和鉑醫藥-B(02142.HK):巴託利單抗治療患有重症肌無力(MG)患者的II期臨牀研究首箇中期分析報吿獲得CDE全面認可
格隆匯6月2日丨和鉑醫藥-B(02142.HK)發佈公吿,有關巴託利單抗(HBM9161)治療患有重症肌無力(MG)患者的II期臨牀研究,其首箇中期分析報吿已提交予中國藥品評審中心(CDE)。公司已獲得CDE的全面認可,將會繼續推進、開展臨牀III期註冊研究的計劃。
有關巴託利單抗治療患有免疫性血小板減少症(ITP)患者的II期臨牀研究,其研究數據已由獨立數據委員會審核,且已確認不存在安全性風險,包括血脂檢查結果。
有關巴託利單抗治療患有視神經脊髓炎(NMOSD)患者的Ib/IIa期臨牀研究,仍按計劃進行中,且未觀察到額外的安全性風險。
據悉,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。早期研究表明巴託利單抗具有良好耐受性,可迅速降低總IgG。研究亦表明巴託利單抗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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