{"id":756556,"date":"2026-03-27T19:26:52","date_gmt":"2026-03-27T11:26:52","guid":{"rendered":"https:\/\/www.alphaseek.cn\/?p=756556"},"modified":"2026-03-27T19:26:52","modified_gmt":"2026-03-27T11:26:52","slug":"%e5%9f%ba%e5%9b%a0%e7%96%97%e6%b3%95%e5%a4%a7%e9%80%80%e6%bd%ae%ef%bc%9a%e4%bb%8e320%e4%b8%87%e7%be%8e%e5%85%83%e4%b8%80%e9%92%88%e5%88%b0%e9%bb%91%e6%a1%86%e8%ad%a6%e5%91%8a%ef%bc%8c%e5%8d%83","status":"publish","type":"post","link":"https:\/\/www.alphaseek.cn\/?p=756556","title":{"rendered":"\u57fa\u56e0\u7597\u6cd5\u5927\u9000\u6f6e\uff1a\u4ece320\u4e07\u7f8e\u5143\u4e00\u9488\u5230\u9ed1\u6846\u8b66\u544a\uff0c\u5343\u4ebf\u8d5b\u9053\u4e3a\u4f55\u7a81\u7136\u201c\u5931\u901f\u201d"},"content":{"rendered":"
\n

\u6587 | GPLP\uff0c\u4f5c\u8005 | \u8001\u841d\u535c\u5934<\/p>\n<\/blockquote>\n

\u8fd9\u4e0d\u662f\u7b80\u5355\u7684\u884c\u4e1a\u8c03\u6574\uff0c\u800c\u662f\u4e00\u573a\u4ece\u6280\u672f\u3001\u5546\u4e1a\u3001\u76d1\u7ba1\u5230\u652f\u4ed8\u4f53\u7cfb\u7684\u591a\u91cd\u7ede\u6740\u3002<\/strong><\/em><\/p>\n

2026\u5e742\u6708\uff0c\u5168\u7403\u751f\u7269\u533b\u836f<\/a>\u5708\u63a5\u8fde\u843d\u4e0b\u4e24\u8bb0\u91cd\u9524\u3002\u6ca1\u6709\u9884\u5146\uff0c\u6ca1\u6709\u7f13\u51b2\u3002<\/p>\n

\u5148\u662fBioMarin\u5ba3\u5e03\u5c06\u65d7\u4e0bA\u578b\u8840\u53cb\u75c5\u57fa\u56e0\u7597\u6cd5Roctavian\u64a4\u51fa\u5168\u7403\u5e02\u573a\uff1b\u7d27\u63a5\u7740\uff0c\u57fa\u56e0\u7597\u6cd5\u660e\u661f\u516c\u53f8Sarepta\u7684\u9996\u5e2d\u6267\u884c\u5b98Doug Ingram\u5ba3\u5e03\u8f9e\u804c\uff0c\u8fd9\u4f4d\u6267\u638c\u516c\u53f8\u8fd1\u5341\u5e74\u7684\u638c\u8235\u4eba\u7a81\u7136\u79bb\u573a\u3002<\/p>\n

\u4e00\u4e2a\u662f\u66fe\u7ecf\u6807\u4ef7320\u4e07\u7f8e\u5143\u3001\u88ab\u89c6\u4e3a“\u4e00\u6b21\u6027\u6cbb\u6108”\u6807\u6746\u7684\u660e\u661f\u4ea7\u54c1\uff0c\u6700\u7ec8\u56e0\u627e\u4e0d\u5230\u4e70\u5bb6\u3001\u5546\u4e1a\u5316\u5f7b\u5e95\u5d29\u76d8\u800c\u9000\u5e02\uff1b\u4e00\u4e2a\u662f\u9876\u7740FDA\u9ed1\u6846\u8b66\u544a\u3001\u6df1\u9677\u5b89\u5168\u4e89\u8bae\u3001\u80a1\u4ef7\u4e00\u5e74\u66b4\u8dcc\u8d85\u516b\u6210\u7684\u8d5b\u9053\u9f99\u5934\uff0c\u8d70\u5230\u4e86\u6362\u5e05\u6c42\u751f\u7684\u5173\u53e3\u3002<\/p>\n

\u4e24\u4ef6\u4e8b\u524d\u540e\u811a\u53d1\u751f\uff0c\u5e76\u4e0d\u662f\u5de7\u5408\u3002<\/p>\n

\u8fc7\u53bb\u51e0\u5e74\uff0c\u57fa\u56e0\u7597\u6cd5\u88ab\u5305\u88c5\u6210\u4e0b\u4e00\u4ee3\u533b\u836f\u9769\u547d\u3001\u7f55\u89c1\u75c5\u7ec8\u6781\u89e3\u836f\u3001\u8d44\u672c\u5e02\u573a\u6700\u6027\u611f\u7684\u6545\u4e8b\u3002\u4e00\u9488\u51e0\u767e\u4e07\u3001\u4e00\u6b21\u6cbb\u7597\u7ec8\u8eab\u53d7\u76ca\uff0c\u542c\u4e0a\u53bb\u8db3\u591f\u98a0\u8986\u3002\u8ba9\u51e0\u4e4e\u6240\u6709\u5927\u836f\u4f01\u90fd\u75af\u72c2\u5e03\u5c40\uff0c\u6536\u8d2d<\/a>\u3001\u5408\u4f5c\u3001\u878d\u8d44<\/a>\u5c42\u51fa\u4e0d\u7a77\uff0cbiotech\u516c\u53f8\u66f4\u662f\u5982\u96e8\u540e\u6625\u7b0b\u822c\u6d8c\u73b0\u3002<\/p>\n

\u53ef\u73b0\u5b9e\u662f\uff0c\u5927\u91cf\u4ea7\u54c1\u5361\u5728\u4e34\u5e8a\u3001\u5012\u5728\u5546\u4e1a\u5316\u3001\u683d\u5728\u76d1\u7ba1\u4e0e\u652f\u4ed8\u624b\u91cc\u3002\u8fd9\u4e2a\u66fe\u7ecf\u88ab\u9884\u4f30\u5343\u4ebf\u7f8e\u91d1\u7684\u9ec4\u91d1<\/a>\u8d5b\u9053\uff0c\u6b63\u5728\u96c6\u4f53\u5931\u901f……<\/p>\n

01 \u4e24\u6b3e\u660e\u661f\u4ea7\u54c1\u7684“\u6b7b\u4ea1\u65e5\u8bb0”<\/strong><\/h2>\n

Roctavian\u7684\u6545\u4e8b\u662f\u4e00\u90e8\u5178\u578b\u7684“\u9ad8\u5f00\u4f4e\u8d70”\u5546\u4e1a\u60b2\u5267\u3002<\/p>\n

\u4f5c\u4e3a\u5168\u7403\u9996\u4e2a\u83b7\u6279\u7684A\u578b\u8840\u53cb\u75c5AAV\u57fa\u56e0\u7597\u6cd5\uff0c\u5b83\u4ece\u83b7\u6279\u90a3\u5929\u8d77\u5c31\u81ea\u5e26\u5149\u73af——2023\u5e74\u83b7FDA\u6279\u51c6\u4e0a\u5e02<\/a>\uff0c\u5b9a\u4ef7290\u4e07-320\u4e07\u7f8e\u5143\uff0c\u4e00\u5ea6\u8dfb\u8eab\u5168\u7403\u6700\u8d35\u836f\u7269\u4e4b\u5217\u3002<\/p>\n

BioMarin\u7684\u903b\u8f91\u5f88\u987a\uff1a\u8840\u53cb\u75c5\u60a3\u8005\u9700\u8981\u7ec8\u8eab\u8f93\u6ce8\u51dd\u8840\u56e0\u5b50\uff0c\u603b\u82b1\u8d39\u8fdc\u8d85\u5343\u4e07\uff0c\u4e00\u6b21\u6027\u57fa\u56e0\u7597\u6cd5\u770b\u4f3c\u5929\u4ef7\uff0c\u957f\u671f\u66f4\u5212\u7b97\u3002<\/p>\n

\u5e76\u4e14\uff0cBioMarin\u8fd8\u4e3a\u8fd9\u6b3e\u4ea7\u54c1\u8bbe\u8ba1\u4e86\u770b\u4f3c\u5b8c\u7f8e\u7684\u5546\u4e1a\u7b56\u7565<\/a>——\u63a8\u51fa\u57fa\u4e8e\u7ed3\u679c\u7684\u4fdd\u4fee\u8ba1\u5212\u3002\u82e5Roctavian\u672a\u80fd\u8fbe\u5230\u6cbb\u7597\u9884\u671f\uff0c\u5c06\u5411\u653f\u5e9c\u548c\u5546\u4e1a\u4ed8\u6b3e\u4eba\u5168\u989d\u9000\u6b3e\uff1b\u82e5\u60a3\u8005\u5728\u7ed9\u836f\u540e\u56db\u5e74\u5185\u53cd\u5e94\u51cf\u5f31\uff0c\u4e5f\u53ef\u90e8\u5206\u9000\u6b3e\u3002<\/p>\n

\u7136\u800c\u73b0\u5b9e\u7ed9\u4e86\u6240\u6709\u4eba\u4e00\u8bb0\u8033\u5149\u3002<\/p>\n

2024\u5e74\uff0cRoctavian\u5168\u7403\u6536\u5165\u4ec5\u4e3a2600\u4e07\u7f8e\u5143\uff1b2025\u5e74\u5fae\u589e\u81f33600\u4e07\u7f8e\u5143\u3002\u8fd9\u662f\u4ec0\u4e48\u6982\u5ff5\uff1f\u534e\u5c14\u8857<\/a>\u66fe\u9884\u6d4b\u5176\u5cf0\u503c\u9500\u552e\u53ef\u8fbe20-22\u4ebf\u7f8e\u5143\uff0c\u6700\u7ec8\u7684\u5b9e\u9645\u8868\u73b0\u8fde\u96f6\u5934\u90fd\u6ca1\u5230\u3002<\/p>\n

2025\u5e7410\u6708\uff0cBioMarin\u8bd5\u56fe\u901a\u8fc7\u5265\u79bb\u8fd9\u4e00\u4ea7\u54c1\u7ba1\u7ebf\u5bfb\u627e\u4e70\u5bb6\uff0c\u4f46\u76f4\u5230\u5ba3\u5e03\u9000\u5e02\u4e5f\u672a\u627e\u5230\u63a5\u76d8\u65b9\u3002<\/p>\n

\u6700\u7ec8\uff0c\u8fd9\u6b3e\u5e26\u7740“\u4e00\u6b21\u6027\u6cbb\u6108”\u5149\u73af\u7684\u660e\u661f\u7597\u6cd5\u5728\u4e0a\u5e02\u4e09\u5e74\u5185\u5ba3\u544a\u843d\u5e55\u3002<\/p>\n

\u5982\u679c\u8bf4Roctavian\u7684\u56f0\u5883\u662f\u5546\u4e1a\u5316\u96be\u9898\uff0c\u90a3\u4e48Sarepta\u7684Elevidys\u5219\u5b8c\u5168\u66b4\u9732\u4e86\u57fa\u56e0\u7597\u6cd5\u7684\u5b89\u5168\u6027\u95ee\u9898\u3002<\/p>\n

Elevidys\u5b9a\u4ef7320\u4e07\u7f8e\u5143\u4e00\u9488\uff0c\u662f\u5168\u7403\u6700\u8d35\u7684\u836f\u7269\u4e4b\u4e00\u30022023\u5e746\u6708\uff0cFDA\u901a\u8fc7\u52a0\u901f\u5ba1\u6279\u9014\u5f84\u6279\u51c6\u5176\u7528\u4e8e4-5\u5c81\u53ef\u884c\u8d70\u7684\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7(DMD)\u60a3\u8005\uff1b2024\u5e746\u6708\uff0c\u9002\u5e94\u75c7\u6269\u5c55\u81f34\u5c81\u4ee5\u4e0a\u60a3\u8005\u3002<\/p>\n

\u5982\u679c\u5355\u7eaf\u4ece\u5546\u4e1a\u4e0a\u770b\uff0cElevidys\u4e00\u5ea6\u8868\u73b0\u582a\u79f0\u4eae\u773c\u30022024\u5e74\u9500\u552e\u989d\u8fbe8.21\u4ebf\u7f8e\u5143\uff0cSarepta\u66fe\u9884\u8ba12025\u5e74\u5168\u5e74\u9500\u552e\u989d\u5c06\u8fbe\u523029-31\u4ebf\u7f8e\u5143\u3002<\/p>\n

\u4f462025\u5e743\u6708\uff0c\u60b2\u5267\u53d1\u751f\u3002<\/p>\n

\u4e00\u540d16\u5c81DMD\u60a3\u8005\u5728\u63a5\u53d7Elevidys\u6cbb\u7597\u540e\u51fa\u73b0\u6025\u6027\u809d\u8870\u7aed\u6b7b\u4ea1\u30023\u4e2a\u6708\u540e\uff0c\u7b2c2\u4f8b\u6b7b\u4ea1\u4e8b\u4ef6\u53d1\u751f\u3002<\/p>\n

\u968f\u540e\u540c\u5e7411\u6708\uff0cFDA\u6b63\u5f0f\u4fee\u8ba2Elevidys\u836f\u54c1\u6807\u7b7e\uff0c\u65b0\u589e\u9488\u5bf9\u4e25\u91cd\u809d\u635f\u4f24\u4e0e\u81f4\u547d\u6027\u809d\u8870\u7aed\u7684\u9ed1\u6846\u8b66\u544a\u3002<\/p>\n

\u8981\u77e5\u9053\uff0c\u8fd9\u662f\u836f\u54c1\u76d1\u7ba1\u4e2d\u6700\u4e25\u5389\u7684\u5b89\u5168\u63d0\u793a\u3002\u540c\u65f6\uff0c\u9002\u7528\u4eba\u7fa4\u88ab\u4e25\u683c\u9650\u5b9a\u4e3a\u53ef\u884c\u8d70\u60a3\u8005\uff0c\u975e\u884c\u8d70\u60a3\u8005\u4e0d\u518d\u9002\u7528\u3002<\/p>\n

\u8fd9\u4e00\u51fb\u76f4\u63a5\u6253\u65ad\u5176\u589e\u957f——2025\u5e74\uff0cElevidys\u7684\u9500\u552e\u989d\u5927\u5e45\u4e0b\u6ed1\u3001\u80a1\u4ef7\u66b4\u8dcc\uff0cSarepta\u88ab\u8feb\u88c1\u5458\u3001\u780d\u7ba1\u7ebf\u3001\u6536\u7f29\u7814\u53d1\u3002<\/p>\n

02 \u6280\u672f\u74f6\u9888\uff1aAAV\u8f7d\u4f53\u7684“\u963f\u5580\u7409\u65af\u4e4b\u8e35”<\/strong><\/h2>\n

\u57fa\u56e0\u7597\u6cd5\u7684\u6280\u672f\u74f6\u9888\u6838\u5fc3\u5c31\u662f\u8f7d\u4f53\u7cfb\u7edf\u3002<\/p>\n

\u76ee\u524d\u4e3b\u6d41\u7684AAV\u8f7d\u4f53\u867d\u7136\u76f8\u5bf9\u5b89\u5168\uff0c\u4f46\u9650\u5236\u5374\u5f88\u591a\uff0c\u6bd4\u5982\u8f7d\u8d27\u80fd\u529b\u6709\u9650\u3001\u53ef\u80fd\u5f15\u53d1\u514d\u75ab\u53cd\u5e94\u3001\u8868\u8fbe\u6301\u7eed\u65f6\u95f4\u4e0d\u786e\u5b9a\u3001\u751f\u4ea7\u6210\u672c\u9ad8\u6602\u7b49\u7b49\u3002\u800c\u4e14AAV\u4ecb\u5bfc\u7684\u57fa\u56e0\u6cbb\u7597\u662f\u4e00\u6b21\u6027\u7684\uff0c\u4e00\u65e6\u51fa\u73b0\u95ee\u9898\uff0c\u51e0\u4e4e\u6ca1\u6709\u8865\u6551\u4f59\u5730\u3002<\/p>\n

Elevidys\u7684\u4e24\u4f8b\u6b7b\u4ea1\u4e8b\u4ef6\uff0c\u66b4\u9732\u7684\u6070\u6070\u5c31\u662fAAV\u8f7d\u4f53\u7684\u5b89\u5168\u6027\u98ce\u9669<\/a>\u3002\u4e1a\u5185\u666e\u904d\u8ba4\u4e3a\u4e0e\u514d\u75ab\u53cd\u5e94\u76f8\u5173——\u5f53\u75c5\u6bd2\u8f7d\u4f53\u8fdb\u5165\u4eba\u4f53\u540e\uff0c\u53ef\u80fd\u89e6\u53d1\u5f3a\u70c8\u7684\u514d\u75ab\u5e94\u7b54\uff0c\u5bfc\u81f4\u809d\u635f\u4f24\u7b49\u4e25\u91cd\u526f\u4f5c\u7528\u3002<\/p>\n

\u5b9e\u9645\u4e0a\u65e9\u57282020\u5e74\uff0cAudentes Therapeutics\u7684\u57fa\u56e0\u7597\u6cd5AT132\u5728\u6cbb\u7597X\u8fde\u9501\u808c\u7ba1\u808c\u75c5\u65f6\uff0c\u5c31\u66fe\u5bfc\u81f43\u540d\u60a3\u8005\u56e0\u809d\u635f\u4f24\u6b7b\u4ea1\u3002<\/p>\n

\u8fd9\u4e9b\u5b89\u5168\u4e8b\u4ef6\u8ba9\u76d1\u7ba1\u673a\u6784\u5bf9AAV\u57fa\u56e0\u7597\u6cd5\u6301\u66f4\u52a0\u5ba1\u614e\u7684\u6001\u5ea6\u3002\u8fd9\u79cd\u8f6c\u53d8\u5728FDA\u751f\u7269\u5236\u54c1\u8bc4\u4f30\u4e0e\u7814\u7a76\u4e2d\u5fc3\uff08CBER\uff09\u4e3b\u4efb\u6362\u4eba\u7684\u80cc\u666f\u4e0b\u66f4\u52a0\u660e\u663e\u3002<\/p>\n

Peter Marks\u65f6\u4ee3\u7684FDA\uff0c\u5bf9\u57fa\u56e0\u7597\u6cd5\u6301\u76f8\u5bf9\u5f00\u653e\u7684\u6001\u5ea6\u3002\u8fd9\u4f4d\u5728\u4f4d\u957f\u8fbe\u5341\u51e0\u5e74\u7684\u76d1\u7ba1\u5b98\u5458\uff0c\u66fe\u63a8\u52a8\u5efa\u7acb\u7684RMAT\uff08\u518d\u751f\u533b\u836f\u5148\u8fdb\u7597\u6cd5\uff09\u901a\u9053\uff0c\u5927\u5927\u52a0\u901f\u4e86\u57fa\u56e0\u7597\u6cd5\u7684\u5ba1\u6279\u8fdb\u7a0b\u3002\u5728\u5176\u4efb\u671f\u5185\uff0c\u5171\u670922\u79cd\u57fa\u56e0\u7597\u6cd5\u83b7\u6279\u4e0a\u5e02\u3002<\/p>\n

\u800c\u65b0\u4e0a\u4efb\u7684Vinay Prasad\u5374\u4ee5\u8c28\u614e\u8457\u79f0\uff0c\u5bf9\u52a0\u901f\u5ba1\u6279\u6301\u66f4\u52a0\u4fdd\u5b88\u7684\u6001\u5ea6\u3002\u5e02\u573a\u666e\u904d\u62c5\u5fc3\uff0c\u76d1\u7ba1\u6536\u7d27\u4f1a\u5ef6\u7f13\u57fa\u56e0\u7597\u6cd5\u7684\u4e0a\u5e02\u8fdb\u7a0b\uff0c\u589e\u52a0\u7814\u53d1\u6210\u672c\uff0c\u751a\u81f3\u627c\u6740\u4e00\u4e9b\u6709\u6f5c\u529b\u7684\u521b\u65b0<\/a>\u3002<\/p>\n

03 \u5546\u4e1a\u5316\u56f0\u5c40\uff1a\u5929\u4ef7\u7597\u6cd5\u4e3a\u4f55\u5356\u4e0d\u52a8\uff1f<\/strong><\/h2>\n

\u5b9e\u9645\u4e0a\uff0c\u5b89\u5168\u6027\u95ee\u9898\u53ea\u4e0d\u8fc7\u662f\u51b0\u5c71\u4e00\u89d2\uff0c\u57fa\u56e0\u7597\u6cd5\u771f\u6b63\u7684\u6311\u6218\u662f\u5546\u4e1a\u5316\u95ee\u9898\u3002<\/p>\n

320\u4e07\u7f8e\u5143\u4e00\u9488\u7684\u4ef7\u683c\u628a“\u6cbb\u6108”\u53d8\u6210\u4e86\u5962\u4f88\u54c1\uff0c\u5373\u4fbf\u5bf9\u53d1\u8fbe\u56fd\u5bb6\u533b\u4fdd\u4f53\u7cfb\u4e5f\u662f\u6c89\u91cd\u8d1f\u62c5\u3002\u800c\u7f55\u89c1\u75c5\u60a3\u8005\u6570\u91cf\u6709\u9650\uff0c\u65e0\u6cd5\u901a\u8fc7\u89c4\u6a21\u6548\u5e94\u644a\u8584\u6210\u672c\u3002<\/p>\n

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\u6700\u7ec8\uff0c\u57282025\u5e742\u6708\uff0c\u4e0a\u5e02\u4ec51\u5e74\u7684Beqvez\u7070\u6e9c\u6e9c\u5730\u64a4\u5e02\u4e86\uff0c\u4ece2014\u5e74\u4fbf\u5f00\u59cb\u771f\u91d1\u767d\u94f6\u6295\u5165\uff0c\u957f\u8fbe\u5341\u5e74\u4e4b\u4e45\u7684\u8c6a\u8d4c\uff0c\u7ec8\u7a76\u7af9\u7bee\u6253\u6c34\u4e00\u573a\u7a7a\u3002<\/p>\n

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2025\u5e74\uff0c\u5171\u6709\u5f3a\u751f\u3001\u798f\u6cf0\u3001\u6b66\u7530\u3001\u6e24\u5065\u7b496\u5bb6\u8de8\u56fd\u836f\u4f01\u96c6\u4f53\u64a4\u79bbAAV\u57fa\u56e0\u7597\u6cd5\u8d5b\u9053\u3002<\/p>\n

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04 \u8d44\u672c\u9000\u6f6e\uff1a\u4ece“\u6280\u672f\u72c2\u70ed”\u5230“\u4ef7\u503c\u5151\u73b0”<\/strong><\/h2>\n

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\u5728\u51cf\u80a5\u836f\u8d5b\u9053\uff0c\u8bfa\u548c\u8bfa\u5fb7\u6267\u638c\u516c\u53f88\u5e74\u591a\u7684\u539fCEO\u5468\u5fb7\u8d4b\u57282025\u5e748\u6708\u88ab\u514d\u804c\uff1b\u968f\u540e\u768411\u6708\uff0c\u8463\u4e8b\u957fHelge Lund\u643a\u516d\u540d\u8463\u4e8b\u96c6\u4f53\u79bb\u804c\u3002<\/p>\n

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\u5bf9\u4e8e\u57fa\u56e0\u7597\u6cd5\u884c\u4e1a\u6765\u8bf4\uff0c\u8d44\u672c\u7684\u6001\u5ea6\u5df2\u7ecf\u53d1\u751f\u4e86\u6839\u672c\u7684\u8f6c\u53d8\u3002<\/p>\n

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05 \u6d77\u5916\u9000\u6f6e\u7684\u8774\u8776\u6548\u5e94\uff1a\u56fd\u5185\u73a9\u5bb6\u7684\u5371\u4e0e\u673a<\/strong><\/h2>\n

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2023\u5e7412\u6708\uff0c\u5176\u7f8e\u56fd\u5b50\u516c\u53f8\u56e0\u751f\u4ea7\u57fa\u5730\u7684\u5408\u89c4\u95ee\u9898\uff0c\u88abFDA\u8981\u6c42\u6682\u505c\u4e86CT053\u7b49\u4ea7\u54c1\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c<\/p>\n

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\u7ed3\u8bed\uff1a<\/strong><\/h3>\n

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