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中國生物製藥(01177.HK)"利拉魯肽注射液"獲批上市 用於成人2型糖尿病患者控制血糖
格隆匯 06-25 16:36

格隆匯6月25日丨中國生物製藥(01177.HK)宣佈,集團開發的"利拉魯肽注射液"(商品名:貝樂林®)已獲得中國國家藥品監督管理局的上市批准,用於成人2型糖尿病患者控制血糖。

利拉魯肽是一種胰高血糖素樣肽-1(GLP-1)長效類似物,與天然GLP-1具有97%的同源性。GLP-1是一種內源性腸促胰島素激素,可以增強胰島β細胞的葡萄糖依賴性胰島素分泌。除胰島細胞外,GLP-1受體還廣泛存在於胃腸、肺、腦、腎臟、心血管系統等器官組織中。利拉魯肽在保留GLP-1生理作用特點的基礎上,延長了GLP-1的半衰期,每日一次給藥即可達到良好的降糖效果。除2型糖尿病外,利拉魯肽在肥胖症患者的體重控制、心血管系統疾病和神經系統疾病的治療中,也能使患者顯著獲益。

目前,利拉魯肽已被納入《美國糖尿病學會(ADA)糖尿病診療標準(2024版)》、《中國2型糖尿病防治指南(2020年版)》、《中國成人2型糖尿病合併心腎疾病患者降糖藥物臨牀應用專家共識》等多個指南。2022年中國糖尿病藥物市場規模超過人民幣600億元,預計2030年將突破人民幣1,300億元。

貝樂林®的原料藥生產製備流程長、工藝複雜、質控難度高。集團通過開發全流程工藝,自制關鍵工具酶和酰化修飾劑,成功提高了原料藥工藝、質量及成本的可控性。集團配有多套萬升級的生物反應器,產能充足,確保了高質量藥品的穩定生產。除利拉魯肽外,集團還佈局了司美格魯肽,目前正在臨牀III期,有望為中國數億的糖尿病和肥胖症患者帶來福音。

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