Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CXSB2000012 | RC28-E注射液 | RC28-E | Injection | Biological Products | Supplementary Application | 2020-05-10 | 荣昌生物制药(烟台)有限公司 | RemeGen Co Ltd | In Review | 2020-05-09 | view |
CXSS1900040 | 注射用泰它西普 | telitacicept | Lyophilized | Biological Products(1) | New Drug Application | 2019-11-13 | 荣昌生物制药(烟台)有限公司 | RemeGen Co Ltd | Certificate Issued | 2021-03-16 | view |
CXSL1900051 | 注射用RC98 | RC98 | Lyophilized | Biological Products(1) | New Drug Application | 2019-05-29 | 荣昌生物制药(烟台)有限公司 | RemeGen Co Ltd | In Review | 2019-05-28 | view |
CXSL1800066 | 注射用RC88 | RC88 | Lyophilized | Biological Products(1) | New Drug Application | 2018-06-04 | 荣昌生物制药(烟台)有限公司 | RemeGen Co Ltd | In Review | 2018-05-31 | view |
CXSL1700191 | 注射用重组人B淋巴细胞刺激因子受体-抗体融合蛋白 | Lyophilized | Biological Products(1) | New Drug Application | 2018-01-08 | 荣昌生物制药(烟台)有限公司 | RemeGen Co Ltd | Certificate Issued | 2018-06-08 | view | |
CXSL1700081 | RC28-E注射液 | RC28-E | Injection | Biological Products(1) | New Drug Application | 2017-08-24 | 荣昌生物制药(烟台)有限公司 | RemeGen Co Ltd | Certificate Issued | 2018-05-30 | view |
CXSL1700080 | RC28-E注射液 | RC28-E | Injection | Biological Products(1) | New Drug Application | 2017-08-24 | 荣昌生物制药(烟台)有限公司 | RemeGen Co Ltd | Certificate Issued | 2018-05-30 | view |