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
CXSB2500044	注射用重组人源化抗BCMA/CD3双特异性抗体	Recombinant Humanized Anti-BCMA/CD3 Bis-specific Antibody Preparation	Lyophilized	Biological Products(1)	Supplementary Application	2025-03-29		Shandong New Time Pharmaceutical Co Ltd			view
CXSL2500199	注射用重组人源化抗BCMA/CD3双特异性抗体	Recombinant Humanized Anti-BCMA/CD3 Bis-specific Antibody Preparation	Lyophilized	Biological Products(1)	New Drug Application	2025-03-05		Shandong New Time Pharmaceutical Co Ltd			view
CXSL2400484	注射用重组人源化抗BCMA/CD3双特异性抗体	Recombinant Humanized Anti-BCMA/CD3 Bis-specific Antibody Preparation	Lyophilized	Biological Products(1)	New Drug Application	2024-07-27		Shandong New Time Pharmaceutical Co Ltd			view
CXSL2100063	注射用重组人源化抗BCMA/CD3双特异性抗体	Recombinant Humanized Anti-BCMA/CD3 Bis-specific Antibody Preparation	Lyophilized	Biological Products(1)	New Drug Application	2021-02-27	山东新时代药业有限公司	Shandong New Time Pharmaceutical Co Ltd	In Review	2021-02-26	view