甘李藥業(603087.SH):擬用於多種晚期實體腫瘤治療的GLR2007臨牀試驗申請獲受理
格隆匯 11 月 29日丨甘李藥業(603087.SH)公佈,公司於2020年11月28日收到國家藥品監督管理局(“國家藥監局”)下發的《受理通知書》,GLR2007的臨牀試驗申請獲得受理。
該藥品為公司自主研發的創新型小分子化學藥物,是一種細胞週期蛋白依賴性激酶4/6(CDK4/6)抑製劑,擬用於包括腦膠質瘤在內的多種晚期實體腫瘤治療。該藥已於2020年7月在美國開展I期臨牀階段,於2020年9月獲得FDA孤兒藥資格認定,用於治療包括膠質母細胞瘤(GBM)在內的惡性膠質瘤。截至2020年9月30日,甘李藥業在該項目中累計投入研發費用5730萬元人民幣。
惡性膠質瘤是最常見的原發性惡性腦腫瘤,發病率為每10萬人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,成人的中位生存期為12個月,5年生存率僅僅為4-5%(數據來源:Ron B, Noam A, Pamela S,etal. Glioblastoma Multiforme, Diagnosis and Treatment; Recent LiteratureReview. Curr Med Chem.2017;24(27):3002-3009.)。
截至2020年8月31日,根據CortellilsTM數據庫不完全數據統計,針對GBM適應症,全球共有23種產品正在進行臨牀試驗,其中5種正在進行I期臨牀,13種正在進行II期臨牀,5種正在進行III期臨牀。根據Globaldata數據庫2019年披露的報告,針對GBM適應症已批准的藥物有三種,分別為替莫唑胺、貝伐珠單抗、卡莫司汀,三種藥物在2017年針對GBM適應症的全球銷售額約為27.8億元人民幣。
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