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
JXSS2200027	帕妥珠单抗曲妥珠单抗注射液（皮下注射）	pertuzumab;trastuzumab	Injection	Biological Products(3.1)	Import Drug Application	2022-07-27					view
JXSS2200026	帕妥珠单抗曲妥珠单抗注射液（皮下注射）	pertuzumab;trastuzumab	Injection	Biological Products(3.1)	Import Drug Application	2022-07-27					view
JYSB2400171	帕妥珠曲妥珠单抗注射液（皮下注射）	pertuzumab;trastuzumab	Injection	Biological Products	Supplementary Application	2024-08-03		Roche Pharma (Schweiz) AG			view
JYSB2400139	帕妥珠曲妥珠单抗注射液（皮下注射）	pertuzumab;trastuzumab	Injection	Biological Products	Supplementary Application	2024-06-28					view
JYSB2400138	帕妥珠曲妥珠单抗注射液（皮下注射）	pertuzumab;trastuzumab	Injection	Biological Products	Supplementary Application	2024-06-28		Roche Pharma (Schweiz) AG			view
JYSB2400170	帕妥珠曲妥珠单抗注射液（皮下注射）	pertuzumab;trastuzumab	Injection	Biological Products	Supplementary Application	2024-08-03					view
CSL01011	曲妥珠单抗	trastuzumab	Lyophilized	Biological Products(4)	New Drug Application	2001-03-13	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2001-11-13	view
JXSS2101004	曲妥珠单抗注射液（皮下注射）	trastuzumab	Injection	Biological Products(3.1)	Import Drug Application	2021-04-21					view
JYSB2300111	曲妥珠单抗注射液（皮下注射）	trastuzumab	Injection	Biological Products	Supplementary Application	2023-06-20					view
JXSS2300089	注射用德曲妥珠单抗	trastuzumab deruxtecan	Lyophilized	Biological Products(3.1)	Import Drug Application	2023-12-12					view
JYSB2400205	注射用德曲妥珠单抗	trastuzumab deruxtecan	Lyophilized	Biological Products	Supplementary Application	2024-09-11					view
JXSL2400217	注射用德曲妥珠单抗	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Import Drug Application	2024-11-11					view
JYSB2400081	注射用德曲妥珠单抗	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2024-04-08					view
JXSS2400013	注射用德曲妥珠单抗	trastuzumab deruxtecan	Lyophilized	Biological Products(3.1)	Import Drug Application	2024-02-08					view
JXSL2400211	注射用德曲妥珠单抗	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Import Drug Application	2024-11-01					view
JXSL2400034	注射用德曲妥珠单抗	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Import Drug Application	2024-02-05					view
JXSS2200033	注射用德曲妥珠单抗	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Import Drug Application	2022-08-18					view
JYSB2400023	注射用德曲妥珠单抗	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2024-02-01					view
JXSB2400050	注射用德曲妥珠单抗	trastuzumab deruxtecan	Lyophilized	Biological Products(2.2)	Supplementary Application	2024-05-09					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