{"id":6164,"date":"2022-07-26T11:44:56","date_gmt":"2022-07-26T03:44:56","guid":{"rendered":"https:\/\/www.eisai.com.cn\/?p=6164"},"modified":"2022-07-28T15:01:01","modified_gmt":"2022-07-28T07:01:01","slug":"%e5%8d%ab%e6%9d%90%e5%b0%86%e5%9c%a82022%e5%b9%b4%e9%98%bf%e5%b0%94%e8%8c%a8%e6%b5%b7%e9%bb%98%e7%97%85%e5%8d%8f%e4%bc%9a%e5%9b%bd%e9%99%85%e4%bc%9a%e8%ae%aeaaic%e4%b8%8a%e5%b1%95%e7%a4%ba%e5%8c%85","status":"publish","type":"post","link":"https:\/\/www.eisai.com.cn\/2022\/07\/26\/%e5%8d%ab%e6%9d%90%e5%b0%86%e5%9c%a82022%e5%b9%b4%e9%98%bf%e5%b0%94%e8%8c%a8%e6%b5%b7%e9%bb%98%e7%97%85%e5%8d%8f%e4%bc%9a%e5%9b%bd%e9%99%85%e4%bc%9a%e8%ae%aeaaic%e4%b8%8a%e5%b1%95%e7%a4%ba%e5%8c%85\/","title":{"rendered":"\u536b\u6750\u5c06\u57282022\u5e74\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u534f\u4f1a\u56fd\u9645\u4f1a\u8bae(AAIC)\u4e0a\u5c55\u793a\u5305\u62ecARIA-E\u548c\u76ae\u4e0b\u7ed9\u836f\u65b9\u9762\u7684lecanemab\u6700\u65b0\u6570\u636e\u4ee5\u53ca\u5176\u5b83\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u7814\u7a76"},"content":{"rendered":"
\u536b\u6750\u682a\u5f0f\u4f1a\u793e\uff08\u4ee5\u4e0b\u7b80\u79f0\u201c\u536b\u6750\u201d\uff097\u670826\u65e5\u5ba3\u5e03\uff0c\u516c\u53f8\u5c06\u4e8e2022\u5e747\u670831\u65e5\u52308\u67084\u65e5\u5728\u7f8e\u56fd\u5723\u5730\u4e9a\u54e5\u4e3e\u884c\u7684\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u56fd\u9645\u4f1a\u8bae(AAIC)\u4e0a\u5c55\u793a\u5176\u963f\u5c14\u8328\u6d77\u9ed8\u75c5(AD)\u7814\u7a76\u9879\u76ee\u7684\u65b0\u6570\u636e\uff0c\u5305\u62eclecanemab (BAN2401)\u7684\u6700\u65b0\u6570\u636e\u3002lecanemab\u662f\u4e00\u79cd\u7814\u7a76\u6027\u836f\u7269\u6297\u03b2\u6dc0\u7c89\u6837\u86cb\u767d\uff08A\u03b2\uff09\u539f\u7ea4\u7ef4\u6297\u4f53\uff0c\u7528\u4e8e\u6cbb\u7597\u963f\u5c14\u8328\u6d77\u9ed8\u75c5(AD)\u5f15\u8d77\u7684\u8f7b\u5ea6\u8ba4\u77e5\u969c\u788d(MCI)\u548c\u8f7b\u5ea6AD(\u5408\u79f0\u4e3a\u65e9\u671fAD)\u3002\u536b\u6750\u5c06\u5728\u4f1a\u8bae\u4e0a\u4ee5\u4e09\u6b21\u6f14\u8bb2\u548c18\u4e2a\u6d77\u62a5\u5c55\u793a\u5f62\u5f0f\u53d1\u5e03\u6570\u636e\u548c\u7814\u7a76\u7ed3\u679c\u3002<\/p>\n
2022\u5e747\u67085\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40(FDA)\u63a5\u53d7\u4e86\u536b\u6750lecanemab\u7684\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u8bc1\u7533\u8bf7(BLA)\uff0c\u5e76\u7ed9\u4e88\u4f18\u5148\u5ba1\u67e5\uff0c\u5904\u65b9\u836f\u7533\u62a5\u8005\u4ed8\u8d39\u6cd5\u6848(PDUFA)\u7684\u76ee\u6807\u8bc4\u5ba1\u65e5\u671f\u4e3a2023\u5e741\u67086\u65e5\u3002Clarity AD\u7684\u4e3b\u8981\u7ec8\u70b9\u6570\u636e\u5c06\u4e8e2022\u5e74\u79cb\u5b63\u516c\u5e03\u3002FDA\u5df2\u7ecf\u540c\u610fClarity AD\u7684\u7ed3\u679c\u5b8c\u6210\u540e\uff0c\u53ef\u4ee5\u4f5c\u4e3a\u9a8c\u8bc1lecanemab\u4e34\u5e8a\u7597\u6548\u7684\u9a8c\u8bc1\u6027\u7814\u7a76\u3002<\/p>\n
<\/p>\n
\u536b\u6750AAIC\u91cd\u70b9\u6f14\u8bb2<\/strong><\/p>\n 1. \u57fa\u56e0\u578b\u5bf9Lecanemab\u81f4ARIA-E\u53d1\u75c5\u7684\u5f71\u54cd\uff1a<\/p>\n 201 Core\u7814\u7a76\u8bc4\u4f30\u4e86APOE4\u57fa\u56e0\u578b\u5bf9ARIA-E\u53d1\u75c5\u7387\u5f71\u54cd\u7684\u5efa\u6a21\u548c\u6a21\u62df\u7ed3\u679c\uff0c\u5e76\u4e14\u4e0e\u65b0\u63a5\u53d7lecanemab\u6cbb\u7597\u7684\u5f00\u653e\u6807\u7b7e\u6269\u5c55\u60a3\u8005\u4e2d\u89c2\u5bdf\u5230\u7684\u53d1\u75c5\u7387\u8fdb\u884c\u4e86\u6bd4\u8f83\u3002<\/p>\n <\/p>\n 2. Lecanemab\u76ae\u4e0b\u7ed9\u836f\uff1a<\/p>\n \u5728\u5065\u5eb7\u53d7\u8bd5\u8005\u4e2d\u8bc4\u4f30lecanemab\u7684\u7edd\u5bf9\u751f\u7269\u5229\u7528\u5ea6\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u3001\u5b89\u5168\u6027\u548c\u514d\u75ab\u539f\u6027\u7684\u7814\u7a76\u7ed3\u679c\uff0c\u5355\u6b21\u76ae\u4e0b\u56fa\u5b9a\u5242\u91cf\u4e3a700mg\u3002<\/p>\n \u5efa\u6a21\u548c\u6a21\u62df\u5206\u6790\u65e8\u5728\u663e\u793alecanemab\u6bcf\u5468\u56fa\u5b9a\u5468\u76ae\u4e0b\u5242\u91cf\u4e0e\u57fa\u4e8e\u4f53\u91cd\u768410mg\/kg\u53cc\u5468\u9759\u8109\u6ce8\u5c04\u5242\u91cf\u7684\u7b49\u6548\u6027\u3002<\/p>\n <\/p>\n 3. \u536b\u6750\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u65cf\u88d4\u548c\u79cd\u65cf\u591a\u6837\u6027\uff1a<\/p>\n \u5bf9lecanemab (Study 201\u548cClarity AD)\u548celenbecestat MissionAD\u65e9\u671f\u7814\u7a76\u5728\u7f8e\u56fd\u7684\u6ce8\u518c\u60c5\u51b5\u8fdb\u884c\u8bc4\u4f30\uff0c\u8bc4\u4f30\u79cd\u65cf\u548c\u65cf\u88d4\u7fa4\u4f53\u4ee5\u53ca\u8d44\u683c\u6807\u51c6\u7684\u5f71\u54cd\u3002<\/p>\n <\/p>\n 4. \u03b2-\u6dc0\u7c89\u6837\u86cb\u767d\u5b9e\u9a8c\u9884\u6d4b\u8111\u03b2-\u6dc0\u7c89\u6837\u86cb\u767d\u75c5\u7406\uff1a<\/p>\n \u536b\u6750\u548cSysmex\u5408\u4f5c\u7684\u6570\u636e\u62a5\u544a\u4e86\u5168\u81ea\u52a8\u8840\u6d46A\u03b240\u548cA\u03b242\u514d\u75ab\u6d4b\u5b9a\uff0c\u4ee5\u53ca\u5b83\u4eec\u9884\u6d4b\u6dc0\u7c89\u6837PET\u5b9a\u4e49\u7684\u8111A\u03b2\u75c5\u7406\u7684\u6027\u80fd\u3002<\/p>\n <\/p>\n 5. \u663e\u6027\u9057\u4f20\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u7f51\u7edc(DIAN)\u7684\u7efc\u5408CSF Tau\u5206\u6790\uff1a<\/p>\n \u6f14\u8bb2\u5c06\u5206\u4eab\u4e00\u9879\u7814\u7a76\u7684\u7ed3\u679c\uff0c\u8be5\u7814\u7a76\u5728\u534e\u76db\u987f\u5927\u5b66\u533b\u5b66\u9662\u7684DIAN\u89c2\u5bdf\u961f\u5217\u4e2d\u767b\u8bb0\u7684\u60a3\u8005\u4e2d\uff0c\u4f7f\u7528\u536b\u6750\u7684\u6297\u5fae\u7ba1\u7ed3\u5408\u533a(MTBR)\u6297\u4f53E2814\u6765\u5206\u6790MTBR-tau\uff0c\u7136\u540e\u8bc4\u4f30CSF\u4e2dMTBR-tau\u53d8\u5316\u7684\u65f6\u95f4\u4e0e\u4e34\u5e8a\u3001\u8ba4\u77e5\u548c\u751f\u7269\u6807\u5fd7\u7269\u53d8\u5316\u7684\u76f8\u5173\u6027\u3002<\/p>\n \u536b\u6750\u7f8e\u56fd\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u4e0e\u8111\u5065\u5eb7\u9ad8\u7ea7\u526f\u603b\u88c1\u3001\u526f\u9996\u5e2d\u4e34\u5e8a\u5b98Michael Irizarry\u535a\u58eb\u8868\u793a\uff0c\u201c\u5373\u5c06\u57282022\u5e74AAIC\u4e0a\u5c55\u793a\u7684lecanemab\u6570\u636e\u4f1a\u7ee7\u7eed\u5efa\u7acb\u7814\u7a76\u6027\u6297\u6dc0\u7c89\u6837\u03b2\u539f\u7ea4\u7ef4\u6297\u4f53\u7684\u77e5\u8bc6\u4f53\u7cfb\uff0c\u536b\u6750\u4e5f\u5c06\u5728\u4eca\u5e74\u79cb\u5b63\u8fdb\u884c\u7b2c\u4e09\u9636\u6bb5\u9a8c\u8bc1\u6027Clarity AD\u8bfb\u6570\u3002\u63d0\u4ea4\u7684\u5176\u5b83\u7814\u7a76\u5c06\u5f3a\u8c03\u4e86\u536b\u6750\u5728\u7f8e\u56fd\u65e9\u671f\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4e3a\u6539\u5584\u65cf\u88d4\u548c\u79cd\u65cf\u591a\u6837\u6027\u6240\u505a\u7684\u52aa\u529b\uff0c\u56e0\u6b64\u7814\u7a76\u4eba\u7fa4\u53cd\u6620\u4e86\u7f8e\u56fd\u533b\u7597\u4fdd\u9669\u4eba\u53e3\u60c5\u51b5\uff0c\u4ee5\u53ca\u6211\u4eec\u4e0eSysmex\u5408\u4f5c\u8fdb\u884c\u7684\u53ef\u80fd\u6709\u52a9\u4e8e\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u65e9\u671f\u8bca\u65ad\u7684\u6f5c\u5728\u751f\u7269\u6807\u8bb0\u7269\u7684\u7814\u7a76\u3002\u201d<\/p>\n <\/p>\n