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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB2000019 重组抗HER2结构域II人源化单克隆抗体注射液 Injection Biological Products Supplementary Application 2020-06-18 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd In Review 2020-06-17 view
CXSL1900139 重组抗HER2结构域II人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2019-12-20 北京双鹭药业股份有限公司 Beijing SL Pharmaceutical Co Ltd;The New Drug Research and Development Co Ltd Beijing History In Review 2019-12-18 view
CXSL1900122 重组抗HER2结构域II人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2019-11-05 上海复宏汉霖生物技术股份有限公司 Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd In Review 2019-11-04 view
CXSB2300131 重组抗HER2结构域II人源化单克隆抗体注射液 Injection Biological Products(3.3) Supplementary Application 2023-11-17 Shanghai Henlius Biopharmaceutical Co Ltd;Shanghai Henlius Biotech Co Ltd view
CXSB2200010 重组抗HER2结构域II人源化单克隆抗体注射液 Injection Biological Products(3.3) Supplementary Application 2022-01-25 Shanghai Henlius Biologics Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd;Shanghai Henlius Biotech Co Ltd view
CXSL1400157 重组抗HER2结构域Ⅱ人源化单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-02-26 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd Certificate Issued 2016-05-19 view
CXSL1600001 重组抗HER2结构域Ⅱ人源化单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2016-03-30 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2016-12-08 view