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
CXSL2100003	重组抗RANKL全人源单克隆抗体注射液	denosumab	Injection	Biological Products(3.3)	New Drug Application	2021-01-06	上海翰森生物医药科技有限公司	Shanghai Hansoh BioMedical Co Ltd	In Review	2021-01-06	view
CXSL1900116	重组抗RANKL全人源单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2019-10-29	昆药集团股份有限公司	KPC Pharmaceuticals Inc;Shanghai Kunheng Medical Technology Co Ltd	In Review	2019-10-28	view
CXSL1900107	重组抗RANKL全人源单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2019-09-28	信立泰（成都）生物技术有限公司	Chengdu Jinkai Biotech Co Ltd	In Review	2019-09-26	view
CXSL1800064	重组抗RANKL全人源单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2018-06-13	浙江海正药业股份有限公司	Zhejiang Hisun Pharmaceutical Co Ltd	Certificate Issued	2018-10-29	view
CXSL1700110	重组抗RANKL全人源单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2017-12-25	华兰基因工程有限公司	Hualan Genetic Engineering Co Ltd	Certificate Issued	2018-10-08	view
CXSL1500116	重组抗RANKL全人源单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2016-01-15	浙江海正药业股份有限公司	Zhejiang Hisun Pharmaceutical Co Ltd	Certificate Issued	2016-12-15	view