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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXSL2200086 Bemarituzumab注射液 bemarituzumab Injection Biological Products(1) Import Drug Application 2022-06-17 Zai Lab (US) LLC;Zai Lab (Shanghai) Co Ltd view
JXSL2200087 Bemarituzumab注射液 bemarituzumab Injection Biological Products(1) Import Drug Application 2022-06-17 Zai Lab (US) LLC;Zai Lab (Shanghai) Co Ltd view
JXSL2300015 Bemarituzumab注射液 bemarituzumab Injection Biological Products(1) Import Drug Application 2023-01-06 Amgen Inc;Zai Lab (Shanghai) Co Ltd view
JXSB2300005 Bemarituzumab注射液 bemarituzumab Injection Biological Products(1) Supplementary Application 2023-01-06 Patheon Manufacturing Services LLC;Zai Lab (US) LLC view
JXSB2300004 Bemarituzumab注射液 bemarituzumab Injection Biological Products(1) Supplementary Application 2023-01-06 Patheon Manufacturing Services LLC;Zai Lab (US) LLC view
JXSL2300138 Bemarituzumab注射液 bemarituzumab Injection Biological Products(1) Import Drug Application 2023-07-22 Amgen Inc;Zai Lab (Shanghai) Co Ltd view
JXSB2300110 Bemarituzumab注射液 bemarituzumab Injection Biological Products(1) Supplementary Application 2023-09-05 Amgen Inc;Patheon Manufacturing Services LLC view
JXSB2400048 Bemarituzumab注射液 bemarituzumab Injection Biological Products(1) Supplementary Application 2024-05-08 Amgen Inc;Amgen Manufacturing Ltd view
JTS2500015 Bemarituzumab注射液 bemarituzumab Injection Biological Products Disposable Import Drug Application 2025-02-25 Amgen Inc;Amgen Manufacturing Ltd;Zai Lab (Shanghai) Co Ltd view