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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
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
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
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
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