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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXSB2500045 罗莫索珠单抗注射液 romosozumab Injection Biological Products(2.2) Supplementary Application 2025-05-23 Amgen Inc view
CXSL2500056 罗莫佐单抗注射液 romosozumab Injection Biological Products(3.3) New Drug Application 2025-01-21 Zhuhai Federal Biomedical Co Ltd view
JXSL2400227 罗莫索珠单抗注射液 romosozumab Injection Biological Products(2.2) Import Drug Application 2024-11-23 Amgen Inc;Amgen Biology Technology Consulting (Shanghai) Co Ltd view
JTS2400147 romosozumab romosozumab Injection Biological Products Disposable Import Drug Application 2024-11-15 Chengdu Jinkai Biotech Co Ltd;Patheon Italia SpA view
JTS2400133 romosozumab romosozumab Injection Biological Products Disposable Import Drug Application 2024-10-23 Chengdu Jinkai Biotech Co Ltd;Patheon Italia SpA view
JXSS2400057 罗莫佐单抗注射液 romosozumab Injection Biological Products(3.1) Import Drug Application 2024-07-16 Patheon Italia SpA;UCB Pharma SA;UCB Trading (SHANGHAI) Co Ltd view
JTS2300026 Romosozumab注射液 romosozumab Injection Biological Products Disposable Import Drug Application 2023-04-27 Patheon Italia SpA;UCB Pharma SA;UCB Trading (SHANGHAI) Co Ltd view
JTS2300027 Romosozumab注射液 romosozumab Injection Biological Products Disposable Import Drug Application 2023-04-27 Patheon Italia SpA;UCB Pharma SA;UCB Trading (SHANGHAI) Co Ltd view
JYSB2200210 Romosozumab注射液 romosozumab Injection Biological Products(3.1) Supplementary Application 2022-10-28 Patheon Italia SpA;UCB Pharma SA view
JXSB2000051 Romosozumab注射液 romosozumab Injection Biological Products Supplementary Application 2020-12-21 优时比贸易(上海)有限公司 UCB Trading (SHANGHAI) Co Ltd;Patheon Italia SpA;UCB Pharma SA In Review 2020-12-18 view
JXSL1900087 Romosozumab注射液 romosozumab Injection Biological Products Import Drug Application 2019-09-13 优时比贸易(上海)有限公司 UCB Trading (SHANGHAI) Co Ltd;Amgen Inc In Review 2019-09-12 view
JXSL1200062 AMG 785 romosozumab Injection Biological Products Import Drug Application 2012-09-07 北京阿克赛诺医药研发咨询有限公司 Linical Accelovance China Ltd;Amgen Inc Certificate Issued 2014-06-10 view