Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CSL01005 | 重组人血管内皮抑制素(UH-16) | Other | Biological Products(1) | New Drug Application | 2001-01-22 | 烟台荣昌生物工程有限公司 | RemeGen Co Ltd | Certificate Issued | 2001-07-24 | view | |
CXSL1000017 | 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 | 2010-07-01 | 烟台荣昌生物工程有限公司 | RemeGen Co Ltd | Certificate Issued | 2011-04-21 | view | |
CYSB1300034 | 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 | Supplementary Application | 2013-03-14 | 烟台荣昌生物工程有限公司 | RemeGen Co Ltd | Certificate Issued | 2013-07-19 | view | |
CXSL1400087 | 注射用重组人源化抗HER2单抗-MMAE偶联剂 | disitamab vedotin | Lyophilized | Biological Products(1) | New Drug Application | 2014-09-18 | 烟台荣昌生物工程有限公司 | RemeGen Co Ltd | Certificate Issued | 2015-10-13 | view |
CXSB1600007 | 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 | Supplementary Application | 2016-10-11 | 烟台荣昌生物工程有限公司 | RemeGen Co Ltd | Certificate Issued | 2017-04-17 | view |