安科生物(300009.SZ):參股公司PA3-17注射液臨牀試驗申請獲受理
格隆匯5月21日丨安科生物(300009.SZ)宣佈,近日,公司參股公司博生吉醫藥科技(蘇州)有限公司(簡稱“博生吉公司”)收到國家藥品監督管理局藥品審評中心行政許可文書《受理通知書》,博生吉醫藥申報的“PA3-17注射液”臨牀試驗申請獲得受理。
該次獲得臨牀試驗受理的是博生吉公司自主研發的國際首款基於納米抗體的CD7-CAR-T細胞注射液(研發代號:PA3-17注射液),其適應症為成人復發、難治性CD7陽性血液淋巴系統惡性腫瘤患者。
CD7陽性的惡性腫瘤大多屬於高侵襲性淋巴瘤或者白血病,病程進展快,預後差,大部分病例化療緩解後短期內就發生復發。這些疾病主要包括:T淋巴母細胞性白血病、淋巴瘤(T-ALL/LBL)、早期前T淋巴母細胞白血病(ETP-ALL)、結外NK/T細胞淋巴瘤,以及多種少見病和罕見病等。
對於難治複發性T-ALL/LBL的治療,國際上僅有美國FDA批准了奈拉濱(nelarabine)作為其治療用藥,但奈拉濱療效有限,因此難治複發性T-ALL/LBL等適應症代表着臨牀上亟待滿足的需求。
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