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
CXSL1500034	重组人源化抗表皮生长因子受体单克隆抗体注射液		Injection	Biological Products(2)	New Drug Application	2015-07-23	上海津曼特生物科技有限公司	Shanghai GeneMab Biological Technology Co Ltd	Certificate Issued	2016-05-31	view
CXSL1600051	重组全人源抗RANKL单克隆抗体注射液	denosumab	Injection	Biological Products(1)	New Drug Application	2016-08-11	上海津曼特生物科技有限公司	Shanghai GeneMab Biological Technology Co Ltd	Certificate Issued	2017-07-06	view
CXSL1600053	重组全人源抗RANKL单克隆抗体注射液	denosumab	Injection	Biological Products(1)	New Drug Application	2016-08-11	上海津曼特生物科技有限公司	Shanghai GeneMab Biological Technology Co Ltd	Certificate Issued	2017-03-15	view
CXSL2000379	重组人源化抗表皮生长因子受体单克隆抗体注射液		Injection	Biological Products(1)	New Drug Application	2021-01-01	上海津曼特生物科技有限公司	Shanghai GeneMab Biological Technology Co Ltd	In Review	2020-12-31	view
CXSL2100022	JMT601注射液	JMT-601	Injection	Biological Products(1)	New Drug Application	2021-01-20	上海津曼特生物科技有限公司	Shanghai GeneMab Biological Technology Co Ltd	In Review	2021-01-19	view