{"id":2566,"date":"2020-10-30T00:00:00","date_gmt":"2021-03-18T00:53:11","guid":{"rendered":"https:\/\/www.9-design.net\/?p=2566"},"modified":"2021-03-18T08:53:11","modified_gmt":"2021-03-18T00:53:11","slug":"%e6%ac%a7%e6%b4%b2%e8%8d%af%e5%93%81%e7%ae%a1%e7%90%86%e5%b1%80%e6%8e%a5%e5%8f%97biogen%e9%98%bf%e5%b0%94%e8%8c%a8%e6%b5%b7%e9%bb%98%e7%97%85%e6%b2%bb%e7%96%97%e8%8d%af%e7%89%a9aducanumab%e7%9a%84","status":"publish","type":"post","link":"https:\/\/www.9-design.net\/2020\/10\/30\/%e6%ac%a7%e6%b4%b2%e8%8d%af%e5%93%81%e7%ae%a1%e7%90%86%e5%b1%80%e6%8e%a5%e5%8f%97biogen%e9%98%bf%e5%b0%94%e8%8c%a8%e6%b5%b7%e9%bb%98%e7%97%85%e6%b2%bb%e7%96%97%e8%8d%af%e7%89%a9aducanumab%e7%9a%84\/","title":{"rendered":"\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\u63a5\u53d7Biogen\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u6cbb\u7597\u836f\u7269aducanumab\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7"},"content":{"rendered":"<p style=\"font-weight: 400;\"><em style=\"font-weight: inherit;\">\u5982\u679c\u83b7\u5f97\u6279\u51c6\uff0caducanumab\u5c06\u6210\u4e3a\u7b2c\u4e00\u4e2a\u80fd\u591f\u5ef6\u7f13\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u4e34\u5e8a\u75c7\u72b6\u8870\u9000\u548c\u6709\u610f\u4e49\u5730\u6539\u53d8\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u75c5\u7a0b\u7684\u6cbb\u7597\u65b9\u6cd5<\/em><\/p>\n<p style=\"font-weight: 400;\">\nBiogen\uff08\u7eb3\u65af\u8fbe\u514b\uff1aBIIB\uff09\u548cEisai, Co., Ltd.\uff08\u65e5\u672c\u4e1c\u4eac\uff09\u8fd1\u65e5\u5ba3\u5e03\uff0c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u5df2\u786e\u8ba4\u53d7\u7406\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u8bd5\u9a8c\u6027\u6cbb\u7597\u836f\u7269aducanumab\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff08MAA\uff09\uff0c\u5e76\u5c06\u6309\u7167\u6807\u51c6\u65f6\u95f4\u8868\u8fdb\u884c\u5ba1\u8bc4\u3002\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u5f15\u8d77\u7684\u8f7b\u5ea6\u8ba4\u77e5\u969c\u788d\u548c\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u60a3\u8005\u7684\u4e34\u5e8a\u6570\u636e\u8868\u660e\uff0caducanumab\u6cbb\u7597\u53ef\u53bb\u9664\u03b2\u6dc0\u7c89\u6837\u86cb\u767d\uff0c\u5177\u6709\u66f4\u597d\u7684\u4e34\u5e8a\u6548\u679c\u3002\u5982\u679c\u83b7\u5f97\u6279\u51c6\uff0caducanumab\u5c06\u6210\u4e3a\u7b2c\u4e00\u4e2a\u80fd\u591f\u5ef6\u7f13\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u4e34\u5e8a\u75c7\u72b6\u8870\u9000\u7684\u6cbb\u7597\u65b9\u6cd5\u3002<\/p>\n<p>Biogen\u9996\u5e2d\u6267\u884c\u5b98Michel Vounatsos\u8868\u793a&#8221;\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u5df2\u7ecf\u6210\u4e3a\u5168\u7403\u793e\u4f1a\u65e5\u76ca\u4e25\u91cd\u7684\u8d1f\u62c5\uff0c\u6211\u4eec\u76f8\u4fe1aducanumab\u662f\u53ef\u4ee5\u6539\u53d8\u8fd9\u79cd\u6bc1\u706d\u6027\u75be\u75c5\u8fdb\u7a0b\u7684\u7b2c\u4e00\u4e2a\u7a81\u7834&#8221;\u3002\u540c\u65f6\uff0cMichel Vounatsos\u4e5f\u8868\u793a&#8221;\u6211\u4eec\u81f4\u529b\u4e8e\u4e0e\u5168\u7403\u76d1\u7ba1\u673a\u6784\u5408\u4f5c\uff0c\u5e76\u671f\u5f85\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\u5bf9\u8be5\u7533\u8bf7\u8fdb\u884c\u5ba1\u8bc4\u3002&#8221;<\/p>\n<p>Eisai Co., Ltd.\u9996\u5e2d\u6267\u884c\u5b98Haruo Naito\u535a\u58eb\u8868\u793a&#8221;\u76ee\u524d\u5c1a\u65e0\u53ef\u901a\u8fc7\u89e3\u51b3\u57fa\u7840\u75be\u75c5\u75c5\u7406\u673a\u5236\u6765\u5f71\u54cd\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u8fdb\u5c55\u7684\u6cbb\u7597\u65b9\u6cd5\u3002Aducanumab\u5177\u6709\u6709\u6548\u5ef6\u7f13\u4e34\u5e8a\u75c7\u72b6\u8870\u9000\u7684\u6f5c\u529b\uff0c\u8fd9\u4e3a\u60a3\u6709\u8fd9\u79cd\u6bc1\u706d\u6027\u75be\u75c5\u7684\u60a3\u8005\u548c\u5bb6\u5ead\u5e26\u6765\u4e86\u65b0\u7684\u5e0c\u671b&#8221;\u3002\u540c\u65f6\uff0cEisai Co., Ltd.\u9996\u5e2d\u6267\u884c\u5b98Haruo Naito\u535a\u58eb\u4e5f\u8868\u793a&#8221;\u5728\u6211\u4eec\u52aa\u529b\u4f7f\u8be5\u6f5c\u5728\u6cbb\u7597\u836f\u7269\u5728\u5168\u7403\u8303\u56f4\u5185\u53ef\u53ca\u7684\u8fc7\u7a0b\u4e2d\uff0c\u6b27\u76df\u63a5\u53d7\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u662f\u4e00\u4e2a\u91cd\u8981\u7684\u91cc\u7a0b\u7891\u3002&#8221;<\/p>\n<p style=\"font-weight: 400;\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u4e5f\u5df2\u7ecf\u63a5\u53d7\u4e86aducanumab\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff0c\u5e76\u4e14\u6388\u4e88\u9996\u9009\u5ba1\u8bc4\u8d44\u683c\u3002\u6839\u636e\u300a\u5904\u65b9\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u6cd5\u6848\u300b\uff08PDUFA\uff09\uff0cFDA\u7684\u5ba1\u8bc4\u76ee\u6807\u65e5\u671f\u4e3a2021\u5e743\u67087\u65e5\u3002<\/p>\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\"><strong>\u5173\u4e8eAducanumab<\/strong><\/p>\n<p style=\"font-weight: 400;\">Aducanumab\uff08BIIB037\uff09\u662f\u4e00\u79cd\u7528\u4e8e\u6cbb\u7597\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u7684\u8bd5\u9a8c\u6027\u4eba\u5355\u514b\u9686\u6297\u4f53\u3002\u57fa\u4e8e\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u5f15\u8d77\u7684\u8f7b\u5ea6\u8ba4\u77e5\u969c\u788d\u548c\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u60a3\u8005\u7684\u4e34\u5e8a\u6570\u636e\uff0caducanumab\u53ef\u80fd\u5f71\u54cd\u57fa\u7840\u75be\u75c5\u7684\u75c5\u7406\u751f\u7406\u673a\u5236\uff0c\u51cf\u7f13\u8ba4\u77e5\u548c\u529f\u80fd\u4e0b\u964d\uff0c\u5e76\u6539\u5584\u60a3\u8005\u7684\u65e5\u5e38\u751f\u6d3b\u6d3b\u52a8\u80fd\u529b\uff0c\u5305\u62ec\u4e2a\u4eba\u7406\u8d22\u3001\u505a\u5bb6\u52a1\uff08\u5982\u6e05\u6d01\u3001\u8d2d\u7269\u548c\u6d17\u8863\uff09\u4ee5\u53ca\u72ec\u7acb\u51fa\u95e8\u65c5\u884c\u3002\u5982\u679c\u83b7\u5f97\u6279\u51c6\uff0caducanumab\u5c06\u6210\u4e3a\u7b2c\u4e00\u4e2a\u80fd\u591f\u6709\u610f\u4e49\u5730\u6539\u53d8\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u60a3\u8005\u75c5\u7a0b\u7684\u6cbb\u7597\u65b9\u6cd5\u3002<\/p>\n<p style=\"font-weight: 400;\">Biogen\u6839\u636e\u5408\u4f5c\u5f00\u53d1\u548c\u8bb8\u53ef\u534f\u8bae\u4eceNeurimmune\u83b7\u5f97\u4e86aducanumab\u7684\u8bb8\u53ef\u3002\u81ea2017\u5e7410\u6708\u4ee5\u6765\uff0cBiogen\u548cEisai Co., Ltd.\u5728\u5168\u7403\u8303\u56f4\u5185\u5408\u4f5c\u5f00\u53d1\u548c\u5546\u4e1a\u5316aducanumab\u3002<\/p>\n<p style=\"font-weight: 400;\">EMERGE\u548cENGAGE\u5747\u4e3aIII\u671f\u3001\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u5e73\u884c\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4ef7aducanumab\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002\u8fd9\u4e24\u9879\u7814\u7a76\u7684\u4e3b\u8981\u76ee\u7684\u662f\u901a\u8fc7\u4e34\u5e8a\u75f4\u5446\u8bc4\u5b9a\u91cf\u8868-\u603b\u5206\uff08CDR-SB\uff09\u8bc4\u5206\u7684\u53d8\u5316\uff0c\u8bc4\u4ef7\u6bcf\u6708\u4e00\u6b21\u7ed9\u4e88aducanumab\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\u5728\u51cf\u5c11\u8ba4\u77e5\u548c\u529f\u80fd\u635f\u5bb3\u65b9\u9762\u7684\u6709\u6548\u6027\u3002\u6b21\u8981\u76ee\u7684\u662f\u4f7f\u7528\u7b80\u6613\u7cbe\u795e\u72b6\u6001\u68c0\u67e5\u8868\uff08MMSE\uff09\u3001\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u8bc4\u4f30\u91cf\u8868-\u8ba4\u77e5\u5b50\u91cf\u886813\u9879\uff08ADAS-Cog 13\uff09\u548c\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u5408\u4f5c\u7814\u7a76-\u65e5\u5e38\u751f\u6d3b\u6d3b\u52a8\u91cf\u8868-\u8f7b\u5ea6\u8ba4\u77e5\u969c\u788d\u7248\u672c\uff08ADC-ADL-MCI\uff09\uff0c\u8bc4\u4f30\u6bcf\u6708\u4e00\u6b21\u7ed9\u4e88aducanumab\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\u5bf9\u4e34\u5e8a\u8bc4\u5206\u964d\u4f4e\u7684\u5f71\u54cd\u3002<\/p>\n<p style=\"font-weight: 400;\">\n<p style=\"font-weight: 400;\"><strong>\u5173\u4e8e\u963f\u5c14\u8328\u6d77\u9ed8\u75c5<\/strong><\/p>\n<p style=\"font-weight: 400;\">\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u662f\u4e00\u79cd\u8fdb\u884c\u6027\u795e\u7ecf\u7cfb\u7edf\u75be\u75c5\uff0c\u4f1a\u635f\u5bb3\u60a3\u8005\u7684\u601d\u7ef4\u3001\u8bb0\u5fc6\u548c\u72ec\u7acb\u6027\uff0c\u5bfc\u81f4\u60a3\u8005\u8fc7\u65e9\u6b7b\u4ea1\u3002\u8be5\u75be\u75c5\u76ee\u524d\u5e76\u6ca1\u6709\u836f\u7269\u80fd\u591f\u5236\u6b62\u3001\u5ef6\u7f13\u6216\u9884\u9632\uff0c\u662f\u4e00\u79cd\u65e5\u76ca\u4e25\u91cd\u7684\u5168\u7403\u5065\u5eb7\u5371\u673a\uff0c\u4f1a\u5bf9\u8be5\u75be\u75c5\u60a3\u8005\u53ca\u5176\u5bb6\u5ead\u4ea7\u751f\u5f71\u54cd\u3002\u6839\u636e\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u7684\u6570\u636e\uff0c\u5168\u7403\u6709\u6570\u5343\u4e07\u4eba\u60a3\u6709\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\uff0c\u5e76\u4e14\u5728\u672a\u6765\u51e0\u5e74\u4e2d\uff0c\u8fd9\u4e00\u6570\u5b57\u8fd8\u5c06\u7ee7\u7eed\u589e\u957f\uff0c\u56e0\u6b64\u76ee\u524d\u5bf9\u6cbb\u7597\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u7684\u533b\u7597\u8d44\u6e90\u9700\u6c42\u6781\u9ad8\uff0c\u8017\u8d44\u9700\u6570\u5341\u4ebf\u7f8e\u5143\u3002<\/p>\n<p style=\"font-weight: 400;\">\u6839\u636e\u56fd\u9645\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u534f\u4f1a\u53d1\u5e03\u7684\u300a2019\u5e74\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u5e74\u9274\u300b\uff0c\u4f30\u8ba1\u6b27\u76df\u7ea6\u67091000\u4e07\u4eba\u60a3\u6709\u75f4\u5446\uff08\u4e0d\u5305\u62ec\u8f7b\u5ea6\u8ba4\u77e5\u969c\u788d\uff09\uff0c\u5176\u4e2d\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u7ea6\u5360\u75f4\u5446\u75c5\u4f8b\u768460%-70%\u3002<\/p>\n<p style=\"font-weight: 400;\">\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u7684\u7279\u5f81\u8868\u73b0\u4e3a\u5927\u8111\u53d8\u5316\uff0c\u5305\u62ec\u6bd2\u6027\u6dc0\u7c89\u6837\u03b2\u86cb\u767d\u6591\u5757\u5f02\u5e38\u84c4\u79ef\uff0c\u7ea6\u5728\u60a3\u8005\u51fa\u73b0\u75be\u75c5\u75c7\u72b6\u524d20\u5e74\u5c31\u5df2\u7ecf\u5f00\u59cb\u51fa\u73b0\u3002\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u5f15\u8d77\u7684\u8f7b\u5ea6\u8ba4\u77e5\u969c\u788d\u662f\u8be5\u75be\u75c5\u7684\u65e9\u671f\u9636\u6bb5\u4e4b\u4e00\uff0c\u5728\u8be5\u75c7\u72b6\u5f00\u59cb\u53d8\u5f97\u66f4\u52a0\u660e\u663e\u65f6\uff0c\u5c31\u53ef\u4ee5\u88ab\u53d1\u73b0\u5e76\u88ab\u8bca\u65ad\u3002\u76ee\u524d\u7684\u7814\u7a76\u5de5\u4f5c\u4fa7\u91cd\u4e8e\u5c3d\u65e9\u53d1\u73b0\u5e76\u6cbb\u7597\u60a3\u8005\uff0c\u4ee5\u83b7\u5f97\u51cf\u7f13\u6216\u963b\u6b62\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u8fdb\u5c55\u7684\u6700\u4f73\u65f6\u673a\u3002<\/p>\n<p style=\"font-weight: 400;\">\u00a0<strong><br \/>\n<\/strong><\/p>\n<p style=\"font-weight: 400;\"><strong>\u5173\u4e8eBiogen<\/strong><\/p>\n<p style=\"font-weight: 400;\">\u5728Biogen\uff0c\u6211\u4eec\u7684\u4f7f\u547d\u6e05\u6670\u660e\u786e\uff1a\u6211\u4eec\u662f\u795e\u7ecf\u79d1\u5b66\u9886\u57df\u7684\u5148\u950b\u3002Biogen\u4e3a\u5168\u7403\u60a3\u6709\u4e25\u91cd\u795e\u7ecf\u7cfb\u7edf\u548c\u795e\u7ecf\u9000\u884c\u6027\u75be\u75c5\u4ee5\u53ca\u76f8\u5173\u6cbb\u7597\u90bb\u8fd1\u75be\u75c5\u7684\u60a3\u8005\u63a2\u5bfb\u3001\u7814\u53d1\u548c\u63d0\u4f9b\u521b\u65b0\u7597\u6cd5\u3002Biogen\u662fCharles Weissmann\u3001Heinz Schaller\u3001Kenneth Murray\u4e0e\u8bfa\u8d1d\u5c14\u5956\u83b7\u5f97\u8005Walter Gilbert\u548cPhillip 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</body>