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和鉑醫藥-B(02142.HK):巴託利單抗治療全身型重症肌無力的II期概念驗證性試驗的積極研究結果
格隆匯 07-06 17:04

格隆匯7月6日丨和鉑醫藥-B(02142.HK)發佈公吿,巴託利單抗(HBM9161)在中國全身型重症肌無力(“gMG”)患者中的II期概念驗證性臨牀試驗(“II期研究”)期中分析的積極研究結果。

作為國內首個獲得臨牀研究證據的抗FcRn療法,II期研究所得數據顯示,相對於安慰劑,巴託利單抗的療效具有統計學意義和臨牀意義,以及良好的安全性和耐受性。

II期研究的數據表明,巴託利單抗可以迅速緩解中國患者的肌無力症狀,且表現出良好的安全性,使巴託利單抗可能成為填補gMG患者目前治療空白的新選擇。

基於II期研究期中分析的積極數據,公司已與國家藥品監督管理局(國家藥監局)藥物評審中心舉行了“II期結束”會議,其對進行III期研究給予全力支持。公司預期該III期研究將於2021年下半年啟動。

巴託利單抗(HBM9161)是一種全人源抗FcRn單克隆抗體(mAb),可阻斷FcRn-IgG 相互結合,加速體內IgG的清除,從而達到有效治療致病性IgG介導的自身免疫性疾病的效果。現有的證據表明重症肌無力患者的致病IgG水平的降低與臨牀獲益相關。早期研究表明巴託利單抗(HBM9161)耐受性良好,能迅速降低總IgG。這些發現使巴託利單抗(HBM9161)成為首個被證實在中國及高加索人羣中經皮下注射(SC)後能持續降低IgG的抗FcRn靶點藥物。巴託利單抗用於gMG治療已被中國國家藥監局授予“突破性療法”。 

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