{"id":41357,"date":"2026-08-12T19:11:32","date_gmt":"2026-08-12T11:11:32","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=41357"},"modified":"2026-08-12T19:11:42","modified_gmt":"2026-08-12T11:11:42","slug":"ros1%e8%82%ba%e7%99%8c%e5%90%8e%e7%ba%bf%e6%b2%bb%e7%96%97%e6%96%b0%e9%80%89%e6%8b%a9%ef%bc%81fda%e8%8e%b7%e6%89%b9%e5%85%a8%e6%96%b0%e9%9d%b6%e5%90%91%e8%8d%afzidesamtinib","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/ros1%e8%82%ba%e7%99%8c%e5%90%8e%e7%ba%bf%e6%b2%bb%e7%96%97%e6%96%b0%e9%80%89%e6%8b%a9%ef%bc%81fda%e8%8e%b7%e6%89%b9%e5%85%a8%e6%96%b0%e9%9d%b6%e5%90%91%e8%8d%afzidesamtinib\/","title":{"rendered":"ROS1\u80ba\u764c\u540e\u7ebf\u6cbb\u7597\u65b0\u9009\u62e9\uff01FDA\u83b7\u6279\u5168\u65b0\u9776\u5411\u836fZidesamtinib"},"content":{"rendered":"\n<p>2026\u5e747\u6708\u4e0b\u65ec\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6\u65b0\u4e00\u4ee3\u53e3\u670dROS1\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242<strong>Zidesamtinib<\/strong>\u4e0a\u5e02\uff0c\u4e3a\u7ecf\u8fc7\u81f3\u5c11\u4e00\u8f6eROS1\u9776\u5411\u6291\u5236\u5242\u6cbb\u7597\u4e4b\u540e\u8fdb\u5c55\u7684\u665a\u671f\u80ba\u764c\u60a3\u8005\uff0c\u65b0\u589e\u91cd\u8981\u7684\u540e\u7ebf\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n\n\n\n<p>\u672c\u6b21\u5ba1\u6279\u4f9d\u6258FDA\u5b9e\u65f6\u80bf\u7624\u5ba1\u8bc4\uff08RTOR\uff09\u8bd5\u70b9\u7a0b\u5e8f\u53ca\u8bc4\u4f30\u8f85\u52a9\u673a\u5236\u5b8c\u6210\uff0c\u6574\u4f53\u5ba1\u6279\u6d41\u7a0b\u9ad8\u6548\u63a8\u8fdb\uff0c\u6700\u7ec8\u83b7\u6279\u65f6\u95f4\u8f83\u539f\u5b9a\u76ee\u6807\u65e5\u671f\u63d0\u524d\u4e24\u4e2a\u6708\u3002\u540c\u65f6\uff0c\u8be5\u836f\u7269\u5df2\u83b7\u5f97FDA\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u5145\u5206\u4f53\u73b0\u4e86\u5176\u9488\u5bf9\u5c0f\u4f17\u96be\u6cbb\u6027\u80ba\u764c\u7684\u4e34\u5e8a\u4ef7\u503c\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"692\" height=\"385\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2.jpg\" alt=\"\" class=\"wp-image-41378 lazyload\" data-srcset=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2.jpg 692w, https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2-300x167.jpg 300w\" sizes=\"(max-width: 692px) 100vw, 692px\" \/><noscript><img decoding=\"async\" width=\"692\" height=\"385\" src=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2.jpg\" alt=\"\" class=\"wp-image-41378 lazyload\" srcset=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2.jpg 692w, https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2-300x167.jpg 300w\" sizes=\"(max-width: 692px) 100vw, 692px\" \/><\/noscript><figcaption class=\"wp-element-caption\">\u56fe\u6e90\uff1aFDA<\/figcaption><\/figure>\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\u53ef\u901a\u8fc7 <a class=\"whatsapp-link\" href=\"https:\/\/wa.me\/85268591419\" target=\"_blank\" rel=\"noopener noreferrer\"><i class=\"fab fa-whatsapp\"><\/i> <b>WhatsApp\u8054\u7edc\u6211\u4eec<\/b><\/a><\/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>\u4e00\u3001\u836f\u7269\u57fa\u7840\u4fe1\u606f<\/strong><strong><\/strong><\/p>\n\n\n\n<p><strong>1. \u901a\u7528\u540d\u79f0\uff1a<\/strong>zidesamtinib<\/p>\n\n\n\n<p><strong>2. \u836f\u7269\u5206\u7c7b\uff1a<\/strong>\u9ad8\u9009\u62e9\u6027 ROS1 \u5c0f\u5206\u5b50\u53e3\u670d\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242<\/p>\n\n\n\n<p><strong>3. \u836f\u7269\u5206\u5b50\u8bbe\u8ba1\u4e3b\u6253\u4e09\u5927\u65b9\u5411<\/strong>\uff1a\u9ad8\u9009\u62e9\u6027\u6291\u5236 ROS1 \u9776\u70b9\u3001\u8986\u76d6\u591a\u79cd ROS1 \u8010\u836f\u7a81\u53d8\u3001\u5177\u5907\u8840\u8111\u5c4f\u969c\u7a7f\u900f\u80fd\u529b\uff0c\u9488\u5bf9<strong>ROS1\u2011\u9633\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c<\/strong>\u4e34\u5e8a\u5e38\u89c1\u7684\u9776\u5411\u8010\u836f\u3001\u8111\u90e8\u8f6c\u79fb\u8fdb\u5c55\u4e24\u5927\u96be\u9898\u5f00\u53d1\u3002<\/p>\n\n\n\n<p><strong>\u4e8c\u3001\u83b7\u6279\u9002\u5e94\u75c7<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u9002\u7528\u4e8e\u6210\u5e74\u5c40\u90e8\u665a\u671f\u6216\u8005\u8f6c\u79fb\u6027<strong>ROS1\u57fa\u56e0\u878d\u5408\u9633\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c<\/strong>\u60a3\u8005\u3002<\/p>\n\n\n\n<p>\u9002\u7528\u6838\u5fc3\u524d\u63d0\uff1a\u60a3\u8005\u65e2\u5f80\u5df2\u7ecf\u63a5\u53d7\u8fc7\u81f3\u5c111\u79cdROS1\u2011TKI\u9776\u5411\u836f\u7269\u6cbb\u7597\uff0c\u4e14\u51fa\u73b0\u75be\u75c5\u8fdb\u5c55\u3002\u9002\u7528\u4eba\u7fa4\u8986\u76d6\u52b3\u62c9\u66ff\u5c3c\u3001\u745e\u6ce2\u66ff\u5c3c\u3001\u4ed6\u96f7\u66ff\u5c3c\u7b49\u4e3b\u6d41ROS1\u6291\u5236\u5242\u8010\u836f\u540e\u7684\u60a3\u8005\u7fa4\u4f53\u3002<\/p>\n\n\n\n<p><strong>\u4e09\u3001\u6838\u5fc3\u652f\u6491\u4e34\u5e8a\u8bd5\u9a8c\uff1aARROS\u20111\uff08NCT05118789\uff09<\/strong><strong><\/strong><\/p>\n\n\n\n<p><strong>\u8bd5\u9a8c\u6982\u51b5<\/strong><strong><\/strong><\/p>\n\n\n\n<p>\u8be5\u7814\u7a76\u4e3a\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u3001\u5355\u81c2\u3001\u591a\u7ec4\u522b\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u6240\u6709\u5165\u7ec4\u53d7\u8bd5\u8005\u5747\u4e3a\u65e2\u5f80ROS1\u9776\u5411\u836f\u6cbb\u7597\u5931\u8d25\u7684\u665a\u671f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u3002\u672c\u6b21\u7597\u6548\u8bc4\u4f30\u5171\u7eb3\u5165117\u4f8b\u6709\u6548\u53d7\u8bd5\u8005\uff0c\u5206\u4e3a\u4e24\u4e2a\u7ec4\u522b\uff1a<\/p>\n\n\n\n<p><strong>&#8211; \u5206\u7ec41\uff0859\u4eba\uff09\uff1a<\/strong>\u4ec5\u63a5\u53d7\u8fc7\u4e00\u7ebfROS1\u9776\u5411\u6291\u5236\u5242\u6cbb\u7597<\/p>\n\n\n\n<p><strong>&#8211; \u5206\u7ec42\uff0858\u4eba\uff09\uff1a<\/strong>\u63a5\u53d7\u8fc7\u4e8c\u7ebf\u53ca\u4ee5\u4e0aROS1\u2011TKI\u6cbb\u7597\uff0c\u4e3a\u91cd\u5ea6\u7ecf\u6cbb\u3001\u591a\u7ebf\u8010\u836f\u60a3\u8005<\/p>\n\n\n\n<p>\u8bd5\u9a8c\u7597\u6548\u7ec8\u70b9\u7531\u76f2\u6cd5\u72ec\u7acb\u4e2d\u5fc3\u8bc4\u5ba1\uff08BICR\uff09\u4f9d\u636eRECIST v1.1\u80bf\u7624\u8bc4\u4ef7\u6807\u51c6\u7edf\u4e00\u5224\u5b9a\uff0c\u6570\u636e\u5ba2\u89c2\u4e25\u8c28\u3002<\/p>\n\n\n\n<p><strong>\u6838\u5fc3\u4e34\u5e8a\u7597\u6548\u6570\u636e<\/strong><strong><\/strong><\/p>\n\n\n\n<p><strong>1. \u5168\u90e8\u53ef\u8bc4\u4f30\u4eba\u7fa4\uff1a<\/strong>\u5ba2\u89c2\u7f13\u89e3\u7387ORR\u4e3a<strong>44%<\/strong>\uff0895%CI\uff1a34%\u201153%\uff09<\/p>\n\n\n\n<p><strong>2. \u80bf\u7624\u7f13\u89e3\u60a3\u8005\u957f\u671f\u83b7\u76ca\uff1a82%<\/strong>\u60a3\u8005\u7f13\u89e3\u65f6\u957f\u22656\u4e2a\u6708\uff0c<strong>69%<\/strong>\u60a3\u8005\u7f13\u89e3\u65f6\u957f\u226512\u4e2a\u6708\uff0c\u5177\u5907\u6301\u7eed\u6297\u80bf\u7624\u6d3b\u6027<\/p>\n\n\n\n<p><strong>3. \u4e9a\u7ec4\u5206\u5c42\u7597\u6548\uff1a<\/strong>\u4ec5\u4e00\u7ebf\u9776\u5411\u836f\u8010\u836f\u4eba\u7fa4ORR\u4e3a49%\uff1b\u4e8c\u7ebf\u53ca\u4ee5\u4e0a\u591a\u7ebf\u8010\u836f\u4eba\u7fa4ORR\u4e3a38%<\/p>\n\n\n\n<p><strong>4.<\/strong><strong>\u9488\u5bf9\u8111\u8f6c\u79fb\u4eba\u7fa4\uff1a<\/strong>\u57fa\u7ebf\u5b58\u5728\u53ef\u6d4b\u91cf\u8111\u8f6c\u79fb\u7684\u53d7\u8bd5\u8005\uff0c\u9885\u5185\u75c5\u7076\u5ba2\u89c2\u7f13\u89e3\u7387\u53ef\u89c2\uff0c\u53ef\u6709\u6548\u7ba1\u63a7\u8111\u90e8\u8f6c\u79fb\u75c5\u7076\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"692\" height=\"284\" src=\"data:image\/gif;base64,R0lGODlhAQABAIAAAAAAAP\/\/\/yH5BAEAAAAALAAAAAABAAEAAAIBRAA7\" data-src=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2.png\" alt=\"\" class=\"wp-image-41384 lazyload\" data-srcset=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2.png 692w, https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2-300x123.png 300w\" sizes=\"(max-width: 692px) 100vw, 692px\" \/><noscript><img decoding=\"async\" width=\"692\" height=\"284\" src=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2.png\" alt=\"\" class=\"wp-image-41384 lazyload\" srcset=\"https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2.png 692w, https:\/\/www.hkioc.com.hk\/wp-content\/uploads\/2026\/08\/image-2-300x123.png 300w\" sizes=\"(max-width: 692px) 100vw, 692px\" \/><\/noscript><figcaption class=\"wp-element-caption\">\u56fe\u6e90\uff1a\u836f\u5382\u83b7\u6279\u65b0\u95fb<\/figcaption><\/figure>\n\n\n\n<p><strong>\u56db\u3001\u6807\u51c6\u7ed9\u836f\u65b9\u6848<\/strong><strong><\/strong><\/p>\n\n\n\n<p><strong>1. \u63a8\u8350\u5242\u91cf\uff1a100mg<\/strong>\uff0c\u6bcf\u65e5\u4e00\u6b21\u53e3\u670d<\/p>\n\n\n\n<p><strong>2. \u670d\u7528\u65b9\u5f0f\uff1a<\/strong>\u7a7a\u8179\u3001\u9910\u540e\u5747\u53ef\u670d\u7528\uff0c\u65e0\u4e25\u683c\u8fdb\u98df\u9650\u5236<\/p>\n\n\n\n<p><strong>3. 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