Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CXSL1700027 | 重组人-鼠嵌合抗CD20单克隆抗体注射液 | rituximab | Injection | Biological Products(2) | New Drug Application | 2017-07-13 | 喜康(武汉)生物医药有限公司 | Xikang(Wuhan)Biopharmaceutical Co Ltd | Certificate Issued | 2018-06-28 | 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 |
CXSL1800037 | 重组人源化抗VEGF单克隆抗体注射液 | Injection | Biological Products(2) | New Drug Application | 2018-04-19 | 喜康(武汉)生物医药有限公司 | Xikang(Wuhan)Biopharmaceutical Co Ltd | Certificate Issued | 2018-09-25 | view |