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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1200030 注射用重组人源化抗肿瘤坏死因子α单克隆抗体 adalimumab Injection Biological Products(1) New Drug Application 2012-06-19 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2014-03-04 view
CXSL1400155 注射用重组人绒促性素 Choriogonadotropin Lyophilized Biological Products(15) New Drug Application 2015-02-26 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2016-10-11 view
CXSL1500027 重组人鼠嵌合抗CD20单克隆抗体注射液 rituximab Injection Biological Products(2) New Drug Application 2015-05-09 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2016-12-08 view
CXSL1600001 重组抗HER2结构域Ⅱ人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2016-03-30 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2016-12-08 view
CXSB1600009 注射用重组人源化抗人肿瘤坏死因子α单克隆抗体 adalimumab Injection Biological Products Supplementary Application 2016-09-05 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2016-11-17 view
CXSB1600010 注射用重组人源化抗人肿瘤坏死因子α单克隆抗体 adalimumab Injection Biological Products Supplementary Application 2016-09-05 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2016-11-17 view
CXSL1600125 注射用重组人源化抗PD-1单克隆抗体 Recombinant humanized anti-PD-1 monoclonal antibody Lyophilized Biological Products(1) New Drug Application 2017-04-20 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2017-10-26 view
CXSL1700048 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2017-07-17 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2017-12-21 view
CXSL1700051 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2017-07-25 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2017-12-21 view
CXSL1700170 重组人源化抗人IL-6R单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-02-08 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2018-10-29 view
CXSL1900024 重组全人源抗OX40单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2019-03-19 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC In Review 2019-03-18 view
CXSL1900130 重组抗人IL-17A/F人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2019-11-20 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC In Review 2019-11-19 view
CXSL2000035 注射用重组肿瘤酶特异性干扰素α-2b Fc融合蛋白 Lyophilized Biological Products(1) New Drug Application 2020-02-25 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC In Review 2020-02-24 view