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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1400030 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2014-04-15 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd Certificate Issued 2016-10-11 view
CXSL1400029 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2014-04-15 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd Certificate Issued 2016-10-11 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
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
CXSL1600131 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2017-02-13 菲洋生物科技(吉林)有限公司 Feiyang Biotechnology (Jilin) Co Ltd Certificate Issued 2017-12-21 view
CXSL1700211 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2018-01-31 苏州信达生物科技有限公司 Suzhou Xinda Biotechnology Co Ltd Certificate Issued 2018-07-06 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
CXSL1700051 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2017-07-25 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2017-12-21 view
CXSL1700048 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2017-07-17 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2017-12-21 view
CXSL1800064 重组抗RANKL全人源单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2018-06-13 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2018-10-29 view
CXSL1500116 重组抗RANKL全人源单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-01-15 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2016-12-15 view
CXSL1600032 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-05-18 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2017-01-11 view
CXSL1400093 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2014-12-11 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2016-09-26 view
CXSL1900116 重组抗RANKL全人源单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2019-10-29 昆药集团股份有限公司 KPC Pharmaceuticals Inc In Review 2019-10-28 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
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
CXSL1600099 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-12-05 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd Certificate Issued 2017-06-20 view
CXSL1600080 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-10-11 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd Certificate Issued 2017-06-09 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
JXSS1800026 地舒单抗注射液 denosumab Injection Biological Products Import Drug Application 2018-10-26 安进生物技术咨询(上海)有限公司 Amgen Biology Technology Consulting (Shanghai) Co Ltd Certificate Issued 2019-05-23 view