µÏÍþ¹ú¼Ê

µÏÍþÖƵÏÍþ¹ú¼Ê µÏÍþÖƵÏÍþ¹ú¼Ê

¼ò ¤™
  • ¼ò
  • ·±
  • EN
¤œ
Ïà¹ØÁ´½Ó
  • ½­ËÕºÀÉ­µÏÍþ¹ú¼ÊÒµ¼¯ÍÅÓÐÏÞ¹«Ë¾¥Y
ÐÂÎÅ·¢²¼
Press Release
Ê×Ò³  >  ÐÂÎÅÖÐÐÄ  >  ÐÂÎÅ·¢²¼
µÏÍþÖƵÏÍþ¹ú¼Ê | ê¿Ô½?µÚ¶þÏîÊÊÓ¦Ö¢»ñÅúÉÏÊУ¬ÊÊÓÃÓÚÃâÒßÇòµ°°×G4Ïà¹ØÐÔ¼²²¡³ÉÈË»¼Õß
·¢²¼ÈÕÆÚ£º2025/09/01
×ÖºÅ

2025Äê9ÔÂ1ÈÕ£¬µÏÍþÖƵÏÍþ¹ú¼Ê¼¯ÍÅÓÐÏÞ¹«Ë¾£¨ÒÔϼò³Æ¡°µÏÍþÖƵÏÍþ¹ú¼Ê¡±£¬03692.HK£©Ðû²¼£¬ê¿Ô½?£¨ÒÁÄÎÀûÖéµ¥¿¹×¢ÉäÒº£©µÚ¶þÏîÊÊÓ¦Ö¢»ñÅúÉÏÊУ¬ÊÊÓÃÓÚÃâÒßÇòµ°°×G4Ïà¹ØÐÔ¼²²¡£¨IgG4-RD£©³ÉÈË»¼Õß¡£¸ÃÊÊÓ¦Ö¢ÔøÓÚ2025Äê2ÔÂ8ÈÕ»ñ¹ú¼ÒµÏÍþ¹ú¼ÊÆ·¼à¶½¹ÜÀí¾Ö£¨NMPA£©ÄÉÈëÓÅÏÈÉóÆÀÉóÅú³ÌÐò¡£

IgG4-RDÊÇÒ»ÖÖÂýÐÔÖ²ÐÐÔÃâÒ߽鵼Ñ×Ö¢ÐÔ¼²²¡£¬¿ÉÀÛ¼°¶à¸öÆ÷¹Ù²¢µ¼ÖÂÏËά»¯ºÍÓÀ¾ÃÐÔÆ÷¹ÙËðÉË¡£ºÏ×÷·½°²½ø¹«Ë¾£¨AMGEN£©ÔøÓÚÃÀ¹úʱ¼ä2025Äê4ÔÂ3ÈÕÐû²¼FDAÅú×¼ÒÁÄÎÀûÖéµ¥¿¹ÓÃÓÚÖÎÁÆIgG4-RD¡£

´Ë´Îê¿Ô½?»ñNMPAÅú×¼ÖÎÁÆIgG4-RD£¬ÊÇ»ùÓÚÆäÈ«Çò¹Ø¼üÐÔ¢óÆÚÊÔÑéMITIGATEµÄ»ý¼«½á¹û¡£¸ÃÊÔÑéÊÇÊ׸öÔÚIgG4-RDÖпªÕ¹µÄËæ»ú¡¢Ë«Ã¤¡¢°²Î¿¼Á¶ÔÕÕÊÔÑ飬֤ʵÒÁÄÎÀûÖéµ¥¿¹¿Éͨ¹ý¼õÉÙ»¼Õß·¢×÷À´½µµÍ¼²²¡»î¶¯¡£Ïà¶Ô°²Î¿¼Á×飬ÒÁÄÎÀûÖéµ¥¿¹Ê¹¼²²¡·¢×÷·çÏÕ½µµÍ87%£¬ÓÐÍûΪ»¼ÕßʵÏÖÎÞ¼¤ËØ¡¢ÎÞ·¢×÷µÄÍêÈ«»º½â¡£

2022Äê3Ô£¬ê¿Ô½?µÚÒ»ÏîÊÊÓ¦Ö¢ÓÚÖйú»ñÅúÉÏÊУ¬ÓÃÓÚ¿¹Ë®Í¨µÀµ°°×4£¨AQP4£©¿¹ÌåÑôÐÔµÄÊÓÉñ¾­¼¹ËèÑ×Æ×ϵ¼²²¡£¨NMOSD£©³ÉÈË»¼ÕßµÄÖÎÁÆ£¬2023Äê1ÔÂÊ״α»ÄÉÈë¹ú¼ÒÒ½±£Ä¿Â¼£¬²¢ÓÚ2024Äê11Ô³ɹ¦ÐøÔ¼¡£

2025Äê5Ô£¬ê¿Ô½?ÓÃÓÚÖÎÁÆÈ«ÉíÐÍÖØÖ¢¼¡ÎÞÁ¦(gMG)³ÉÈË»¼ÕߵĵÚÈýÏîÉÏÊÐÐí¿ÉÉêÇ루BLA£©»ñNMPAÊÜÀí¡£

¹ØÓÚMITIGATEÑо¿

MITIGATE (NCT04540497) ÔÚ°üÀ¨ÖйúÔÚÄÚµÄ22¸ö¹ú¼ÒµÄ80¸öÁÙ´²ÊÔÑéÑо¿ÖÐÐĽøÐС£ÕâÊÇÊ×´ÎÔÚIgG4-RDÖнøÐеÄËæ»ú¡¢Ë«Ã¤¡¢°²Î¿¼Á¶ÔÕÕÑо¿£¬Ö¤ÊµÁËÒÁÄÎÀûÖéµ¥¿¹Í¨¹ýCD19+Bϸ°ûºÄ½ßÖÎÁÆIgG4-RDµÄ°²È«ÐÔºÍÓÐЧÐÔ¡£2024Äê11Ô£¬¸ÃÊý¾ÝÒÑ·¢±íÓÚ¡¶ÐÂÓ¢¸ñÀ¼Ò½Ñ§ÔÓÖ¾¡·£¨The New England Journal of Medicine£©¡£[1] 

¹ØÓÚIgG4-RD

ÃâÒßÇòµ°°×G4Ïà¹ØÐÔ¼²²¡£¨IgG4-RD£©ÊÇÒ»ÖÖÂýÐÔ¡¢È«ÉíÐÔ¡¢ÃâÒ߽鵼µÄÏËάÑ×Ö¢ÐÔ¼²²¡£¬¿ÉÓ°ÏìÉíÌåµÄ¶à¸öÆ÷¹Ù¡£ÕâÊÇÒ»ÖÖ½øÕ¹ÐÔ¼²²¡£¬Ëæ×Åʱ¼äÍÆÒÆ¿ÉÒÔÁ¬Ðø»òͬʱӰÏìеÄÆ÷¹Ù£¬²¢ÒÔ»º½âÆںͲ»¿ÉÔ¤²âµÄ²¡Ç鸴·¢ÎªÌØÕ÷¡£IgG4-RD ¿Éµ¼ÖÂÓÐÖ¢×´»òÎÞÖ¢×´µÄ²»¿ÉÄæµÄÆ÷¹ÙË𺦣¬Á˽âÆ÷¹ÙË𺦵ıíÏÖ¶ÔÓÚ¼°Ê±Õï¶ÏIgG4-RDÖÁ¹ØÖØÒª¡£Bϸ°ûÔÚ IgG4-RD µÄ·¢²¡»úÖÆÖÐÆðºËÐÄ×÷Óá£ÔÚIgG4-RDÖУ¬±í´ïCD19£¨CD19+£©µÄBϸ°û±»ÈÏΪÇý¶¯Ñ×Ö¢ºÍÏËά»¯¹ý³Ì£¬²¢ÓëÆäËû²ÎÓë¼²²¡»î¶¯µÄÃâÒßϸ°ûÏ໥×÷Óá£[2-7]

IgG4-RD·¢²¡ÂʹÀ¼ÆΪÿ10ÍòÈËÖÐÓÐ1-5Àý£¬µ«ÓÉÓÚÁ÷Ðв¡Ñ§Êý¾ÝÓÐÏÞ£¬IgG4-RD»¼ÕßµÄÊýÁ¿ÄÑÒÔÈ·¶¨¡£IgG4-RDµÄµäÐÍ·¢²¡ÄêÁäÔÚ50ÖÁ70ËêÖ®¼ä£¬²¢ÇÒÓëÐí¶àÆäËûÃâÒ߽鵼µÄ¼²²¡²»Í¬£¬IgG4-RD¸üÈÝÒ×·¢ÉúÔÚÄÐÐÔ¶ø²»ÊÇÅ®ÐÔÉíÉÏ¡£[8-9]

¹ØÓÚµÏÍþÖƵÏÍþ¹ú¼Ê

µÏÍþÖƵÏÍþ¹ú¼ÊÊÇÖйúÁìÏȵĴ´ÐÂÇý¶¯ÐÍÖƵÏÍþ¹ú¼ÊÆóÒµ£¬ÒÔ¡¸³ÖÐø´´Ð£¬Ìá¸ßÈËÀàÉúÃüÖÊÁ¿¡¹ÎªÊ¹Ãü£¬Öصã¹Ø×¢¿¹Ö×Áö¡¢¿¹¸ÐȾ¡¢ÖÐÊàÉñ¾­ÏµÍ³¡¢´úл¼°×ÔÉíÃâÒßµÈÖØ´ó¼²²¡ÖÎÁÆÁìÓò¡£½ØÖÁÄ¿Ç°£¬¹«Ë¾ÔÚÖйú²úÉúÏúÊÛÊÕÈëµÄ´´ÐµÏÍþ¹ú¼Ê¹²7¿î£¬ÐγÉÁ˷ḻµÄ²úÆ·¹ÜÏß¡£µÏÍþÖƵÏÍþ¹ú¼ÊÁ¬Ðø¶àÄêλ¾ÓÈ«ÇòÖƵÏÍþ¹ú¼ÊÆóÒµ°ÙÇ¿¡¢ÖйúÒ½µÏÍþ¹ú¼ÊÑз¢²úÆ·Ïß×î¼Ñ¹¤ÒµÆóҵǰ3Ç¿£¬Êǹú¼ÒÖصã¸ßм¼ÊõÆóÒµ¡¢¹ú¼Ò¼¼Êõ´´ÐÂʾ·¶ÆóÒµ¡£µÏÍþÖƵÏÍþ¹ú¼ÊÓÚ2019Äê6ÔÂÔÚÏã¸ÛÁª½»Ëù¹ÒÅÆÉÏÊУ¨¹ÉƱ´úÂ룺03692.HK£©¡£¸ü¶àÐÅÏ¢Çë·ÃÎÊ£º/¡£

²Î¿¼ÎÄÏ×£º

[1] Inebilizumab for Treatment of IgG4-Related Disease | New England Journal of Medicine

[2]Perugino, C. A., & Stone, J. H. (2020). IgG4-related disease: an update on pathophysiology and implications for clinical care. Nature Reviews Rheumatology, 16(12), 702¨C714.

[3] Stone, J. H., Zen, Y., & Deshpande, V. (2012). IgG4-Related Disease. New England Journal of Medicine, 366(6), 539¨C551.

[4] Floreani, A., Okazaki, K., Uchida, K., & Gershwin, M. E. (2021). IgG4-related disease: Changing epidemiology and new thoughts on a multisystem disease. Journal of Translational Autoimmunity, 4, 100074.

[5] Wallace, Z. S., Mattoo, H., Mahajan, V. S., Kulikova, M., Lu, L., Deshpande, V., Choi, H. K., Pillai, S., & Stone, J. H. (2016). Predictors of disease relapse in IgG4-related disease following rituximab. Rheumatology, 55(6), 1000¨C1008.

[6] Zhang, W., & Stone, J. H. (2019). Management of IgG4-related disease. The Lancet Rheumatology, 1(1), e55¨Ce65.

[7] Wolfson, A. R., & Hamilos, D. L. (2017). Recent advances in understanding and managing IgG4-related disease. F1000Research, 6, 185.

[8]https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.41120

[9]https://pubmed.ncbi.nlm.nih.gov/22218969/

ÃâÔðÉùÃ÷

1. ±¾ÎĽö¹©Ò½ÁÆÎÀÉúרҵÈËÊ¿²ÎÔÄ£¬·Ç¹ã¸æÓÃ;¡£

2. µÏÍþÖƵÏÍþ¹ú¼Ê²»ÍƼöÈκÎδ»ñÅúµÏÍþ¹ú¼ÊƷʹÓúÍ/»òδ»ñÅúÊÊÓ¦Ö¢ÓõÏÍþ¹ú¼Ê£¬Ò಻¶ÔÈκεÏÍþ¹ú¼ÊÆ·ºÍ/»òÊÊÓ¦Ö¢×÷ÍƼö¡£

3. ±¾ÎÄÖÐÉæ¼°µÄÐÅÏ¢½ö¹©²Î¿¼£¬Çë×ñ´ÓÒ½Éú»òÆäËûÒ½ÁÆÎÀÉúרҵÈËÊ¿µÄÒâ¼û»òÖ¸µ¼¡£Ò½ÁÆÎÀÉúרҵÈËÊ¿×÷³öµÄÈκÎÓëÖÎÁÆÓйصľö¶¨Ó¦¸ù¾Ý»¼ÕߵľßÌåÇé¿ö²¢×ñÕÕµÏÍþ¹ú¼ÊƷ˵Ã÷Êé¡£

4. ÈçÐèÁ˽⹫˾ÈκβúÆ·¡¢Ò½ÁÆ»ò¼²²¡µÄÏà¹ØÐÅÏ¢£¬ÇëÎñ±Ø×ÉѯҽÁÆÎÀÉúרҵÈËÊ¿¡£

Ç°Õ°ÐÔ˵Ã÷

±¾ÐÂΟåÖ¼ÔÚÌṩ¹ØÓÚµÏÍþÖƵÏÍþ¹ú¼Ê¼¯ÍÅÓÐÏÞ¹«Ë¾¼°Æ丽Êô¹«Ë¾£¨°üÀ¨Æä×Ó¹«Ë¾£¬Í³³ÆΪ¡°µÏÍþÖƵÏÍþ¹ú¼Ê¡±£©µÄÐÅÏ¢¡£Ëü²»¹¹³É¶ÔµÏÍþÖƵÏÍþ¹ú¼Ê»òÈκÎͶ×ʽ¨ÒéµÄÐÅÏ¢Åû¶¡£±¾ÐÂΟå°üº¬µÄÐÅÏ¢¿ÉÄÜ°üÀ¨ÓëµÏÍþÖƵÏÍþ¹ú¼ÊÒµÎñºÍ²úÆ·Ç°¾°¡¢¼Æ»®¡¢ÐÅÄî¡¢Ô¤ÆںͲßÂÔÏà¹ØµÄÇ°Õ°ÐÔÉùÃ÷¡£ÕâЩÉùÃ÷ÊÇ»ùÓÚÍƲâÐÔ¼ÙÉèµÄÔ¤²â£¬²¢²»±£Ö¤Î´À´µÄ±íÏÖ¡£ËüÃÇÊܵ½ÖîÈç¿Æѧ¡¢ÉÌÒµ¡¢ÕþÖΡ¢¾­¼Ã¡¢²ÆÎñ¡¢·¨ÂÉÒòËØÒÔ¼°¾ºÕù»·¾³ºÍÉç»áÌõ¼þµÈ·çÏպͲ»È·¶¨ÐÔµÄÓ°Ï죬ÕâЩÒòËغܶ඼ÊǵÏÍþÖƵÏÍþ¹ú¼ÊÎÞ·¨¿ØÖÆÇÒÄÑÒÔÔ¤²âµÄ£¬Òò´Ëʵ¼Ê½á¹û¿ÉÄÜÓë´Ë´¦ËùÊöÓÐÏÔÖø²îÒ죬ÇÒ¹ýÈ¥µÄ֤ȯ¼Û¸ñÇ÷ÊƲ»Ó¦×÷ΪδÀ´ÐÐÇéµÄÖ¸µ¼¡£Òò´Ë£¬Í¶×ÊÕßÔÚʹÓÃÕâЩÐÅÏ¢½øÐÐͶ×ʾö²ßʱӦ½÷É÷ÐÐÊ¡£¡°ÖÂÁ¦ÓÚ¡±¡°Ô¤ÆÚ¡±¡°ÏàÐÅ¡±¡°Ô¤²â¡±¡°Òâͼ¡±¡°Ô¤¼Æ¡±¡°¿ÉÄÜ¡±¡°½«¡±¡°Ó¦¸Ã¡±¡°¼Æ»®¡±¡°¼ÌÐø¡±¡°Ä¿±ê¡±¡°¿¼ÂÇ¡±¡°¹À¼Æ¡±¡°Ö¸µ¼¡±¡°Ç±ÔÚ¡±¡°×·Çó¡±ÒÔ¼°ÓÚÈκÎδÀ´¼Æ»®¡¢Ðж¯»òʼþµÄÌÖÂÛÖÐʹÓõÄÀàËÆ´ÊÓïºÍÊõÓ¾ù±íʾǰհÐÔÉùÃ÷¡£µÏÍþÖƵÏÍþ¹ú¼Ê²»³Ðŵ»ò±£Ö¤Ç°Õ°ÐÔÐÅÏ¢µÄ׼ȷÐÔ¡¢¼°Ê±ÐÔ»òÍêÕûÐÔ£¬²¢ÇÒ²»³Ðµ£¸üлòÐÞ¶©ÕâЩǰհÐÔÉùÃ÷µÄÒåÎñ¡£ÎÞÂÛÊǵÏÍþÖƵÏÍþ¹ú¼Ê»¹ÊÇÆäÈκζ­Ê¡¢Ô±¹¤»ò´úÀíÈË£¬¾ù²»¶ÔÈκÎÖ¤Ã÷²»×¼È·»òÎÞ·¨ÊµÏÖµÄÇ°Õ°ÐÔÉùÃ÷¸ºÔð£¬Ò²²»¶ÔÒòÒÀÀµ±¾ÐÂΟåÖÐÌṩµÄÐÅÏ¢¶ø²úÉúµÄÈκÎËðʧ»òË𺦸ºÔ𣬰üÀ¨µ«²»ÏÞÓÚÖ±½Ó¡¢Å¼È»¡¢¼ä½Ó»ò³Í·£ÐÔµÄËðº¦

¡¾ÍøÕ¾µØͼ¡¿¡¾sitemap¡¿