{"id":1450,"date":"2024-12-25T16:19:54","date_gmt":"2024-12-25T08:19:54","guid":{"rendered":"https:\/\/xiaoenjiyao.com\/?p=1450"},"modified":"2024-12-25T16:19:55","modified_gmt":"2024-12-25T08:19:55","slug":"%e8%ae%b0%e4%bd%8f2024%e5%b9%b411%e6%9c%88fda%e8%8e%b7%e6%89%b9%e7%94%9f%e7%89%a9%e8%8d%af-her2%e5%8f%8c%e6%8a%97%e6%b2%bb%e7%96%97%e8%83%86%e9%81%93%e7%99%8c-zanidatamab-%e6%b3%bd%e5%b0%bc","status":"publish","type":"post","link":"https:\/\/xiaoenjiyao.com\/?p=1450","title":{"rendered":"\u8bb0\u4f4f2024\u5e7411\u6708FDA\u83b7\u6279\u751f\u7269\u836f | HER2\u53cc\u6297\u6cbb\u7597\u80c6\u9053\u764c | Zanidatamab \u6cfd\u5c3c\u8fbe\u59a5\u5355\u6297"},"content":{"rendered":"\n

Zanidatamab \u662f\u4e00\u79cd\u53cc\u7279\u5f02\u6027HER2\u9776\u5411\u6297\u4f53\u3002<\/p>\n\n\n\n

\u836f\u7269\u6700\u521d\u7531Zymeworks\u7814\u53d1\uff0c2022 Jazz Pharmaceuticals\u4e0eZymeworks\u8fbe\u6210\u534f\u8bae\uff0c\u83b7\u5f97\u4e86\u836f\u7269\u5728\u7f8e\u56fd\u3001\u6b27\u6d32\u3001\u65e5\u672c\u7b49\u5730\u533a\u7684\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u6743\u76ca\u3002<\/p>\n\n\n\n

\u5728\u4e9a\u592a\u5730\u533a\uff08\u65e5\u672c\u9664\u5916\uff09\uff0c\u767e\u6d4e\u795e\u5dde\u4e8e2018\u5e74\u83b7\u5f97\u4e86Zanidatamab\u7684\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u6743\u5229\u3002<\/p>\n\n\n\n

\u836f\u7269\u5df2\u4e8e2024\u5e7411\u6708\u83b7\u5f97FDA\u6279\u51c6\uff08ZIIHERA\u00ae Zanidatamab\uff09\uff0c\u7528\u4e8e\u6cbb\u7597\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027HER2\u9633\u6027\uff08IHC 3+\uff09\u80c6\u9053\u764c\uff08BTC\uff09\u6210\u4eba\u60a3\u8005\u3002<\/p>\n\n\n\n

\u56fd\u5185\uff0c\u836f\u7269\u76ee\u524d\u5904\u4e8e\u7533\u62a5\u751f\u4ea7\u9636\u6bb5\uff0c\u6309\u7167CDE\u5b98\u7f51\uff0c\u767e\u6d4e\u795e\u5dde\u7533\u62a5\u7684\u53d7\u7406\u53f7\uff08CXSS2400056\uff09\uff0c\u4e2d\u6587\u540d\u8bd1\u4e3a\u6cfd\u5c3c\u8fbe\u59a5\u5355\u6297\u3002<\/p>\n\n\n\n

1\u3001\u4f5c\u7528\u673a\u5236<\/h2>\n\n\n\n
\"\"
Nat Commun . 2023 Mar 13;14(1):1394.<\/em><\/figcaption><\/figure>\n\n\n\n

\u6cfd\u5c3c\u8fbe\u59a5\u5355\u6297\u662f\u57fa\u4e8e Azymetric\u2122 \u5e73\u53f0\u5f00\u53d1\u7684\u53cc\u7279\u5f02\u6027\u6297\u4f53\u3002<\/p>\n\n\n\n

\u8be5\u5e73\u53f0\u4e3aIgG1 \u7c7b\u6297\u4f53\u6846\u67b6\uff0c\u5305\u62ec\u4e24\u4e2a\u6297\u539f\u7ed3\u5408\u533a\uff08\u4e00\u4e2a Fab \u548c\u4e00\u4e2a scFv\uff09\uff0c\u5141\u8bb8\u66f4\u7075\u6d3b\u548c\u9ad8\u6548\u7684\u8de8\u5206\u5b50\u7ed3\u5408\u3002<\/p>\n\n\n\n

\u8fd9\u79cd\u8bbe\u8ba1\u8fd8\u63d0\u4f9b\u4e86\u66f4\u9ad8\u7684\u7ed3\u5408\u4eb2\u548c\u529b\u548c\u751f\u7269\u5b66\u6d3b\u6027\uff0c\u5176\u4e3b\u8981\u7279\u70b9\u5305\u62ec\u80fd\u591f\u540c\u65f6\u9776\u5411 HER2 \u7684\u4e24\u4e2a\u4e0d\u540c\u7ed3\u6784\u57df\uff08ECD2 \u548c ECD4\uff09\u3002<\/p>\n\n\n\n

    \n
  • ECD2\uff08\u80de\u5916\u7ed3\u6784\u57df2\uff09\uff1a\u5e15\u6377\u7279\u00ae \u5e15\u59a5\u73e0\u5355\u6297\u4f4d\u70b9\uff0c\u8d1f\u8d23 HER2 \u7684\u4e8c\u805a\u5316\uff0c\u4e0e\u80bf\u7624\u4fe1\u53f7\u7684\u542f\u52a8\u5bc6\u5207\u76f8\u5173\u3002<\/li>\n\n\n\n
  • ECD4\uff08\u80de\u5916\u7ed3\u6784\u57df4\uff09\uff1a\u8d6b\u8d5b\u6c40\u00ae \u66f2\u59a5\u73e0\u5355\u6297\u4f4d\u70b9\uff0c\u7528\u4e8e\u963b\u65ad HER2 \u4fe1\u53f7\u4f20\u5bfc\u3002<\/li>\n<\/ul>\n\n\n\n

    Zanidatamab \u540c\u65f6\u7ed3\u5408\u8fd9\u4e24\u4e2a\u5173\u952e\u4f4d\u70b9\uff0c\u5b9e\u73b0\u66f4\u5e7f\u6cdb\u7684 HER2 \u4fe1\u53f7\u963b\u65ad\u3002<\/p>\n\n\n\n

    \u8de8\u5206\u5b50\u7ed3\u5408\uff1a<\/h3>\n\n\n\n
    \"\"
    Nat Commun . 2023 Mar 13;14(1):1394.<\/em><\/figcaption><\/figure>\n\n\n\n

    \u6cfd\u5c3c\u8fbe\u59a5\u5355\u6297\u7684\u53cc\u7279\u5f02\u6027\u8bbe\u8ba1\u5141\u8bb8\u5176\u7ed3\u5408\u4e8e\u4e24\u4e2a\u76f8\u90bb\u7684 HER2 \u5206\u5b50\uff0c\u800c\u4e0d\u662f\u4ec5\u4e0e\u5355\u4e2a\u5206\u5b50\u7ed3\u5408\u3002\u8fd9\u4e00\u7ed3\u6784\u7279\u70b9\u7684\u4f18\u52bf\u5305\u62ec\uff1a<\/p>\n\n\n\n

      \n
    • HER2 \u5206\u5b50\u8de8\u8054<\/strong>\uff1a\u901a\u8fc7\u8fde\u63a5\u4e24\u4e2a HER2 \u5206\u5b50\uff0c\u6cfd\u5c3c\u8fbe\u59a5\u5355\u6297\u8bf1\u5bfc\u4e86 HER2 \u5206\u5b50\u7684\u91cd\u65b0\u5206\u5e03\u548c\u805a\u96c6\uff0c\u5f62\u6210\u5927\u578b HER2 \u7c07\u5316\u7ed3\u6784\u3002<\/li>\n\n\n\n
    • HER2 \u805a\u96c6\u6548\u5e94<\/strong>\uff1a\u8bf1\u5bfc HER2 \u5206\u5b50\u5f62\u6210\u201c\u5e3d\u72b6\u201d\u805a\u96c6\u7ed3\u6784\u3002<\/li>\n\n\n\n
    • \u4fe1\u53f7\u4f20\u5bfc\u6291\u5236<\/strong>\uff1a\u901a\u8fc7\u6291\u5236 HER2 \u4e0e HER3\u3001EGFR \u7b49\u5176\u4ed6\u53d7\u4f53\u7684\u76f8\u4e92\u4f5c\u7528\uff0c\u963b\u65ad\u4e0b\u6e38\u4fe1\u53f7\u901a\u8def\uff08\u5982 PI3K-AKT \u548c MAPK \u901a\u8def\uff09\u3002<\/li>\n<\/ul>\n\n\n\n

      \u529f\u80fd\u589e\u5f3a\u7684 Fc \u533a\uff1a<\/h3>\n\n\n\n
      \"\"
      Nat Commun . 2023 Mar 13;14(1):1394.<\/em><\/figcaption><\/figure>\n\n\n\n

      \u6cfd\u5c3c\u8fbe\u59a5\u5355\u6297\u7684 Fc \u533a\u7ecf\u8fc7\u4f18\u5316\uff0c\u80fd\u591f\u589e\u5f3a\u6297\u4f53\u4f9d\u8d56\u6027\u7ec6\u80de\u6bd2\u6027 (ADCC) \u548c \u6297\u4f53\u4f9d\u8d56\u6027\u7ec6\u80de\u541e\u566c (ADCP)\u6548\u5e94\u3002<\/p>\n\n\n\n

      \u5176\u8fd8\u80fd\u591f\u901a\u8fc7\u7279\u5b9a\u51e0\u4f55\u7ed3\u6784\u589e\u5f3a C1q \u7684\u7ed3\u5408\uff0c\u4ece\u800c\u6fc0\u6d3b\u8865\u4f53\u4f9d\u8d56\u6027\u7ec6\u80de\u6bd2\u6027 (CDC)\u3002\u8fd9\u79cd\u8865\u4f53\u6fc0\u6d3b\u673a\u5236\u662f\u5176\u4ed6\u5355\u7279\u5f02\u6027 HER2 \u6297\u4f53\uff08\u5982\u66f2\u59a5\u73e0\u5355\u6297\u548c\u5e15\u59a5\u73e0\u5355\u6297\uff09\u65e0\u6cd5\u5b9e\u73b0\u7684\u3002<\/p>\n\n\n\n

      \u4e0e\u4f20\u7edfHER2\u6297\u4f53\u7684\u9776\u5411\u529b\u5bf9\u6bd4\uff1a<\/p>\n\n\n\n

      \u66f2\u59a5\u73e0\u5355\u6297\uff08trastuzumab\uff09\u548c\u5e15\u59a5\u73e0\u5355\u6297\uff08pertuzumab\uff09\u662f\u4e24\u79cd\u9776\u5411 HER2 \u7684\u5355\u514b\u9686\u6297\u4f53\uff0c\u5404\u81ea\u5177\u6709\u72ec\u7279\u7684\u4f5c\u7528\u673a\u5236\u3002<\/p>\n\n\n\n

        \n
      • \u66f2\u59a5\u73e0\u5355\u6297<\/strong>\uff1a\u4e3b\u8981\u7ed3\u5408 HER2 \u7684\u80de\u5916\u7ed3\u6784\u57df IV\uff08ECD4\uff09\uff0c\u963b\u65ad HER2 \u7684\u4e0b\u6e38\u4fe1\u53f7\u901a\u8def\uff0c\u6291\u5236\u80bf\u7624\u7ec6\u80de\u589e\u6b96\uff0c\u5e76\u901a\u8fc7\u6297\u4f53\u4f9d\u8d56\u7684\u7ec6\u80de\u4ecb\u5bfc\u7684\u7ec6\u80de\u6bd2\u6027\uff08ADCC\uff09\u6fc0\u6d3b\u514d\u75ab\u7ec6\u80de\u6740\u4f24\u80bf\u7624\u7ec6\u80de\u3002\u00a0<\/li>\n\n\n\n
      • \u5e15\u59a5\u73e0\u5355\u6297<\/strong>\uff1a\u9776\u5411 HER2 \u7684\u80de\u5916\u7ed3\u6784\u57df II\uff08ECD2\uff09\uff0c\u5e72\u6270 HER2 \u4e0e\u5176\u4ed6\u53d7\u4f53\uff08\u5982 HER3\uff09\u7684\u4e8c\u805a\u5316\uff0c\u4ece\u800c\u6291\u5236\u53d7\u4f53\u7684\u914d\u4f53\u9a71\u52a8\u4fe1\u53f7\u901a\u8def\uff0c\u963b\u6b62\u80bf\u7624\u7ec6\u80de\u7684\u751f\u957f\u3002<\/li>\n<\/ul>\n\n\n\n

        \u8054\u5408\u4f7f\u7528\u8fd9\u4e24\u79cd\u6297\u4f53\uff0c\u53ef\u4ee5\u901a\u8fc7\u4e0d\u540c\u7684\u4f5c\u7528\u4f4d\u70b9\u5b9e\u73b0\u534f\u540c\u6297\u80bf\u7624\u6548\u679c\uff0c\u663e\u8457\u589e\u5f3a HER2 \u9776\u5411\u6cbb\u7597\u7684\u7597\u6548\u3002<\/p>\n\n\n\n

        \"\"<\/figure>\n\n\n\n

        \u6cfd\u5c3c\u8fbe\u59a5\u5355\u6297\u5728 HER2 \u9633\u6027\u80bf\u7624\u7ec6\u80de\uff08\u5982 SK-BR-3 \u7ec6\u80de\u7cfb\uff09\u4e2d\u8868\u73b0\u51fa\u663e\u8457\u66f4\u9ad8\u7684\u7ed3\u5408\u9971\u548c\u5ea6\u548c\u6548\u7387\uff0c\u8f83\u66f2\u59a5\u73e0\u5355\u6297\u548c\u5e15\u59a5\u73e0\u5355\u6297\u5355\u72ec\u4f7f\u7528\u7684\u7ed3\u5408\u5f3a\u5ea6\u66f4\u9ad8\uff0c\u4e0e\u8054\u5408\u4f7f\u7528\u66f2\u59a5\u73e0\u5355\u6297\u548c\u5e15\u59a5\u73e0\u5355\u6297\u7684\u7ed3\u5408\u5f3a\u5ea6\u4e00\u81f4\u3002<\/p>\n\n\n\n

        \u8fd9\u8868\u660e\u5176\u53cc\u7279\u5f02\u6027\u7ed3\u6784\u8bbe\u8ba1\u80fd\u591f\u540c\u65f6\u9776\u5411 HER2 \u7684 ECD2 \u548c ECD4 \u533a\u57df\uff0c\u4ece\u800c\u589e\u5f3a\u6297\u4f53\u4e0e\u80bf\u7624\u7ec6\u80de\u7684\u7ed3\u5408\u80fd\u529b\uff0c\u5177\u6709\u66f4\u5f3a\u7684\u6297\u80bf\u7624\u6f5c\u529b\u3002<\/p>\n\n\n\n

        2\u3001\u9002\u5e94\u75c7<\/h2>\n\n\n\n

        \u6cfd\u5c3c\u8fbe\u59a5\u5355\u6297\u662f\u4e00\u79cd\u53cc\u7279\u5f02\u6027 HER2 \u9776\u5411\u6297\u4f53\uff0c\u9002\u7528\u4e8e\u66fe\u63a5\u53d7\u8fc7\u6cbb\u7597\u7684\uff0c\u7ecf FDA \u6279\u51c6\u7684\u68c0\u6d4b\u786e\u8ba4\u4e3a HER2 \u9633\u6027\uff08IHC 3+\uff09\u7684\u665a\u671f\u6216\u4e0d\u53ef\u5207\u9664\u6027\u8f6c\u79fb\u6027\u80c6\u9053\u764c\uff08BTC\uff09\u6210\u5e74\u60a3\u8005\u3002<\/p>\n\n\n\n

        3\u3001\u56fe\u50cf\u8bb0\u5fc6<\/h2>\n\n\n\n
        \"\"
        \u4e24\u4e2a\u5c0f\u5973\u5b69\u6307\u7740\u5730\u4e0a\u5927\u558a\uff0c\u8fd9\u91cc\u6709\u4e00\u5927\u5768\u3002\u5176\u4e2d\u4e00\u4e2a\u5c0f\u5973\u5b69\u6076\u5fc3\u7684\u80c6\u90fd\u5410\u51fa\u6765\u4e86\u3002<\/em><\/figcaption><\/figure>\n\n\n\n

        \u4e24\u4e2a\u5973\u5b69\uff08her\uff09\u4ee3\u8868\u836f\u7269\u9776\u70b9\uff0cHER2\u53cc\u6297\u3002<\/strong><\/p>\n\n\n\n

        \u8fd9\u91cc\u4e00\u5927\u5768\u53d6\u8c10\u97f3\uff0c\u4ee3\u8868\u836f\u7269\u540d\u79f0\uff0c\u6cfd\u5c3c\u8fbe\u59a5\u5355\u6297\u3002<\/strong><\/p>\n\n\n\n

        \u5410\u51fa\u6765\u7684\u80c6\uff0c\u4ee3\u8868\u836f\u7269\u9002\u5e94\u75c7\uff0c\u80c6\u9053\u764c\u3002<\/strong><\/p>\n\n\n\n

        \u4f60\u8bb0\u4f4f\u4e86\u4e48<\/p>\n","protected":false},"excerpt":{"rendered":"

        Zanidatamab \u662f\u4e00\u79cd\u53cc\u7279…<\/p>\n","protected":false},"author":1,"featured_media":1456,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-1450","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\/1450","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=1450"}],"version-history":[{"count":1,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=\/wp\/v2\/posts\/1450\/revisions"}],"predecessor-version":[{"id":1457,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=\/wp\/v2\/posts\/1450\/revisions\/1457"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=\/wp\/v2\/media\/1456"}],"wp:attachment":[{"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1450"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1450"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/xiaoenjiyao.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1450"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}