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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1900033 BAT4406F注射液 BAT4406F Injection Biological Products(1) New Drug Application 2019-04-17 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2019-04-16 view
CXSL1900032 BAT4406F注射液 BAT4406F Injection Biological Products(1) New Drug Application 2019-04-17 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2019-04-16 view
CXSL1900103 重组人抗白介素12单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2019-09-12 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2019-09-10 view
CXSL1900134 重组抗VEGF人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2019-12-03 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2019-12-02 view
CXSL2000042 BAT1308注射液 BAT1308 Injection Biological Products(1) New Drug Application 2020-03-11 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2020-03-10 view
CYSB2000171 阿达木单抗注射液 adalimumab Injection Biological Products Supplementary Application 2020-07-04 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2020-07-02 view
CYSB2000048 阿达木单抗注射液 adalimumab Injection Biological Products Supplementary Application 2020-03-25 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd Certificate Issued 2020-07-27 view
CXSL2000220 BAT4706注射液 BAT4706 Injection Biological Products(1) New Drug Application 2020-08-04 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2020-08-03 view
CXSL2000221 BAT4706注射液 BAT4706 Injection Biological Products(1) New Drug Application 2020-08-04 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2020-08-03 view
CYSB2000120 阿达木单抗注射液 adalimumab Injection Biological Products Supplementary Application 2020-05-29 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd Certificate Issued 2020-08-12 view
CXSL2000257 BAT1006注射液 BAT-1006 Injection Biological Products(2.4) New Drug Application 2020-09-08 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2020-09-08 view
CXHS2000039 巴替非班注射液 bevifibatide citrate Injection Chemical Drugs(1) New Drug Application 2020-10-14 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2020-10-13 view
CXSL2000344 司库奇尤单抗注射液 secukinumab Injection Biological Products(3.3) New Drug Application 2020-12-07 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2020-12-07 view
CXSL2100049 BAT4706注射液 BAT4706 Injection Biological Products(2.4) New Drug Application 2021-02-11 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2021-02-10 view
CXSL2100050 BAT4706注射液 BAT4706 Injection Biological Products(2.4) New Drug Application 2021-02-11 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2021-02-10 view
CYSB2000172 阿达木单抗注射液 adalimumab Injection Biological Products(2) Supplementary Application 2020-07-08 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd Certificate Issued 2021-02-18 view
CXSL2100070 BAT6026注射液 BAT-6026 Injection Biological Products(1) New Drug Application 2021-02-25 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2021-02-24 view
CXSL2100074 托珠单抗注射液 tocilizumab Injection Biological Products(3.4) New Drug Application 2021-02-27 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2021-02-26 view
CXSL2100105 贝伐珠单抗注射液 bevacizumab Injection Biological Products(3.3) New Drug Application 2021-03-25 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2021-03-24 view
CXSL2100104 贝伐珠单抗注射液 bevacizumab Injection Biological Products(3.3) New Drug Application 2021-03-25 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2021-03-24 view