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
CXSL1700059	QX001S注射液	ustekinumab	Injection	Biological Products(2)	New Drug Application	2017-07-07	江苏荃信生物医药有限公司	Jiangsu Quan Xin Biomedical Co Ltd	Certificate Issued	2018-01-23	view
CXSL2101529	乌司奴单抗注射液	ustekinumab	Injection	Biological Products(3.3)	New Drug Application	2021-12-30		CSPC Megalith Biopharmaceutical Co Ltd			view
CXSS2300065	乌司奴单抗注射液	ustekinumab	Injection	Biological Products(3.3)	New Drug Application	2023-08-12					view
CXSS2400046	乌司奴单抗注射液	ustekinumab	Injection	Biological Products(3.3)	New Drug Application	2024-05-09		Bio-Thera Solutions Ltd			view
CXSS2400047	乌司奴单抗注射液（静脉输注）	ustekinumab	Injection	Biological Products(3.3)	New Drug Application	2024-05-09		Bio-Thera Solutions Ltd			view
CXSS2400048	乌司奴单抗注射液	ustekinumab	Injection	Biological Products(3.3)	New Drug Application	2024-05-09		Bio-Thera Solutions Ltd			view
JXSL0700050	人源抗白介素12单克隆抗体(CNTO1275)注射剂	ustekinumab	Injection	Biological Products(1)	Import Drug Application	2007-12-26	西安杨森制药有限公司	Xian Janssen Pharmaceutical Ltd	Certificate Issued	2009-04-08	view
JXSL1000043	人源抗白介素12单克隆抗体(CNTO 1275)注射剂	ustekinumab	Injection	Biological Products	Import Drug Application	2010-09-15	Janssen-Cilag International NV	Janssen-Cilag International NV	Certificate Issued	2013-02-18	view
JXSL1200020	人源抗白介素12单克隆抗体(CNTO1275)注射液	ustekinumab	Injection	Biological Products	Import Drug Application	2012-04-11	Janssen -Cilag International N.V.	Janssen-Cilag International NV	Certificate Issued	2015-01-16	view
JXSL1200021	人源抗白介素12单克隆抗体(CNTO1275)注射液[玻璃瓶装成品]	ustekinumab	Injection	Biological Products	Import Drug Application	2012-04-11	Janssen -Cilag International N.V.	Janssen-Cilag International NV	Certificate Issued	2015-01-16	view
JXSL1200022	人源抗白介素12单克隆抗体(CNTO1275)注射液[玻璃瓶装成品]	ustekinumab	Injection	Biological Products	Import Drug Application	2012-04-06	Janssen ？CCilag International N.V.	Janssen-Cilag International NV	Certificate Issued	2015-01-16	view
JXSL1200035	乌司奴单抗注射液	ustekinumab	Injection	Biological Products	Import Drug Application	2012-05-09	Janssen-Cilag International N.V.	Janssen-Cilag International NV	Certificate Issued	2015-01-06	view
JXSL1200036	乌司奴单抗注射液	ustekinumab	Injection	Biological Products	Import Drug Application	2012-05-03	Janssen-Cilag International N.V.	Janssen-Cilag International NV	Certificate Issued	2015-01-06	view
JXSL1800014	乌司奴单抗注射液	ustekinumab	Injection	Biological Products	Import Drug Application	2018-06-13	Janssen-Cilag International NV	Janssen-Cilag International NV	In Review	2018-06-12	view
JXSL1800015	乌司奴单抗注射液	ustekinumab	Injection	Biological Products	Import Drug Application	2018-06-13	Janssen-Cilag International NV	Janssen-Cilag International NV	In Review	2018-06-12	view
JXSL1800017	乌司奴单抗注射液	ustekinumab	Injection	Biological Products	Import Drug Application	2018-07-26	Janssen-Cilag International NV	Janssen-Cilag International NV	In Review	2018-07-25	view
JXSL1800018	乌司奴单抗注射液	ustekinumab	Injection	Biological Products	Import Drug Application	2018-07-26	Janssen-Cilag International NV	Janssen-Cilag International NV	In Review	2018-07-25	view
JXSL1800036	乌司奴单抗注射液	ustekinumab	Injection	Biological Products	Import Drug Application	2018-10-22	Janssen-Cilag International NV	Janssen-Cilag International NV	In Review	2018-10-20	view
JXSL1800037	乌司奴单抗注射液	ustekinumab	Injection	Biological Products	Import Drug Application	2018-10-22	Janssen-Cilag International NV	Janssen-Cilag International NV	In Review	2018-10-20	view
JXSL1800073	乌司奴单抗注射液	ustekinumab	Injection	Biological Products	Import Drug Application	2018-12-24	Janssen-Cilag International NV	Janssen-Cilag International NV	In Review	2018-12-21	view