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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB2200096 人源化抗人TNFα单克隆抗体注射液(CHO细胞) adalimumab Injection Biological Products(1) Supplementary Application 2022-11-08 Shenyang Sunshine Pharmaceutical Co Ltd view
CXSB2101002 人源化抗人TNFα单克隆抗体注射液(CHO细胞) adalimumab Injection Biological Products(1) Supplementary Application 2021-03-18 Shenyang Sunshine Pharmaceutical Co Ltd view
CXSL1900007 重组抗肿瘤坏死因子α全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2019-01-29 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2019-01-28 view
CXSL1900004 重组抗TNF-α全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2019-01-21 广东东阳光生物制剂有限公司 Guangdong HEC Bio&Pharm Co Ltd In Review 2019-01-18 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
CXSL1800048 重组抗肿瘤坏死因子-α(TNF-α)全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2018-04-28 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd Certificate Issued 2018-10-08 view
CXSL1800014 重组全人源抗人TNF-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2018-02-13 武汉生物制品研究所有限责任公司 Wuhan Institute of Biological Products Co Ltd In Review 2018-02-11 view
CXSL1700098 重组抗TNFα全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2017-11-01 安徽未名达木生物医药有限公司 Anhui Weiming Damu Biomedical Co Ltd Certificate Issued 2018-09-03 view
CXSL1700017 重组全人源抗TNF-α单抗注射液 adalimumab Injection Biological Products(2) New Drug Application 2017-09-14 北京双鹭药业股份有限公司 Beijing SL Pharmaceutical Co Ltd Certificate Issued 2018-09-03 view
CXSB1700005 重组人抗肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products Supplementary Application 2017-08-18 信达生物制药(苏州)有限公司 Innovent Biologics (Suzhou) Co Ltd Certificate Issued 2018-01-17 view
CXSL1700057 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 2017-07-20 上海华奥泰生物药业有限公司 Shanghai Huaota Biopharmaceutical Co Ltd Certificate Issued 2018-06-28 view
CXSL1700056 重组全人源抗TNF-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2017-06-30 康宁杰瑞(吉林)生物科技有限公司 Alphamab Jilin Co Ltd Certificate Issued 2018-10-29 view
CXSL1700013 重组抗肿瘤坏死因子α全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2017-04-24 上海谐生医药科技有限公司 Shanghai Xiesheng Medical Technology Co Ltd Certificate Issued 2018-03-20 view
CXSL1600108 重组全人抗肿瘤坏死因子α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2017-04-13 深圳龙瑞药业有限公司 Lonn Ryonn PHARMA Ltd Certificate Issued 2017-12-11 view
CXSL1700003 重组人抗TNF-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2017-01-19 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2017-09-14 view
CXSL1600095 重组抗TNFα全人单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2016-12-12 上海复宏汉霖生物技术有限公司 Shanghai Henlius Biotech Co Ltd Certificate Issued 2017-04-20 view
CXSL1600064 抗人肿瘤坏死因子-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2016-11-10 北京绿竹生物技术股份有限公司 Beijing Lvzhu Biological Technology Co Ltd Certificate Issued 2017-11-21 view
CXSL1600059 重组人TNFα单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2016-09-12 海南赛乐敏生物科技有限公司 Hainan Sailemin Biotechnology Co Ltd Certificate Issued 2017-12-21 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