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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYSB1900257 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products Supplementary Application 2019-09-18 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd Certificate Issued 2019-12-13 view
JYHB2000641 诺西那生钠注射液 nusinersen sodium Injection Chemical Drugs(5.1) Supplementary Application 2020-06-10 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd Certificate Issued 2020-12-04 view
JYHB2000330 诺西那生钠注射液 nusinersen sodium Injection Chemical Drugs(5.1) Supplementary Application 2020-03-27 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd Filed 2020-04-10 view
JYHB2000200 伊立替康脂质体注射液 irinotecan hydrochloride Injection Chemical Drugs(2.4) Supplementary Application 2020-03-18 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd Certificate Issued 2020-04-27 view
JXSL2000040 Belantamab mafodotin belantamab mafodotin Lyophilized Biological Products Import Drug Application 2020-04-30 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2020-04-27 view
JXSL1900065 DAS181 oplunofusp Active ingredient Biological Products Import Drug Application 2019-08-01 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2019-07-31 view
JXHS2000014 富马酸二甲酯肠溶胶囊 dimethyl fumarate Capsule Chemical Drugs(5.1) Import Drug Application 2020-02-15 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2020-02-14 view
JXHS2000013 富马酸二甲酯肠溶胶囊 dimethyl fumarate Capsule Chemical Drugs(5.1) Import Drug Application 2020-02-15 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2020-02-14 view
JXHL2100096 Atrasentan片 atrasentan Tablet Chemical Drugs(1) Import Drug Application 2021-03-20 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2021-03-19 view
JXHL2000212 复溶用tricaprilin口服散剂(AC-SD-03) tricaprilin Powder Chemical Drugs(1) Import Drug Application 2020-07-10 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2020-07-09 view
JXHL2000211 复溶用tricaprilin口服散剂(AC-SD-03) tricaprilin Powder Chemical Drugs(1) Import Drug Application 2020-07-10 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2020-07-09 view
JXHL1900255 注射用格列本脲 glibenclamide Lyophilized Chemical Drugs(2.2) Import Drug Application 2019-10-08 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2019-09-30 view
JXHL1900239 Radotinib HCl 胶囊 Radotinib Hydrochloride Capsule Chemical Drugs(2.4) Import Drug Application 2019-09-27 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2019-09-26 view
JXHL1900228 DCC-2618 ripretinib Active ingredient Chemical Drugs(1) Import Drug Application 2019-09-18 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2019-09-17 view
JXHL1900184 伊立替康脂质体注射液 irinotecan hydrochloride Injection Chemical Drugs(2.4) Import Drug Application 2019-08-01 艾昆纬医药科技(上海)有限公司 Aikunwei Medical Technology (Shanghai) Co Ltd In Review 2019-07-31 view