甘李药业CDK4/6抑制剂获FDA孤儿药资格,治疗恶性胶质瘤

2020-09-11 医药魔方 医药魔方

9月10日,甘李药业宣布FDA授予其细胞周期蛋白依赖性激酶 4/6(CDK4/6)抑制剂GLR2007孤儿药资格,用于治疗包括胶质母细胞瘤(GBM)在内的恶性胶质瘤。

9月10日,甘李药业宣布FDA授予其细胞周期蛋白依赖性激酶 4/6(CDK4/6)抑制剂GLR2007孤儿药资格,用于治疗包括胶质母细胞瘤(GBM)在内的恶性胶质瘤。

GLR2007 是甘李药业自主研发的创新型小分子化学药物。周期蛋白依赖性激酶(CDK)是一类与细胞周期调控密切相关的关键调节因子,而CDK4/6是 人体细胞分裂增殖周期的关键条件蛋白,在病理条件下,两种激酶过度活跃,表现出显着活性,与细胞周期蛋白 D(CyclinD)结合,可磷酸化视网膜细胞瘤基 因(Rb),从而释放转录因子 E2F,促进细胞周期相关基因的转录。CDK4/6 抑制剂可以有效阻断 CDK4/6 激酶的活性,恢复细胞周期控制,阻断肿瘤细胞增殖,进而抑制癌细胞的生长。

GBM 作为高级别胶质瘤,恶性程度高。美国国家癌症研究所估计,恶性胶质瘤发病率为每十万人二到三人,占所有原发性脑部肿瘤的 52%,占所有脑部肿瘤(包括原发和转 移瘤)的 17%。

目前临床上用于脑胶质瘤治疗的手段主要为手术切除结合 DNA 甲 基化剂放疗和药物化疗,术后极易复发,患者五年生存率仍不足 5%。根据 GlobalData 2018 年发布的预测,到 2027 年全球 GBM 药物市场规模预计达到 14 亿美元,复合年增长率(CAGR)达 7.5%。

截至 2020 年 6 月 30 日,甘李药业开发GLR2007 三个适应症的累计研发投入 3989 万元。

根据美国 1983 年颁布的《孤儿药法案》及最 新修订,本次甘李药业在研产品获 FDA 孤儿药资格认定,项目的后续研发、注册及商业化等方面将享受一定的政策支持,包括:(1)市场独占权。获得认定的孤儿药经美国 FDA 批准上市后可享有 7 年的市场独占权,且不受专利的影响。(2)税收抵免。孤儿药用于后续临床试验费用的 50%可作为税收抵免,并向前延伸 3 年,向后延伸15 年。(3)免除新药申请费。

甘李药业 GLR2007 项目的 GBM 适应症获得孤儿药资格后,将获得与美国 FDA 直接沟通的通道,就后续项目研发及临床试验、注册申报等与美国 FDA 进行 沟通与协商,并选择最佳方案推进,从而尽快实现药品获批上市。

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    2021-05-08 soongzhihua
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    2021-01-13 jklm09
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  4. 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encryptionId=08f236865a8, topicName=卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sat Sep 12 07:04:45 CST 2020, time=2020-09-12, status=1, ipAttribution=)]
    2020-10-14 lovetcm

    #CDK4/6抑制剂#用于#胶质瘤#,最后的结果,可能并不看好!

    0

  5. 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encryptionId=08f236865a8, topicName=卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sat Sep 12 07:04:45 CST 2020, time=2020-09-12, status=1, ipAttribution=)]
    2020-09-13 zhouqu_8
  6. 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href='/topic/show?id=dad04542ede' target=_blank style='color:#2F92EE;'>#孤儿药#</a>资格,用于治疗包括<a href='/topic/show?id=01858406438' target=_blank style='color:#2F92EE;'>#胶质母细胞瘤#</a>(GBM)在内的<a href='/topic/show?id=8d2452942c2' target=_blank style='color:#2F92EE;'>#恶性胶质瘤#</a>,有些迷惑了。CDK4/6不是用于<a href='/topic/show?id=73c423e2572' target=_blank style='color:#2F92EE;'>#乳腺癌#</a>,<a href='/topic/show?id=08f236865a8' target=_blank style='color:#2F92EE;'>#卵巢癌#</a>的吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=290, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68811, encryptionId=b11868811f1, topicName=甘李药业), TopicDto(id=7291, encryptionId=f336e29134, topicName=FDA), TopicDto(id=45427, encryptionId=dad04542ede, topicName=孤儿药), TopicDto(id=84064, encryptionId=01858406438, topicName=胶质母细胞瘤), TopicDto(id=52942, encryptionId=8d2452942c2, topicName=恶性胶质瘤), TopicDto(id=23725, encryptionId=73c423e2572, topicName=乳腺癌), TopicDto(id=36865, encryptionId=08f236865a8, topicName=卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sat Sep 12 07:04:45 CST 2020, time=2020-09-12, status=1, ipAttribution=)]
    2020-09-13 zhangj7111
  7. 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topicName=null, topicId=null, topicList=[TopicDto(id=4405, encryptionId=fc9744059a, topicName=CDK4/6抑制剂), TopicDto(id=84066, encryptionId=53668406668, topicName=胶质瘤)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Wed Oct 14 14:06:49 CST 2020, time=2020-10-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1435549, encodeId=184014355498f, content=<a href='/topic/show?id=09dc439915' target=_blank style='color:#2F92EE;'>#CDK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4399, encryptionId=09dc439915, topicName=CDK)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, 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href='/topic/show?id=dad04542ede' target=_blank style='color:#2F92EE;'>#孤儿药#</a>资格,用于治疗包括<a href='/topic/show?id=01858406438' target=_blank style='color:#2F92EE;'>#胶质母细胞瘤#</a>(GBM)在内的<a href='/topic/show?id=8d2452942c2' target=_blank style='color:#2F92EE;'>#恶性胶质瘤#</a>,有些迷惑了。CDK4/6不是用于<a href='/topic/show?id=73c423e2572' target=_blank style='color:#2F92EE;'>#乳腺癌#</a>,<a href='/topic/show?id=08f236865a8' target=_blank style='color:#2F92EE;'>#卵巢癌#</a>的吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=290, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68811, encryptionId=b11868811f1, topicName=甘李药业), TopicDto(id=7291, encryptionId=f336e29134, topicName=FDA), TopicDto(id=45427, encryptionId=dad04542ede, topicName=孤儿药), TopicDto(id=84064, encryptionId=01858406438, topicName=胶质母细胞瘤), TopicDto(id=52942, encryptionId=8d2452942c2, topicName=恶性胶质瘤), TopicDto(id=23725, encryptionId=73c423e2572, topicName=乳腺癌), TopicDto(id=36865, encryptionId=08f236865a8, topicName=卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sat Sep 12 07:04:45 CST 2020, time=2020-09-12, status=1, ipAttribution=)]
    2020-09-12 lovetcm

    #甘李药业#宣布#FDA#授予其细胞周期蛋白依赖性激酶 4/6(CDK4/6)抑制剂GLR2007#孤儿药#资格,用于治疗包括#胶质母细胞瘤#(GBM)在内的#恶性胶质瘤#,有些迷惑了。CDK4/6不是用于#乳腺癌##卵巢癌#的吗?

    0

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