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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYSB2500031 注射用贝林妥欧单抗 blinatumomab Lyophilized Biological Products Supplementary Application 2025-02-12 Amgen Inc;Amgen Technology (Ireland) UnLtd Company view
JYSZ2400059 注射用贝林妥欧单抗 blinatumomab Lyophilized Biological Products License Renew 2024-12-10 Amgen Inc;BeiGene (Beijing) Co Ltd;Amgen Technology (Ireland) UnLtd Company view
JYSB2300008 注射用贝林妥欧单抗 blinatumomab Lyophilized Biological Products Supplementary Application 2023-01-14 Amgen Inc;Amgen Technology (Ireland) UnLtd Company view
JYSB2200192 注射用贝林妥欧单抗 blinatumomab Lyophilized Biological Products Supplementary Application 2022-10-11 Amgen Inc;Amgen Technology (Ireland) UnLtd Company view
JXSS2100020 注射用贝林妥欧单抗 blinatumomab Lyophilized Biological Products(3.1) Import Drug Application 2021-03-31 百济神州(北京)生物科技有限公司 BeiGene (Beijing) Co Ltd;Amgen Inc;Amgen Technology (Ireland) UnLtd Company In Review 2021-03-30 view
JYSB2100061 注射用贝林妥欧单抗 blinatumomab Lyophilized Biological Products(3.1) Supplementary Application 2021-02-26 百济神州(北京)生物科技有限公司 BeiGene (Beijing) Co Ltd;Amgen Inc;Amgen Technology (Ireland) UnLtd Company In Review 2022-01-27 view
JXSS1900060 注射用倍林妥莫双抗 blinatumomab Lyophilized Biological Products Import Drug Application 2019-10-29 安进生物技术咨询(上海)有限公司 Amgen Biology Technology Consulting (Shanghai) Co Ltd;Amgen Inc;Boehringer Ingelheim Pharma Gmbh & Co KG Certificate Issued 2020-12-08 view
JXSL1500056 Blinatumomab blinatumomab Lyophilized Biological Products Import Drug Application 2015-09-17 Amgen Inc. Amgen Inc Certificate Issued 2016-09-29 view