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
CXSL2000113	注射用重组人源化抗HER2单抗-AS269偶联物（ARX788）	Lyophilized	Biological Products(1)	New Drug Application	2020-06-05	浙江医药股份有限公司	Zhejiang Medicine Co Ltd;Zhejiang New Code Biological Medicine Co Ltd	In Review	2020-06-04	view
CXSL2200080	注射用重组人源化抗HER2单抗-AS269偶联物（ARX788）	Lyophilized	Biological Products(1)	New Drug Application	2022-02-14		Zhejiang New Code Biological Medicine Co Ltd			view
CXSL2200381	注射用重组人源化抗HER2单抗-AS269偶联物（ARX788）	Lyophilized	Biological Products(1)	New Drug Application	2022-08-19		Zhejiang New Code Biological Medicine Co Ltd			view
CXSL2200033	注射用重组人源化抗HER2单抗-AS269偶联物（ARX788）	Lyophilized	Biological Products(1)	New Drug Application	2022-01-21		Zhejiang New Code Biological Medicine Co Ltd			view
CXSL2000362	注射用重组人源化抗HER2单抗-AS269偶联物（ARX788）	Lyophilized	Biological Products(1)	New Drug Application	2020-12-16	浙江医药股份有限公司；浙江新码生物医药有限公司	Zhejiang Medicine Co Ltd;Zhejiang New Code Biological Medicine Co Ltd	In Review	2020-12-15	view