Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
CXSS2000029 | 贝伐珠单抗注射液 | bevacizumab | Injection | Biological Products(2) | New Drug Application | 2020-06-24 | 百奥泰生物制药股份有限公司 | Bio-Thera Solutions Ltd | Certificate Issued | 2021-11-19 | view |
CXSS2000030 | 贝伐珠单抗注射液 | bevacizumab | Injection | Biological Products(2) | New Drug Application | 2020-06-24 | 百奥泰生物制药股份有限公司 | Bio-Thera Solutions Ltd | Certificate Issued | 2021-11-19 | 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 |
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 |