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甘李藥業(603087.SH):在研創新藥“GLR2007”獲得美國FDA孤兒藥資格認定
格隆匯 09-10 18:13

格隆匯 9 月 10日丨甘李藥業(603087.SH)公告,近日,公司收到美國食品藥品監督管理局(以下簡稱“美國FDA”)孤兒藥開發辦公室的正式書面回函,授予本公司在研創新藥細胞週期蛋白依賴性激酶4/6(CDK4/6)抑制劑(以下簡稱“GLR2007”)孤兒藥資格認定,用於治療包括膠質母細胞瘤(以下簡稱“GBM”)在內的惡性膠質瘤。美國FDA同時在其官方網站上對GLR2007的孤兒藥認定情況進行了公示。

藥品基本情況:

藥品名稱:細胞週期蛋白依賴性激酶4/6(CDK4/6)抑制劑

適應症:惡性膠質瘤

申請編號:DRU-2020-7606

申請人:甘李藥業美國公司

藥品審批狀態:尚未獲得美國FDA批准上市

審批結論:根據美國《聯邦食品、藥品和化粧品法案》第526條(美國法典第21360bb),授予公司研發的細胞週期蛋白依賴性激酶4/6(CDK4/6)抑制劑用以治療包括膠質母細胞瘤在內的惡性膠質瘤的孤兒藥資格。

其他説明:在該藥物獲得上市批准前,如有相同適應症的其他相同藥物已被批准上市,則須證明該藥品在臨牀上優於已批准的藥物,以獲得市場獨佔權。否則,將不能獲得孤兒藥的市場獨佔權。

自獲得孤兒藥資格之日起14個月內,需向美國FDA孤兒藥開發辦公室提交簡要的開發進度報告,此後每年提交一次,直至獲得上市批准。

甘李藥業作為一家中國生物仿製藥企業,正在研發的GLR2007項目中用於治療GBM的孤兒藥申請獲得美國FDA的認定,體現出甘李藥業在創新型小分子化學藥物的平台技術、研發創新能力與水平上獲得美國藥監部門的進一步認可,將有助於甘李藥業進一步推進GLR2007項目作為新藥在全球的研發進度,並在一定程度上能夠降低新藥研發成本,加快完成新藥臨牀試驗和新藥上市工作。

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