{"id":1173,"date":"2023-08-24T22:49:41","date_gmt":"2023-08-24T14:49:41","guid":{"rendered":"https:\/\/xiaoenjiyao.com\/?p=1173"},"modified":"2023-08-24T22:49:42","modified_gmt":"2023-08-24T14:49:42","slug":"%e8%ae%b0%e4%bd%8f%e6%89%80%e6%9c%89fda%e7%94%9f%e7%89%a9%e8%8d%af-%e9%9d%b6%e5%90%91%e7%a5%9e%e7%bb%8f%e8%8a%82%e8%8b%b7%e8%84%82gd2-%e8%be%be%e5%a6%a5%e6%98%94%e5%8d%95%e6%8a%97%ce%b2%ef%bc%8c","status":"publish","type":"post","link":"https:\/\/xiaoenjiyao.com\/?p=1173","title":{"rendered":"\u8bb0\u4f4f\u6240\u6709FDA\u751f\u7269\u836f | \u9776\u5411\u795e\u7ecf\u8282\u82f7\u8102GD2 | \u8fbe\u59a5\u6614\u5355\u6297\u03b2\uff0c\u90a3\u897f\u59a5\u5355\u6297 | \u795e\u7ecf\u6bcd\u7ec6\u80de\u7624"},"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>\u76ee\u524d\u6cbb\u7597\u9ad8\u5371\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u7684\u9776\u5411\u836f\u7269\uff0c\u9664\u4e86ALK\u5c0f\u5206\u5b50\u836f\u7269\u5916\uff0c\u8fd8\u6709GD2\u7684\u751f\u7269\u5236\u5242\uff0c\u4e3b\u8981\u5305\u62ec\uff1a<\/p>\n\n\n\n<p><strong>UNITUXIN\u00ae dinutuximab<\/strong><\/p>\n\n\n\n<p>Dinutuximab\u7531\u7f8e\u56fd\u5236\u836f\u516c\u53f8United Therapeutics\u516c\u53f8\u5f00\u53d1\u30022015\u5e74\u83b7\u7f8e\u56fdFDA\u6279\u51c6\u3002\u8be5\u836f\u7269\u672a\u5728\u6b27\u6d32\u4e0a\u5e02\u3002\u56fd\u5185\u4e5f\u672a\u4e0a\u5e02\u3002<\/p>\n\n\n\n<p><strong>\u51ef\u6cfd\u767e\u00ae \u8fbe\u59a5\u6614\u5355\u6297 \u03b2\uff08Qarziba\u00ae Dinutuximab \u03b2\uff09<\/strong><\/p>\n\n\n\n<p>\u8fbe\u59a5\u6614\u5355\u6297\u03b2\u7531\u5fb7\u56fd\u5236\u836f\u516c\u53f8Apeiron Biologics AG \u5f00\u53d1\uff0c\u540e\u8f6c\u8ba9\u7ed9EUSA\u516c\u53f8\uff0c\u5e76\u4e8e2017\u5e74\u83b7\u5f97\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u6279\u51c6\u4e0a\u5e02\u3002<\/p>\n\n\n\n<p>\u56fd\u5185\u8fbe\u59a5\u6614\u5355\u6297 \u03b2\u7531\u767e\u6d4e\u795e\u5dde\u5f15\u8fdb\uff0c\u5e76\u4e8e2021\u5e74\u83b7\u5f97\u56fd\u5bb6NMPA\u6279\u51c6\u4e0a\u5e02\u3002<\/p>\n\n\n\n<p><strong>\u8fbe\u4f51\u6cfd\u00ae \u90a3\u897f\u59a5\u5355\u6297\uff08DANYELZA\u00ae naxitamab\uff09<\/strong><\/p>\n\n\n\n<p>\u90a3\u897f\u59a5\u5355\u6297\u7531\u7f8e\u56fd\u5236\u836f\u516c\u53f8Y-mAbs Therapeutics\u5f00\u53d1\uff0c2020\u5e74\u83b7FDA\u6279\u51c6\u4e0a\u5e02\u3002<\/p>\n\n\n\n<p>\u56fd\u5185\u7531\u8d5b\u751f\u836f\u4e1a\u5f15\u8fdb\uff0c\u5e76\u4e0e2022\u5e74\u5e95\u83b7\u56fd\u5bb6NMPA\u6279\u51c6\u4e0a\u5e02\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1\u3001\u4f5c\u7528\u673a\u5236<\/h2>\n\n\n\n<p><strong>GD2<\/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\/08\/image-18.png\" alt=\"\" class=\"wp-image-1174\" style=\"width:606px;height:403px\" width=\"606\" height=\"403\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-18.png 680w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-18-300x199.png 300w\" sizes=\"auto, (max-width: 606px) 100vw, 606px\" \/><figcaption class=\"wp-element-caption\"><em>\u200bhttps:\/\/unituxin.com\/hcp\/about-unituxin\/mechanism-of-action\/<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p>GD2\uff08\u53cc\u553e\u6db2\u9178\u795e\u7ecf\u8282\u82f7\u8102\uff09\u662f\u4e00\u79cd\u590d\u6742\u7684\u7cd6\u8102\u6297\u539f\uff0c\u4f4d\u4e8e\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u7ec6\u80de\u819c\u4e0a\u3002\u8fd9\u79cd\u6297\u539f\u5728\u6b63\u5e38\u795e\u7ecf\u7cfb\u7edf\u4e2d\u4e5f\u6709\u5b58\u5728\uff0c\u4f46\u5728\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u4e2d\u8868\u8fbe\u6c34\u5e73\u660e\u663e\u5347\u9ad8\u3002<\/p>\n\n\n\n<p>GD2\u6297\u539f\u5728\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u7ec6\u80de\u7684\u8868\u9762\u8d77\u5230\u6807\u8bc6\u4f5c\u7528\uff0c\u5e2e\u52a9\u8bc6\u522b\u548c\u653b\u51fb\u8fd9\u4e9b\u80bf\u7624\u7ec6\u80de\u3002\u7531\u4e8e\u5176\u5728\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u4e2d\u7684\u7279\u5f02\u6027\u548c\u9ad8\u8868\u8fbe\uff0cGD2\u6210\u4e3a\u4e86\u6f5c\u5728\u7684\u6cbb\u7597\u9776\u70b9\u3002<\/p>\n\n\n\n<p>\u7531\u4e8eGD2\u6297\u539f\u5728\u6b63\u5e38\u795e\u7ecf\u7ec6\u80de\u8868\u9762\u5b58\u5728\u4e00\u5b9a\u7a0b\u5ea6\u7684\u8868\u8fbe\uff0c\u4f7f\u7528GD2\u6297\u4f53\u836f\u7269\u6cbb\u7597\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u53ef\u80fd\u4f1a\u5bfc\u81f4\u4e00\u4e9b\u4e0d\u826f\u6548\u5e94\uff0c\u5176\u4e2d\u6700\u663e\u8457\u7684\u662f\u5f15\u8d77\u60a3\u8005\u75bc\u75db\uff0c\u53ef\u7528\u5417\u5561\u7f13\u89e3\u3002<\/p>\n\n\n\n<p><strong>\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u6297\u4f53\u836f\u7269<\/strong><\/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\/08\/image-19-1024x652.png\" alt=\"\" class=\"wp-image-1175\" style=\"width:660px;height:420px\" width=\"660\" height=\"420\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-19-1024x652.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-19-300x191.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-19-768x489.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-19-1218x776.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-19-880x560.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-19.png 1492w\" sizes=\"auto, (max-width: 660px) 100vw, 660px\" \/><figcaption class=\"wp-element-caption\"><em>Vaccines (Basel) . 2021 Jan 13;9(1):43.<\/em><\/figcaption><\/figure>\n<\/div>\n\n\n<p>\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\uff08NB\uff09\u7684\u514d\u75ab\u7597\u6cd5\u57fa\u4e8e\u6297\u4f53\uff0c\u5e76\u6db5\u76d6\u591a\u79cd\u4f5c\u7528\u673a\u5236\u3002\u9664\u4e86\u5df2\u7ecf\u4e0a\u5e02\u7684\u9488\u5bf9GD2\u6297\u539f\u7684\u8fbe\u59a5\u6614\u5355\u6297\u548c\u90a3\u897f\u59a5\u5355\u6297\u5916\uff0c\u8fd8\u6709\u76ee\u524d\u5904\u4e8e\u4e34\u5e8a\u9636\u6bb5\u7684\u9488\u5bf9B7H3\u7684enoblituzumab\u7b49\u3002\u5b83\u4eec\u53ef\u4ee5\u901a\u8fc7\u4ee5\u4e0b\u65b9\u5f0f\u53d1\u6325\u4f5c\u7528\uff1a<\/p>\n\n\n\n<p><strong>1\u3001\u76f4\u63a5\u7ec6\u80de\u6740\u4f24\uff1a<\/strong>\u6297\u4f53\u80fd\u591f\u76f4\u63a5\u4e0e\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u7ec6\u80de\u7ed3\u5408\u5e76\u8bf1\u5bfc\u7ec6\u80de\u6b7b\u4ea1\uff0c\u4ece\u800c\u51cf\u5c11\u80bf\u7624\u8d1f\u8377\u3002<\/p>\n\n\n\n<p><strong>2\u3001\u8865\u4f53\u4f9d\u8d56\u7684\u7ec6\u80de\u6bd2\u4f5c\u7528\uff08CDC\uff09\uff1a<\/strong>\u6297\u4f53\u7ed3\u5408\u5230\u7ec6\u80de\u8868\u9762\u7684\u6297\u539f\uff0c\u968f\u540e\u6fc0\u6d3b\u4e86\u514d\u75ab\u7cfb\u7edf\u4e2d\u7684\u8865\u4f53\u7cfb\u7edf\uff0c\u5bfc\u81f4\u7ec6\u80de\u6eb6\u89e3\u548c\u6b7b\u4ea1\u3002<\/p>\n\n\n\n<p><strong>3\u3001\u6297\u4f53\u4f9d\u8d56\u7684\u7ec6\u80de\u4ecb\u5bfc\u7684\u7ec6\u80de\u6bd2\u4f5c\u7528\uff08ADCC\uff09\uff1a<\/strong>\u6297\u4f53\u4e0e\u7ec6\u80de\u8868\u9762\u7684\u6297\u539f\u7ed3\u5408\uff0c\u7136\u540e\u6fc0\u6d3b\u514d\u75ab\u7ec6\u80de\uff08\u5982\u81ea\u7136\u6740\u4f24\u7ec6\u80de\uff09\uff0c\u8fd9\u4e9b\u514d\u75ab\u7ec6\u80de\u8bc6\u522b\u5e76\u6467\u6bc1\u88ab\u6297\u4f53\u6807\u8bb0\u7684\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\u7ec6\u80de\u3002<\/p>\n\n\n\n<p>\u6b64\u5916\uff0c\u4e00\u4e9b\u7ec6\u80de\u56e0\u5b50\u5982\u767d\u7ec6\u80de\u4ecb\u7d20-2\uff08IL-2\uff09\u548c\u7c92\u7ec6\u80de-\u5de8\u566c\u7ec6\u80de\u96c6\u843d\u523a\u6fc0\u56e0\u5b50\uff08GM-CSF\uff09\u53ef\u4ee5\u589e\u5f3a\u8fd9\u4e9b\u6297\u4f53\u7684\u6297\u80bf\u7624\u6d3b\u6027\u3002\u56e0\u6b64\uff0c\u8fd9\u4e9b\u836f\u7269\u53ef\u4ee5\u8054\u7528\uff0c\u901a\u8fc7\u591a\u79cd\u673a\u5236\u6765\u653b\u51fb\u795e\u7ecf\u6bcd\u7ec6\u80de\u7624\uff0c\u4ee5\u63d0\u9ad8\u6cbb\u7597\u6548\u679c\u3002<\/p>\n\n\n\n<p>\u90a3\u897f\u59a5\u5355\u6297\u4e0e\u4e24\u6b3e\u8fbe\u59a5\u6614\u5355\u6297\u76f8\u6bd4\uff0c\u5177\u6709\u4eba\u6e90\u5316\u7a0b\u5ea6\u9ad8\u3002\u7ed9\u836f\u4fbf\u6377\uff0c\u6bcf\u6b21\u9759\u8109\u8f93\u6ce8\u65f6\u95f4\u901a\u5e38\u53ea\u970030\u81f360\u5206\u949f\u3002\u4ee5\u53ca\u65e0\u9700\u81ea\u4f53\u9020\u8840\u5e72\u7ec6\u80de\u79fb\u690d\u7b49\u7279\u70b9\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2\u3001\u9002\u5e94\u75c7<\/h2>\n\n\n\n<p><strong>GD2\u836f\u7269FDA\u83b7\u6279\u9002\u5e94\u75c7<\/strong><\/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\/08\/image-20-1024x343.png\" alt=\"\" class=\"wp-image-1176\" style=\"width:588px;height:197px\" width=\"588\" height=\"197\" srcset=\"https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-20-1024x343.png 1024w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-20-300x101.png 300w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-20-768x257.png 768w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-20-1218x408.png 1218w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-20-880x295.png 880w, https:\/\/xiaoenjiyao.com\/wp-content\/uploads\/2023\/08\/image-20.png 1244w\" sizes=\"auto, (max-width: 588px) 100vw, 588px\" \/><figcaption class=\"wp-element-caption\"><em><strong><mark style=\"background-color:rgba(0, 0, 0, 0);color:#661bac\" 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