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石藥集團(01093.HK):抗腫瘤納米藥物“注射用SYHA1908”獲臨牀試驗批准
格隆匯 02-07 18:11

格隆匯2月7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1類新藥“注射用SYHA1908”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。

SYHA1908(該化合物)是新一代高效、低毒的紫杉烷類化合物,作用於微管或微管蛋白系統。該產品為本集團自主開發以人血白蛋白作為載體的藥物,以實現新一代紫杉烷類化合物在體內的有效遞送。該化合物對正常組織沒有細胞毒作用,但可以被腫瘤微環境中的酶轉化成活性物質發揮抗腫瘤作用,因此具有顯着改善的安全窗,和已上市的紫杉烷類藥物相比,安全性提高至少> 100倍,而療效相當。因此,該化合物可改善現有紫杉烷類藥物由於劑量限制性毒性而無法實現更高劑量給藥的臨牀限制。

本次獲批的臨牀適應症為實體瘤,臨牀前研究結果顯示該產品在多種實體瘤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1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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