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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXSS2300031 地舒单抗注射液 denosumab Injection Biological Products(3.1) Import Drug Application 2023-04-13 Amgen Europe BV;Amgen Manufacturing Ltd;Amgen Biology Technology Consulting (Shanghai) Co Ltd view
CXSL2400532 地舒单抗注射液 denosumab Injection Biological Products(3.3) New Drug Application 2024-08-10 Hualan Genetic Engineering Co Ltd;Hualan Genetic Engineering (Henan) Co Ltd view
JYSB2101008 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2021-04-10 Amgen Europe BV;Amgen Manufacturing Ltd view
CXSS2101033 地舒单抗注射液 denosumab Injection Biological Products(3.3) New Drug Application 2021-10-14 Shandong BoAn Biotechnology Co Ltd view
CXSL2500127 地舒单抗注射液 denosumab Injection Biological Products(3.3) New Drug Application 2025-02-09 Hualan Genetic Engineering Co Ltd;Hualan Genetic Engineering (Henan) Co Ltd view
CXSS2300014 地舒单抗注射液 denosumab Injection Biological Products(3.3) New Drug Application 2023-03-21 Shandong BoAn Biotechnology Co Ltd view
CYSB2400135 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2024-05-24 QILU Pharmaceutical Co Ltd view
CXSS2101076 地舒单抗注射液 denosumab Injection Biological Products(3.3) New Drug Application 2021-12-22 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd view
CXSS2500018 地舒单抗注射液 denosumab Injection Biological Products(3.3) New Drug Application 2025-01-27 Taizhou Maibotaike Pharmaceutical Co Ltd view
CXSS2300009 地舒单抗注射液 denosumab Injection Biological Products(3.3) New Drug Application 2023-03-08 Feiyang Biotechnology (Jilin) Co Ltd;Alphamab Jilin Co Ltd view
JYSZ2300054 地舒单抗注射液 denosumab Injection Biological Products License Renew 2023-12-21 Amgen Inc;BeiGene (Beijing) Co Ltd;Amgen Manufacturing Ltd view
JYSB2200025 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2022-02-25 Amgen Inc;Amgen Manufacturing Ltd;Bushu Pharmaceuticals Ltd view
CXSS2500019 地舒单抗注射液 denosumab Injection Biological Products(3.3) New Drug Application 2025-01-27 Taizhou Maibotaike Pharmaceutical Co Ltd view
CXSS2101077 地舒单抗注射液 denosumab Injection Biological Products(3.3) New Drug Application 2021-12-22 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd view
JYSB2300213 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2023-12-14 Amgen Europe BV;Amgen Manufacturing Ltd view
JYSB2101087 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2021-07-24 Amgen Europe BV;Amgen Manufacturing Ltd view
CYSB2400287 地舒单抗注射液 denosumab Injection Biological Products(3.3) Supplementary Application 2024-10-31 Feiyang Biotechnology (Jilin) Co Ltd;Alphamab Jilin Co Ltd view
CXSS2101027 地舒单抗注射液 denosumab Injection Biological Products(3.3) New Drug Application 2021-09-06 QILU Pharmaceutical Co Ltd view
JYSB2300112 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2023-06-22 Amgen Inc;Amgen Manufacturing Ltd;Bushu Pharmaceuticals Ltd view
JYSZ2400053 地舒单抗注射液 denosumab Injection Biological Products License Renew 2024-09-30 Amgen Europe BV;Amgen Manufacturing Ltd;Amgen Biology Technology Consulting (Shanghai) Co Ltd view