Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CXSL1400110 | 重组抗血管内皮生长因子人源化单克隆抗体注射液 | Injection | Biological Products(2) | New Drug Application | 2015-05-13 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | Certificate Issued | 2016-10-11 | view | |
CXSL1300035 | 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 | 2013-07-22 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | Certificate Issued | 2016-03-28 | view |
CXSL1200053 | 注射用重组抗TNF-alpha人鼠嵌合单克隆抗体 | Lyophilized | Biological Products(2) | New Drug Application | 2012-11-08 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | Certificate Issued | 2015-01-26 | view | |
CXSL1100032 | 注射用重组抗HER2人源化单克隆抗体 | Recombinant humanized monoclonal antibody against HER2 | Lyophilized | Biological Products(2) | New Drug Application | 2011-08-26 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | Certificate Issued | 2013-07-19 | view |
CXSL1700030 | 注射用GB251 | GB251 | Lyophilized | Biological Products(1) | New Drug Application | 2017-07-27 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | Certificate Issued | 2018-05-08 | view |
CXSL1700020 | 注射用GB235 | GB-235 | Lyophilized | Biological Products(1) | New Drug Application | 2017-08-11 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | Certificate Issued | 2018-03-06 | view |
CXSL2000055 | 杰诺单抗注射液 | genolimzumab | Injection | Biological Products(1) | New Drug Application | 2020-04-02 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | In Review | 2020-04-01 | view |
CXSL1900138 | 杰诺单抗注射液 | genolimzumab | Injection | Biological Products(1) | New Drug Application | 2019-12-06 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | In Review | 2019-12-05 | view |
CXSL1900137 | 杰诺单抗注射液 | genolimzumab | Injection | Biological Products(1) | New Drug Application | 2019-12-06 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | In Review | 2019-12-05 | view |
CXSL1600016 | 杰诺单抗注射液 | genolimzumab | Injection | Biological Products(1) | New Drug Application | 2016-04-07 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | Certificate Issued | 2016-12-08 | view |
CXSL2000068 | 杰诺单抗注射液 | genolimzumab | Injection | Biological Products(1) | New Drug Application | 2020-04-15 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | In Review | 2020-04-14 | view |
CXSL1500110 | 杰瑞单抗注射液 | Injection | Biological Products(1) | New Drug Application | 2016-01-28 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | Certificate Issued | 2016-12-15 | view | |
CXSL2100005 | 杰洛利单抗注射液 | geptanolimab | Injection | Biological Products(1) | New Drug Application | 2021-01-08 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | In Review | 2021-01-07 | view |
CXSL1700042 | GB223注射液 | GB223 | Injection | Biological Products(1) | New Drug Application | 2017-08-16 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | Certificate Issued | 2017-12-21 | view |
CXSL1700041 | GB223注射液 | GB223 | Injection | Biological Products(1) | New Drug Application | 2017-08-17 | 嘉和生物药业有限公司 | Genor Biopharma Co Ltd | Certificate Issued | 2018-01-17 | view |