首个国产司美格鲁肽上市申请未获通过

第一财经
31 Dec 2024

12月31日,国家药品监督管理局的药品通知件送达信息显示,九源基因(02566.HK)的司美格鲁肽注射液在列。这意味着该药品上市申请暂时未能通过。   2024年4月2日,九源基因递交了司美格鲁肽注射液的上市申请并获受理,适应证为用于成人2型糖尿病血糖控制。这是国内第一家申报上市的司美格鲁肽生物类似药。  2024年11月28日,九源基因在香港联合交易所主板挂牌上市,发行价为12.42港元/股。...

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