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	Active Ingredient	Dosage Form	Classification	Submission	Acceptance Date	Manufacturers	Manufacturers	Review Status	Status Date	View
CXSS1900040	注射用泰它西普	telitacicept	Lyophilized	Biological Products(1)	New Drug Application	2019-11-13	荣昌生物制药（烟台）有限公司	RemeGen Co Ltd	Certificate Issued	2021-03-16	view
CYSB2101282	注射用泰它西普	telitacicept	Lyophilized	Biological Products	Supplementary Application	2021-12-09		RemeGen Co Ltd			view
CXSL2200101	注射用泰它西普	telitacicept	Lyophilized	Biological Products(2.2)	New Drug Application	2022-02-23		RemeGen Co Ltd			view
CXSL2200320	注射用泰它西普	telitacicept	Lyophilized	Biological Products(2.2)	New Drug Application	2022-07-14		RemeGen Co Ltd			view
CYSB2300008	注射用泰它西普	telitacicept	Lyophilized	Biological Products(1)	Supplementary Application	2023-01-11		RemeGen Co Ltd			view
CYSB2300009	注射用泰它西普	telitacicept	Lyophilized	Biological Products(1)	Supplementary Application	2023-01-11		RemeGen Co Ltd			view
CYSB2300125	注射用泰它西普	telitacicept	Lyophilized	Biological Products(2.2)	Supplementary Application	2023-07-06		RemeGen Co Ltd			view
CXSS2300074	注射用泰它西普	telitacicept	Lyophilized	Biological Products(2.2)	New Drug Application	2023-09-07		RemeGen Co Ltd			view
CXSS2400115	注射用泰它西普	telitacicept	Lyophilized	Biological Products(2.2)	New Drug Application	2024-10-26		RemeGen Co Ltd			view