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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYSB2400254 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2024-12-09 Genentech Inc;Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG view
CXSS2400134 帕妥珠单抗注射液 pertuzumab Injection Biological Products(3.3) New Drug Application 2024-12-04 Shanghai Henlius Biologics Co Ltd view
CXSS2400116 帕妥珠单抗注射液 pertuzumab Injection Biological Products(3.3) New Drug Application 2024-10-28 Hisun Biopharmaceutical Co Ltd view
JYSB2300197 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2023-11-14 Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG view
CXSS2300038 帕妥珠单抗注射液 pertuzumab Injection Biological Products(3.3) New Drug Application 2023-05-24 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
JYSZ2300019 帕妥珠单抗注射液 pertuzumab Injection Biological Products License Renew 2023-04-21 Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG;Roche (China) Holding Ltd view
JYSB2300063 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2023-04-11 Genentech Inc;Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG view
JYSB2300016 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2023-02-07 Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG view
JYSB2300009 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2023-01-17 Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG view
CXSS2300002 帕妥珠单抗注射液 pertuzumab Injection Biological Products(3.3) New Drug Application 2023-01-10 QILU Pharmaceutical Co Ltd view
JYSB2200111 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2022-06-30 Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG view
CXSL2101162 帕妥珠单抗注射液 pertuzumab Injection Biological Products(3.3) New Drug Application 2021-06-29 CSPC Megalith Biopharmaceutical Co Ltd view
JYSB2101061 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2021-06-25 Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG view
JYSB2101013 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2021-04-23 Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG view
JYSB2000696 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2021-01-05 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) Ltd Certificate Issued 2021-03-17 view
JYSB2000662 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2020-12-28 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) Ltd In Review 2020-12-24 view
JYSB2000601 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2020-12-07 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) Ltd Filed 2020-12-17 view
JYSB2000387 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2020-08-21 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) Ltd Certificate Issued 2020-10-15 view
JYSB2000386 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2020-08-21 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) Ltd Filed 2020-09-02 view
JYSB2000140 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2020-05-06 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG In Review 2020-05-01 view