石藥集團(01093.HK):抗腫瘤納米藥物“鹽酸表柔比星脂質體注射液”獲臨牀許可
格隆匯10月22日丨石藥集團(01093.HK)發佈公告,公司附屬公司石藥集團中奇製藥技術(石家莊)有限公司開發的“鹽酸表柔比星脂質體注射液”已獲國家藥品監督管理局批准可以在中國開展臨牀試驗。
根據披露,該產品將活性成分鹽酸表柔比星裝載於聚乙二醇化的脂質體中,能夠減少藥物向正常組織的分佈,並且通過高通透性和滯留(Enhanced Permeability and Retention)效應靶向到腫瘤區。與普通注射液相比,該產品可顯着降低毒副作用及提高療效。該產品計劃開發的適應症為實體瘤,基於非臨牀研究結果,該產品極有希望在臨牀研究中展現出良好的抗癌治療效果。
公告表示,“鹽酸表柔比星脂質體注射液”屬於化藥2類,目前全球尚無同類產品上市。集團將全力推進該產品的臨牀研究工作,力爭該產品儘快上市。
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