【九源基因回应司美格鲁肽大规格申报受挫：意料之中，不会影响药物注册进度】金十数据1月1日讯，九源基因申报的司美格鲁肽注射液两个大规格出现在国家药监局药品通知件送达信息中，意味着该药物上述两个大规格的审批流程未能通过。此次两个大规格申报失利，是否会对其领先优势造成影响？对此，九源基因表示基本不会。据该公司相关负责人透露，此次吉优泰未获批的两个规格分别是2.68mg/ml，3ml（笔芯）和2.68mg/ml，3ml（预填充注射笔），适用的给药剂量是2mg每周一次。“事实上，原研药物的这一给药剂量在欧、美已获批，但并未在中国申请上市，因此对于申报不通过我们是有预判的。我们原先申报也只是希望可以进行更多尝试，占得一些先机。”
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