甘李藥業(603087.SH):腦膠質瘤治療藥獲美國FDA藥品臨牀試驗批准
格隆匯7月7日丨甘李藥業(603087.SH)公佈,近日,公司全資子公司甘李藥業美國公司(Gan&Lee Pharmaceuticals USA Corporation)獲得美國食品藥品監督管理局(以下簡稱“FDA”)同意GLR2007進行 I 期臨牀試驗的批准(Clinical Trials. govIdentifier: NCT04444427)。子公司將在美國開展該項I期臨牀試驗。
該藥品為公司自主研發的創新型小分子化學藥物,擬用於包括腦膠質瘤在內的多種晚期實體腫瘤治療,目前處於美國新藥註冊的I期臨牀階段,根據美國相關新藥研發的法規要求,該新藥尚需開展一系列臨牀研究並經藥品審評部門審批通過等,方可上市。
至目前,公司該項目研發投入為3989萬元人民幣左右。惡性膠質瘤是最常見的原發性惡性腦腫瘤,發病率為每十萬人3.19人,腦膠質瘤是最常見的惡性腦部腫瘤之一,從確診之日開始算起,成人的中值生存期為12個月,5年的生存率僅僅為4-5%。
自從1999年FDA批准細胞毒性類藥物替莫唑胺用於腦膠質瘤的治療,已經20多年沒有新的化學類藥物被批准用於腦膠質瘤的治療。米內網數據顯示,2015-2017年,替莫唑胺膠囊在中國公立醫療機構終端銷售額分別為12.13億元、14.22億元、18.55億元,且銷售額增長率逐年上升。替莫唑胺是細胞毒性類藥物,GLR2007為靶向藥物,迄今為止還沒有一個靶向藥物被批准用於腦膠質瘤的治療。因此,GLR2007獲准進入臨牀階段具有重要意義。該新藥有望成為一個擁有完全自主知識產權、有效治療包括腦膠質瘤在內的多種晚期實體腫瘤的新型靶向藥物,具有較大的市場潛力和社會效益。
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