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
JTS2000062	伊匹木单抗注射液	ipilimumab	Injection	Biological Products	Disposable Import Drug Application	2021-01-01	苏州信达生物科技有限公司	Suzhou Xinda Biotechnology Co Ltd;Bristol-Myers Squibb Pharma Eeig;Bristol-Myers Squibb Holdings Pharma Ltd Liability Company	Pending Approval	2021-06-22	view
CXSL1700211	重组全人源抗RANKL单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2018-01-31	苏州信达生物科技有限公司	Suzhou Xinda Biotechnology Co Ltd	Certificate Issued	2018-07-06	view
CXSL1700077	重组全人源抗细胞毒T淋巴细胞相关抗原4（CTLA-4）单克隆抗体注射液		Injection	Biological Products(2)	New Drug Application	2017-08-16	苏州信达生物科技有限公司	Suzhou Xinda Biotechnology Co Ltd	Certificate Issued	2018-03-06	view