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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL0900021 重组人鼠嵌合抗CD20单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2009-11-12 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2011-08-03 view
CXSL1100047 重组全人源抗人表皮生长因子受体单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2011-11-10 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2014-02-13 view
CYSB1400070 重组人鼠嵌合抗CD20单克隆抗体注射液 Injection Biological Products Supplementary Application 2014-07-11 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2014-10-10 view
CXSL1400061 注射用重组人凝血因子VIII Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(10) New Drug Application 2014-07-11 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2016-01-14 view
CXSL1400060 注射用重组人凝血因子VIII Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(10) New Drug Application 2014-07-11 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2016-01-14 view
CXSL1300109 重组人源化抗H7N9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2014-02-24 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2016-02-19 view
CXSL1500036 重组人源化抗VEGF单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-06-19 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2016-10-11 view
CXSL1500089 重组全人源抗肿瘤坏死因子α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2015-11-19 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2017-05-22 view
CXSL1700078 重组人源化抗VEGF单克隆抗体眼用注射液 Injection Biological Products(2) New Drug Application 2017-09-30 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2018-05-08 view
CXSL1800025 重组人源化抗PD-1单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2018-03-06 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2018-07-06 view
CXSL1800067 重组全人源抗肿瘤坏死因子α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2018-06-14 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2018-10-15 view
CXSS1900047 利珀妥单抗注射液 ripertamab Injection Biological Products(2) New Drug Application 2019-12-16 神州细胞工程有限公司 SinoCelltech Ltd In Review 2019-12-13 view
CXSS1900049 利珀妥单抗注射液 ripertamab Injection Biological Products(2) New Drug Application 2019-12-16 神州细胞工程有限公司 SinoCelltech Ltd In Review 2019-12-13 view
CXSS1900048 利珀妥单抗注射液 ripertamab Injection Biological Products(2) New Drug Application 2019-12-16 神州细胞工程有限公司 SinoCelltech Ltd In Review 2019-12-13 view
CXSL2000119 重组人源化抗VEGF单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2020-05-29 神州细胞工程有限公司 SinoCelltech Ltd In Review 2020-05-28 view
CXSL2000118 重组人源化抗PD-1单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2020-05-29 神州细胞工程有限公司 SinoCelltech Ltd In Review 2020-05-28 view
CXSB2100003 重组十四价人乳头瘤病毒疫苗(6,11,16,18,31,33,35,39,45,51,52,56,58,59型)(昆虫细胞) Injection Biological Products(1.1) Supplementary Application 2021-01-09 神州细胞工程有限公司 SinoCelltech Ltd In Review 2021-01-08 view
CXSS1900042 注射用重组人凝血因子VIII Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(10) New Drug Application 2019-11-19 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2021-07-28 view
CXSS1900043 注射用重组人凝血因子VIII Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(10) New Drug Application 2019-11-19 神州细胞工程有限公司 SinoCelltech Ltd Certificate Issued 2021-07-28 view