{"id":39820,"date":"2026-05-21T14:26:36","date_gmt":"2026-05-21T06:26:36","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=39820"},"modified":"2026-05-21T14:26:19","modified_gmt":"2026-05-21T06:26:19","slug":"fda-%e6%ad%a3%e5%bc%8f%e6%89%b9%e5%87%86-zenocutuzumab-zbco%ef%bc%9anrg1-%e8%9e%8d%e5%90%88%e9%98%b3%e6%80%a7%e6%99%9a%e6%9c%9f%e8%83%86%e7%ae%a1%e7%99%8c%e8%bf%8e%e6%9d%a5%e5%85%a8%e7%90%83%e9%a6%96","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/fda-%e6%ad%a3%e5%bc%8f%e6%89%b9%e5%87%86-zenocutuzumab-zbco%ef%bc%9anrg1-%e8%9e%8d%e5%90%88%e9%98%b3%e6%80%a7%e6%99%9a%e6%9c%9f%e8%83%86%e7%ae%a1%e7%99%8c%e8%bf%8e%e6%9d%a5%e5%85%a8%e7%90%83%e9%a6%96\/","title":{"rendered":"FDA \u6b63\u5f0f\u6279\u51c6 zenocutuzumab-zbco\uff1aNRG1 \u878d\u5408\u9633\u6027\u665a\u671f\u80c6\u7ba1\u764c\u8fce\u6765\u5168\u7403\u9996\u6b3e\u9776\u5411\u836f"},"content":{"rendered":"\n<p>2026\u5e745\u67088\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u901a\u8fc7<strong>\u56fd\u5bb6\u4f18\u5148\u5ba1\u8bc4\u5238\uff08CNPV\uff09\u8bd5\u70b9\u9879\u76ee<\/strong>\uff0c\u6b63\u5f0f\u52a0\u901f\u6279\u51c6\u53cc\u7279\u5f02\u6027\u6297\u4f53<strong>zenocutuzumab-zbco<\/strong>\uff0c\u7528\u4e8e\u6cbb\u7597<strong>\u643a\u5e26 NRG1 \u57fa\u56e0\u878d\u5408\u3001\u65e2\u5f80\u5168\u8eab\u6cbb\u7597\u540e\u75be\u75c5\u8fdb\u5c55\u7684\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u80c6\u7ba1\u764c\u6210\u4eba\u60a3\u8005<\/strong>\u3002<\/p>\n\n\n\n<p>\u8fd9\u662f<strong>\u5168\u7403\u9996\u6b3e\u83b7\u6279\u7528\u4e8e NRG1 \u878d\u5408\u9633\u6027\u80c6\u7ba1\u764c\u7684\u9776\u5411\u836f\u7269<\/strong>\uff0c\u4e3a\u8fd9\u4e00\u7f55\u89c1\u4e14\u96be\u6cbb\u7684\u764c\u75c7\u4e9a\u578b\u586b\u8865\u4e86\u6cbb\u7597\u7a7a\u767d\u3002<\/p>\n\n\n\n<p>***\u672c\u836f\u7269\u76ee\u524d\u5c1a\u672a\u5728\u9999\u6e2f\u53ca\u4e2d\u56fd\u5927\u9646\u83b7\u5f97\u4e0a\u5e02\u6279\u51c6\u3002\u6709\u76f8\u5173\u6cbb\u7597\u9700\u6c42\u7684\u60a3\u8005\uff0c\u5728\u7ecf\u533b\u751f\u9762\u8bca\u8bc4\u4f30\u540e\uff0c\u53ef\u901a\u8fc7\u9999\u6e2f<strong>\u201c \u6307\u5b9a\u836f\u7269\u4f7f\u7528\u8ba1\u5212\uff08NPA\uff09 \u201d<\/strong>\u7533\u8bf7\u76f8\u5173\u6cbb\u7597\u7528\u836f\uff0c\u6709\u9700\u8981\u5373\u53ef\u8054\u7cfb\u6211\u4eec\u9999\u6e2f\u7efc\u5408\u80bf\u7624\u4e2d\u5fc3\u7684\u5ba2\u670d\u67e5\u8be2\u4e86\u89e3\u66f4\u591a\u3002<\/p>\n\n\n\n<p>* Name Patient Access Program\uff08\u5373NPA\uff09\u201c\u6307\u5b9a\u836f\u7269\u4f7f\u7528\u8ba1\u5212\u201d\uff0c\u4fd7\u79f0\u201c\u65b0\u836f\u7eff\u8272\u901a\u9053\u201d\uff0c\u7b26\u5408\u4ee5\u4e0b\u4e24\u4e2a\u60c5\u51b5\u7684\u75c5\u4eba\uff0c\u53ef\u4ee5\u900f\u8fc7NPA\u4f7f\u7528\u8fd9\u4e9b\u521b\u65b0\u764c\u75c7\u836f\u7269\uff1a<\/p>\n\n\n\n<p>1. \u75c5\u4eba\u9700\u8981\u7684\u521b\u65b0\u836f\u7269\u5728\u9999\u6e2f\u4ecd\u672a\u6ce8\u518c\uff0c\u4f46\u5728\u6b27\u7f8e\u6216\u5185\u5730\u5df2\u4e0a\u5e02\u3002<\/p>\n\n\n\n<p>2. \u5fc5\u987b\u7ecf\u9999\u6e2f\u7684\u533b\u751f\uff08\u4e3b\u8981\u662f\u4e34\u5e8a\/\u5185\u79d1\u80bf\u7624\u79d1\u4e13\u79d1\u533b\u751f\uff09\u8bca\u65ad\u548c\u8bc4\u4f30\u540e\uff0c\u786e\u5b9a\u75c5\u4eba\u7684\u60c5\u51b5\u9002\u5408\u6216\u6709\u5fc5\u8981\u4f7f\u7528\u8be5\u9879\u521b\u65b0\u836f\u7269\u3002<\/p>\n\n\n\n<p><strong>1<\/strong><strong>. <\/strong><strong>\u80c6\u7ba1\u764c\uff1a\u7f55\u89c1\u4e14\u9884\u540e\u6781\u5dee\u7684\u6076\u6027\u80bf\u7624<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u80c6\u7ba1\u764c\uff08BTC\uff09\u662f\u8d77\u6e90\u4e8e\u80c6\u7ba1\u4e0a\u76ae\u7ec6\u80de\u7684\u7f55\u89c1\u809d\u80c6\u7cfb\u7edf\u6076\u6027\u80bf\u7624\uff0c\u5168\u7403\u53d1\u75c5\u7387\u5448\u9010\u5e74\u4e0a\u5347\u8d8b\u52bf\uff0c<strong>\u4fb5\u88ad\u6027\u5f3a\u3001\u65e9\u671f\u8bca\u65ad\u7387\u4f4e<\/strong>\u3002<\/p>\n\n\n\n<p><strong>\u2022 \u6cbb\u7597\u73b0\u72b6\uff1a<\/strong>\u624b\u672f\u5207\u9664\u662f\u552f\u4e00\u6f5c\u5728\u6cbb\u6108\u624b\u6bb5\uff0c\u4f46\u4ec5\u7ea630%\u60a3\u8005\u53ef\u624b\u672f\uff0c\u672f\u540e2\u5e74\u590d\u53d1\u7387\u9ad8\u8fbe75%\uff1b\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u60a3\u8005\uff0c\u4e00\u7ebf\u6807\u51c6\u6cbb\u7597\u4e3a\u5409\u897f\u4ed6\u6ee8+\u987a\u94c2\u8054\u5408\u65b9\u6848\uff0c<strong>\u4e2d\u4f4d\u751f\u5b58\u671f\u4ec5\u7ea612\u4e2a\u6708<\/strong>\uff0c\u4e8c\u7ebf\u53ca\u540e\u7ebf\u6cbb\u7597\u9009\u62e9\u6781\u4e3a\u6709\u9650\u3002<\/p>\n\n\n\n<p><strong>\u2022 NRG1 \u878d\u5408\u4e9a\u578b\uff1a<\/strong>NRG1 \u57fa\u56e0\u878d\u5408\u662f\u80c6\u7ba1\u764c\u7684<strong>\u7f55\u89c1\u9a71\u52a8\u7a81\u53d8<\/strong>\uff0c\u4e3b\u8981\u89c1\u4e8e\u809d\u5185\u80c6\u7ba1\u764c\uff08iCCA\uff09\uff0c\u5728\u80c6\u7ba1\u764c\u4e2d\u53d1\u751f\u7387\u7ea61%-3%\uff0c\u5c5e\u4e8e\u201c\u8d85\u7f55\u89c1\u201d\u5206\u5b50\u4e9a\u578b\uff0c\u6b64\u524d<strong>\u65e0\u9488\u5bf9\u6027\u9776\u5411\u836f\u7269\u83b7\u6279<\/strong>\uff0c\u60a3\u8005\u9884\u540e\u6781\u5dee\u3002<\/p>\n\n\n\n<p>\u7f8e\u56fd\u764c\u75c7\u534f\u4f1a\uff08ACS\uff09\u6570\u636e\u663e\u793a\uff0c2015-2021\u5e74\u786e\u8bca\u7684\u80c6\u7ba1\u764c\u60a3\u8005\u4e2d\uff0c<strong>\u8f6c\u79fb\u6027\uff08\u8fdc\u5904\u8f6c\u79fb\uff09\u60a3\u80055\u5e74\u76f8\u5bf9\u751f\u5b58\u7387\u4ec52%<\/strong>\uff0c\u4e34\u5e8a\u4e9f\u9700\u7cbe\u51c6\u6cbb\u7597\u836f\u7269\u7a81\u7834\u751f\u5b58\u74f6\u9888\u3002<\/p>\n\n\n\n<p><strong>2<\/strong><strong>. <\/strong><strong>\u836f\u7269\u673a\u5236\uff1a\u5168\u7403\u9996\u6b3eHER2\/HER3\u53cc\u7279\u5f02\u6027\u6297\u4f53<\/strong><strong><\/strong><\/p>\n\n\n\n<p>zenocutuzumab-zbco \u662f<strong>\u5168\u7403\u9996\u6b3e\u83b7\u6279\u7684\u9776\u5411HER2\/HER3\u7684\u53cc\u7279\u5f02\u6027\u6297\u4f53<\/strong>\uff0c\u5176\u4f5c\u7528\u673a\u5236\u7cbe\u51c6\u9488\u5bf9NRG1\u878d\u5408\u9a71\u52a8\u7684\u80bf\u7624\u751f\u957f\u901a\u8def\uff1a<\/p>\n\n\n\n<p>\u2022 NRG1 \u86cb\u767d\u53ef\u7ed3\u5408HER3\u53d7\u4f53\uff0c\u8bf1\u5bfcHER2-HER3\u5f02\u4e8c\u805a\u5316\uff0c\u6fc0\u6d3b\u4e0b\u6e38PI3K\/AKT\u7b49\u589e\u6b96\u3001\u5b58\u6d3b\u4fe1\u53f7\u901a\u8def\uff0c\u9a71\u52a8\u80bf\u7624\u53d1\u751f\u4e0e\u8fdb\u5c55\u3002<\/p>\n\n\n\n<p>\u2022 zenocutuzumab-zbco \u53ef\u540c\u65f6\u7ed3\u5408HER2\u4e0eHER3\uff0c<strong>\u963b\u65adNRG1\u4ecb\u5bfc\u7684HER2\/HER3\u4fe1\u53f7\u4f20\u5bfc<\/strong>\uff0c\u6291\u5236\u80bf\u7624\u7ec6\u80de\u589e\u6b96\u5e76\u8bf1\u5bfc\u51cb\u4ea1\uff0c\u5b9e\u73b0\u5bf9 NRG1 \u878d\u5408\u9633\u6027\u80bf\u7624\u7684\u7cbe\u51c6\u6291\u5236\u3002<\/p>\n\n\n\n<p>\u8be5\u836f\u7269\u6b64\u524d\u5df2\u83b7FDA\u52a0\u901f\u6279\u51c6\u7528\u4e8e<strong><strong>NRG1\u878d\u5408\u9633\u6027\u665a\u671f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09<\/strong><\/strong>\u548c<strong><strong>\u80f0\u817a\u5bfc\u7ba1\u817a\u764c\uff08PDAC\uff09<\/strong><\/strong>\uff0c\u672c\u6b21\u4e3a<strong><strong>\u65b0\u589e\u80c6\u7ba1\u764c\u9002\u5e94\u75c7<\/strong><\/strong>\uff0c\u4e14\u83b7 FDA\u4f18\u5148\u5ba1\u8bc4\u3001\u7a81\u7834\u6027\u7597\u6cd5\u3001\u5b64\u513f\u836f\u4e09\u91cd\u8d44\u683c\u8ba4\u5b9a\uff0c\u4f53\u73b0\u5176\u9488\u5bf9\u672a\u7adf\u533b\u7597\u9700\u6c42\u7684\u91cd\u5927\u4ef7\u503c\u3002<\/p>\n\n\n\n<p><strong>3<\/strong><strong>. <\/strong><strong>\u4e34\u5e8a\u6570\u636e\uff1aeNRGy\u7814\u7a76\u8bc1\u5b9e\u660e\u786e\u6297\u80bf\u7624\u6d3b\u6027<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u672c\u6b21FDA\u6279\u51c6\u57fa\u4e8e **\u5168\u7403\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u3001\u5355\u81c2 I\/II \u671f eNRGy \u7814\u7a76\uff08NCT02912949\uff09** \u7684\u80c6\u7ba1\u764c\u961f\u5217\u6570\u636e\uff0c\u7814\u7a76\u7ed3\u679c\u53d1\u8868\u4e8e\u300a\u4e34\u5e8a\u80bf\u7624\u5b66\u6742\u5fd7\u300b\uff08JCO\uff09\u76f8\u5173\u5206\u6790\u53caFDA\u5b98\u65b9\u5ba1\u8bc4\u6587\u4ef6\u3002<\/p>\n\n\n\n<p><strong>\u7814\u7a76\u8bbe\u8ba1<\/strong><\/p>\n\n\n\n<p><strong>\u2022 \u5165\u7ec4\u4eba\u7fa4\uff1a<\/strong>22\u4f8b\u665a\u671f\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027NRG1\u878d\u5408\u9633\u6027\u80c6\u7ba1\u764c\u6210\u4eba\u60a3\u8005\uff0c\u5747\u4e3a\u65e2\u5f80\u5168\u8eab\u6cbb\u7597\u540e\u75be\u75c5\u8fdb\u5c55\uff1b\u5176\u4e2d19\u4f8b\u7eb3\u5165\u7597\u6548\u8bc4\u4f30\uff0c18\u4f8b\u4e3a\u8f6c\u79fb\u6027\u75be\u75c5\uff0c100%\u53ef\u8bc4\u4f30\u539f\u53d1\u7076\u60a3\u8005\u4e3a\u809d\u5185\u80c6\u7ba1\u764c\u3002<\/p>\n\n\n\n<p><strong>\u2022 \u6cbb\u7597\u65b9\u6848\uff1a<\/strong>zenocutuzumab-zbco 750mg\uff0c\u9759\u8109\u8f93\u6ce8\uff0c\u6bcf2\u5468\u4e00\u6b21\uff0c\u76f4\u81f3\u75be\u75c5\u8fdb\u5c55\u6216\u51fa\u73b0\u4e0d\u53ef\u8010\u53d7\u6bd2\u6027\u3002<\/p>\n\n\n\n<p><strong>\u2022 \u8bc4\u4f30\u7ec8\u70b9\uff1a<\/strong>\u4e3b\u8981\u7ec8\u70b9\u4e3a\u7ecf\u76f2\u6cd5\u72ec\u7acb\u4e2d\u5fc3\u5ba1\u67e5\uff08BICR\uff09\u4f9d\u636e RECIST v1.1 \u6807\u51c6\u8bc4\u4f30\u7684\u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\u4e0e\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\u3002<\/p>\n\n\n\n<p><strong>\u6838\u5fc3\u7597\u6548\u6570\u636e\uff08n=19\uff0cBICR\u8bc4\u4f30\uff09<\/strong><\/p>\n\n\n\n<p><strong>\u2022 \u5ba2\u89c2\u7f13\u89e3\u7387\uff08ORR\uff09\uff1a<\/strong>36.8%\uff0895% CI\uff1a16.3%-61.6%\uff09\uff0c\u5176\u4e2d\u5b8c\u5168\u7f13\u89e3\uff08CR\uff09\u7387 5.3%\uff0c\u90e8\u5206\u7f13\u89e3\uff08PR\uff09\u7387 31.6%\u3002<\/p>\n\n\n\n<p><strong>\u2022 \u7f13\u89e3\u6301\u7eed\u65f6\u95f4\uff08DOR\uff09\uff1a<\/strong>2.8\u4e2a\u6708 &#8211; 12.9\u4e2a\u6708\uff0c28.6%\u7684\u7f13\u89e3\u60a3\u8005\u6301\u7eed\u7f13\u89e3\u22656\u4e2a\u6708\u3002<\/p>\n\n\n\n<p><strong>\u2022 \u75be\u75c5\u63a7\u5236\u7387<\/strong>\uff08DCR\uff0cCR+PR + \u7a33\u5b9a\u75be\u75c5\uff09\u8fbe63.2%\uff0c\u591a\u6570\u60a3\u8005\u6cbb\u7597\u540e\u80bf\u7624\u7f29\u5c0f\u6216\u7ef4\u6301\u7a33\u5b9a\uff0c\u663e\u793a\u51fa\u660e\u786e\u7684\u4e34\u5e8a\u83b7\u76ca\u3002<\/p>\n\n\n\n<p><strong>\u5b89\u5168\u6027\u6570\u636e<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u572822\u4f8b\u80c6\u7ba1\u764c\u60a3\u8005\u4e2d\uff0czenocutuzumab-zbco<strong>\u5b89\u5168\u6027\u826f\u597d<\/strong>\uff0c\u4e0d\u826f\u53cd\u5e94\u591a\u4e3a1-2\u7ea7\uff0c\u53ef\u63a7\u53ef\u9006\uff1a<\/p>\n\n\n\n<p>\u2022 \u5e38\u89c1\u4e0d\u826f\u53cd\u5e94\uff08\u53d1\u751f\u7387\u226510%\uff09\uff1a\u8179\u6cfb\uff0827%\uff09\u3001\u808c\u8089\u9aa8\u9abc\u75bc\u75db\uff0823%\uff09\u3001\u75b2\u52b3\uff0823%\uff09\u3001\u6076\u5fc3\uff0818%\uff09\u3001\u8f93\u6db2\u76f8\u5173\u53cd\u5e94\uff0814%\uff09\u3002<\/p>\n\n\n\n<p>\u2022 \u65e0\u65b0\u7684\u5b89\u5168\u6027\u4fe1\u53f7\uff0c\u672a\u53d1\u751f\u6cbb\u7597\u76f8\u5173\u6b7b\u4ea1\u4e8b\u4ef6\uff0c\u5b89\u5168\u6027\u7279\u5f81\u4e0e\u6b64\u524d NSCLC\u3001\u80f0\u817a\u764c\u961f\u5217\u4e00\u81f4\u3002<\/p>\n\n\n\n<p><strong>4. <\/strong><strong>\u4e34\u5e8a\u610f\u4e49\uff1a\u7f55\u89c1\u4e9a\u578b\u7cbe\u51c6\u6cbb\u7597\u7684\u91cc\u7a0b\u7891<\/strong><strong><\/strong><\/p>\n\n\n\n<p>FDA\u672c\u6b21\u6279\u51c6 zenocutuzumab-zbco \u7528\u4e8eNRG1\u878d\u5408\u9633\u6027\u665a\u671f\u80c6\u7ba1\u764c\uff0c\u5177\u6709<strong>\u4e09\u91cd\u4e34\u5e8a\u91cc\u7a0b\u7891\u610f\u4e49<\/strong>\uff1a<\/p>\n\n\n\n<p><strong>1. \u586b\u8865\u6cbb\u7597\u7a7a\u767d\uff1a<\/strong>\u7ec8\u7ed3 NRG1 \u878d\u5408\u9633\u6027\u80c6\u7ba1\u764c \u201c\u65e0\u9776\u5411\u836f\u53ef\u7528\u201d \u7684\u5386\u53f2\uff0c\u4e3a\u8fd9\u4e00\u8d85\u7f55\u89c1\u4e9a\u578b\u63d0\u4f9b\u9996\u4e2a\u7cbe\u51c6\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n\n\n\n<p><strong>2. 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