石藥集團(01093.HK):JMT202(重組全人源抗βKLOTHO單克隆抗體)獲美國臨牀試驗批准
格隆匯5月2日丨石藥集團(01093.HK)公吿,集團開發的重組全人源抗β Klotho單克隆抗體藥物JMT202已獲美國食品藥品監督管理局(FDA)批准,可以在美國開展臨牀研究。該產品亦已於2024年5月獲得中國國家藥品監督管理局批准,目前正在中國開展臨牀試驗。
該產品為FGFR1c/β Klotho受體激動劑,通過結合β Klotho蛋白,特異性地激活FGFR1c/β Klotho受體複合物,從而模擬其天然配體FGF21蛋白的作用,以調控糖脂代謝。該產品潛在可用於治療血脂異常、代謝功能障礙相關脂肪性肝炎(MASH)、2型糖尿病和肥胖等代謝相關的疾病,且具有與其他調控糖脂代謝的靶點藥物(如GLP-1等)聯用的潛力。本次獲批的臨牀適應症為高甘油三酯血癥(HTG)。臨牀前研究顯示,該產品具有良好的安全性和較長的給藥間隔,可顯著降低甘油三酯(TG),同時具有降肝脂作用,具備較高的臨牀開發價值。
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