首藥控股(688197.SH):SY-7166獲得藥物臨牀試驗批准通知書
格隆匯8月25日丨首藥控股(688197.SH)公吿,首藥控股(北京)股份有限公司(以下簡稱“公司”)於近日收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》,公司SY-7166片單藥用於治療多發性骨髓瘤的臨牀試驗申請獲得批准。
多發性骨髓瘤(MultipleMyeloma,MM)是一種克隆漿細胞異常增殖的惡性疾病,其特徵為骨髓漿細胞異常增生伴有單克隆免疫球蛋白或輕鏈(M蛋白)過度生成。目前,我國多發性骨髓瘤位居血液系統惡性腫瘤第2位,2020年新增多發性骨髓瘤病例21,116例,死亡病例16,182例,發病率以每年2.5%的速率上升。目前,MM的一線標準療法主要是蛋白酶體抑制劑聯合免疫調節劑和地塞米松,已獲批上市的蛋白酶體抑制劑有硼替佐米、卡非佐米和伊沙佐米(均為非選擇性蛋白酶體抑制劑),安全性有待提高。另外,標準治療後耐藥患者還有明顯的臨牀需求。
臨牀前系統的藥理學、藥代動力學、毒理學研究結果顯示,SY-7166是一款高活性、高選擇性的免疫蛋白酶體抑制劑,擁有良好的臨牀前抗腫瘤活性、安全性優良,單藥或與其它藥物聯合對MM以及硼替佐米耐藥的MM有顯著的抑制作用,未來有望在治療MM的臨牀研究中取得良好的臨牀療效,同時提高安全性和依從性,從而為MM患者提供更多的治療選擇。
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