石藥集團(01093.HK):"鹽酸米託蒽醌脂質體注射液"新藥上市申請獲得受理
格隆匯 8 月 25日丨石藥集團(01093.HK)宣佈,公司附屬公司石藥集團中諾藥業(石家莊)有限公司開發的"鹽酸米託蒽醌脂質體注射液(10ml:10mg)"已向中國國家藥品監督管理局藥品審評中心提交新藥上市申請並獲得受理。此次申請的適應症為用於既往至少接受過一次一線標準治療的復發或難治的外周T細胞淋巴瘤患者的治療。
該產品是集團自主開發的全球首個米託蒽醌脂質體制劑,屬2.2類改良型新藥,具有完全知識產權。此次新藥上市申請主要基於一項鹽酸米託蒽醌脂質體注射液在復發╱難治的外周T細胞和NK/T細胞淋巴瘤中的單臂、開放、多中心的II期研究結果。
該產品目前在全球沒有相似產品上市,集團將全力以赴,力爭該產品儘快上市。
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