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中国自主研发生产的抗癌药,可治疗晚期转移性肠癌

2018-06-30 佚名 澎湃新闻

首个独立由中国人发明、中国医生研究、中国企业研发的抗癌药“呋喹替尼”即将面世,可为接受过至少两次化疗方案,但仍发生疾病进展的转移性结直肠癌患者带来希望,在临床研究中被证实可显着延长患者的生存期。

首个独立由中国人发明、中国医生研究、中国企业研发的抗癌药“呋喹替尼”即将面世,可为接受过至少两次化疗方案,但仍发生疾病进展的转移性结直肠癌患者带来希望,在临床研究中被证实可显着延长患者的生存期。

澎湃新闻记者6月28日从同济大学附属东方医院获悉,这一药物的III期关键性临床研究由该院肿瘤医学部主任李进教授和中国人民解放军第八一医院副院长秦叔逵教授共同领导,复旦大学附属肿瘤医院、和记黄埔医药与礼来制药等全国28家临床药物研究机构参与完成。而这一临床研究结果也被发表在6月26日出版的国际顶尖医学期刊《美国医学会杂志》上。

李进表示,这一国际权威杂志被评为国际医学界公认为“四大”顶尖医学期刊之一,此前从未发表过中国创新研发的国产抗癌药物,“让中国制药走上世界舞台已经是我们国家未来的发展方向,而这一药物的研发成果将对中国推动国产药物的研发具有里程碑的意义。”

生存期延长到9.3个月

全球每年新发结直肠癌136万例,病死69万4000例。在中国,每年新发结直肠癌37万6000例,且大部分结直肠癌患者诊断时已至中晚期。

目前,转移性结直肠癌的标准治疗为化疗,对于化疗失败的晚期结直肠癌患者,有效的治疗选择非常有限。两期化疗失败后,许多患者仍然体质较好,生存愿望强烈,亟需安全有效的后续治疗方案。

对此,呋喹替尼的III期关键性临床研究吸纳了416名晚期结直肠癌患者,平均年龄54.6岁,其中161例为女性,这些患者分成两组,一组使用呋喹替尼新药,另一组则使用安慰剂,通过每日一次,28天为一疗程(治疗21天,停药7天)的治疗,研究随访至2017年1月17日。

经比对:使用呋喹替尼组的患者的生存期延长到9.3个月,比使用安慰剂组的患者生命周期显着延长了2.7个月;同时呋喹替尼也显示出了良好的安全性,尤其对肝脏毒性相较于其他同类要来讲是最低的,和使用安慰剂组的患者没有差异。

通过临床试验,呋喹替尼显示出了对结直肠癌作用强、毒性低、耐受性好的优势。据李进介绍,试验所得结果是目前国际上此领域内所能达到的最大延长期数据。

目前此项临床研究已获得了国家“十二五”“重大新药创制”专项课题支持、上海市科委科技专项、浦东新区科委科技发展基金专项以及张江高科技园区管理委员会对应的配套资金支持。

据了解,基于上述临床研究的数据,和记黄埔医药已向国家药品监督管理局递交了呋喹替尼治疗晚期结直肠癌的新药上市申请,呋喹替尼的上市申请因“具有明显临床价值”被授予“优先审评”资格。李进表示,预计今年年底可获得国家药品监督管理局的批文,届时即可上市销售。

推动国内抗肿瘤药物从“仿制”向“原创”

抗肿瘤药物的研发一直掌握在欧美国家手中,目前,国内抗癌新药数量和效果与发达国家仍有很大差距。国内抗癌药物创新与研发现状如何?存在哪些发展瓶颈?

统计数据显示,在2010-2014年上市的49种癌症新药中,只有6种在中国上市。截至2018年1月,在中国进行的与癌症相关的临床试验研究约为33407个项目,而美国数量已超过11万,为中国的3倍多。

国内上市和在研的新药绝大多数是以仿制为主,处于仿创结合阶段。究其中国医药企业研发生产原创药薄弱的原因:新药研发是一个高投入、高风险、长周期(10 -15年)的过程,需要足够的人力、财力和设备的投入。

作为自主研发的抗癌新药呋喹替尼从立项到目前的上市冲刺阶段,整个研究团队走过了12年的研发历程,“期待呋喹替尼的后期上市能带动抗癌新药的创制体系建立,加速国内医药企业从抗癌药物的仿制向创制转变。”李进说。

据悉,目前在东方医院南院六楼的肿瘤药物一期临床试验中心正在开展20项肿瘤药物的临床试验,李进表示,中心将计划以每年30-35项的研发速度来推进肿瘤新药研发创制。

原始出处:
Jin Li, MD; Shukui Qin, MD; Rui-Hua Xu, MD, PhD; et al.Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer.The FRESCO Randomized Clinical Trial.June 26, 2018.JAMA. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855

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    2018-07-02 lqvr
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    2018-07-02 sunylz
  4. [GetPortalCommentsPageByObjectIdResponse(id=1672164, encodeId=d27116e21648e, content=<a href='/topic/show?id=177c85966dc' target=_blank style='color:#2F92EE;'>#自主研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85966, encryptionId=177c85966dc, topicName=自主研发)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6d2c26890289, createdName=xlwang2700, createdTime=Wed Mar 27 12:24:00 CST 2019, time=2019-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1300159, encodeId=3bed1300159ed, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Mon Jul 02 04:24:00 CST 2018, time=2018-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1314769, encodeId=cb951314e69cb, content=<a href='/topic/show?id=9d4b5554131' target=_blank style='color:#2F92EE;'>#抗癌药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55541, encryptionId=9d4b5554131, topicName=抗癌药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Mon Jul 02 04:24:00 CST 2018, time=2018-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386403, encodeId=3944138640322, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Mon Jul 02 04:24:00 CST 2018, time=2018-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517768, encodeId=009c151e768af, content=<a href='/topic/show?id=44156886664' target=_blank style='color:#2F92EE;'>#生产#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68866, encryptionId=44156886664, topicName=生产)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=37a111112788, createdName=ms1343860338762272, createdTime=Mon Jul 02 04:24:00 CST 2018, time=2018-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=328236, encodeId=787b328236a8, content=学习了.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Sat Jun 30 14:10:18 CST 2018, time=2018-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=328230, encodeId=44b032823009, content=学习了.获益匪浅.感谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=110, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/02/27/c53a212859edcad4f60a54feffff50bb.jpg, createdBy=67cf1525321, createdName=13718711b3m, createdTime=Sat Jun 30 13:48:54 CST 2018, time=2018-06-30, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1672164, encodeId=d27116e21648e, content=<a href='/topic/show?id=177c85966dc' target=_blank style='color:#2F92EE;'>#自主研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85966, encryptionId=177c85966dc, topicName=自主研发)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6d2c26890289, createdName=xlwang2700, createdTime=Wed Mar 27 12:24:00 CST 2019, time=2019-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1300159, encodeId=3bed1300159ed, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Mon Jul 02 04:24:00 CST 2018, time=2018-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1314769, encodeId=cb951314e69cb, content=<a href='/topic/show?id=9d4b5554131' target=_blank style='color:#2F92EE;'>#抗癌药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55541, encryptionId=9d4b5554131, topicName=抗癌药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Mon Jul 02 04:24:00 CST 2018, time=2018-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386403, encodeId=3944138640322, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Mon Jul 02 04:24:00 CST 2018, time=2018-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517768, encodeId=009c151e768af, content=<a href='/topic/show?id=44156886664' target=_blank style='color:#2F92EE;'>#生产#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68866, encryptionId=44156886664, topicName=生产)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=37a111112788, createdName=ms1343860338762272, createdTime=Mon Jul 02 04:24:00 CST 2018, time=2018-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=328236, encodeId=787b328236a8, content=学习了.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Sat Jun 30 14:10:18 CST 2018, time=2018-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=328230, encodeId=44b032823009, content=学习了.获益匪浅.感谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=110, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/02/27/c53a212859edcad4f60a54feffff50bb.jpg, createdBy=67cf1525321, createdName=13718711b3m, createdTime=Sat Jun 30 13:48:54 CST 2018, time=2018-06-30, status=1, ipAttribution=)]
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    2018-06-30 1209e435m98(暂无昵称)

    学习了.谢谢分享

    0

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    2018-06-30 13718711b3m

    学习了.获益匪浅.感谢分享

    0

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