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\u258e\u836f\u660e<\/span><\/strong>\u5eb7\u5fb7\/\u62a5\u9053<\/span><\/strong><\/strong><\/strong><\/strong><\/span><\/strong><\/strong><\/p>\n


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\u8fd1\u65e5\uff0c Regeneron\u533b\u836f\u516c\u53f8\u5ba3\u5e03\u7f8e\u56fdFDA\u5df2\u63a5\u53d7EYLEA\u00ae\uff08aflibercept\uff09\u6ce8\u5c04\u5242\u7528\u4e8e\u6cbb\u7597\u7cd6\u5c3f\u75c5\u89c6\u7f51\u819c\u75c5\u53d8\u7684\u8865\u5145\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\uff08sBLA\uff09<\/strong>\u3002\u6b64\u6b21\u7533\u8bf7\u662f\u57fa\u4e8e\u4e34\u5e8a3\u671fPANORAMA\u8bd5\u9a8c\u516d\u4e2a\u6708\u7684\u79ef\u6781\u7ed3\u679c\u3002PANORAMA\u8bd5\u9a8c\u65e8\u5728\u8bc4\u4f30EYLEA\u00ae\u6ce8\u5c04\u6db2\u7528\u4e8e\u4e2d\u91cd\u5ea6\u81f3\u91cd\u5ea6\u975e\u589e\u6b96\u671f\u7cd6\u5c3f\u75c5\u89c6\u7f51\u819c\u75c5\u53d8\uff08NPDR\uff09\u4e14\u65e0\u7cd6\u5c3f\u75c5\u9ec4\u6591\u6c34\u80bf\uff08DME\uff09\u7684\u6cbb\u7597\u6548\u679c\uff0c\u6570\u636e\u663e\u793a\uff0c\u7814\u7a76\u8fbe\u523024\u5468\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u3002\u5bf9\u4e8e\u6b64\u6b21\u7533\u8bf7\uff0cFDA\u9884\u8ba1\u5c06\u4e8e2019\u5e745\u670813\u65e5\u524d\u505a\u51fa\u51b3\u5b9a\u3002<\/span><\/p>\n


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\"\u901f\u9012<\/p>\n


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<\/p>\n

EYLEA\u00ae\u6ce8\u5c04\u6db2\u662f\u7ecfFDA\u6279\u51c6\u7684\u4e00\u79cd\u8840\u7ba1\u5185\u76ae\u751f\u957f\u56e0\u5b50\uff08VEGF\uff09\u6291\u5236\u5242\uff0c<\/span><\/strong>\u901a\u8fc7\u963b\u65ad\u8840\u7ba1\u751f\u6210\u4e2d\u6d89\u53ca\u7684\u4e24\u79cd\u751f\u957f\u56e0\u5b50\u2014\u2014VEGF-A\u548c\u80ce\u76d8\u751f\u957f\u56e0\u5b50\uff08PLGF\uff09\uff0cEYLEA\u00ae\u53ef\u4ee5\u963b\u65ad\u65b0\u8840\u7ba1\u7684\u751f\u957f\u5e76\u964d\u4f4e\u6db2\u4f53\u901a\u8fc7\u8840\u7ba1\u7684\u80fd\u529b\uff08\u8840\u7ba1\u901a\u900f\u6027\uff09\u3002\u76ee\u524d\u7684\u9002\u5e94\u75c7\u5305\u62ec\u6e7f\u6027\u5e74\u9f84\u76f8\u5173\u6027\u9ec4\u6591\u53d8\u6027\uff0c\u89c6\u7f51\u819c\u9759\u8109\u6813\u585e\u540e\u7684\u9ec4\u6591\u6c34\u80bf\uff0c\u7cd6\u5c3f\u75c5\u9ec4\u6591\u6c34\u80bf\u4ee5\u53ca\u7cd6\u5c3f\u75c5\u9ec4\u6591\u6c34\u80bf\u60a3\u8005\u7684\u89c6\u7f51\u819c\u75c5\u53d8\u3002<\/strong><\/span><\/p>\n


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\"\u901f\u9012<\/strong><\/span><\/p>\n


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PANORAMA\u662f\u4e00\u9879\u6301\u7eed\u4e14\u5173\u952e\u7684\u53cc\u76f2\u968f\u673a\u8bd5\u9a8c\uff0c\u8bc4\u4f30\u5728\u4e2d\u91cd\u5ea6\u81f3\u91cd\u5ea6NPDR\u4e14\u65e0\u7cd6\u5c3f\u75c5\u9ec4\u6591\u6c34\u80bf\u7684\u60a3\u8005\u4e2d\uff0cEYLEA\u00ae\u7684\u6cbb\u7597\u6548\u679c\u3002\u8bd5\u9a8c\u4e3a\u671f\u4e24\u5e74\uff0c\u5171\u62db\u52df\u4e86402\u540d\u60a3\u8005\u3002<\/span><\/p>\n


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\u7ed3\u679c\u663e\u793a\uff0c\u4e0eDRSS\u7684\u57fa\u7ebf\u60c5\u51b5\u6bd4\u8f83\uff0c58\uff05\u7684EYLEA\u00ae\u6cbb\u7597\u60a3\u8005\u5728\u7b2c24\u5468\u65f6\u5f97\u5230\u4e86\u4e24\u7ea7\u53ca\u4ee5\u4e0a\u7684\u6539\u5584\uff0c<\/strong>\u800c\u63a5\u53d7\u5b89\u6170\u5242\u6ce8\u5c04\u7684\u60a3\u8005\u4e2d\u4ec5\u67096\uff05\u5f97\u5230\u6539\u5584\uff08p <0.0001\uff09\u3002<\/span><\/p>\n


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\u5728\u6700\u521d\u768424\u5468\u5185\uff0c\u79ef\u6781\u6cbb\u7597\u7ec4\u7684\u60a3\u8005\u5e73\u5747\u63a5\u53d7\u4e864.4\u6b21EYLEA\u00ae\u6ce8\u5c04\u3002\u8bd5\u9a8c\u4e2d\u6ca1\u6709\u65b0\u7684\u5b89\u5168\u95ee\u9898\u3002EYLEA\u00ae\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\u6709\u4e00\u4f8b\u8f7b\u5ea6\u773c\u5185\u708e\u75c7\uff08IOI\uff09\uff08\u6bcf\u6b21\u6ce8\u5c04\u53d1\u751f\u73870.085\uff05\uff09\uff0c\u8fd9\u4e0e\u4e4b\u524d\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u89c2\u5bdf\u5230\u7684IOI\u7387\u4e00\u81f4\u3002<\/span><\/p>\n


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Regeneron\u603b\u88c1\u517c\u9996\u5e2d\u79d1\u5b66\u5b98George D. Yancopoulos\u535a\u58eb\u65e9\u524d\u8868\u793a\uff1a\u201c\u5728\u65e0\u7cd6\u5c3f\u75c5\u9ec4\u6591\u6c34\u80bf\u7684\u4e2d\u91cd\u5ea6\u81f3\u91cd\u5ea6NPDR\u7684\u60a3\u8005\u4e2d\uff0c\u8fd9\u662f\u9996\u6b21\u8bc1\u660e\u4e00\u9879\u7597\u6cd5\u53ef\u4ee5\u9006\u8f6c\u75be\u75c5\u8fdb\u5c55\u3002\u201d <\/strong><\/span><\/p>\n


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\"\u901f\u9012<\/p>\n

\u25b2Regeneron\u603b\u88c1\u517c\u9996\u5e2d\u79d1\u5b66\u5b98George D. Yancopoulos\u535a\u58eb\uff08\u56fe\u7247\u6765\u6e90\uff1aRegeneron\u5b98\u7f51<\/span><\/strong>\uff09<\/span><\/strong><\/span>
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\u6211\u4eec\u671f\u5f85PANORAMA\u8bd5\u9a8c\u53d6\u5f97\u66f4\u597d\u7684\u4e00\u5e74\u7ed3\u679c\uff0c\u65e9\u65e5\u4e3a\u7cd6\u5c3f\u75c5\u89c6\u7f51\u819c\u75c5\u53d8\u60a3\u8005\u5e26\u6765\u65b0\u7597\u6cd5\u3002<\/span><\/p>\n


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\u53c2\u8003\u8d44\u6599\uff1a<\/span><\/p>\n

[1] FDA to Review EYLEA (aflibercept) Injection for the Treatment of Diabetic Retinopathy. Retrieved Sep 13, 2018, from https:\/\/newsroom.regeneron.com\/news-releases\/news-release-details\/fda-review-eylea-aflibercept-injection-treatment-diabetic<\/span><\/p>\n

[2] EYLEA\u00ae (aflibercept) Injection Demonstrates Positive Topline Results in Phase 3 NonProliferative Diabetic Retinopathy Trial. Retrieved March 19, 2018, from https:\/\/investor.regeneron.com\/static-files\/9c354b79-f6f5-4dce-a863-af232fcb80cb<\/span><\/p>\n


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