再获新适应症!新型三唑类抗真菌药物康新博在我国获批,用于治疗成人侵袭性曲霉病

2022-01-06 辉瑞 辉瑞

值得关注!

2022年1月6日,辉瑞公司宣布,国家药品监督管理局批准创新药物康新博(硫酸艾沙康唑胶囊,CRESEMBA,100mg)用于治疗成人侵袭性曲霉病。这是康新博侵袭性毛霉病适应症获批后,在中国获批的第二个适应症。作为新型三唑类抗真菌药物,康新博成为我国目前唯一一个获批用于治疗成人患者侵袭性毛霉病和曲霉病的口服抗真菌药物,为这类患者带来新的治疗选择。

侵袭性曲霉病可侵犯肺、中枢神经系统或骨骼、眼、鼻窦等全身多个部位。近年来,我国侵袭性曲霉病的发病率不断上升,如不及时治疗死亡率极高。

侵袭性曲霉病和侵袭性毛霉病同为侵袭性霉菌病,往往在早期诊断上难以区分。随着恶性肿瘤发病人数的增加、移植手术的大量开展,免疫受损人群增多,侵袭性霉菌病发病率日趋增高。异基因造血干细胞移植患者、实体器官移植患者、ICU危重患者、肿瘤放化疗患者,以及高龄且长期患有慢性疾病等免疫力低下者是侵袭性霉菌病的高危人群。

目前,我国在侵袭性霉菌病临床治疗领域面对诸多挑战,主要体现在治疗耐受性、药物相互作用、长期治疗依从性、需要监测药物浓度等问题。


作为广谱的新型三唑类抗真菌药物,康新博成人侵袭性毛霉病和侵袭性曲霉病两个适应症的相继获批,将助力临床侵袭性霉菌病的全程治疗。在2017 ECIL-6《白血病及造血干细胞移植患者侵袭性念珠菌病、曲霉病及毛霉病指南》中艾沙康唑被推荐作为侵袭性曲霉病的一线治疗, 在2017 ESCMID-ECMM-ERS《曲霉病诊断管理指南》中,艾沙康唑被推荐作为侵袭性肺曲霉病的一线治疗。

辉瑞生物制药集团中国区总裁彭振科表示,“辉瑞以‘为患者带来改变其生活的突破创新’为目标,作为抗感染领域的领导企业,康新博的两个适应症相继在中国获批,将为侵袭性曲霉病和侵袭性毛霉病成人患者提供创新治疗方案,助力临床医生积极应对这一类疾病威胁。我们将加快上市进程,让这一创新药尽快惠及中国患者。”

目前康新博已在美国、英国、法国、瑞士等超过60个国家和地区获批。

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    2022-01-07 1244c0ebm28暂无昵称

    不错不错

    0

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  5. [GetPortalCommentsPageByObjectIdResponse(id=1775765, encodeId=4d5b1e757655e, content=<a href='/topic/show?id=19e45556efa' target=_blank style='color:#2F92EE;'>#抗真菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55567, encryptionId=19e45556efa, topicName=抗真菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Sun Nov 27 06:09:25 CST 2022, time=2022-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1937025, encodeId=e127193e02514, content=<a href='/topic/show?id=2300555e0c9' target=_blank style='color:#2F92EE;'>#抗真菌药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55570, encryptionId=2300555e0c9, topicName=抗真菌药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=636e2500187, createdName=12498da4m32(暂无昵称), createdTime=Sun Nov 20 19:09:25 CST 2022, time=2022-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181727, encodeId=85341181e2792, content=不错不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e8212476654, createdName=1244c0ebm28暂无昵称, createdTime=Fri Jan 07 08:46:58 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336861, encodeId=f4b4133686134, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1353827, encodeId=03d2135382e74, content=<a href='/topic/show?id=dddce266537' target=_blank style='color:#2F92EE;'>#真菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72665, encryptionId=dddce266537, topicName=真菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1366401, encodeId=4be713664019b, content=<a href='/topic/show?id=186126998e2' target=_blank style='color:#2F92EE;'>#侵袭性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26998, encryptionId=186126998e2, topicName=侵袭性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1be8234, createdName=sunyl07, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416234, encodeId=ec691416234ef, content=<a href='/topic/show?id=a24f58e0879' target=_blank style='color:#2F92EE;'>#新适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58708, encryptionId=a24f58e0879, topicName=新适应症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=613c3147617, createdName=sunyl08, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181589, encodeId=99ad11815890b, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8be75220179, createdName=向药师, createdTime=Thu Jan 06 22:47:46 CST 2022, time=2022-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181489, encodeId=600e118148964, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2020/02/01/1078d2e0242b103ff542afeb81c7ba21.jpg, createdBy=eb5f5271958, createdName=1354824f40m, createdTime=Thu Jan 06 20:20:23 CST 2022, time=2022-01-06, status=1, ipAttribution=)]
    2022-01-07 zhaojie88
  6. [GetPortalCommentsPageByObjectIdResponse(id=1775765, encodeId=4d5b1e757655e, content=<a href='/topic/show?id=19e45556efa' target=_blank style='color:#2F92EE;'>#抗真菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55567, encryptionId=19e45556efa, topicName=抗真菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Sun Nov 27 06:09:25 CST 2022, time=2022-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1937025, encodeId=e127193e02514, content=<a href='/topic/show?id=2300555e0c9' target=_blank style='color:#2F92EE;'>#抗真菌药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55570, encryptionId=2300555e0c9, topicName=抗真菌药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=636e2500187, createdName=12498da4m32(暂无昵称), createdTime=Sun Nov 20 19:09:25 CST 2022, time=2022-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181727, encodeId=85341181e2792, content=不错不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e8212476654, createdName=1244c0ebm28暂无昵称, createdTime=Fri Jan 07 08:46:58 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336861, encodeId=f4b4133686134, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1353827, encodeId=03d2135382e74, content=<a href='/topic/show?id=dddce266537' target=_blank style='color:#2F92EE;'>#真菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72665, encryptionId=dddce266537, topicName=真菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1366401, encodeId=4be713664019b, content=<a href='/topic/show?id=186126998e2' target=_blank style='color:#2F92EE;'>#侵袭性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26998, encryptionId=186126998e2, topicName=侵袭性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1be8234, createdName=sunyl07, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416234, encodeId=ec691416234ef, content=<a href='/topic/show?id=a24f58e0879' target=_blank style='color:#2F92EE;'>#新适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58708, encryptionId=a24f58e0879, topicName=新适应症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=613c3147617, createdName=sunyl08, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181589, encodeId=99ad11815890b, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8be75220179, createdName=向药师, createdTime=Thu Jan 06 22:47:46 CST 2022, time=2022-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181489, encodeId=600e118148964, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2020/02/01/1078d2e0242b103ff542afeb81c7ba21.jpg, createdBy=eb5f5271958, createdName=1354824f40m, createdTime=Thu Jan 06 20:20:23 CST 2022, time=2022-01-06, status=1, ipAttribution=)]
    2022-01-07 sunyl07
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  8. [GetPortalCommentsPageByObjectIdResponse(id=1775765, encodeId=4d5b1e757655e, content=<a href='/topic/show?id=19e45556efa' target=_blank style='color:#2F92EE;'>#抗真菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55567, encryptionId=19e45556efa, topicName=抗真菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Sun Nov 27 06:09:25 CST 2022, time=2022-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1937025, encodeId=e127193e02514, content=<a href='/topic/show?id=2300555e0c9' target=_blank style='color:#2F92EE;'>#抗真菌药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55570, encryptionId=2300555e0c9, topicName=抗真菌药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=636e2500187, createdName=12498da4m32(暂无昵称), createdTime=Sun Nov 20 19:09:25 CST 2022, time=2022-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181727, encodeId=85341181e2792, content=不错不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e8212476654, createdName=1244c0ebm28暂无昵称, createdTime=Fri Jan 07 08:46:58 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336861, encodeId=f4b4133686134, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1353827, encodeId=03d2135382e74, content=<a href='/topic/show?id=dddce266537' target=_blank style='color:#2F92EE;'>#真菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72665, encryptionId=dddce266537, topicName=真菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1366401, encodeId=4be713664019b, content=<a href='/topic/show?id=186126998e2' target=_blank style='color:#2F92EE;'>#侵袭性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=26998, encryptionId=186126998e2, topicName=侵袭性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1be8234, createdName=sunyl07, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416234, encodeId=ec691416234ef, content=<a href='/topic/show?id=a24f58e0879' target=_blank style='color:#2F92EE;'>#新适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58708, encryptionId=a24f58e0879, topicName=新适应症)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=613c3147617, createdName=sunyl08, createdTime=Fri Jan 07 02:09:25 CST 2022, time=2022-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181589, encodeId=99ad11815890b, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8be75220179, createdName=向药师, createdTime=Thu Jan 06 22:47:46 CST 2022, time=2022-01-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1181489, encodeId=600e118148964, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2020/02/01/1078d2e0242b103ff542afeb81c7ba21.jpg, createdBy=eb5f5271958, createdName=1354824f40m, createdTime=Thu Jan 06 20:20:23 CST 2022, time=2022-01-06, status=1, ipAttribution=)]
    2022-01-06 向药师

    学习

    0

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    2022-01-06 1354824f40m

    学习了

    0

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