和鉑醫藥-B(02142.HK)在研產品巴託利單抗被CDE授予突破性治療藥物資格
格隆匯1月28日丨和鉑醫藥-B(02142.HK)宣佈,公司在研產品巴託利單抗(HBM9161),一種用於治療重症肌無力(“MG”)的全人源單克隆抗體(mAb),近日被國家藥品監督管理局藥品審評中心(“CDE”)授予突破性治療藥物資格。
MG,由致病性IgG介導,是一種嚴重的使人衰弱的疾病,表現為骨骼肌收縮和無力限制運動,甚至可能導致致命性的呼吸衰竭。在中國,大約有25萬患者受重症肌無力困擾,現有的治療在療效、安全性及供應方面有所限制,急需新的有效且安全的治療手段。
巴託利單抗(HBM9161)是一種全人源單克隆抗體(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水準的降低與臨牀獲益相關。早期研究表明巴託利單抗(HBM9161)具有良好耐受性,可迅速降低總IgG。研究亦表明巴託利單抗(HBM9161)是首個被證實在中國和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。
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