{"id":39408,"date":"2026-04-02T14:17:52","date_gmt":"2026-04-02T06:17:52","guid":{"rendered":"https:\/\/www.hkioc.com.hk\/?p=39408"},"modified":"2026-04-02T14:18:35","modified_gmt":"2026-04-02T06:18:35","slug":"%e9%87%8d%e7%a3%85%ef%bd%9cfda%e6%9c%80%e6%96%b0%e6%89%b9%e5%87%86%ef%bc%81%e5%85%a8%e7%90%83%e9%a6%96%e6%ac%besgra%e7%96%97%e6%b3%95%e8%90%bd%e5%9c%b0%ef%bc%8c%e9%93%82%e8%80%90%e8%8d%af%e5%8d%b5","status":"publish","type":"post","link":"https:\/\/www.hkioc.com.hk\/zh-hans\/%e9%87%8d%e7%a3%85%ef%bd%9cfda%e6%9c%80%e6%96%b0%e6%89%b9%e5%87%86%ef%bc%81%e5%85%a8%e7%90%83%e9%a6%96%e6%ac%besgra%e7%96%97%e6%b3%95%e8%90%bd%e5%9c%b0%ef%bc%8c%e9%93%82%e8%80%90%e8%8d%af%e5%8d%b5\/","title":{"rendered":"\u91cd\u78c5\uff5cFDA\u6700\u65b0\u6279\u51c6\uff01\u5168\u7403\u9996\u6b3eSGRA\u7597\u6cd5\u843d\u5730\uff0c\u94c2\u8010\u836f\u5375\u5de2\u764c\u8fce\u6765\u751f\u5b58\u65b0\u7a81\u7834"},"content":{"rendered":"\n

2026\u5e743\u670825\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6b63\u5f0f\u6279\u51c6Corcept Therapeutics\u516c\u53f8\u7814\u53d1\u7684Relacorilant <\/strong>\u8054\u5408\u767d\u86cb\u767d\u7d2b\u6749\u9187\uff08nab-paclitaxel\uff09\uff0c\u7528\u4e8e\u6cbb\u7597\u65e2\u5f80\u63a5\u53d7\u8fc7 1-3 \u7ebf\u542b\u8d1d\u4f10\u73e0\u5355\u6297\u7cfb\u7edf\u6cbb\u7597\u7684\u94c2\u8010\u836f\u5375\u5de2\u764c\u6210\u4eba\u60a3\u8005\u3002<\/p>\n\n\n\n

\u8fd9\u4e00\u6279\u51c6\u4e0d\u4ec5\u6807\u5fd7\u7740\u5168\u7403\u9996\u6b3e\u9009\u62e9\u6027\u7cd6\u76ae\u8d28\u6fc0\u7d20\u53d7\u4f53\u62ee\u6297\u5242\uff08SGRA\uff09 <\/strong>\u6b63\u5f0f\u83b7\u6279\u7528\u4e8e\u80bf\u7624\u6cbb\u7597\uff0c\u66f4\u57fa\u4e8e\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\u7684\u9633\u6027\u7ed3\u679c\uff0c\u4e3a\u4e34\u5e8a\u96be\u6cbb\u7684\u94c2\u8010\u836f\u5375\u5de2\u764c\u60a3\u8005\u5e26\u6765\u4e86\u7ecf\u8bc1\u5b9e\u7684\u751f\u5b58\u83b7\u76ca\uff0c\u6210\u4e3a\u8be5\u7c7b\u60a3\u8005\u7684\u5168\u65b0\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n\n\n\n

***\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\u201c \u6307\u5b9a\u836f\u7269\u4f7f\u7528\u8ba1\u5212<\/strong> \u201d\u7533\u8bf7\u76f8\u5173\u6cbb\u7597\u65b9\u6848\u3002<\/p>\n\n\n\n

* 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

    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

\u00a0\u00a0\u00a0\u00a02. \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

1. <\/strong>\u83b7\u6279\u4f9d\u636e\uff1a381\u4f8b\u591a\u4e2d\u5fc3\u8bd5\u9a8c<\/strong><\/strong><\/p>\n\n\n\n

\u6b64\u6b21Relacorilant\u7684\u83b7\u6279\uff0c\u57fa\u4e8e\u5173\u952e\u6027ROSELLA \u4e34\u5e8a\u8bd5\u9a8c<\/strong>\u7684\u5b8c\u6574\u9633\u6027\u6570\u636e\uff0c\u8be5\u8bd5\u9a8c\u4e3a\u5168\u7403\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u5bf9\u7167\u7814\u7a76\uff0c\u5728\u7f8e\u3001\u6b27\u3001\u97e9\u3001\u6fb3\u7b49\u591a\u4e2a\u56fd\u5bb6\u548c\u5730\u533a\u7eb3\u5165381\u4f8b<\/strong>\u94c2\u8010\u836f\u5375\u5de2\u764c\u60a3\u8005\uff0c\u4e14\u65e0\u751f\u7269\u6807\u5fd7\u7269\u7b5b\u9009\u8981\u6c42\uff0c\u60a3\u8005\u6309 1:1 \u968f\u673a\u5206\u4e3a\u8054\u5408\u6cbb\u7597\u7ec4\uff08Relacorilant + \u767d\u86cb\u767d\u7d2b\u6749\u9187\uff09\u548c\u5355\u836f\u6cbb\u7597\u7ec4\uff08\u767d\u86cb\u767d\u7d2b\u6749\u9187\uff09\uff0c\u5165\u7ec4\u60a3\u8005\u5747\u63a5\u53d7\u8fc7 1-3 \u7ebf\u6cbb\u7597\u4e14\u81f3\u5c11 1 \u7ebf\u542b\u8d1d\u4f10\u73e0\u5355\u6297\uff0c\u8d34\u5408\u4e34\u5e8a\u771f\u5b9e\u6cbb\u7597\u573a\u666f\u3002<\/p>\n\n\n\n

\u8bd5\u9a8c\u9884\u8bbe\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09<\/strong>\u548c\u603b\u751f\u5b58\u671f\uff08OS\uff09<\/strong>\u53cc\u4e3b\u8981\u7ec8\u70b9\u5747\u5b9e\u73b0\u7edf\u8ba1\u5b66\u663e\u8457\u83b7\u76ca\uff0c\u5b98\u65b9\u6838\u5fc3\u6570\u636e\u5982\u4e0b\uff1a<\/p>\n\n\n\n

\u00b7<\/strong> \u603b\u751f\u5b58\u671f\u663e\u8457\u5ef6\u957f<\/strong>\uff1a\u8054\u5408\u6cbb\u7597\u7ec4\u4e2d\u4f4d OS \u8fbe16.0\u4e2a\u6708\uff0c\u5355\u836f\u7ec4\u4e3a 11.9\u4e2a\u6708\uff0c\u7edd\u5bf9\u5ef6\u957f4.1\u4e2a\u6708\uff0c\u60a3\u8005\u6b7b\u4ea1\u98ce\u9669\u964d\u4f4e 35%\uff08HR=0.65\uff0cP=0.0004\uff09\uff1b<\/p>\n\n\n\n

\u00b7 <\/strong>\u75be\u75c5\u8fdb\u5c55\u98ce\u9669\u964d\u4f4e<\/strong>\uff1a\u7ecf\u76f2\u6001\u72ec\u7acb\u4e2d\u5fc3\u8bc4\u4f30\uff08PFS-BICR\uff09\uff0c\u8054\u5408\u6cbb\u7597\u7ec4\u75be\u75c5\u8fdb\u5c55\u98ce\u9669\u964d\u4f4e30%\uff08HR=0.70\uff0cP=0.008\uff09\uff1b<\/p>\n\n\n\n

\u00b7 <\/strong>\u9002\u7528\u4eba\u7fa4\u5e7f\u6cdb<\/strong>\uff1a\u65e0\u751f\u7269\u6807\u5fd7\u7269\u9650\u5236\uff0c\u65e0\u8bba\u60a3\u8005\u662f\u5426\u63a5\u53d7\u8fc7 PARP \u6291\u5236\u5242\u7b49\u5176\u4ed6\u6cbb\u7597\uff0c\u5747\u53ef\u4ece\u4e2d\u83b7\u76ca\uff0c\u8986\u76d6\u66f4\u591a\u4e34\u5e8a\u96be\u6cbb\u60a3\u8005\u3002<\/p>\n\n\n\n

\u8be5\u8bd5\u9a8c\u6570\u636e\u6b64\u524d\u5df2\u57282025\u5e74\u7f8e\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff08ASCO\uff09\u5e74\u4f1a\u516c\u5e03\uff0c\u5e76\u540c\u6b65\u53d1\u8868\u4e8e\u300a\u67f3\u53f6\u5200\u300b\uff08The Lancet\uff09\uff0c\u5b8c\u6574\u7ed3\u679c\u5c06\u4e8e2026\u5e744\u6708\u5987\u79d1\u80bf\u7624\u5b66\u4f1a\uff08SGO\uff09\u5e74\u4f1a\u8fdb\u4e00\u6b65\u62ab\u9732\u3002<\/p>\n\n\n\n

2. <\/strong>\u4f5c\u7528\u673a\u5236\uff1a\u76f4\u51fb\u5316\u7597\u8010\u836f\u5173\u952e<\/strong><\/strong><\/p>\n\n\n\n

Relacorilant\u7684\u83b7\u6279\uff0c\u586b\u8865\u4e86\u5375\u5de2\u764c\u76ae\u8d28\u9187 – \u7cd6\u76ae\u8d28\u6fc0\u7d20\u53d7\u4f53\uff08GR\uff09\u901a\u8def<\/strong>\u9776\u5411\u6cbb\u7597\u7684\u7a7a\u767d\uff0c\u5176\u4f5c\u7528\u673a\u5236\u7ecf\u4e34\u5e8a\u8bc1\u5b9e\u53ef\u76f4\u63a5\u9006\u8f6c\u80bf\u7624\u5316\u7597\u8010\u836f\uff0c\u4e14\u5177\u6709\u9ad8\u5ea6\u9009\u62e9\u6027\uff1a<\/p>\n\n\n\n

    1. \u963b\u65ad\u80bf\u7624\u4fdd\u62a4\u673a\u5236\uff1a<\/strong>\u76ae\u8d28\u9187\u4f1a\u901a\u8fc7\u7ed3\u5408GR\u6291\u5236\u80bf\u7624\u7ec6\u80de\u51cb\u4ea1\u3001\u4fc3\u8fdb\u80bf\u7624\u751f\u957f\u5e76\u6291\u5236\u673a\u4f53\u514d\u75ab\uff0c\u6210\u4e3a\u80bf\u7624 \u201c\u62b5\u6297\u5316\u7597\u201d \u7684\u4fdd\u62a4\u4f1e\uff1b<\/p>\n\n\n\n

    2. \u6062\u590d\u5316\u7597\u654f\u611f\u6027\uff1a<\/strong>Relacorilant\u53ef\u7ade\u4e89\u6027\u7ed3\u5408GR\uff0c\u7279\u5f02\u6027\u963b\u65ad\u76ae\u8d28\u9187\u7684\u4e0a\u8ff0\u4f5c\u7528\uff0c\u91cd\u65b0\u6fc0\u6d3b\u5316\u7597\u7684\u80bf\u7624\u6740\u4f24\u6548\u5e94\uff1b<\/p>\n\n\n\n

    3. \u9ad8\u9009\u62e9\u6027\u66f4\u5b89\u5168\uff1a<\/strong>\u4ec5\u4f5c\u7528\u4e8e\u7cd6\u76ae\u8d28\u6fc0\u7d20\u53d7\u4f53\uff0c\u5bf9\u4eba\u4f53\u5176\u4ed6\u7c7b\u56fa\u9187\u53d7\u4f53\u65e0\u5f71\u54cd\uff0c\u5927\u5e45\u964d\u4f4e\u8131\u9776\u526f\u4f5c\u7528\uff1b<\/p>\n\n\n\n

    4. \u670d\u7528\u4fbf\u6377\uff1a<\/strong>\u53e3\u670d\u5236\u5242\uff0c\u4ec5\u9700\u5728\u767d\u86cb\u767d\u7d2b\u6749\u9187\u6cbb\u7597\u7684\u524d1\u5929\u3001\u5f53\u5929\u3001\u540e1\u5929\u670d\u7528\uff0c\u63d0\u5347\u60a3\u8005\u6cbb\u7597\u4f9d\u4ece\u6027\u3002<\/p>\n\n\n\n

\u8fd9\u4e00\u673a\u5236\u4e5f\u9a8c\u8bc1\u4e86 \u201c\u76ae\u8d28\u9187\u8c03\u5236\u201d \u5728\u80bf\u7624\u6cbb\u7597\u4e2d\u7684\u4e34\u5e8a\u4ef7\u503c\uff0c\u4e3a\u540e\u7eed\u5176\u4ed6\u764c\u79cd\u7684\u7814\u7a76\u5960\u5b9a\u4e86\u57fa\u7840\u3002<\/p>\n\n\n\n

3. <\/strong>\u5b89\u5168\u6027\uff1a\u8054\u5408\u7597\u6cd5\u8010\u53d7\u6027\u826f\u597d<\/strong><\/strong><\/p>\n\n\n\n

\u6839\u636eROSELLA\u8bd5\u9a8c\u53ca2\u671f\u8bd5\u9a8c\u7684\u5408\u5e76\u5b89\u5168\u6027\u5206\u6790\uff0cRelacorilant\u8054\u5408\u767d\u86cb\u767d\u7d2b\u6749\u9187\u7684\u6574\u4f53\u5b89\u5168\u6027\u53ef\u63a7\uff0c\u65e0\u65b0\u7684\u5b89\u5168\u6027\u4fe1\u53f7\u51fa\u73b0<\/strong>\uff0c\u5b98\u65b9\u516c\u5e03\u7684\u6838\u5fc3\u5b89\u5168\u6570\u636e\u5982\u4e0b\uff1a<\/p>\n\n\n\n

    1. \u5e38\u89c1\u4e0d\u826f\u53cd\u5e94\uff1a<\/strong>\u53d1\u751f\u7387\uff1e20% \u7684\u4e0d\u826f\u53cd\u5e94\uff08\u542b\u5b9e\u9a8c\u5ba4\u5f02\u5e38\uff09\u4e3a\u8840\u7ea2\u86cb\u767d\u964d\u4f4e\u3001\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u3001\u75b2\u52b3\u3001\u6076\u5fc3\u3001\u8179\u6cfb\u3001\u8840\u5c0f\u677f\u964d\u4f4e\u3001\u76ae\u75b9\u3001\u98df\u6b32\u51cf\u9000\uff0c\u5747\u4e3a\u80bf\u7624\u5316\u7597\u4e2d\u5e38\u89c1\u7684\u53ef\u63a7\u53cd\u5e94\uff1b<\/p>\n\n\n\n

    2. \u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\uff1a<\/strong>35% \u7684\u60a3\u8005\u51fa\u73b0\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\uff0c\u22652% \u7684\u4e3a\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\uff084%\uff09\u3001\u80ba\u708e\uff083.2%\uff09\u3001\u80f8\u8154\u79ef\u6db2\uff083.2%\uff09\u3001\u53d1\u70ed\u6027\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\uff082.1%\uff09\uff0c\u53ef\u901a\u8fc7\u4e34\u5e8a\u5bf9\u75c7\u5904\u7406\u7ba1\u7406\uff1b<\/p>\n\n\n\n

    3. \u6cbb\u7597\u4e2d\u65ad\u7387\u4f4e\uff1a<\/strong>\u56e0\u4e0d\u826f\u53cd\u5e94\u6c38\u4e45\u505c\u836f\u7684\u6bd4\u4f8b\u4ec5\u4e3a9%\uff0c\u4ec5 2.6% \u7684\u60a3\u8005\u56e0\u80a0\u6897\u963b\u505c\u836f\uff0c\u5927\u90e8\u5206\u60a3\u8005\u53ef\u5b8c\u6210\u5168\u7a0b\u6cbb\u7597\uff1b<\/p>\n\n\n\n

    4. \u7279\u6b8a\u4eba\u7fa4\u63d0\u793a\uff1a<\/strong>\u226565 \u5c81\u8001\u5e74\u60a3\u8005 3-4 \u7ea7\u4e0d\u826f\u53cd\u5e94\u53d1\u751f\u7387\u7565\u9ad8\uff0c\u9700\u914c\u60c5\u8c03\u6574\u5242\u91cf\uff1b\u4e2d\u91cd\u5ea6\u809d\u529f\u80fd\u4e0d\u5168\u60a3\u8005\uff08\u603b\u80c6\u7ea2\u7d20\uff1e1.5-10\u00d7ULN\uff09\u4e0d\u5efa\u8bae\u4f7f\u7528\u3002<\/p>\n\n\n\n

\u540c\u65f6\uff0cFDA\u5728\u836f\u54c1\u8bf4\u660e\u4e66\u4e2d\u660e\u786e\u4e86\u4e2d\u6027\u7c92\u7ec6\u80de\u51cf\u5c11\u3001\u80be\u4e0a\u817a\u529f\u80fd\u4e0d\u5168\u3001\u80da\u80ce – \u80ce\u513f\u6bd2\u6027\u7b49\u8b66\u793a\u4e8b\u9879\uff0c\u4e34\u5e8a\u4f7f\u7528\u65f6\u9700\u4e25\u683c\u9075\u5faa\u76d1\u6d4b\u89c4\u8303\u3002<\/p>\n\n\n\n

\u7ed3\u8bed<\/strong><\/strong><\/p>\n\n\n\n

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