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
CXSL2200265	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2022-06-14		Sichuan Kelun-Biotech Biopharmaceutical Co Ltd			view
CXSL2000010	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2020-01-21	四川科伦博泰生物医药股份有限公司	Sichuan Kelun-Biotech Biopharmaceutical Co Ltd	In Review	2020-01-20	view
CXSL2300666	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2023-10-08		Sichuan Kelun-Biotech Biopharmaceutical Co Ltd			view
CXSL2200543	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2022-10-26		Sichuan Kelun-Biotech Biopharmaceutical Co Ltd			view
CXSL2300490	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2023-07-18		Sichuan Kelun-Biotech Biopharmaceutical Co Ltd			view
CXSL2200208	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2022-05-07		Sichuan Kelun-Biotech Biopharmaceutical Co Ltd			view
CXSL2400425	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2024-07-04		Sichuan Kelun-Biotech Biopharmaceutical Co Ltd			view
CXSL2300288	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2023-04-27		Sichuan Kelun-Biotech Biopharmaceutical Co Ltd			view
CXSS2300093	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2023-12-09		Sichuan Kelun-Biotech Biopharmaceutical Co Ltd			view
CXSL2200024	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2022-01-18		Sichuan Kelun-Biotech Biopharmaceutical Co Ltd			view
CXSL2200057	注射用SKB264	sacituzumab tirumotecan	Lyophilized	Biological Products(1)	New Drug Application	2022-01-28		Sichuan Kelun-Biotech Biopharmaceutical Co Ltd			view