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增肌減脂,來凱LAE102肥胖適應症新藥臨牀試驗申請獲CDE受理
格隆匯 02-28 08:51

2024年2月28日-來凱醫藥(2105.HK)宣佈,中國國家藥品監督管理局藥品審評中心(CDE)已受理了LAE102在肥胖症的新藥臨牀試驗申請(IND)。該藥是來凱自主研發的針對ActRIIA的強效、選擇性單克隆抗體,潛在用於治療成人肥胖或代謝性疾病患者。此前,LAE102的腫瘤臨牀試驗申請已經於2024年2月獲得CDE批准。

公司將與監管機構密切溝通,待IND獲批後,啟動LAE102臨牀試驗流程,為肥胖或代謝病患者提供新型、精準的治療選擇。

"LAE102是來凱自主研發的成果之一,很高興看到它從實驗室一步步走向臨牀。"來凱醫藥首席執行官呂向陽博士表示:"肥胖是當前全球生物醫藥的聚焦領域之一,來凱將以患者需求為首要目標,全力加速這一領域的研發進程。"

LAE102是一種強效、選擇性單克隆抗體,針對肌肉再生具有調控作用的新靶點ActRIIA。在臨牀前研究中,LAE102已顯示出增加骨骼肌並減少白色脂肪的效果,是一種潛在的、用於肥胖和其他代謝性疾病適應症開發的候選藥物。在肥胖小鼠模型中,LAE102與GLP-1的聯合療法顯示出協同增效作用,有效加大減脂效果,同時避免肌肉流失,有望實現高質量減脂結果。

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