CXSL2100003 | 重组抗RANKL全人源单克隆抗体注射液 | denosumab | Injection | Biological Products(3.3) | New Drug Application | 2021-01-06 | 上海翰森生物医药科技有限公司 | Shanghai Hansoh BioMedical Co Ltd | In Review | 2021-01-06 | view |
CXSL2000374 | 重组全人源抗RANKL单克隆抗体注射液 | denosumab | Injection | Biological Products(3.3) | New Drug Application | 2020-12-23 | 广东安普泽生物医药股份有限公司 | Annpo Biotechnology Inc | In Review | 2020-12-22 | view |
JXSS2000009 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Import Drug Application | 2020-04-23 | 安进生物技术咨询(上海)有限公司 | Amgen Biology Technology Consulting (Shanghai) Co Ltd | Certificate Issued | 2020-11-19 | view |
JTS2000044 | 地舒单抗(狄诺塞麦)注射液 | denosumab | Injection | Biological Products | Disposable Import Drug Application | 2020-10-12 | Amgen Manufacturing Limited | Amgen Manufacturing Ltd | Certificate Issued | 2020-10-30 | view |
JTS2000046 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Disposable Import Drug Application | 2020-10-19 | Amgen Manufacturing Limited | Amgen Manufacturing Ltd | In Review | 2020-10-14 | view |
JTS2000045 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Disposable Import Drug Application | 2020-10-19 | Amgen Technology (Ireland) Unlimited Company | Amgen Technology (Ireland) UnLtd Company | In Review | 2020-10-14 | view |
JTS2000037 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Disposable Import Drug Application | 2020-08-26 | Amgen Manufacturing, Limited | Amgen Manufacturing Ltd | In Review | 2020-08-21 | view |
CXSB2000038 | 重组抗RANKL全人单克隆抗体注射液 | denosumab | Injection | Biological Products(3.3) | Supplementary Application | 2020-08-04 | 山东博安生物技术有限公司 | Shandong BoAn Biotechnology Co Ltd | In Review | 2020-08-03 | view |
JTS2000029 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Disposable Import Drug Application | 2020-07-08 | Amgen Manufacturing Limited (AML) | Amgen Manufacturing Ltd | Certificate Issued | 2020-07-24 | view |
JTS2000028 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Disposable Import Drug Application | 2020-06-28 | Amgen Manufacturing Limited | Amgen Manufacturing Ltd | Certificate Issued | 2020-07-13 | view |
JTS2000026 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Disposable Import Drug Application | 2020-06-15 | Amgen Manufacturing, Limited | Amgen Manufacturing Ltd | Certificate Issued | 2020-07-03 | view |
JXSS1900034 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Import Drug Application | 2019-06-22 | 安进生物技术咨询(上海)有限公司 | Amgen Biology Technology Consulting (Shanghai) Co Ltd | Certificate Issued | 2020-06-22 | view |
JTS2000021 | 地诺单抗注射液 | denosumab | Injection | Biological Products | Disposable Import Drug Application | 2020-06-03 | Amgen Manufacturing Limited | Amgen Manufacturing Ltd | Certificate Issued | 2020-06-16 | view |
JYSB2000222 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Supplementary Application | 2020-06-02 | 百济神州(北京)生物科技有限公司 | BeiGene (Beijing) Co Ltd | Filed | 2020-06-09 | view |
CXSB2000013 | 重组抗RANKL全人单克隆抗体注射液 | denosumab | Injection | Biological Products | Supplementary Application | 2020-05-13 | 齐鲁制药有限公司 | QILU Pharmaceutical Co Ltd | In Review | 2020-05-12 | view |
JTS2000004 | Denosumab | denosumab | Injection | Biological Products | Disposable Import Drug Application | 2020-03-24 | Amgen Manufacturing Limited (AML) | Amgen Manufacturing Ltd | In Review | 2020-03-16 | view |
CXSL2000043 | 重组抗RANKL全人单克隆抗体注射液 | denosumab | Injection | Biological Products(2) | New Drug Application | 2020-03-12 | 上海复宏汉霖生物技术股份有限公司 | Shanghai Henlius Biotech Co Ltd | In Review | 2020-03-11 | view |
JTS2000003 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Disposable Import Drug Application | 2020-03-12 | Amgen Manufacturing,Limited | Amgen Manufacturing Ltd | In Review | 2020-03-10 | view |
CXSB1900028 | 重组抗RANKL全人单克隆抗体注射液 | denosumab | Injection | Biological Products | Supplementary Application | 2019-12-07 | 齐鲁制药有限公司 | QILU Pharmaceutical Co Ltd | Certificate Issued | 2020-02-20 | view |
JXSL1900137 | 地舒单抗注射液 | denosumab | Injection | Biological Products | Import Drug Application | 2019-12-06 | 安进生物技术咨询(上海)有限公司 | Amgen Biology Technology Consulting (Shanghai) Co Ltd | In Review | 2019-12-05 | view |