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君实生物特瑞普利单抗联合阿昔替尼治疗黏膜黑色素瘤获得美国FDA孤儿药资格认定

2020-03-28 医药魔方 医药魔方

FDA阿昔替尼孤儿药特瑞普利单抗黏膜黑色素瘤
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3月27日，君实生物宣布，由公司自主研发的抗PD-1单抗特瑞普利单抗（商品名：拓益，产品代号：JS001）联合阿昔替尼治疗黏膜黑色素瘤于近日获得美国食品药品监督管理局（FDA）孤儿药资格认定。

3月27日，君实生物宣布，由公司自主研发的抗PD-1单抗特瑞普利单抗（商品名：拓益，产品代号：JS001）联合阿昔替尼治疗黏膜黑色素瘤于近日获得美国食品药品监督管理局（FDA）孤儿药资格认定。
“孤儿药”，即治疗罕见病的药物。美国在1983年通过《孤儿药法案》，并在2013年发布了最新的修订版本，对于在美国患者少于20万人的罕见疾病，授予治疗用药特别的优惠权利。本次获得美国FDA颁发的孤儿药资格认定将有助于特瑞普利单抗联合用药在美国的后续研发、注册及商业化等享受一定的政策支持，包括临床试验费用的税收抵免、新药申请费免除及享有7年的市场独占权且不受专利影响，将在一定程度上降低研发投入，有利于推进临床试验。
特瑞普利单抗是《孤儿药法案》颁布以来，第一个在黏膜黑色素瘤领域被授予“孤儿药”认定的品种。
值得注意的是，FDA在给君实生物的批准文件中指出：此次授予孤儿药资格认证的适应症为“黏膜黑色素瘤”，其范围比君实生物提交的适应症申请更为广泛，“不可切除或转移性黏膜黑色素瘤”被包括在此范围内。这意味着特瑞普利单抗有望在更大的治疗领域发挥作用。
黏膜黑色素瘤在白色人种中是一种罕见的黑色素瘤亚型，约占其所有黑色素瘤患者的1.3%；然而，该亚型是亚洲黑色素瘤患者的第二大常见亚型，占比22%~25%。除了更有侵袭性外，容易出现内脏转移，黏膜型黑色素瘤目前没有成熟的治疗指南，传统化疗和单药免疫治疗效果都不佳。临床前研究显示免疫联合治疗可协同抑制肿瘤生长，为黏膜黑色素瘤的治疗指出了新的治疗方向。
君实生物自主研发的特瑞普利单抗是我国成功上市的首个国产PD-1药物，目前在中国获批适应症为既往标准治疗失败后的局部进展或转移性黑色素瘤。为了进一步提升抗PD-1单抗药物治疗黏膜黑色素瘤的有效性，北京大学肿瘤医院院长郭军教授团队首创特瑞普利单抗与阿昔替尼的联合疗法，为一线治疗方案带来了前所未有的新突破。
2017年，“JS001联合阿昔替尼一线治疗晚期黏膜黑色素瘤的Ib期临床研究”在世界黑色素瘤大会（2017WCM）上首次亮相，并于次年的美国临床肿瘤学会年会(2018 ASCO)和中国临床肿瘤学会年会（2018 CSCO）上公布更新结果，引发全球关注。基于这项研究的突破性成果，抗PD-1单抗联合阿昔替尼治疗黏膜黑色素瘤获得了2019年版《中国临床肿瘤学会（CSCO）黑色素瘤诊疗指南》的II级专家推荐。
2019年8月，该研究在国际著名期刊《临床肿瘤学杂志》(Journal of Clinical Oncology) (IF：28.245)上发表。研究结果显示：特瑞普利单抗联合阿昔替尼治疗未接受过化疗的晚期黏膜黑色素瘤患者可获得48.3%客观缓解率（ORR），及86.2%的疾病控制率（DCR），中位无进展生存期（mPFS）达7.5个月，中位总生存期（mOS）未成熟。
君实生物副总经理姚盛博士表示：“此次FDA授予我们孤儿药资格认定，是对我们在研发探索上的充分认可。在抗肿瘤领域，君实生物十分重视对免疫治疗敏感以及中国特有瘤种的研究。当发现特瑞普利单抗在治疗国人高发的黏膜黑色素瘤方面尚有提升空间时，我们决定继续探索，希望为中国乃至全球的患者找到更有效的治疗方法。今后，君实生物还将继续在肿瘤等重大疾病领域不断投入，为人类的健康事业做出贡献！”
截至目前，君实生物已在全球开展超过30个特瑞普利单药治疗及联合治疗的临床试验，包括14项关键注册临床试验，以及一项正在美国开展的针对多种实体瘤的Ib期临床试验，涉及鼻咽癌、尿路上皮癌、肺癌、胃癌、食管癌、肝癌、乳腺癌等。

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    2020-06-30 lfcmxl

    #瑞普利单抗#

    0

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    2021-03-08 sunylz

    #色素#

    0

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    2020-03-30 ms1692212821629096

    #阿昔替尼#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=2027418, encodeId=6a0a202e41867, content=<a href='/topic/show?id=48b368e28ea' target=_blank style='color:#2F92EE;'>#瑞普利单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68728, encryptionId=48b368e28ea, topicName=瑞普利单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da20314, createdName=lfcmxl, createdTime=Tue Jun 30 11:14:48 CST 2020, time=2020-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1680661, encodeId=f1551680661d3, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=343027846633, createdName=sunylz, createdTime=Mon Mar 08 15:14:48 CST 2021, time=2021-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1329924, encodeId=3a921329924ff, content=<a href='/topic/show?id=e6c99e836f0' target=_blank style='color:#2F92EE;'>#阿昔替尼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97836, encryptionId=e6c99e836f0, topicName=阿昔替尼)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/DC48AC6B5FFD609EED5594C15A97B420/100, createdBy=57dc2500034, createdName=ms1692212821629096, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1520056, encodeId=42d5152005650, content=<a href='/topic/show?id=6ab11032506f' target=_blank style='color:#2F92EE;'>#黏膜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103250, encryptionId=6ab11032506f, topicName=黏膜)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=057f11309297, createdName=snowpeakxu, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551476, encodeId=b34e15514e679, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559001, encodeId=a17b155900180, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565010, encodeId=1c48156501047, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=)]
    2020-03-30 snowpeakxu

    #黏膜#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=2027418, encodeId=6a0a202e41867, content=<a href='/topic/show?id=48b368e28ea' target=_blank style='color:#2F92EE;'>#瑞普利单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68728, encryptionId=48b368e28ea, topicName=瑞普利单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da20314, createdName=lfcmxl, createdTime=Tue Jun 30 11:14:48 CST 2020, time=2020-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1680661, encodeId=f1551680661d3, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=343027846633, createdName=sunylz, createdTime=Mon Mar 08 15:14:48 CST 2021, time=2021-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1329924, encodeId=3a921329924ff, content=<a href='/topic/show?id=e6c99e836f0' target=_blank style='color:#2F92EE;'>#阿昔替尼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97836, encryptionId=e6c99e836f0, topicName=阿昔替尼)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/DC48AC6B5FFD609EED5594C15A97B420/100, createdBy=57dc2500034, createdName=ms1692212821629096, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1520056, encodeId=42d5152005650, content=<a href='/topic/show?id=6ab11032506f' target=_blank style='color:#2F92EE;'>#黏膜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103250, encryptionId=6ab11032506f, topicName=黏膜)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=057f11309297, createdName=snowpeakxu, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551476, encodeId=b34e15514e679, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559001, encodeId=a17b155900180, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565010, encodeId=1c48156501047, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=)]
    2020-03-30 10518098zz

    #美国FDA#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=2027418, encodeId=6a0a202e41867, content=<a href='/topic/show?id=48b368e28ea' target=_blank style='color:#2F92EE;'>#瑞普利单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68728, encryptionId=48b368e28ea, topicName=瑞普利单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da20314, createdName=lfcmxl, createdTime=Tue Jun 30 11:14:48 CST 2020, time=2020-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1680661, encodeId=f1551680661d3, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=343027846633, createdName=sunylz, createdTime=Mon Mar 08 15:14:48 CST 2021, time=2021-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1329924, encodeId=3a921329924ff, content=<a href='/topic/show?id=e6c99e836f0' target=_blank style='color:#2F92EE;'>#阿昔替尼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97836, encryptionId=e6c99e836f0, topicName=阿昔替尼)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/DC48AC6B5FFD609EED5594C15A97B420/100, createdBy=57dc2500034, createdName=ms1692212821629096, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1520056, encodeId=42d5152005650, content=<a href='/topic/show?id=6ab11032506f' target=_blank style='color:#2F92EE;'>#黏膜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103250, encryptionId=6ab11032506f, topicName=黏膜)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=057f11309297, createdName=snowpeakxu, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551476, encodeId=b34e15514e679, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559001, encodeId=a17b155900180, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565010, encodeId=1c48156501047, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=)]
    2020-03-30 cqlidoudou

    #黑色素#

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=2027418, encodeId=6a0a202e41867, content=<a href='/topic/show?id=48b368e28ea' target=_blank style='color:#2F92EE;'>#瑞普利单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68728, encryptionId=48b368e28ea, topicName=瑞普利单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=da20314, createdName=lfcmxl, createdTime=Tue Jun 30 11:14:48 CST 2020, time=2020-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1680661, encodeId=f1551680661d3, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=343027846633, createdName=sunylz, createdTime=Mon Mar 08 15:14:48 CST 2021, time=2021-03-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1329924, encodeId=3a921329924ff, content=<a href='/topic/show?id=e6c99e836f0' target=_blank style='color:#2F92EE;'>#阿昔替尼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97836, encryptionId=e6c99e836f0, topicName=阿昔替尼)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/DC48AC6B5FFD609EED5594C15A97B420/100, createdBy=57dc2500034, createdName=ms1692212821629096, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1520056, encodeId=42d5152005650, content=<a href='/topic/show?id=6ab11032506f' target=_blank style='color:#2F92EE;'>#黏膜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103250, encryptionId=6ab11032506f, topicName=黏膜)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=057f11309297, createdName=snowpeakxu, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551476, encodeId=b34e15514e679, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559001, encodeId=a17b155900180, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565010, encodeId=1c48156501047, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Mon Mar 30 04:14:48 CST 2020, time=2020-03-30, status=1, ipAttribution=)]
    2020-03-30 cqlidoudou

    #黑色素#

    0

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