{"id":88452,"date":"2022-12-30T21:03:00","date_gmt":"2022-12-30T14:03:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2022123021030088452"},"modified":"2023-01-03T22:18:00","modified_gmt":"2023-01-03T14:18:00","slug":"%e7%99%be%e6%b5%8e%e7%a5%9e%e5%b7%9e%e5%ae%a3%e5%b8%83%e7%99%be%e6%b3%bd%e5%ae%89%e5%9c%a8%e4%b8%ad%e5%9b%bd%e9%80%92%e4%ba%a4%e7%9a%84%e7%ac%ac12%e9%a1%b9%e9%80%82%e5%ba%94%e7%97%87%e4%b8%8a","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2022123021030088452","title":{"rendered":"\u767e\u6d4e\u795e\u5dde\u5ba3\u5e03\u767e\u6cfd\u5b89\u00ae\u5728\u4e2d\u56fd\u9012\u4ea4\u7684\u7b2c12\u9879\u9002\u5e94\u75c7\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u5df2\u83b7\u53d7\u7406"},"content":{"rendered":"

\u4ee5\u83b7\u6279\u7528\u4e8e\u6cbb\u7597\u4e00\u7ebf\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u809d\u7ec6\u80de\u764c<\/i><\/p>\n

\u4e2d\u56fd\u5317\u4eac\uff0c\u7f8e\u56fd\u9ebb\u7701\u5251\u6865\u548c\u745e\u58eb\u5df4\u585e\u5c14<\/span>2022\u5e7412\u670830\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — \u767e\u6d4e\u795e\u5dde\uff08\u7eb3\u65af\u8fbe\u514b\u4ee3\u7801\uff1aBGNE\uff1b\u9999\u6e2f\u8054\u4ea4\u6240\u4ee3\u7801\uff1a06160\uff1b\u4e0a\u4ea4\u6240\u4ee3\u7801\uff1a688235\uff09\u662f\u4e00\u5bb6\u5168\u7403\u6027\u751f\u7269\u79d1\u6280\u516c\u53f8\u3002\u516c\u53f8\u4eca\u65e5\u5ba3\u5e03\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u5df2\u53d7\u7406\u767e\u6cfd\u5b89®<\/sup><\/i>\uff08\u66ff\u96f7\u5229\u73e0\u5355\u6297\uff09\u7528\u4e8e\u6cbb\u7597\u4e00\u7ebf\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u809d\u7ec6\u80de\u764c\uff08HCC\uff09\u60a3\u8005\u7684\u65b0\u9002\u5e94\u75c7\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff08sBLA\uff09\u3002 <\/p>\n

HCC\u662f\u4e16\u754c\u8303\u56f4\u5185\u6700\u5e38\u89c1\u7684\u539f\u53d1\u6027\u809d\u764c\u7c7b\u578b\u4e14\u9884\u540e\u6781\u5ea6\u4e0d\u826f[1]<\/sup>\u3002\u4e2d\u56fd\u7684HCC\u65b0\u53d1\u75c5\u4f8b\u548c\u6b7b\u4ea1\u75c5\u4f8b\u7ea6\u5360\u5168\u7403\u603b\u6570\u7684\u4e00\u534a\uff0c\u51765\u5e74\u751f\u5b58\u7387\u4ec5\u4e3a14%[2]<\/sup> \u3002<\/p>\n

\u767e\u6d4e\u795e\u5dde\u5168\u7403\u7814\u53d1\u8d1f\u8d23\u4eba\u6c6a\u6765\u535a\u58eb\u8868\u793a\uff1a\u201c\u867d\u7136\u4e2d\u56fd\u7684HCC\u53d1\u75c5\u7387\u6301\u7eed\u4e0a\u5347\uff0c\u4f46\u5176\u6cbb\u7597\u73b0\u72b6\u5e76\u672a\u53d6\u5f97\u76f8\u5e94\u8fdb\u5c55\uff0c\u8f83\u65b0\u7684\u6cbb\u7597\u65b9\u6848\u6240\u5e26\u6765\u7684\u751f\u5b58\u83b7\u76ca\u76f8\u5bf9\u6709\u9650\uff0c\u591a\u6fc0\u9176\u6291\u5236\u5242\u7684\u8010\u53d7\u6027\u4e5f\u4ec5\u4e3a\u6b21\u4f18\u3002\u767e\u6d4e\u795e\u5dde\u9488\u5bf9\u767e\u6cfd\u5b89®<\/sup><\/i>\u7528\u4e8eHCC\u6cbb\u7597\u9ad8\u6807\u51c6\u5730\u5f00\u5c55\u4e86\u5168\u7403\u4e34\u5e8a\u5f00\u53d1\u9879\u76ee\uff0c\u6211\u4eec\u76f8\u4fe1\u8be5\u9879\u76ee\u6240\u4ea7\u51fa\u7684\u8bc1\u636e\u6709\u529b\u5730\u652f\u6301\u4e86\u767e\u6cfd\u5b89®<\/sup><\/i>\u6709\u6548\u6027\u548c\u8010\u53d7\u6027\u826f\u597d\u7684\u7279\u5f81\u3002\u6211\u4eec\u5c06\u6301\u7eed\u4e0eNMPA\u5c31\u672c\u6b21\u7533\u8bf7\u7d27\u5bc6\u6c9f\u901a\uff0c\u4e3a\u4e2d\u56fdHCC\u60a3\u8005\u5e26\u6765\u65b0\u6cbb\u7597\u9009\u62e9\u3002\u201d<\/p>\n

\u672c\u6b21\u9012\u4ea4\u7684sBLA\u57fa\u4e8eRATIONALE 301\uff08NCT03412773\uff09\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u3002\u8be5\u4e34\u5e8a\u8bd5\u9a8c\u4ece\u4e9a\u6d32\u3001\u6b27\u6d32\u548c\u7f8e\u56fd\u5404\u7814\u7a76\u4e2d\u5fc3\u5171\u5165\u7ec4674\u4f8b\u60a3\u8005\uff0c\u5176\u7ed3\u679c\u4ee5\u6700\u65b0\u7a81\u7834\u53e3\u5934\u62a5\u544a\u7684\u5f62\u5f0f\u516c\u5e03\u4e8e2022\u5e74\u5728\u6cd5\u56fd\u5df4\u9ece\u4e3e\u529e\u7684\u6b27\u6d32\u80bf\u7624\u5185\u79d1\u5b66\u4f1a\uff08ESMO\uff09\u5927\u4f1a\u3002<\/p>\n

\u767e\u6cfd\u5b89®<\/sup>\u5df2\u88abNMPA\u6279\u51c6\u7528\u4e8e9\u9879\u9002\u5e94\u75c7\u7684\u6cbb\u7597\uff0c\u5305\u62ec\u9644\u6761\u4ef6\u6279\u51c6\u7528\u4e8e\u6cbb\u7597\u81f3\u5c11\u7ecf\u8fc7\u4e00\u79cd\u5168\u8eab\u6cbb\u7597\u7684\u809d\u7ec6\u80de\u764c (HCC)\u3002\u6b64\u5916\uff0c\u767e\u6cfd\u5b89®<\/sup> \u7684\u5982\u4e0b\u65b0\u9002\u5e94\u75c7\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u6b63\u5728\u63a5\u53d7CDE\u7684\u6280\u672f\u5ba1\u8bc4\uff1a\u8054\u5408\u5316\u7597\u7528\u4e8e\u4e00\u7ebf\u6cbb\u7597\u80bf\u7624\u8868\u8fbePD-L1\u7684\u665a\u671f\u6216\u8f6c\u79fb\u6027\u80c3\u6216\u80c3\u98df\u7ba1\u7ed3\u5408\u90e8\uff08G\/GEJ\uff09\u817a\u764c\u60a3\u8005\uff0c\u4ee5\u53ca\u8054\u5408\u5316\u7597\u7528\u4e8e\u4e00\u7ebf\u6cbb\u7597\u4e0d\u53ef\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\u3001\u590d\u53d1\u6216\u8f6c\u79fb\u6027\u98df\u7ba1\u9cde\u72b6\u7ec6\u80de\u764c\uff08ESCC\uff09\u3002\u76ee\u524d\uff0c\u767e\u6cfd\u5b89®<\/sup>\u5728\u4e2d\u56fd\u4ee5\u5916\u56fd\u5bb6\u6216\u5730\u533a\u5c1a\u672a\u83b7\u6279\u3002<\/p>\n

\u5173\u4e8e\u767e\u6cfd\u5b89<\/b>®<\/sup><\/b> <\/p>\n

\u767e\u6cfd\u5b89®<\/sup>\uff08\u66ff\u96f7\u5229\u73e0\u5355\u6297\uff09\u662f\u4e00\u6b3e\u4eba\u6e90\u5316IgG4\u6297PD-1\u5355\u514b\u9686\u6297\u4f53\uff0c\u8bbe\u8ba1\u76ee\u7684\u65e8\u5728\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u4e0e\u5de8\u566c\u7ec6\u80de\u4e2d\u7684Fc\u03b3\u53d7\u4f53\u7ed3\u5408\uff0c\u5e2e\u52a9\u4eba\u4f53\u514d\u75ab\u7ec6\u80de\u8bc6\u522b\u5e76\u6740\u4f24\u80bf\u7624\u7ec6\u80de\u3002\u4e34\u5e8a\u524d\u6570\u636e\u8868\u660e\uff0c\u5de8\u566c\u7ec6\u80de\u4e2d\u7684Fc\u03b3\u53d7\u4f53\u7ed3\u5408\u4e4b\u540e\u4f1a\u6fc0\u6d3b\u6297\u4f53\u4f9d\u8d56\u7ec6\u80de\u4ecb\u5bfc\u6740\u4f24T\u7ec6\u80de\uff0c\u4ece\u800c\u964d\u4f4e\u4e86PD-1\u6297\u4f53\u7684\u6297\u80bf\u7624\u6d3b\u6027\u3002<\/p>\n

\u767e\u6cfd\u5b89®<\/sup>\u662f\u7b2c\u4e00\u6b3e\u7531\u767e\u6d4e\u795e\u5dde\u514d\u75ab\u80bf\u7624\u751f\u7269\u5e73\u53f0\u7814\u53d1\u7684\u836f\u7269\uff0c\u76ee\u524d\u6b63\u8fdb\u884c\u5355\u836f\u53ca\u8054\u5408\u7597\u6cd5\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u5f00\u53d1\u9488\u5bf9\u5b9e\u4f53\u7624\u548c\u8840\u6db2\u80bf\u7624\u7684\u9002\u5e94\u75c7\u3002<\/p>\n

\u767e\u6cfd\u5b89®<\/sup>\u5168\u7403\u4e34\u5e8a\u5f00\u53d1\u9879\u76ee\u5df2\u5728\u8d85\u8fc730\u4e2a\u56fd\u5bb6\u548c\u5730\u533a\u5f00\u5c5521\u9879\u6ce8\u518c\u76f8\u5173\u7684\u8bd5\u9a8c\uff0c\u5165\u7ec4\u8d85\u8fc711,500\u4f8b\u60a3\u8005\u3002 <\/p>\n

\u5173\u4e8e<\/b>RATIONALE 301<\/b>\u7814\u7a76<\/b><\/p>\n

RATIONALE 301\uff08NCT03412773\uff09\u662f\u4e00\u9879\u968f\u673a\u3001\u5f00\u653e\u6027\u7684\u5168\u74033\u671f\u4e34\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30\u767e\u6cfd\u5b89®<\/sup>\uff08\u66ff\u96f7\u5229\u73e0\u5355\u6297\uff09\u5bf9\u6bd4\u7d22\u62c9\u975e\u5c3c\u4f5c\u4e3a\u4e0d\u53ef\u5207\u9664\u7684HCC\u6210\u4eba\u60a3\u8005\u4e00\u7ebf\u6cbb\u7597\u7684\u6548\u679c\u3002\u6b64\u7814\u7a76\u7684\u4e3b\u8981\u7ec8\u70b9\u662f\u4e24\u4e2a\u6cbb\u7597\u7ec4\u7684\u603b\u751f\u5b58\u671f\u7684\u975e\u52a3\u6548\u6027\u6bd4\u8f83\uff0c\u5173\u952e\u6b21\u8981\u7ec8\u70b9\u662f\u76f2\u6001\u72ec\u7acb\u5ba1\u67e5\u59d4\u5458\u4f1a\uff08BIRC\uff09\u6839\u636eRECIST 1.1 \u7248\u8bc4\u4f30\u7684\u603b\u4f53\u7f13\u89e3\u7387\u3002\u5176\u4ed6\u6b21\u8981\u7ec8\u70b9\u5305\u62ec\u6839\u636eBIRC\u8bc4\u4f30\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u3001\u7f13\u89e3\u6301\u7eed\u65f6\u95f4\u548c\u81f3\u75be\u75c5\u8fdb\u5c55\u65f6\u95f4\u7b49\u7684\u6709\u6548\u6027\u8bc4\u4f30\uff0c\u8fd8\u6709\u5065\u5eb7\u76f8\u5173\u7684\u751f\u6d3b\u8d28\u91cf\u6307\u6807\uff0c\u4ee5\u53ca\u5b89\u5168\u6027\u4e0e\u8010\u53d7\u6027\u3002 <\/p>\n

\u5173\u4e8e\u767e\u6d4e\u795e\u5dde<\/b><\/p>\n

\u767e\u6d4e\u795e\u5dde\u662f\u4e00\u5bb6\u5168\u7403\u6027\u751f\u7269\u79d1\u6280\u516c\u53f8\uff0c\u4e13\u6ce8\u4e8e\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u521b\u65b0\u3001\u53ef\u8d1f\u62c5\u7684\u6297\u80bf\u7624\u836f\u7269\uff0c\u65e8\u5728\u4e3a\u5168\u7403\u60a3\u8005\u6539\u5584\u6cbb\u7597\u6548\u679c\uff0c\u63d0\u9ad8\u836f\u7269\u53ef\u53ca\u6027\u3002\u901a\u8fc7\u5f3a\u5927\u7684\u81ea\u4e3b\u7814\u53d1\u80fd\u529b\u548c\u5916\u90e8\u6218\u7565\u5408\u4f5c\uff0c\u6211\u4eec\u4e0d\u65ad\u52a0\u901f\u5f00\u53d1\u591a\u5143\u3001\u521b\u65b0\u7684\u836f\u7269\u7ba1\u7ebf\u3002\u6211\u4eec\u81f4\u529b\u4e8e\u4e3a\u5168\u7403\u66f4\u591a\u60a3\u8005\u5168\u9762\u6539\u5584\u836f\u7269\u53ef\u53ca\u6027\u3002\u767e\u6d4e\u795e\u5dde\u5728\u5168\u7403\u4e94\u5927\u6d32\u6253\u9020\u4e86\u4e00\u652f\u8d85\u8fc79,000\u4eba\u7684\u56e2\u961f\uff0c\u5e76\u5728\u4e2d\u56fd\u5317\u4eac\u3001\u7f8e\u56fd\u9ebb\u7701\u5251\u6865\u548c\u745e\u58eb\u5df4\u585e\u5c14\u8bbe\u7acb\u4e86\u4e3b\u8981\u529e\u4e8b\u5904\u3002\u6b32\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95eehttp:\/\/www.beigene.com.cn<\/a>\u3002<\/p>\n

\u524d\u77bb\u6027\u58f0\u660e<\/b><\/p>\n

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[1] <\/sup>Sung, H, Ferlay, J, Siegel, RL, Laversanne, M, Soerjomataram, I, Jemal, A, Bray, F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin<\/i>. 2021: 71: 209- 249. https:\/\/doi.org\/10.3322\/caac.21660<\/a>
[2] <\/sup>Zheng R, Qu C, Zhang S, Zeng H, Sun K, Gu X, Xia C, Yang Z, Li H, Wei W, Chen W, He J. Liver cancer incidence and mortality in China<\/span>: Temporal trends and projections to 2030. Chin J Cancer Res. 2018 Dec;30(6):571-579. https:\/\/doi.org\/10.21147\/j.issn.1000-9604.2018.06.01<\/a>.<\/p>\n

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[1] Sung, H, Ferlay, J, Siegel, RL, Laversanne, M, Soerjomataram, I, Jemal, A, Bray, F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA… Read 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