| Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CXSL1500047 | 注射用重组人源化抗HER2单克隆抗体-美登素偶联物 | BAT-8001 | Lyophilized | Biological Products(1) | New Drug Application | 2015-07-09 | 百奥泰生物科技（广州）有限公司 | Bio-Thera Solutions Ltd | Certificate Issued | 2016-10-11 | view |
| CXSL1800121 | 注射用重组人源化抗HER2单克隆抗体-美登素偶联物 | BAT-8001 | Lyophilized | Biological Products(1) | New Drug Application | 2018-12-25 | 百奥泰生物科技（广州）有限公司 | Bio-Thera Solutions Ltd | In Review | 2018-12-24 | view |
| CXSL1900083 | 注射用重组人源化抗HER2单克隆抗体 | Recombinant humanized monoclonal antibody against HER2 | Lyophilized | Biological Products(2) | New Drug Application | 2019-08-06 | 喜康（武汉）生物医药有限公司 | Xikang(Wuhan)Biopharmaceutical Co Ltd | In Review | 2019-08-05 | view |