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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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;Shire Pharmaceutical Contracts Ltd;Cosmo SpA Filed 2017-11-28 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;Daiichi Sankyo 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;Biogen Idec Ltd;Patheon Italia SpA Certificate Issued 2019-02-28 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;AstraZeneca AB Certificate Issued 2017-07-26 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;AstraZeneca AB 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;IL-Yang Pharm 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;Daiichi Sankyo Co Ltd Certificate Issued 2017-03-14 view