{"id":894,"date":"2023-04-14T18:26:52","date_gmt":"2023-04-14T10:26:52","guid":{"rendered":"https:\/\/xiaoenjiyao.com\/?p=894"},"modified":"2023-04-14T18:26:52","modified_gmt":"2023-04-14T10:26:52","slug":"%e8%ae%b0%e4%bd%8f%e6%89%80%e6%9c%89fda%e7%94%9f%e7%89%a9%e8%8d%af-%e6%9c%80%e5%90%8e3%e6%ac%becd20-%e5%a5%a5%e6%b3%95%e5%a6%a5%e6%9c%a8%e5%8d%95%e6%8a%97ibritumomab-tiuxetanublituximab","status":"publish","type":"post","link":"https:\/\/xiaoenjiyao.com\/?p=894","title":{"rendered":"\u8bb0\u4f4f\u6240\u6709FDA\u751f\u7269\u836f | \u6700\u540e3\u6b3eCD20 | \u5965\u6cd5\u59a5\u6728\u5355\u6297,Ibritumomab tiuxetan,Ublituximab"},"content":{"rendered":"\n<p>\u7528\u56fe\u50cf\u8bb0\u5fc6\u7684\u65b9\u6cd5\uff0c\u4e00\u4e2a\u836f\u4e00\u5f20\u56fe\uff0c\u8bb0\u4f4f\u6240\u6709FDA\u6279\u51c6\u4e0a\u5e02\u751f\u7269\u5236\u5242\u7684\u540d\u79f0\uff0c\u9776\u70b9\uff0c\u9002\u5e94\u75c7\u7b49\u4fe1\u606f\u3002<\/p>\n\n\n\n<p>\u9776\u5411CD20\u751f\u7269\u5236\u5242\uff0c\u9664\u4e86\u524d\u51e0\u7bc7\u4e2d\u63a2\u8ba8\u7684\u7f57\u6c0f\u516c\u53f8\u76845\u6b3e\u836f\u7269\u5916\uff0c\u8fd8\u67093\u6b3e\u836f\u7269\uff0c\u5206\u522b\u4e3a\uff1a\u5965\u6cd5\u59a5\u6728\u5355\u6297\u3001Ibritumomab tiuxetan\u3001Ublituximab\u3002<\/p>\n\n\n\n<p>\u5176\u4f5c\u7528\u673a\u5236\u548c\u9002\u5e94\u75c7\u4e0e\u7f57\u6c0f\u76845\u6b3eCD20\u751f\u7269\u5236\u5242\u5927\u540c\u5c0f\u5f02\uff0c\u56e0\u6b64\u5728\u672c\u6587\u4e2d\u4e00\u8d77\u4ecb\u7ecd\u3002<\/p>\n\n\n\n<p>Ibritumomab tiuxetan\u662fSpectrum\u516c\u53f8\u4ea7\u54c1\uff0c2002\u83b7\u7f8e\u56fdFDA\u6279\u51c6\u4e0a\u5e02(Zevalin<sup>\u00ae&nbsp;<\/sup>ibritumomab tiuxetan)\uff0c\u662f\u5168\u7403\u9996\u4e2a\u6838\u7d20\u5076\u8054\u5355\u6297\u836f\u7269(RDC)\u3002\u9002\u7528\u4e8e\u6cbb\u7597B\u7ec6\u80de\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u3002\u56fd\u5185\u5c1a\u672a\u4e0a\u5e02\uff0cCDE\u6ce8\u518c\u7533\u62a5\u7684\u4e2d\u6587\u540d\u4e3a\u66ff\u4f0a\u83ab\u5355\u6297\uff08JXSL1700038\uff09\u3002<\/p>\n\n\n\n<p>\u5965\u6cd5\u59a5\u6728\u5355\u6297\u662f\u8bfa\u534e\u516c\u53f8\u4ea7\u54c1\uff0c2009\u5e74\u83b7\u7f8e\u56fdFDA\u6279\u51c6\u4e0a\u5e02\uff0c\u6709\u4e24\u4e2a\u5546\u54c1\u540d\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Arzerra<sup>\u00ae&nbsp;<\/sup>Ofatumumab\u7528\u4e8e\u6cbb\u7597\u6162\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5(CLL)\uff0c\u56fd\u5185\u5c1a\u672a\u4e0a\u5e02\u3002<\/li>\n\n\n\n<li>Kesimpta<sup>\u00ae&nbsp;<\/sup>Ofatumumab\u7528\u4e8e\u6cbb\u7597\u590d\u53d1\u578b\u591a\u53d1\u6027\u786c\u5316\uff08MS\uff09\uff0c2021\u5e74\u5728\u56fd\u5185\u4e0a\u5e02\uff08\u5168\u6b23\u8fbe<sup>\u00ae<\/sup>\u5965\u6cd5\u59a5\u6728\u5355\u6297\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<p>Ublituximab\u662fTG Therapeutics\u516c\u53f8\u4ea7\u54c1\uff0c2022\u5e74\u83b7\u7f8e\u56fdFDA\u6279\u51c6\u4e0a\u5e02(Briumvi<sup>\u00ae&nbsp;<\/sup>Ublituximab)\uff0c\u7528\u4e8e\u6cbb\u7597\u590d\u53d1\u578b\u591a\u53d1\u6027\u786c\u5316(MS)\uff0c\u56fd\u5185\u5c1a\u672a\u4e0a\u5e02\uff0c\u4e2d\u6587\u540d\u4e4c\u5229\u59a5\u6614\u5355\u6297\uff08\u97f3\u8bd1\u65e0\u51fa\u5904\uff09\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1\u3001\u4f5c\u7528\u673a\u5236<\/h2>\n\n\n\n<p>CD20\u836f\u7269\u4f5c\u7528\u673a\u5236\u53ca\u9002\u5e94\u75c7\u76f8\u5173\u4fe1\u606f\uff0c\u53ef\u4ee5\u53c2\u89c1\u524d\u9762\u51e0\u7bc7\u7684\u5185\u5bb9\u3002<\/p>\n\n\n\n<p><strong>\u66ff\u4f0a\u83ab\u5355\u6297\u7ed3\u6784<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-15.png\" alt=\"\" class=\"wp-image-895\" width=\"596\" height=\"475\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-15.png 1000w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-15-300x239.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-15-768x612.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-15-880x701.png 880w\" sizes=\"auto, (max-width: 596px) 100vw, 596px\" \/><figcaption class=\"wp-element-caption\"><em>Curr Radiopharm . 2013 Jun&nbsp;6;6(2):57-71.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p>Ibritumomab tiuxetan\u66ff\u4f0a\u83ab\u5355\u6297\u662f\u5168\u7403\u9996\u4e2a\u6838\u7d20\u5076\u8054\u5355\u6297\u836f\u7269(RDC)\uff0c\u6279\u51c6\u7528\u4e8e\u96be\u6cbb\u590d\u53d1B\u7ec6\u80de\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u7684\u6cbb\u7597\u3002<\/p>\n\n\n\n<p>\u836f\u7269\u7ed3\u5408\u4e86\u5355\u6297\u836f\u7269\u9776\u5411\u6027\u548c\u653e\u5c04\u6027\u540c\u4f4d\u7d20\u5f3a\u5927\u7684\u653e\u5c04\u6cbb\u7597\u4f5c\u7528\uff0c\u56e0\u6b64\u53ef\u4ee5\u6700\u5927\u7a0b\u5ea6\u5730\u6740\u706d\u80bf\u7624\u7ec6\u80de\u3002<\/p>\n\n\n\n<p>\u7c7b\u4f3c\u4e8eADC\u836f\u7269\uff0cRDC\u836f\u7269\uff08Ibritumomab tiuxetan\u66ff\u4f0a\u83ab\u5355\u6297\uff09\u7531\u653e\u5c04\u6027\u540c\u4f4d\u7d20\u948790\u548cCD20\u5355\u6297\u7ec4\u6210\uff0c\u4e0e\u5176\u4ed6\u653e\u5c04\u6027\u540c\u4f4d\u7d20\u76f8\u6bd4\uff0c\u948790\u653e\u5c04\u7eaf\u03b2\u5c04\u7ebf\uff0c\u5177\u6709\u66f4\u5f3a\u7684\u5c04\u7ebf\u80fd\u91cf\u3002\u540c\u65f6\uff0c\u948790\u4e0d\u4ea7\u751f\u03b3\u5c04\u7ebf\uff0c\u5bf9\u533b\u62a4\u4eba\u5458\u53ca\u60a3\u8005\u5bb6\u5c5e\u76f8\u5bf9\u5b89\u5168\u3002<\/p>\n\n\n\n<p>Ublituximab\u901a\u8fc7\u7cd6\u5de5\u7a0b\u5316\u53bb\u9664\u4e86\u6297\u4f53\u4e2d\u67d0\u4e9b\u7cd6\u5206\u5b50\uff0c\u4ece\u800c\u663e\u8457\u589e\u5f3aublituximab\u7684\u6548\u529b\uff0c\u5c24\u5176\u662fADCC\u6d3b\u6027\uff0c\u6467\u6bc1\u81f4\u75c5B\u7ec6\u80de\u3002\u8fd9\u4e9b\u7ec6\u80de\u88ab\u8ba4\u4e3a\u662f\u5bfc\u81f4\u9ad3\u9798\u548c\u795e\u7ecf\u7ec6\u80de\u8f74\u7a81\u635f\u4f24\uff08MS\u7684\u53d1\u75c5\u673a\u5236\uff09\u7684\u5173\u952e\u56e0\u7d20\u3002<\/p>\n\n\n\n<p>CD20\u5355\u6297\u4eba\u6e90\u5316\u7a0b\u5ea6<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-20-1024x563.png\" alt=\"\" class=\"wp-image-900\" width=\"706\" height=\"387\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-20-1024x563.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-20-300x165.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-20-880x484.png 880w\" sizes=\"auto, (max-width: 706px) 100vw, 706px\" \/><figcaption class=\"wp-element-caption\"><em>Biomedicines . 2019 Mar 14;7(1):20.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p>\u5965\u6cd5\u59a5\u6728\u5355\u6297\u662f\u4e00\u6b3e\u5168\u4eba\u6e90\u5355\u6297\uff0c\u901a\u8fc7\u4e0eCD20\u7684B\u7ec6\u80de\u7ed3\u5408\uff0c\u8bf1\u5bfc\u81f4\u75c5\u6027B\u7ec6\u80de\u6eb6\u89e3\u548c\u6d88\u9664\uff0c\u5728\u5b9e\u73b0\u7cbe\u51c6\u6cbb\u7597\u7684\u540c\u65f6\uff0c\u4fdd\u7559B\u7ec6\u80de\u7684\u91cd\u5efa\u529f\u80fd\u548c\u6d46\u7ec6\u80de\u7684\u514d\u75ab\u76d1\u89c6\u529f\u80fd\u3002<\/p>\n\n\n\n<p>\u836f\u7269\u4e0eCD20\u7ed3\u5408\u4f4d\u7f6e<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-21-1024x504.png\" alt=\"\" class=\"wp-image-901\" width=\"686\" height=\"337\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-21-1024x504.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-21-300x148.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-21-768x378.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-21-1218x599.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-21-880x433.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-21.png 1230w\" sizes=\"auto, (max-width: 686px) 100vw, 686px\" \/><figcaption class=\"wp-element-caption\"><em>Expert Opin Biol Ther . 2021 Feb;21(2):161-181.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p>\u53e6\u5916\uff0c\u51e0\u6b3e\u6297\u4f53\u4e0eCD20\u7ed3\u5408\u4f4d\u70b9\u4e0d\u540c\u3002<\/p>\n\n\n\n<p>CD20\u662f\u4e00\u4e2a4\u6b21\u8de8\u819c\u7684\u86cb\u767d\uff0c\u5176\u5728\u7ec6\u80de\u5916\u6709\u4e24\u4e2a\u73af\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e00\u4e2a\u6bd4\u8f83\u957f\u7684\u5927\u73af(large loop)\uff0c\u6c28\u57fa\u9178\u662f142-188\u3002<\/li>\n\n\n\n<li>\u53e6\u5916\u4e00\u4e2a\u662f\u6bd4\u8f83\u77ed\u7684\u5c0f\u73af(short loop)\uff0c\u6c28\u57fa\u9178\u662f79-84\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u5965\u6cd5\u59a5\u6728\u5355\u6297\u4e0e\u5927\u73af(145-161\u6b8b\u57fa)\u548c\u5c0f\u73af(74-80\u6b8b\u57fa)\u5171\u540c\u7ed3\u5408\u3002\u5176\u4ed6\u51e0\u6b3eCD20\u5355\u6297\u4e0eCD20\u7684\u7ed3\u5408\u4f4d\u70b9\u89c1\u56fe\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2\u3001\u9002\u5e94\u75c7<\/h2>\n\n\n\n<p>\u73b0\u5c06\u5df2\u4e0a\u5e02CD20\u9776\u70b9\u751f\u7269\u5236\u5242\u7684\u9002\u5e94\u75c7\u603b\u7ed3\u5982\u4e0b\uff1a<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-22-752x1024.png\" alt=\"\" class=\"wp-image-902\" width=\"716\" height=\"975\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-22-752x1024.png 752w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-22-220x300.png 220w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-22-768x1046.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-22.png 826w\" sizes=\"auto, (max-width: 716px) 100vw, 716px\" \/><figcaption class=\"wp-element-caption\"><em><strong><mark style=\"background-color:rgba(0, 0, 0, 0);color:#59129c\" class=\"has-inline-color\">\u7d2b\u8272\u4ee3\u8868\u76ee\u524d\u56fd\u5185\u5df2\u6279\u51c6<\/mark><\/strong><\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\">3\u3001\u56fe\u50cf\u8bb0\u5fc6<\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-23-1024x680.png\" alt=\"\" class=\"wp-image-903\" width=\"640\" 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