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
CXSL1500131	重组抗EGFR人源化单克隆抗体注射液	Injection	Biological Products(1)	New Drug Application	2016-02-25	上海复宏汉霖生物技术有限公司	Shanghai Henlius Biotech Co Ltd	Certificate Issued	2016-09-28	view
CXSL1900026	重组抗EGFR人源化单克隆抗体注射液	Injection	Biological Products(1)	New Drug Application	2019-03-25	上海复宏汉霖生物技术股份有限公司	Shanghai Henlius Biotech Co Ltd	In Review	2019-03-22	view
CXSL2101349	重组抗EGFR人源化单克隆抗体注射液	Injection	Biological Products(1)	New Drug Application	2021-10-14		Shanghai Henlius Biotech Co Ltd			view
CXSL2200077	重组抗EGFR人源化单克隆抗体注射液	Injection	Biological Products(1)	New Drug Application	2022-02-10		Shanghai Henlius Biotech Co Ltd			view
CXSB2200073	重组抗EGFR人源化单克隆抗体注射液	Injection	Biological Products(1)	Supplementary Application	2022-09-17		Shanghai Henlius Biotech Co Ltd			view
CXSB2400010	重组抗EGFR人源化单克隆抗体注射液	Injection	Biological Products(1)	Supplementary Application	2024-02-02		Shanghai Henlius Biopharmaceutical Co Ltd			view