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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
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