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石藥集團(01093.HK):抗腫瘤納米藥物“注射用西羅莫司(白蛋白結合型)”獲臨牀試驗批准
格隆匯 06-09 17:22

格隆匯6月9日丨石藥集團(01093.HK)發佈公吿,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“注射用西羅莫司(白蛋白結合型)”已獲中國國家藥品監督管理局批准,可在中國開展臨牀試驗,為國內首個獲得臨牀許可注射給藥的西羅莫司製劑。

西羅莫司又稱雷帕黴素,是一種大環內酯抗生素類免疫抑制劑,為mTOR特異性抑制劑。目前國內外已上市的西羅莫司均為口服制劑,用於預防接受腎移植患者的器官排斥。

該產品採用特殊技術將西羅莫司包裹於人血白蛋白中,克服口服制劑無法向靶部位遞送足夠濃度藥量的缺點,有望實現治療mTOR信號通路驅動的一系列疾病。該產品實現了西羅莫司的注射給藥,且無需激素預處理,同時拓展了該藥物的應用領域。本次批准的臨牀適應症為實體瘤和血液瘤,臨牀前研究結果顯示該產品在多種實體瘤和血液瘤模型中有較好的抗腫瘤活性,極有希望在臨牀試驗中展現出良好的抗腫瘤效果。該產品屬於中國化藥註冊分類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試驗工作,力爭該產品儘快上市。

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