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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB2500108 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2025-05-17 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
CYSB2500082 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(原2) Supplementary Application 2025-04-16 Shanghai Fuhong Ruilin Biotechnology Co Ltd;Shanghai Henlius Biologics Co Ltd view
CYSB2500083 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(原2) Supplementary Application 2025-04-16 Shanghai Fuhong Ruilin Biotechnology Co Ltd;Shanghai Henlius Biologics Co Ltd view
CYSB2500040 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) Supplementary Application 2025-02-09 Hisun Biopharmaceutical Co Ltd view
CXSS2500007 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) New Drug Application 2025-01-22 Shanghai Institute of Biological Products Co Ltd view
CYSB2400292 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) Supplementary Application 2024-11-09 Anhui Anke Biotechnology (Group) Co Ltd view
CYSB2400281 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) Supplementary Application 2024-10-25 QILU Pharmaceutical Co Ltd view
CYSB2400265 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) Supplementary Application 2024-10-09 QILU Pharmaceutical Co Ltd view
CYSB2400138 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2024-06-01 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
CYSB2400136 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) Supplementary Application 2024-05-25 Anhui Anke Biotechnology (Group) Co Ltd view
JYSB2300119 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2023-07-12 Genentech Inc;Roche Pharma (Schweiz) AG view
JYSB2300117 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2023-07-12 Genentech Inc;Roche Pharma (Schweiz) AG view
JYSB2300118 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2023-07-12 Genentech Inc;Roche Pharma (Schweiz) AG view
CXSS2300027 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) New Drug Application 2023-04-27 QILU Pharmaceutical Co Ltd view
JYSZ2200056 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products License Renew 2022-11-01 Shanghai Roche Pharmaceutical Co Ltd;Genentech Inc;Roche Pharma (Schweiz) AG view
JYSZ2200058 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products License Renew 2022-11-01 Shanghai Roche Pharmaceutical Co Ltd;Genentech Inc;Roche Pharma (Schweiz) AG view
JYSZ2200057 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products License Renew 2022-11-01 Shanghai Roche Pharmaceutical Co Ltd;Genentech Inc;Roche Pharma (Schweiz) AG view
CXSS2200015 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) New Drug Application 2022-02-17 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
CYSB2200023 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2022-01-21 Shanghai Henlius Biopharmaceutical Co Ltd view
CXSS2200005 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) New Drug Application 2022-01-14 Hisun Biopharmaceutical Co Ltd view