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	Dosage Form	Classification	Submission	Acceptance Date	Manufacturers	Manufacturers	Review Status	Status Date	View
CXSL2400547	重组全人源抗PCSK9单克隆抗体注射液	Injection	Biological Products(1)	New Drug Application	2024-08-17		Shenzhen Salubris Pharmaceuticals Co Ltd;Chengdu Jinkai Biotech Co Ltd;Suzhou Genemen Biotech Co Ltd			view
CXSB2300075	重组全人源抗PCSK9单克隆抗体注射液	Injection	Biological Products(原1)	Supplementary Application	2023-07-19		Shenzhen Salubris Pharmaceuticals Co Ltd;Chengdu Jinkai Biotech Co Ltd;Suzhou Genemen Biotech Co Ltd			view
CXSL2000019	重组全人源抗PCSK9单克隆抗体注射液	Injection	Biological Products(1)	New Drug Application	2020-02-14	天士力生物医药股份有限公司	Shanghai Tasly Pharmaceutical Co Ltd	In Review	2020-02-13	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;Shenzhen Salubris Pharmaceuticals Co Ltd;Suzhou Genemen Biotech Co Ltd	In Review	2019-09-09	view