ltd | Certificate Issued | 2018-03-06 | view |