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
JTS2100529	注射用Trastuzumab deruxtecan (DS-8201a， T-DXd )	trastuzumab deruxtecan	Lyophilized	Biological Products	Disposable Import Drug Application	2021-10-11					view
JTS2100530	Trastuzumab deruxtecan (DS-8201a， T-DXd ) 原液	trastuzumab deruxtecan	Lyophilized	Biological Products	Disposable Import Drug Application	2021-10-11					view
JXSB2000028	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2020-10-12	第一三共（中国）投资有限公司	Daiichi Sankyo (CHINA) HOLDINGS Co Ltd	In Review	2020-10-10	view
JXSB2100005	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2021-01-08			In Review	2021-01-07	view
JXSB2101024	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2021-06-15					view
JXSB2101068	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2021-10-19					view
JXSB2101102	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2021-12-07					view
JXSB2200012	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2022-01-25					view
JXSB2200044	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2022-04-22					view
JXSB2200068	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2022-06-13					view
JXSB2200120	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2022-09-19					view
JXSB2300066	注射用德曲妥珠单抗（DS-8201a）	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2023-05-31					view
JXSB2300086	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2023-07-08					view
JXSB2300103	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2023-08-24					view
JXSB2400011	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2024-02-02					view
JXSB2400023	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2024-03-04					view
JXSL1800052	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products	Import Drug Application	2018-11-21	昆泰企业管理（上海）有限公司	Aikunwei Medical Technology (Shanghai) Co Ltd	In Review	2018-11-20	view
JXSL1900019	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products	Import Drug Application	2019-02-18	第一三共（中国）投资有限公司	Daiichi Sankyo (CHINA) HOLDINGS Co Ltd	In Review	2019-02-16	view
JXSL2000037	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products	Import Drug Application	2020-04-15	Daiichi Sankyo, Inc.	Daiichi Sankyo Co Ltd	In Review	2020-04-14	view
JXSL2000147	DS-8201a	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Import Drug Application	2020-09-01	Daiichi Sankyo, Inc.	Daiichi Sankyo Co Ltd	In Review	2020-08-31	view