{"id":885,"date":"2023-04-11T10:18:40","date_gmt":"2023-04-11T02:18:40","guid":{"rendered":"https:\/\/xiaoenjiyao.com\/?p=885"},"modified":"2023-04-11T10:18:40","modified_gmt":"2023-04-11T02:18:40","slug":"%e8%ae%b0%e4%bd%8f%e6%89%80%e6%9c%89fda%e7%94%9f%e7%89%a9%e8%8d%af-%e4%b8%a4%e6%ac%becd20-x-cd3%e5%8f%8c%e6%8a%97-mosunetuzumab%e3%80%81glofitamab-b%e7%bb%86%e8%83%9e%e6%b7%8b%e5%b7%b4%e7%98%a4","status":"publish","type":"post","link":"https:\/\/xiaoenjiyao.com\/?p=885","title":{"rendered":"\u8bb0\u4f4f\u6240\u6709FDA\u751f\u7269\u836f | \u4e24\u6b3eCD20 x CD3\u53cc\u6297 | Mosunetuzumab\u3001Glofitamab | B\u7ec6\u80de\u6dcb\u5df4\u7624"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">\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 class=\"wp-block-paragraph\">Mosunetuzumab \u548c Glofitamab \u5747\u4e3a\u9776\u5411 CD20 x CD3 \u7684\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff0c\u53ef\u8fde\u63a5T\u7ec6\u80de\u8868\u9762\u7684CD3\u4e0e\u6076\u6027B\u7ec6\u80de\u8868\u9762\u7684CD20\u3002\u4e24\u4e2a\u53cc\u6297\u836f\u7269\u5747\u7531\u745e\u58eb\u7f57\u6c0f\u516c\u53f8\u5f00\u53d1\uff0c\u662f\u7f57\u6c0f\u7b2c4\u6b3e\u548c\u7b2c5\u6b3e\u9776\u5411CD20\u7684\u751f\u7269\u5236\u5242\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Mosunetuzumab\u4e8e2022\u5e74\u83b7\u7f8e\u56fdFDA\u6279\u51c6 (Lunsumio<sup>\u00ae&nbsp;<\/sup>Mosunetuzumab)\uff0c\u7528\u4e8e\u6cbb\u7597\u6ee4\u6ce1\u6027\u6dcb\u5df4\u7624\u3002\u5728\u56fd\u5185\u5c1a\u672a\u83b7\u6279\uff0c\u4e2d\u6587\u540d\u6682\u8bd1\u4e3a\u83ab\u59a5\u73e0\u5355\u6297\uff08\u97f3\u8bd1\u65e0\u51fa\u5904\uff09\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Glofitamab\u662f\u4e00\u6b3e\u5177\u67092:1\u7ed3\u6784\uff082\u4e2aCD20\u7ed3\u5408\u57df\u548c1\u4e2aCD3\u7ed3\u5408\u57df\uff09\u7684IgG1\u5168\u4eba\u6e90\u53cc\u7279\u5f02\u6027\u6297\u4f53\u3002\u8be5\u836f\u5c1a\u672a\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\uff0c\u4f46\u4e8e2022\u5e746\u6708\u5728\u6b27\u76df\u83b7\u6279\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u5957\u7ec6\u80de\u6dcb\u5df4\u7624\u3001\u5f25\u6f2b\u6027\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Glofitamab\u4e8e2023\u5e74\u5728\u56fd\u5185\u7533\u62a5\u4e0a\u5e02\uff08JXSS2300014\uff09\uff0c\u5e76\u88ab\u7eb3\u5165\u62df\u4f18\u5148\u5ba1\u8bc4\u540d\u5355\uff0c\u62df\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e24\u7ebf\u7cfb\u7edf\u6027\u6cbb\u7597\u7684\u590d\u53d1\u6216\u96be\u6cbb\u6027\u5f25\u6f2b\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\uff08DLBCL\uff09\u548c\u539f\u53d1\u6027\u7eb5\u9694\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\u6210\u4eba\u60a3\u8005\u3002\u7533\u62a5\u65f6\u7684\u5b98\u65b9\u4e2d\u6587\u540d\u4e3a\uff0c\u683c\u7f57\u83f2\u59a5\u5355\u6297\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1\u3001\u4f5c\u7528\u673a\u5236<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5173\u4e8eB\u7ec6\u80de\u8868\u9762CD20\u5206\u5b50\u7684\u4f5c\u7528\u53ca\u673a\u5236\uff0c\u53ef\u4ee5\u53c2\u89c1\u524d\u9762\u51e0\u7bc7\u7684\u5185\u5bb9\u3002CD20 x CD3\u5c5e\u4e8eT\u7ec6\u80de\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff08T-cell bispecific antibody\uff09\uff0c\u53cc\u6297\u836f\u7269\u7684\u4e00\u7aef\u9776\u5411\u80bf\u7624\u7ec6\u80de\u8868\u9762\u6297\u539f\uff0c\u53e6\u4e00\u7aef\u9776\u5411\u6548\u5e94T\u7ec6\u80de\u8868\u9762\u6297\u539f\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u836f\u7269\u5c06\u5065\u5eb7\u7684T\u7ec6\u80de\u5e26\u5230\u764c\u6027B\u7ec6\u80de\u9644\u8fd1\uff0c\u5e2e\u52a9T\u7ec6\u80de\u6e05\u9664\u764c\u6027B\u7ec6\u80de\uff0c\u4f5c\u7528\u673a\u5236\u7c7b\u4f3cCAR-T\u3002\u56e0\u6b64\u66f4\u80fd\u51c6\u786e\u9776\u5411\u80bf\u7624\u7ec6\u80de\uff0c\u964d\u4f4e\u8131\u9776\u6bd2\u6027\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Mosunetuzumab (CD20 x CD3)\uff0c\u548c\u5b89\u8fdb\u516c\u53f8\u7684\u8d1d\u6797\u59a5\u6b27\u5355\u6297 (CD19 x CD3)\u5747\u4e3a\u53cc\u6297\u836f\u7269\uff0c\u5b83\u4eec\u9664\u4e86\u4f5c\u7528B\u7ec6\u80de\u8868\u9762\u9776\u70b9\u4e0d\u540c\u5916\uff0c\u6297\u4f53\u7ed3\u6784\u4e5f\u6709\u6240\u4e0d\u540c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u83ab\u59a5\u73e0\u5355\u6297\u548c<strong>\u8d1d\u6797\u59a5\u6b27\u5355\u6297<\/strong>\u7ed3\u6784<\/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-10-1024x661.png\" alt=\"\" class=\"wp-image-886\" width=\"736\" height=\"475\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-10-1024x661.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-10-300x194.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-10-768x496.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-10-1218x786.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-10-880x568.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-10.png 1384w\" sizes=\"auto, (max-width: 736px) 100vw, 736px\" \/><figcaption class=\"wp-element-caption\"><em>https:\/\/www.molecularcloud.org\/p\/from-bispecific-to-trispecific-antibodies-in-cancer-immunotherapy<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">\u8d1d\u6797\u59a5\u6b27\u5355\u6297\u7ed3\u6784\u662f\u7531\u4e24\u4e2a\u5355\u94fe\u53ef\u53d8\u533a(single-chain variable fragment, scFv)\u901a\u8fc7\u7075\u6d3b\u7684\u80bd\u94fe\u8fde\u63a5\u800c\u6210\u3002\u5f62\u6210BiTE(bispecific T-cell engager\uff0c\u53cc\u7279\u5f02\u6027T\u7ec6\u80de\u8854\u63a5\u5668) \u7ed3\u6784\uff0c\u4e0e\u5b8c\u6574\u7684\u6297\u4f53\u5206\u5b50\u76f8\u6bd4\uff0cscFv\u5206\u5b50\u8f83\u5c0f\uff0c\u6e17\u900f\u6027\u597d\uff0c\u80fd\u591f\u66f4\u597d\u5730\u8fdb\u5165\u7ec4\u7ec7\u548c\u7ec6\u80de\u5185\u90e8\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Mosunetuzumab\u7ed3\u6784\u7c7b\u4f3c\u4e8e\u5929\u7136\u6297\u4f53\uff0c\u4f46\u542b\u67092\u4e2aFab\u533a\uff0c\u5176\u4e2d\u4e00\u4e2aFab\u533a\u9776\u5411\u6076\u6027B\u7ec6\u80de\u8868\u9762\u7684CD20\uff0c\u53e6\u4e00\u4e2aFab\u533a\u9776\u5411\u6548\u5e94T\u7ec6\u80de\u8868\u9762\u7684CD3\u3002\u4f7f\u6548\u5e94T\u7ec6\u80de\u5411\u6076\u6027B\u7ec6\u80de\u9760\u8fd1\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u683c\u7f57\u83f2\u59a5\u5355\u6297\u7ed3\u6784<\/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-11-1024x524.png\" alt=\"\" class=\"wp-image-887\" width=\"734\" height=\"375\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-11-1024x524.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-11-300x153.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-11-768x393.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-11-1536x786.png 1536w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-11-1218x623.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-11-880x450.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-11.png 1621w\" sizes=\"auto, (max-width: 734px) 100vw, 734px\" \/><figcaption class=\"wp-element-caption\"><em>https:\/\/acrobiosystems.com.cn\/A1343-Targeting-CD20-and-CD3-the-witness-and-creator-in-the-process-of-antibody-drug-development.html<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">Glofitamab \u548cMosunetuzumab \u4e00\u6837\uff0c\u5747\u4e3aCD20 x CD3\u53cc\u7279\u5f02\u6027\u6297\u4f53\uff0c\u4f46Glofitamab\u6297\u4f53\u7684Fab\u6bb5\u542b\u67092\u4e2aCD20\u7ed3\u5408\u533a\u548c1\u4e2aCD3\u7ed3\u5408\u533a\uff0c2\u4e2a\u9776\u5411CD20\u7684Fab\u533a\u53ef\u4ee5\u7ed3\u5408\u6076\u6027B\u7ec6\u80de\u8868\u97622\u4e2aCD20\u5206\u5b50\uff0c\u7279\u5f02\u6027\u66f4\u5f3a\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u53e6\u5916\uff0cGlofitamab\u7684Fc\u533a\uff0c\u88ab\u8bbe\u8ba1\u4e3a\u53d6\u6d88Fc\u03b3Rs\u548cC1q\u7684\u7ed3\u5408\uff0c\u540c\u65f6\u4fdd\u6301FcRn\u7684\u7ed3\u5408\uff0c\u8fd9\u53ef\u5ef6\u957f\u836f\u7269\u7684\u5faa\u73af\u534a\u8870\u671f\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2\u3001\u9002\u5e94\u75c7<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4e24\u6b3eCD2<\/strong><strong>0&nbsp;x CD3\u53cc\u6297\u9002\u5e94\u75c7<\/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-12.png\" alt=\"\" class=\"wp-image-888\" width=\"618\" height=\"237\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-12.png 1002w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-12-300x115.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-12-768x295.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-12-880x338.png 880w\" sizes=\"auto, (max-width: 618px) 100vw, 618px\" \/><figcaption class=\"wp-element-caption\"><em>\u8be5\u836f\u7269\u76ee\u524d\u56fd\u5185\u6682\u672a\u6279\u51c6\u4e0a\u5e02<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">Mosunetuzumab \u83ab\u59a5\u73e0\u5355\u6297FDA\u83b7\u6279\u9002\u5e94\u75c7\u4e3a\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6ee4\u6ce1\u6027\u6dcb\u5df4\u7624<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Glofitamab \u683c\u7f57\u83f2\u59a5\u5355\u6297 EMA\u83b7\u6279\u9002\u5e94\u75c7\u4e3a\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5957\u7ec6\u80de\u6dcb\u5df4\u7624<\/li>\n\n\n\n<li>\u5f25\u6f2b\u6027\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624<\/li>\n<\/ul>\n\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-14-1024x662.png\" alt=\"\" class=\"wp-image-891\" width=\"652\" height=\"421\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-14-1024x662.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-14-300x194.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-14-768x496.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-14-1536x992.png 1536w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-14-1218x787.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-14-880x569.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/04\/image-14.png 1650w\" sizes=\"auto, (max-width: 652px) 100vw, 652px\" \/><figcaption class=\"wp-element-caption\">\u80d6\u732a\u9a91\u7740\u6469\u6258\u8f66\uff0c\u6765\u5230\u6536\u8d39\u7ad9\uff0c\u6536\u8d39\u5458\u542c\u5230\u94c3\u94db\u58f0\u54cd\u8d77\uff0c\u8d77\u6765\u6536\u8fc7\u8def\u8d39\u3002<\/figcaption><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">\u9a91\u7740\u6469\u6258\u8f66\u7684\u732a\uff0c\u4ee3\u8868\u83ab\u59a5\u73e0\u5355\u6297\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fc7\u8def\u8d39\uff0c\u4ee3\u8868\u683c\u7f57\u83f2\u59a5\u5355\u6297\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u94c3\u94db\u662f\u6211\u7684\u6570\u5b57\u7f16\u780120\uff0c\u4ee3\u8868\u9776\u70b9CD20\u30022\u4e2aB\u578b\u7684\u94c3\u94db\uff0c\u4ee3\u8868\u836f\u7269\u4e3a\u6cbb\u7597B\u7ec6\u80de\u6dcb\u5df4\u7624\u7684\u53cc\u6297\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e00\u4e2a\u94c3\u94db\u5916\u9762\u6709\u6ce1\u6ce1\uff0c\u4ee3\u8868\u6ee4\u6ce1\u6027\u6dcb\u5df4\u7624\uff1b\u53e6\u4e00\u4e2a\u6709\u5957\u5b50\uff0c\u4ee3\u8868\u5957\u7ec6\u80de\u6dcb\u5df4\u7624\u53ca\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f60\u8bb0\u4f4f\u4e86\u4e48\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7528\u56fe\u50cf\u8bb0\u5fc6\u7684\u65b9\u6cd5\uff0c\u4e00\u4e2a\u836f\u4e00\u5f20\u56fe\uff0c\u8bb0&#8230;<\/p>\n","protected":false},"author":1,"featured_media":890,"comment_status":"open","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-885","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-3","wpcat-3-id"],"_links":{"self":[{"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=\/wp\/v2\/posts\/885","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=885"}],"version-history":[{"count":1,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=\/wp\/v2\/posts\/885\/revisions"}],"predecessor-version":[{"id":892,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=\/wp\/v2\/posts\/885\/revisions\/892"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=\/wp\/v2\/media\/890"}],"wp:attachment":[{"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=885"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=885"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=885"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}