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石藥集團(01093.HK)司美格魯(月太)注射液上市申請獲受理
阿思達克 08-05 22:44
石藥集團(01093.HK)公布,附屬石藥集團百克開發的司美格魯(月太)注射液的上市申請已獲中國國家藥品監督管理局受理。本次申報的適應症為成人2型糖尿病患者的血糖控制。 該產品是基於天然人胰高血糖素樣(月太)-1「GLP -1」結構的胰高血糖素樣(月太)-1受體激動劑,為化學合成法製備的司美格魯(月太)製劑,按照化藥註冊分類2.2類新藥申報,屬含有已知活性成份的新處方工藝且具有明顯臨床優勢的藥品。
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