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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0306590 自体肝癌细胞及脾B淋巴细胞融合瘤苗 Other Biological Products(3) New Drug Application 2003-12-17 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2004-10-29 view
X0306268 注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 Lyophilized Biological Products(7) New Drug Application 2003-12-10 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2004-07-12 view
X0305679 注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 Lyophilized Biological Products(7) New Drug Application 2003-11-05 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2004-05-14 view
X0304073 重组人白细胞介素-1受体拮抗剂注射液 Injection Biological Products(7) New Drug Application 2003-08-09 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2004-04-02 view
X0303849 注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 Lyophilized Biological Products(14) New Drug Application 2003-08-06 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2004-04-02 view
X0302917 注射用重组抗HER2人源化单克隆抗体 Recombinant humanized monoclonal antibody against HER2 Lyophilized Biological Products(2) New Drug Application 2004-04-02 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2004-07-12 view
X0301010 重组人-鼠嵌合抗CD20单克隆抗体注射液 rituximab Injection Biological Products(2) New Drug Application 2003-11-25 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2004-03-05 view
X0300202 重组人白细胞介素-1受体拮抗剂注射液 Injection Biological Products(7) New Drug Application 2003-08-13 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2003-12-30 view
CYSS0600094 注射用重组人生长激素 Somatropin Lyophilized Biological Products(15) Generic Drug 2007-07-20 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2009-02-25 view
CYSB0900204 注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 Lyophilized Biological Products Supplementary Application 2010-01-07 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2011-04-12 view
CYSB0900203 注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 Lyophilized Biological Products Supplementary Application 2010-01-07 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2011-04-12 view
CXSS1000001 重组人白细胞介素-1受体拮抗剂注射液 Injection Biological Products(7) New Drug Application 2010-06-29 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2014-02-13 view
CXSS0800004 重组抗CD25人源化单克隆抗体注射液 Recombinant anti-CD25 humanized monoclonal antibody Injection Biological Products(2) New Drug Application 2008-03-28 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2011-01-18 view
CXSS0700053 注射用重组抗HER2人源化单克隆抗体 Recombinant humanized monoclonal antibody against HER2 Lyophilized Biological Products(2) New Drug Application 2007-08-22 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2008-10-29 view
CXSS0600037 注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 Lyophilized Biological Products(7) New Drug Application 2006-03-13 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2007-05-21 view
CXSS0600036 注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 Lyophilized Biological Products(7) New Drug Application 2006-03-13 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2007-05-21 view
CXSS0500152 注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 Lyophilized Biological Products(7) New Drug Application 2005-12-07 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2012-07-27 view
CXSS0500150 注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 Lyophilized Biological Products(7) New Drug Application 2005-12-07 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2012-07-27 view
CXSL0500014 注射用重组人CTLA4-抗体融合蛋白 Lyophilized Biological Products(1) New Drug Application 2005-03-02 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2006-05-29 view
CXSB0500178 注射用重组人白细胞介素-11 recombinant human interleukin-11 Lyophilized Biological Products Supplementary Application 2006-08-02 上海中信国健药业有限公司 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd Certificate Issued 2007-10-26 view