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石藥集團(01093.HK):司美格魯肽注射液獲臨牀試驗批准
格隆匯 08-29 17:31

格隆匯8月29日丨石藥集團(01093.HK)發佈公吿,集團開發的司美格魯肽注射液已獲中國國家藥品監督管理局批准,可在中國開展臨牀試驗。

根據披露,司美格魯肽注射液是2型糖尿病治療的一線用藥,也是目前減重領域的最大單品,市場巨大。該產品使用的原料完全通過化學合成法制備,採用先進的合成、純化和表徵技術,製備出的原料純度更高,避免了生物發酵過程引入的宿主蛋白等免疫原性物質,並保證了雜質水平不高於DNA重組技術製備的司美格魯肽。雜質譜對比研究結果顯示,與DNA 重組技術製備的司美格魯肽注射液相比,該產品雜質水平更低且2~8o C長期儲存條件下無新雜質產生。

本次批准的臨牀適應症為成人2型糖尿病患者的血糖控制。臨牀前研究結果顯示,該產品與DNA重組技術製備的司美格魯肽注射液具有相似的體外生物活性和體內降糖效果;在食蟹猴體內具有一致的代謝特徵和安全性,無全身主動過敏反應且局部耐受性良好。該產品屬中國化藥註冊分類2.2類,目前全球尚無化學合成的司美格魯肽產品上市,極具臨牀開發價值。 

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