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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1600045 GLS-010注射液 Zimberelimab Injection Biological Products(1) New Drug Application 2016-06-06 哈尔滨誉衡药业股份有限公司 Harbin Gloria Pharmaceuticals Co Ltd Certificate Issued 2017-03-15 view
CYSB2200203 赛帕利单抗注射液 Zimberelimab Injection Biological Products Supplementary Application 2022-08-15 Wuxi Biologics Co Ltd;Guangzhou Gloria Biosciences Co Ltd view
CXSB2400158 赛帕利单抗注射液 Zimberelimab Injection Biological Products(2.2) Supplementary Application 2024-12-09 Wuxi Biologics Co Ltd;Gilead (Shanghai) Pharmaceutical Technology Co Ltd view
CXSL2300709 赛帕利单抗注射液 Zimberelimab Injection Biological Products(2.2) New Drug Application 2023-10-18 Gilead (Shanghai) Pharmaceutical Technology Co Ltd view
CXSS2200025 赛帕利单抗注射液 Zimberelimab Injection Biological Products(2.2) New Drug Application 2022-03-15 Wuxi Biologics Co Ltd;Guangzhou Gloria Biosciences Co Ltd view
CXSL2400475 赛帕利单抗注射液 Zimberelimab Injection Biological Products(2.2) New Drug Application 2024-07-24 Gilead (Shanghai) Pharmaceutical Technology Co Ltd view
CXSL2300530 赛帕利单抗注射液 Zimberelimab Injection Biological Products(2.2) New Drug Application 2023-08-01 Guangzhou Gloria Biosciences Co Ltd view
CYSB2400017 赛帕利单抗注射液 Zimberelimab Injection Biological Products Supplementary Application 2024-01-17 Wuxi Biologics Co Ltd;Guangzhou Gloria Biosciences Co Ltd view
CXSL2300188 赛帕利单抗注射液 Zimberelimab Injection Biological Products(2.2) New Drug Application 2023-03-15 Gilead (Shanghai) Pharmaceutical Technology Co Ltd view
CXSL2200132 赛帕利单抗注射液 Zimberelimab Injection Biological Products(2.2) New Drug Application 2022-03-18 Guangzhou Gloria Biosciences Co Ltd view
CYSB2200274 赛帕利单抗注射液 Zimberelimab Injection Biological Products Supplementary Application 2022-12-08 Wuxi Biologics Co Ltd;Zhixiang Biotechnology (Suzhou) Co Ltd;Guangzhou Gloria Biosciences Co Ltd view
CYSB2500024 赛帕利单抗注射液 Zimberelimab Injection Biological Products Supplementary Application 2025-01-24 Intellective Biologics (Suzhou) Co Ltd;Wuxi Biologics Co Ltd;Zhixiang Biotechnology (Suzhou) Co Ltd;Guangzhou Gloria Biosciences Co Ltd view
CXSS2000005 赛帕利单抗注射液 Zimberelimab Injection Biological Products(1) New Drug Application 2020-02-21 无锡药明生物技术股份有限公司,广州誉衡生物科技有限公司 Wuxi Biologics Co Ltd;Guangzhou Gloria Biosciences Co Ltd Certificate Issued 2021-09-02 view
CXSL2300708 赛帕利单抗注射液 Zimberelimab Injection Biological Products(2.2) New Drug Application 2023-10-18 Gilead (Shanghai) Pharmaceutical Technology Co Ltd view