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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
BS20020011 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Import Drug Application 2002-09-25 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-05-08 view
CSL01011 曲妥珠单抗 trastuzumab Lyophilized Biological Products(4) New Drug Application 2001-03-13 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2001-11-13 view
CXSB2000101 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(原2) Supplementary Application 2020-11-24 上海复宏汉霖生物制药有限公司 Shanghai Henlius Biopharmaceutical Co Ltd In Review 2020-11-23 view
CXSL1400013 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(2) New Drug Application 2014-04-30 正大天晴药业集团股份有限公司 Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-09-26 view
CXSL1400077 注射用重组抗人表皮生长因子受体2(HER2)单抗(曲妥珠单抗) trastuzumab Lyophilized Biological Products(2) New Drug Application 2014-09-12 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2016-07-21 view
CXSS1900021 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(2) New Drug Application 2019-04-29 上海复宏汉霖生物制药有限公司 Shanghai Henlius Biopharmaceutical Co Ltd Certificate Issued 2020-08-19 view
CXSS2101019 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(3.3) New Drug Application 2021-08-05 Anhui Anke Biotechnology (Group) 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
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
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
CXSS2400099 注射用瑞康曲妥珠单抗 SHR-A1811 Lyophilized Biological Products(1) New Drug Application 2024-09-14 Suzhou Suncadia Biopharmaceuticals Co Ltd view
CYSB2000228 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(原2) Supplementary Application 2020-10-17 上海复宏汉霖生物制药有限公司 Shanghai Henlius Biopharmaceutical Co Ltd In Review 2020-10-16 view
CYSB2000229 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(原2) Supplementary Application 2020-10-17 上海复宏汉霖生物制药有限公司 Shanghai Henlius Biopharmaceutical Co Ltd In Review 2020-10-16 view
CYSB2000306 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(原2) Supplementary Application 2020-11-25 上海复宏汉霖生物制药有限公司 Shanghai Henlius Biopharmaceutical Co Ltd In Review 2022-01-27 view
CYSB2000307 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(原2) Supplementary Application 2020-11-25 上海复宏汉霖生物制药有限公司 Shanghai Henlius Biopharmaceutical Co Ltd Certificate Issued 2021-02-05 view
CYSB2101215 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2021-10-09 Shanghai Henlius Biopharmaceutical Co Ltd view
CYSB2101216 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2021-10-09 Shanghai Henlius Biopharmaceutical Co Ltd view
CYSB2101224 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(原2) Supplementary Application 2021-10-14 view
CYSB2101225 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(原2) Supplementary Application 2021-10-14 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