Drug Registration and Acceptance

Drug Name

Exact

Active Ingredient

Acceptance No.

Manufacturers

Acceptance Date

Status Date

Classification

Review Status

Drug Type

Submission

Evaluation Conclusion

ATC Category

Special Approval Varieties

Task Type

Major Special Varieties

Sequence No.

Stock Code

Visualized Analysis Export Evaluation Conclusion Evaluation Progress

Acceptance No.	Drug Name	Dosage Form	Classification	Submission	Acceptance Date	Manufacturers	Manufacturers	Review Status	Status Date	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
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