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
CXSB2000038	重组抗RANKL全人单克隆抗体注射液	denosumab	Injection	Biological Products(3.3)	Supplementary Application	2020-08-04	山东博安生物技术有限公司	Shandong BoAn Biotechnology Co Ltd	In Review	2020-08-03	view
CXSB2000013	重组抗RANKL全人单克隆抗体注射液	denosumab	Injection	Biological Products	Supplementary Application	2020-05-13	齐鲁制药有限公司	QILU Pharmaceutical Co Ltd	In Review	2020-05-12	view
CXSL2000043	重组抗RANKL全人单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2020-03-12	上海复宏汉霖生物技术股份有限公司	Shanghai Henlius Biotech Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd	In Review	2020-03-11	view
CXSB1900028	重组抗RANKL全人单克隆抗体注射液	denosumab	Injection	Biological Products	Supplementary Application	2019-12-07	齐鲁制药有限公司	QILU Pharmaceutical Co Ltd	Certificate Issued	2020-02-20	view
CXSL1600099	重组抗RANKL全人单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2016-12-05	山东博安生物技术有限公司	Shandong BoAn Biotechnology Co Ltd	Certificate Issued	2017-06-20	view
CXSL1600080	重组抗RANKL全人单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2016-10-11	山东博安生物技术有限公司	Shandong BoAn Biotechnology Co Ltd	Certificate Issued	2017-06-09	view
CXSL1400029	重组抗RANKL全人单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2014-04-15	齐鲁制药有限公司	QILU Pharmaceutical Co Ltd	Certificate Issued	2016-10-11	view
CXSL1400030	重组抗RANKL全人单克隆抗体注射液	denosumab	Injection	Biological Products(2)	New Drug Application	2014-04-15	齐鲁制药有限公司	QILU Pharmaceutical Co Ltd	Certificate Issued	2016-10-11	view