吉貝爾(688566.SH):在研抗腫瘤新藥注射用JJH201601脂質體獲批單藥在晚期實體瘤中開展臨牀試驗
格隆匯4月17日丨吉貝爾(688566.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,公司在研抗腫瘤新藥注射用JJH201601脂質體符合藥品註冊的有關要求,批准該品單藥在晚期實體瘤中開展臨牀試驗。
JJH201601是公司依託脂質體藥物研發技術平台開發的一類抗腫瘤新藥。公司通過分子設計和藥效試驗篩選,得到全新化合物JJH201601,利用脂質體技術將其開發為脂質體制劑。注射用JJH201601脂質體在多種實體瘤CDX模型上的抑瘤作用顯著,且均強於進口多西他賽注射液(商品名:泰索帝),並具有更低的毒副作用。同時,在多項由重度免疫缺陷小鼠構建的PDX荷瘤模型上,JJH201601也表現出優於陽性對照多西他賽、白蛋白紫杉醇、替吉奧和吉西他濱的抑瘤效果,且藥物的耐受性和安全性較好。目前JJH201601化合物專利已獲得國內授權。
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