和鉑醫藥-B(02142.HK)完成向首名患者以巴託利單抗III期試驗治療全身型重症肌無力的首次給藥
格隆匯9月27日丨和鉑醫藥-B(02142.HK)發佈公吿,巴託利單抗(HBM9161,一款由公司開發用於自身免疫性疾病療法的新型藥物)用於治療全身型重症肌無力(gMG)的臨牀試驗已完成註冊III期試驗中首名患者的首次給藥。該臨牀試驗旨在評估巴託利單抗(HBM9161)在治療中國gMG患者時的療效及安全性。此乃繼2021年8月完成的用於治療gMG的首款抗FcRn治療概念驗證研究報導積極結果之後的又一里程碑。作為首個在中國獲得臨牀研究依據的抗FcRn療法,自II期研究接獲的數據顯示巴託利單抗具有統計學顯著性和臨牀意義的療效,以及良好的安全性及耐受性。
作為產品管線的一部分,公司正在開發巴託利單抗(HBM9161)用於治療多種有大量未獲滿足醫療需求的且由致病性IgG介導的自身免疫性疾病。公司正於中國針對多種適應症開發候選藥物,而gMG為當中最早展開研究的適應症之一併於2021年初獲得NMPA授予突破性治療認證。
據悉,重症肌無力(MG)是一種由抗乙酰膽礆受體(AChR)免疫球蛋白G(IgG)抗體和抗肌肉特異性酪氨酸激酶(Anti-MuSK)IgG等抗體介導的獲得性自身免疫性疾病。該疾病導致神經肌肉接頭的傳遞受損,表現為骨骼肌收縮無力。患者常有眼肌表現,約85%的患者會出現眼肌以外的症狀,發展為全身性重症肌無力(gMG),甚至發生肌無力危象。
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