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
CXSL1900092	地特胰岛素注射液	insulin detemir	Injection	Biological Products(15)	New Drug Application	2019-08-28	华润昂德生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	In Review	2019-08-27	view
CXSL2000082	注射用重组人组织型纤溶酶原激酶衍生物	Recombinant Human Tissue-type Plasminogen Activator Derivative	Lyophilized	Biological Products(1)	New Drug Application	2020-05-06	华润昂德生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	In Review	2020-05-01	view
CXSB2100006	聚乙二醇重组人促红素注射液（CHO细胞）		Injection	Biological Products(原7)	Supplementary Application	2021-01-14	华润昂德生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	In Review	2021-01-13	view
CXSL2100101	重组人GLP-1-Fc融合蛋白注射液		Injection	Biological Products(3.3)	New Drug Application	2021-03-23	华润昂德生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	In Review	2021-03-22	view
CXSL2100102	重组人GLP-1-Fc融合蛋白注射液		Injection	Biological Products(3.3)	New Drug Application	2021-03-23	华润昂德生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	In Review	2021-03-22	view