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
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
JXHS1800032	Spinraza注射液	NUSINERSEN SODIUM	Injection	Chemical Drugs(5.1)	Import Drug Application	2018-09-05	昆泰企业管理（上海）有限公司	Aikunwei Medical Technology (Shanghai) Co Ltd	Certificate Issued	2019-02-28	view
JYHB1701399	美沙拉秦缓释片	mesalazine	Tablet, extended release	Chemical Drugs	Supplementary Application	2017-11-09	昆泰企业管理（上海）有限公司	Aikunwei Medical Technology (Shanghai) Co Ltd	Filed	2017-11-28	view
JXHL1700081	艾塞那肽注射液	exenatide	Injection	Chemical Drugs(2.4)	Import Drug Application	2017-04-21	昆泰企业管理（上海）有限公司	Aikunwei Medical Technology (Shanghai) Co Ltd	Certificate Issued	2017-07-26	view
JXHL1700082	艾塞那肽注射液	exenatide	Injection	Chemical Drugs(2.4)	Import Drug Application	2017-04-21	昆泰企业管理（上海）有限公司	Aikunwei Medical Technology (Shanghai) Co Ltd	Certificate Issued	2017-07-26	view
JXHL1700008	Radotinib HCl胶囊	Radotinib Hydrochloride	Capsule	Chemical Drugs(5.1)	Import Drug Application	2017-02-03	昆泰企业管理（上海）有限公司	Aikunwei Medical Technology (Shanghai) Co Ltd	Certificate Issued	2018-03-19	view
JXHL1600071	PLX3397 HCl胶囊	pexidartinib hydrochloride	Capsule	Chemical Drugs	Import Drug Application	2016-07-15	昆泰企业管理（上海）有限公司	Aikunwei Medical Technology (Shanghai) Co Ltd	Certificate Issued	2017-03-14	view