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
CXSL1900102	重组全人源抗PCSK9单克隆抗体注射液		Injection	Biological Products(1)	New Drug Application	2019-09-10	信立泰（成都）生物技术有限公司	Chengdu Jinkai Biotech Co Ltd	In Review	2019-09-09	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
CXSL2000162	重组人神经调节蛋白1-抗HER3抗体融合蛋白注射液		Injection	Biological Products(1)	New Drug Application	2020-06-30	信立泰（成都）生物技术有限公司	Chengdu Jinkai Biotech Co Ltd	In Review	2020-06-29	view
CXSB2100011	重组胰高血糖素样肽-1-Fc融合蛋白注射液	SAL-015	Injection	Biological Products(原7)	Supplementary Application	2021-02-06	信立泰（成都）生物技术有限公司	Chengdu Jinkai Biotech Co Ltd	In Review	2021-02-05	view
CXSB2100010	重组胰高血糖素样肽-1-Fc融合蛋白注射液	SAL-015	Injection	Biological Products(原7)	Supplementary Application	2021-02-06	信立泰（成都）生物技术有限公司	Chengdu Jinkai Biotech Co Ltd	In Review	2021-02-05	view