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石藥集團(01093.HK):司美格魯肽注射液的上市申請獲國家藥品監督管理局受理
格隆匯 08-05 20:15

格隆匯8月5日丨石藥集團(01093.HK)公吿,公司附屬公司石藥集團百克(山東)生物製藥股份有限公司開發的司美格魯肽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肽-1(GLP-1)結構的胰高血糖素樣肽-1受體激動劑,為化學合成法制備的司美格魯肽製劑,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牀優勢的藥品。GLP-1是由腸道L細胞分泌的腸源性激素,可通過與廣泛分佈於全身多種器官和組織的GLP-1受體結合而發揮作用,並通過多重機制實現降糖、減重以及心血管和腎臟保護等方面的綜合獲益。

本次申請基於一項關鍵性Ⅲ期臨牀試驗。該臨牀試驗結果表明,在經二甲雙胍治療血糖控制不佳的2型糖尿病患者中,與諾和諾德開發的司美格魯肽相比,該產品展現出高度一致的療效,且其胃腸道反應發生率略低。該產品遵循相關指導原則,通過藥學、非臨牀、臨牀藥代動力學、臨牀有效性及安全性等一系列研究,科學、嚴謹、完整地驗證了其與諾和諾德開發的司美格魯肽的一致性。

基於在療效、安全性、製劑等方面的優勢,該產品具有顯著的臨牀應用價值。集團也在積極推進該產品針對肥胖╱超重適應症的Ⅲ期臨牀試驗,以期使更多患者從中獲益。

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