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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1800121 注射用重组人源化抗HER2单克隆抗体-美登素偶联物 BAT-8001 Lyophilized Biological Products(1) New Drug Application 2018-12-25 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2018-12-24 view
CXSL1300033 重组人抗TNF-α单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2013-05-28 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2016-01-14 view
CXSL1700153 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2017-12-13 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2018-06-28 view
CXSL1800131 重组人源化抗VEGF单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2019-01-07 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2019-01-04 view
CXHL0501733 巴替非班注射液 bevifibatide citrate Injection Chemical Drugs(1.1) New Drug Application 2005-10-16 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2006-11-27 view
CXSL1600102 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2017-01-12 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2017-09-14 view
CXHB1000456 巴替非班注射液 bevifibatide citrate Injection Chemical Drugs Supplementary Application 2011-02-10 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2012-07-23 view
CXSL1700071 重组Fc糖基化修饰抗CD20人源化单克隆抗体注射液 Recombinant Glycosylation-modified Anti-human-CD20 Monoclonal Antibody Injection Biological Products(1) New Drug Application 2017-08-10 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2018-03-20 view
CXSL1800130 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2019-01-07 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2019-01-04 view
CXSL1600048 重组人源化抗人白介素6受体单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2016-07-15 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2017-11-21 view
CXSL1800122 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2018-12-25 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2018-12-24 view
CXSL1600124 重组人源化抗人白介素6受体单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2017-02-13 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2017-05-22 view
CXSL1800123 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2018-12-25 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2018-12-24 view
CXSL1500047 注射用重组人源化抗HER2单克隆抗体-美登素偶联物 BAT-8001 Lyophilized Biological Products(1) New Drug Application 2015-07-09 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2016-10-11 view
CXSL1800110 注射用重组人源化抗Trop2单克隆抗体-美登素偶联物 Lyophilized Biological Products(1) New Drug Application 2018-11-14 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2018-11-12 view
CXHB0800660 巴替非班注射液 bevifibatide citrate Injection Chemical Drugs Supplementary Application 2008-05-23 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2008-08-07 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
CXSL1800124 重组人源化抗VEGF单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2018-12-25 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd In Review 2018-12-24 view
CXSL1400014 重组人源化抗VEGF单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2014-05-04 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2016-05-11 view
CXSS1800018 阿达木单抗注射液 adalimumab Injection Biological Products(2) New Drug Application 2018-08-27 百奥泰生物科技(广州)有限公司 Bio-Thera Solutions Ltd Certificate Issued 2019-11-13 view