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\u672c\u6b21NDS\u662f\u57fa\u4e8eIII\u671fClarity AD\u7814\u7a76\u548cIIb\u671f\u4e34\u5e8a\u7814\u7a76\uff08Study 201\uff09\u7684\u7ed3\u679c\uff0c\u8fd9\u4e9b\u7814\u7a76\u8868\u660e\uff0cLecanemab\u7684\u6cbb\u7597\u663e\u793a\u4e86\u65e9\u671fAD\u4e34\u5e8a\u8870\u9000\u7684\u51cf\u5c11\u3002Lecanemab\u80fd\u9009\u62e9\u6027\u5730\u7ed3\u5408\u5e76\u6d88\u9664\u53ef\u6eb6\u4e14\u6709\u6bd2\u7684A\u03b2\u805a\u96c6\u7269\uff08\u539f\u7ea4\u7ef4\uff09\uff0c\u8fd9\u4e9b\u805a\u96c6\u7269\u88ab\u8ba4\u4e3a\u662f\u5bfc\u81f4AD\u795e\u7ecf\u6bd2\u6027\u7684\u539f\u56e0\u3002\u56e0\u6b64\uff0cLecanemab\u5177\u6709\u5bf9\u75be\u75c5\u75c5\u7406\u4ea7\u751f\u5f71\u54cd\u5e76\u51cf\u7f13\u75be\u75c5\u8fdb\u5c55\u7684\u6f5c\u529b\u3002Lecanemab\u7684Clarity AD\u7814\u7a76\u8fbe\u5230\u4e86\u4e3b\u8981\u7ec8\u70b9\u548c\u6240\u6709\u5173\u952e\u6b21\u8981\u7ec8\u70b9\uff0c\u7ed3\u679c\u5177\u6709\u9ad8\u5ea6\u7edf\u8ba1\u5b66\u610f\u4e49\u30022022\u5e7411\u6708\uff0cClarity AD\u7814\u7a76\u7684\u7ed3\u679c\u57282022\u5e74\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u4e34\u5e8a\u8bd5\u9a8c\uff08CTAD\uff09\u4f1a\u8bae\u4e0a\u516c\u5e03\uff0c\u5e76\u540c\u65f6\u53d1\u8868\u4e8e\u540c\u884c\u8bc4\u8bae\u7684\u533b\u5b66\u6742\u5fd7\u300a\u65b0\u82f1\u683c\u5170\u533b\u5b66\u6742\u5fd7\u300b\u3002<\/p>\n

Lecanemab\u5728\u7f8e\u56fd\u7684\u5ba1\u8bc4\u8fdb\u7a0b<\/strong><\/p>\n

Lecanemab\u5df2\u5728\u5feb\u901f\u901a\u9053\u8ba4\u5b9a\u4e0b\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\uff0c\u5e76\u4e8e2023\u5e741\u670818\u65e5\u4e0a\u5e02\u3002\u8be5\u6279\u51c6\u662f\u57fa\u4e8eLecanemab\u7684II\u671f\u6570\u636e\uff0c\u8be5\u6570\u636e\u8868\u660eLecanemab\u80fd\u51cf\u5c11\u5927\u8111\u4e2dA\u03b2\u6591\u5757\u7684\u79ef\u7d2f\u2014\u2014AD\u7684\u4e00\u4e2a\u51b3\u5b9a\u6027\u7279\u5f81\uff0c\u540e\u7eed\u6279\u51c6\u5c06\u53d6\u51b3\u4e8eLecanemab\u5728\u9a8c\u8bc1\u6027\u8bd5\u9a8c\u4e2d\u7684\u4e34\u5e8a\u83b7\u76ca\u3002<\/p>\n

2023\u5e741\u67086\u65e5\uff0c\u536b\u6750\u5411\u7f8e\u56fdFDA\u63d0\u4ea4\u4e86\u4e00\u4efd\u8865\u5145\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\uff08sBLA\uff09\uff0c\u4ee5\u83b7\u5f97\u4f20\u7edf\u9014\u5f84\u7684\u6279\u51c6\u30023\u67083\u65e5\uff0cFDA\u6839\u636eClarity AD\u7684\u4e34\u5e8a\u6570\u636e\u63a5\u53d7\u4e86\u536b\u6750\u7684sBLA\uff0c\u5e76\u4e14\u6388\u4e88\u4e86Lecanemab\u4f18\u5148\u5ba1\u8bc4\uff0c\u5904\u65b9\u836f\u7528\u6237\u6536\u8d39\u6cd5\u6848\uff08PDUFA\uff09\u7684\u751f\u6548\u65e5\u671f\u4e3a2023\u5e747\u67086\u65e5\u3002FDA\u8ba1\u5212\u4e8e6\u67089\u65e5\u53ec\u5f00\u54a8\u8be2\u59d4\u5458\u4f1a\u8ba8\u8bba\u8be5\u7533\u8bf7\u3002<\/p>\n

Lecanemab\u5728\u65e5\u672c\u7684\u5ba1\u8bc4\u8fdb\u7a0b<\/strong><\/p>\n

\u536b\u6750\u4e8e2023\u5e741\u670816\u65e5\u5411\u65e5\u672c\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u7ba1\u7406\u5c40\uff08PMDA\uff09\u63d0\u4ea4\u4e86\u751f\u4ea7\u548c\u9500\u552e\u6279\u51c6\u7533\u8bf7\u3002\u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701\u5df2\u4e8e1\u670826\u65e5\u6279\u51c6Lecanemab\u7684\u4f18\u5148\u5ba1\u67e5\u3002\u672c\u6b21\u5ba1\u8bc4\uff0c\u536b\u6750\u5229\u7528\u4e86PMDA\u7684\u4e8b\u5148\u8bc4\u4f30\u54a8\u8be2\u7cfb\u7edf\uff0c\u4ee5\u7f29\u77edLecanemab\u7684\u5ba1\u67e5\u5468\u671f\u3002<\/p>\n

Lecanemab\u5728\u6b27\u6d32\u548c\u4e2d\u56fd\u7684\u5ba1\u8bc4\u8fdb\u7a0b<\/strong><\/p>\n

2023\u5e741\u67089\u65e5\u536b\u6750\u5411\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u63d0\u4ea4\u4e86\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff08MAA\uff09\uff0c\u8be5\u7533\u8bf7\u4e8e1\u670826\u65e5\u88ab\u53d7\u7406\u3002\u536b\u6750\u4e8e2022\u5e7412\u6708\u5411\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u63d0\u4ea4\u4e86BLA\u7684\u6570\u636e\uff0c\u5e76\u4e8e2\u670827\u65e5\u83b7\u5f97\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\u3002<\/p>\n

Lecanemab\u7684\u5168\u7403\u5f00\u53d1\u548c\u76d1\u7ba1\u63d0\u4ea4\u7531\u536b\u6750\u4e3b\u5bfc\uff0c\u800c\u4ea7\u54c1\u5219\u7531\u536b\u6750\u548c\u6e24\u5065\u5171\u540c\u5546\u4e1a\u5316\u548c\u63a8\u5e7f\u3002\u5176\u4e2d\uff0c\u536b\u6750\u62e5\u6709\u6700\u7ec8\u51b3\u7b56\u6743\u3002<\/p>\n

^{*<\/sup>\u539f\u7ea4\u7ef4\uff1a75- 5000kd\u7684\u5927\u03b2\u805a\u96c6\u53ef\u6eb6\u79cd^{1<\/sup><\/p>\n}}

^{1<\/sup> S\u00f6derberg, L., Johannesson, M., Nygren, P. et al. Lecanemab, Aducanumab, and Gantenerumab – Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer\u2019s Disease. Neurotherapeutics (2022). https:\/\/doi.org\/10.1007\/s13311-022-01308-6. Accessed February 9, 2023<\/p>\n","protected":false},"excerpt":{"rendered":"}

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