{"id":3091,"date":"2019-03-12T00:00:00","date_gmt":"2021-03-18T06:47:33","guid":{"rendered":"https:\/\/www.eisai.com.cn\/?p=3091"},"modified":"2021-03-18T14:47:33","modified_gmt":"2021-03-18T06:47:33","slug":"%e5%8d%ab%e6%9d%90%e5%92%8cimbrium-therapeutics%e5%ae%a3%e5%b8%83%e7%be%8e%e5%9b%bdfda%e6%8e%a5%e5%8f%97lemborexant%e7%94%a8%e4%ba%8e%e6%b2%bb%e7%96%97%e5%a4%b1%e7%9c%a0%e7%97%87%e7%9a%84%e6%96%b0","status":"publish","type":"post","link":"https:\/\/www.eisai.com.cn\/2019\/03\/12\/%e5%8d%ab%e6%9d%90%e5%92%8cimbrium-therapeutics%e5%ae%a3%e5%b8%83%e7%be%8e%e5%9b%bdfda%e6%8e%a5%e5%8f%97lemborexant%e7%94%a8%e4%ba%8e%e6%b2%bb%e7%96%97%e5%a4%b1%e7%9c%a0%e7%97%87%e7%9a%84%e6%96%b0\/","title":{"rendered":"\u536b\u6750\u548cImbrium Therapeutics\u5ba3\u5e03\u7f8e\u56fdFDA\u63a5\u53d7Lemborexant\u7528\u4e8e\u6cbb\u7597\u5931\u7720\u75c7\u7684\u65b0\u836f\u7533\u8bf7"},"content":{"rendered":"
\u4e1c\u4eac\u548c\u5eb7\u6d85\u72c4\u683c\u5dde\u65af\u5766\u798f\u5fb7\u7535\u00a0–\u00a0<\/span>\u536b\u6750\u682a\u5f0f\u4f1a\u793e\uff08\u73b0\u4efb\u793e\u957f\u4e3a\u5185\u85e4\u6674\u592b\uff0c\u4ee5\u4e0b\u7b80\u79f0\u201c<\/span>\u536b\u6750\u201d<\/span>\uff09\u548c\u666e\u6e21\u5236\u836f\uff08Purdue Pharma<\/span>\uff09\u4e00\u5bb6\u4e34\u5e8a\u9636\u6bb5\u751f\u7269\u5236\u836f\u5b50\u516c\u53f8Imbrium \u00a0Therapeutics<\/span>\uff08\u603b\u88c1\u517c\u9996\u5e2d\u6267\u884c\u5b98\u4e3aCraig Landau\u00a0<\/span>\u535a\u58eb\uff09\u4eca\u65e5\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA<\/span>\uff09\u5df2\u53d7\u7406lemborexant<\/span>\u6cbb\u7597\u5931\u7720\u75c7\uff08\u4e00\u79cd\u7761\u7720\u89c9\u9192\u969c\u788d\uff09\u7684\u65b0\u836f\u7533\u8bf7\uff08NDA<\/span>\uff09\uff0c\u5e76\u5df2\u6307\u5b9a\u5904\u65b9\u836f\u7528\u6237\u6536\u8d39\u6cd5\uff08PDUFA<\/span>\uff09\u76ee\u6807\u65e5\u671f\u4e3a2019<\/span>\u5e7412<\/span>\u670827<\/span>\u65e5\u3002 \u8be5\u65b0\u836f\u7533\u8bf7\u57fa\u4e8e\u4e34\u5e8a\u5f00\u53d1\u9879\u76ee\u7684\u6570\u636e\uff0c\u5176\u4e2d\u5305\u62ec\u4e24\u9879\u5173\u4e8elemborexant<\/span>\u7684\u5173\u952eIII<\/span><\/span>\u671f\u7814\u7a76\uff0c\u5373SUNRISE 1<\/span>\uff08\u7814\u7a76304<\/span>\uff09\u548cSUNRISE2<\/span>\uff08\u7814\u7a76303<\/span>\uff09\u3002<\/p>\n \u00b7 <\/span><\/b>SUNRISE 1<\/span>\uff1a\u4e00\u9879\u4e3a\u671f\u4e00\u4e2a\u6708\u7684III<\/span>\u671f\u4e34\u5e8a\u7814\u7a76\uff0c\u610f\u5728\u8bc4\u4f30\u57281,006<\/span>\u540d55<\/span>\u5c81\u53ca\u4ee5\u4e0a\u7684\u8001\u5e74\u4eba\uff08\u8fd9\u4e9b\u60a3\u8005\u4e2d45<\/span>\uff05\u5e74\u9f84\u572865<\/span>\u5c81\u53ca\u4ee5\u4e0a\uff09\u4e2dlemborexant<\/span>\u4e0e\u5b89\u6170\u5242\u53ca\u9633\u6027\u5bf9\u7167\u836f\u7269\u9152\u77f3\u9178\u5511\u5421\u5766\u7f13\u91ca\u5242\uff08zolpidem ER<\/span>\uff09\u5bf9\u6bd4\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u3002\u8be5\u7814\u7a76\u4f7f\u7528\u591a\u5bfc\u7761\u7720\u76d1\u6d4b\u56fe\u5ba2\u89c2\u5730\u5bf9\u7761\u7720\u6f5c\u4f0f\u671f\uff08\u4ece\u6f5c\u4f0f\u671f\u5230\u6301\u7eed\u7761\u7720\u671f\uff0c\u4e3b\u8981\u76ee\u6807\uff09\u3001\u7761\u7720\u6548\u7387\u548c\u7761\u540e\u89c9\u9192\u65f6\u95f4\uff08\u7ef4\u6301\u7761\u7720\u7684\u6548\u679c\uff1b\u5173\u952e\u6b21\u8981\u76ee\u6807\uff09\u8fdb\u884c\u4e86\u8bc4\u4f30\uff0c\u5e76\u8fbe\u5230\u4e86\u4e3b\u8981\u548c\u5173\u952e\u6b21\u8981\u76ee\u6807\u3002Lemborexant<\/span>\u7ec4\u4e2d\u62a5\u544a\u7684\u6700\u5e38\u89c1\u7684\u4e0d\u826f\u4e8b\u4ef6\uff08AEs<\/span>\uff09\u662f\u5934\u75db\u548c\u55dc\u7761\u3002<\/span>1<\/sup><\/span> \u00b7 <\/span><\/b>SUNRISE 2<\/span>\uff1a\u4e00\u9879\u4e3a\u671f12<\/span>\u4e2a\u6708\u7684\u5b89\u6170\u5242\u5bf9\u7167\uff08\u524d6<\/span>\u4e2a\u6708\uff09III<\/span>\u671f\u4e34\u5e8a\u7814\u7a76\uff0c\u8bc4\u4f30lemborexant<\/span>\u5728949<\/span>\u4f8b\u5e74\u9f84\u4e3a18<\/span>\u81f388<\/span>\u5c81\u7684\u6210\u4eba\u5931\u7720\u75c7\u60a3\u8005\u4e2d\u7684\u957f\u671f\u7597\u6548\u548c\u5b89\u5168\u6027\u3002\u8be5\u7814\u7a76\u4f7f\u7528\u7761\u7720\u65e5\u5fd7\u8bc4\u4f30\u4e86\u4e3b\u89c2\uff08\u60a3\u8005\u62a5\u544a\u7684\uff09\u7761\u7720\u6f5c\u4f0f\u671f\uff08\u4e3b\u8981\u76ee\u6807\uff09\u3001\u7761\u7720\u6548\u7387\u548c\u5165\u7761\u540e\u89c9\u9192\uff08\u5173\u952e\u6b21\u8981\u76ee\u6807\uff09\uff0c\u5e76\u8fbe\u5230\u4e86\u9884\u5148\u8bbe\u5b9a\u7684\u4e3b\u8981\u7597\u6548\u76ee\u6807\u548c\u5173\u952e\u6b21\u8981\u7597\u6548\u76ee\u6807\u3002\u5728lemborexant<\/span>\u6cbb\u7597\u7ec4\u4e2d\u62a5\u544a\u7684\u6700\u5e38\u89c1\u7684\u4e0d\u826f\u53cd\u5e94\u662f\u55dc\u7761\u3001\u9f3b\u54bd\u708e\u3001\u5934\u75db\u548c\u6d41\u611f\u3002<\/span>2<\/sup><\/span><\/p>\n \u00a0<\/span><\/p>\n \u201c<\/span>\u6211\u4eec\u5f00\u53d1\u8fd9\u4e00\u7761\u7720\u00a0–\u00a0<\/span>\u89c9\u9192\u7597\u6cd5\u7684\u7ec8\u6781\u76ee\u6807\u662f\u4e3a\u5931\u7720\u75c7\u60a3\u8005\u5e26\u6765\u4e00\u79cd\u65b0\u9009\u62e9\uff0c\u6709\u53ef\u80fd\u63d0\u9ad8\u4ed6\u4eec\u5165\u7761\u3001\u4fdd\u6301\u7761\u7720\u548c\u7b2c\u4e8c\u5929\u65e9\u4e0a\u5b89\u7136\u9192\u6765\u7684\u80fd\u529b\uff0c\u201d<\/span>\u536b\u6750\u795e\u7ecf\u4e8b\u4e1a\u90e8\u9996\u5e2d\u4e34\u5e8a\u5b98\u548c\u9996\u5e2d\u533b\u7597\u5b98Lynn Kramer<\/span>\u533b\u5b66\u535a\u58eb\u5766\u8a00\uff0c\u201cLemborexant<\/span>\u521b\u9020\u7684\u8fd9\u4e00\u91cc\u7a0b\u7891\u8ba9\u6211\u4eec\u8ddd\u79bb\u89e3\u51b3\u6570\u767e\u4e07\u9971\u53d7\u5931\u7720\u75c7\u6298\u78e8\u7684\u60a3\u8005\u672a\u6ee1\u8db3\u7684\u9700\u6c42\u66f4\u8fd1\u4e86\u4e00\u6b65\u3002\u201d<\/span><\/p>\n \u00a0<\/span><\/p>\n \u201c<\/span>\u5931\u7720\u662f\u4e00\u79cd\u7761\u7720\u8d28\u91cf\u548c\u65f6\u957f\u969c\u788d\uff0c\u4f1a\u5bfc\u81f4\u60a3\u8005\u65e5\u5e38\u884c\u4e3a\u529f\u80fd\u53d7\u5230\u4e25\u91cd\u635f\u5bb3\uff0c\u5e76\u5bf9\u5065\u5eb7\u548c\u5e78\u798f\u4ea7\u751f\u957f\u671f\u5f71\u54cd\uff0c\u201d<\/span>3<\/sup><\/span><\/span>\u00a0<\/span>Imbrium Therapeutics\u526f\u603b\u88c1\u3001\u7814\u53d1\u548c\u6cd5\u89c4\u4e8b\u52a1\u603b\u76d1John Renger\u535a\u58eb\u6307\u51fa\uff0c\u201c\u6211\u4eec\u81f4\u529b\u4e8e\u4e0e\u536b\u6750\u5408\u4f5c\u6765\u4e3a\u60a3\u8005\u63d0\u4f9b\u8fd9\u79cd\u7814\u7a76\u6027\u6cbb\u7597\uff0c\u76ee\u524d\u6b63\u5904\u4e8e\u76d1\u7ba1\u90e8\u95e8\u6279\u51c6\u671f\u95f4\u3002\u201d <\/span><\/p>\n \u00a0<\/span><\/p>\n Lemborexant<\/span>\u7531\u536b\u6750\u548cImbrium Therapeutics\u548c\u5171\u540c\u5f00\u53d1<\/span>\uff0c\u7528\u4e8e\u6cbb\u7597\u5305\u62ec\u5931\u7720\u75c7\u5728\u5185\u7684\u591a\u79cd\u7761\u7720\u00a0–\u00a0<\/span>\u89c9\u9192\u969c\u788d\u3002\u4e86\u89e3\u6709\u5173\u5c1a\u5728\u8fdb\u884c\u4e2d\u7684\u4e34\u5e8a\u7814\u7a76\u7684\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95eeclinicaltrials.gov\u00a0<\/span>\u3002<\/p>\n \u00a0<\/span><\/p>\n \u536b\u6750\u548cImbrium Therapeutics<\/span>\u81f4\u529b\u4e8e\u6ee1\u8db3\u65b0\u5174\u7684\u533b\u7597\u9700\u6c42\uff0c\u5e76\u6539\u5584\u60a3\u8005\u53ca\u5176\u5bb6\u4eba\u7684\u751f\u6d3b\u3002<\/p>\n \u00a0<\/span><\/p>\n \u672c\u65b0\u95fb\u7a3f\u63a2\u8ba8\u4e86\u8fd9\u4e00\u5c1a\u5728\u5f00\u53d1\u7684\u836f\u7269\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u7528\u9014\uff0c\u5e76\u975e\u65e8\u5728\u4f20\u8fbe\u6709\u5173\u7597\u6548\u6216\u5b89\u5168\u6027\u7684\u7ed3\u8bba\u3002\u6211\u4eec\u65e0\u6cd5\u4fdd\u8bc1\u6b64\u8bd5\u9a8c\u836f\u7269\u80fd\u591f\u6210\u529f\u5b8c\u6210\u4e34\u5e8a\u5f00\u53d1\u6216\u83b7\u5f97\u536b\u751f\u5f53\u5c40\u7684\u6279\u51c6\u3002<\/p>\n <\/p>\n \u8054\u7cfb\u65b9\u5f0f\uff1a<\/span><\/strong> <\/p>\n \u00a0<\/span> <<\/span>\u7f16\u8005\u6309><\/span><\/strong><\/p>\n 1.\u00a0<\/span>\u5173\u4e8eLemborexant<\/span><\/b><\/p>\n Lemborexant<\/span>\u662f\u4e00\u79cd\u65b0\u578b\u7684\u4e34\u5e8a\u8bd5\u7528\u5c0f\u5206\u5b50\u5316\u5408\u7269\uff0c\u7531\u536b\u6750\u7684\u79d1\u5b66\u5bb6\u53d1\u73b0\u5e76\u8fdb\u884c\u5f00\u53d1\u3002\u8be5\u836f\u901a\u8fc7\u4e0e\u4e24\u79cd\u98df\u6b32\u7d20\u53d7\u4f53\u4e9a\u578b\uff08\u98df\u6b32\u7d20\u53d7\u4f531<\/span>\u548c2<\/span>\uff09\u8fdb\u884c\u7ade\u4e89\u6027\u7ed3\u5408\u6765\u6291\u5236\u98df\u6b32\u7d20\u7684\u4fe1\u53f7\u4f20\u5bfc\u3002\u5728\u5177\u6709\u6b63\u5e38\u7684\u6bcf\u65e5\u7761\u7720 – <\/span>\u89c9\u9192\u8282\u5f8b\u7684\u4e2a\u4f53\u4e2d\uff0c\u98df\u6b32\u7d20\u4fe1\u53f7\u4f20\u5bfc\u88ab\u8ba4\u4e3a\u53ef\u4fc3\u8fdb\u6e05\u9192\u3002\u5728\u60a3\u6709\u7761\u7720 – <\/span>\u89c9\u9192\u969c\u788d\u7684\u4e2a\u4f53\u4e2d\uff0c\u8c03\u8282\u89c9\u9192\u7684\u98df\u6b32\u7d20\u4fe1\u53f7\u4f20\u5bfc\u53ef\u80fd\u4e0d\u80fd\u6b63\u5e38\u5de5\u4f5c\u3002\u4e5f\u5c31\u662f\u8bf4\uff0c\u6291\u5236\u4e0d\u6b63\u5e38\u7684\u98df\u6b32\u7d20\u4fe1\u53f7\u4f20\u5bfc\u53ef\u4ee5\u4fc3\u8fdb\u5165\u7761\u548c\u7ef4\u6301\u7761\u7720\u3002\u536b\u6750\u548cImbrium Therapeutics<\/span>\u6b63\u5728\u5c06lemborexant<\/span>\u4f5c\u4e3a\u591a\u79cd\u7761\u7720 – <\/span>\u89c9\u9192\u969c\u788d\uff08\u5982\u5931\u7720\u75c7\uff09\u7684\u4e00\u79cd\u53ef\u80fd\u7684\u6cbb\u7597\u9009\u62e9\u8fdb\u884c\u7814\u7a76\u3002\u6b64\u5916\uff0c\u4e00\u9879\u5173\u4e8elemborexant <\/span>\u7684\u4e8c\u671f\u4e34\u5e8a\u7814\u7a76\u6b63\u5728\u4e0d\u89c4\u5219\u7684\u7761\u7720–<\/span>\u89c9\u9192\u8282\u5f8b\u7d0a\u4e71\uff08ISWRD<\/span>\uff09\u548c\u8f7b\u4e2d\u5ea6\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u75f4\u5446\u60a3\u8005\u4e2d\u8fdb\u884c\u3002<\/p>\n \u00a0<\/span><\/p>\n 2.\u00a0<\/span>\u5173\u4e8eSUNRISE 1\u00a0<\/span>\uff08\u7814\u7a76304<\/span>\uff09<\/strong>1<\/sup><\/span><\/strong><\/p>\n SUNRISE 1\u662f\u4e00\u9879\u5728\u5317\u7f8e\u548c\u6b27\u6d32\u8fdb\u884c\u7684\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u9633\u6027\u5bf9\u7167\u5e73\u884c\u7814\u7a76\uff0c\u8bc4\u4f30lemborexant<\/span>\u57281,006<\/span>\u540d55<\/span>\u5c81\u53ca\u4ee5\u4e0a\u7684\u7537\u6027\u6216\u5973\u6027\u6210\u5e74\u5931\u7720\u75c7\u60a3\u8005\u4e2d\u7684\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\uff0845<\/span>\uff05\u7684\u60a3\u8005\u5e74\u9f84\u4e3a65<\/span>\u5c81\u53ca\u4ee5\u4e0a\uff09\u3002SUNRISE 1<\/span>\u5305\u62ec\u4e00\u4e2a\u957f\u8fbe35<\/span>\u5929\u7684\u9884\u968f\u673a\u5316\u9636\u6bb5\uff08\u5305\u62ec\u4e3a\u671f\u4e24\u5468\u7684\u5b89\u6170\u5242\u51c6\u5907\u671f\uff09\uff0c\u4ee5\u53ca\u753130<\/span>\u5929\u6cbb\u7597\u671f\u548c\u5728\u7814\u7a76\u7ed3\u675f\u4e4b\u524d\u81f3\u5c11\u4e3a\u671f\u4e24\u5468\u7684\u65e0\u6cbb\u7597\u671f\u7ec4\u6210\u7684\u968f\u673a\u5316\u9636\u6bb5\u3002\u5728\u8fd9\u9879\u7814\u7a76\u4e2d\uff0c\u60a3\u8005\u88ab\u968f\u673a\u5206\u914d\u63a5\u53d7\u5b89\u6170\u5242\u6216\u4e09\u79cd\u6cbb\u7597\u65b9\u6848\u4e2d\u7684\u4e00\u79cd\uff08lemborexant 5mg<\/span>\uff0clemborexant 10mg<\/span>\uff0c\u5511\u5421\u5766ER 6.25mg<\/span>\uff09\u3002<\/p>\n SUNRISE 1\u7684\u4e3b\u8981\u76ee\u7684\u662f\u4f7f\u7528\u591a\u5bfc\u7761\u7720\u56fe\u6765\u8bc1\u660e5mg<\/span>\u548c10mg<\/span>\u5242\u91cf\u7684lemborexant<\/span>\u5728\u5ba2\u89c2\u5165\u7761\u65b9\u9762\u7684\u6548\u679c\u90fd\u4f18\u4e8e\u5b89\u6170\u5242\uff0c\u901a\u8fc7\u4e00\u4e2a\u6708\u6cbb\u7597\u671f\u7684\u6700\u540e\u4e24\u665a\u7684\u7761\u7720\u6f5c\u4f0f\u671f\u81f3\u7761\u7720\u6301\u7eed\u671f\u6765\u8bc4\u4f30\u3002\u5173\u952e\u6b21\u8981\u76ee\u6807\u5305\u62ec\u4e24\u79cdlemborexant<\/span>\u5242\u91cf\u7ec4\u4e0e\u5b89\u6170\u5242\u7ec4\u76f8\u6bd4\u5728\u7761\u7720\u6548\u7387\u548c\u7761\u7720\u540e\u89c9\u9192\u65b9\u9762\u4ece\u57fa\u7ebf\u7684\u53d8\u5316\uff0c\u4ee5\u53ca\u4e24\u79cdlemborexant<\/span>\u5242\u91cf\u7ec4\u4e0e\u5511\u5421\u5766\u5443\uff08ER<\/span>\uff09\u7ec4\u76f8\u6bd4\u5728\u540e\u534a\u591c\u7761\u7720\u540e\u89c9\u9192\uff08WASO2H<\/span>\uff09\u65b9\u9762\u7684\u53d8\u5316\uff0c\u5747\u5728\u4e00\u4e2a\u6708\u6cbb\u7597\u671f\u7684\u6700\u540e\u4e24\u665a\u8fdb\u884c\u3002<\/p>\n \u00a0<\/span><\/p>\n 3.\u00a0<\/span>\u5173\u4e8eSUNRISE 2\u00a0<\/span>\uff08\u7814\u7a76303<\/span>\uff09<\/strong>2<\/sup><\/span><\/strong><\/p>\n SUNRISE 2<\/span>\u662f\u4e00\u9879\u4e3a\u671f12<\/span>\u4e2a\u6708\u7684\u591a\u4e2d\u5fc3\u3001\u5168\u7403\u3001\u968f\u673a\u3001\u5bf9\u7167\u3001\u53cc\u76f2\u5e73\u884c\u7814\u7a76\uff0c\u5728949<\/span>\u4f8b18<\/span>\u81f388<\/span>\u5c81\u7684\u7537\u6027\u548c\u5973\u6027\u5931\u7720\u75c7\u60a3\u8005\u4e2d\u63a2\u7d22lemborexant<\/span>\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u3002SUNRISE 2<\/span>\u5305\u62ec\u957f\u8fbe35<\/span>\u5929\u7684\u9884\u968f\u673a\u5316\u9636\u6bb5\uff08\u5305\u62ec\u4e3a\u671f\u4e24\u5468\u7684\u5b89\u6170\u5242\u51c6\u5907\u671f\uff09\uff0c\u4ee5\u53ca\u7531\u516d\u4e2a\u6708\u5b89\u6170\u5242\u5bf9\u7167\u6cbb\u7597\u671f\u3001\u516d\u4e2a\u6708\u7684\u4ec5\u6d3b\u6027\u836f\u7269\u6cbb\u7597\u671f\u548c\u5728\u7814\u7a76\u7ed3\u675f\u968f\u8bbf\u4e4b\u524d\u4e3a\u671f\u4e24\u5468\u7684\u65e0\u6cbb\u7597\u671f\u7ec4\u6210\u7684\u968f\u673a\u5316\u9636\u6bb5\u3002\u5728\u672c\u7814\u7a76\u4e2d\uff0c\u5728\u5b89\u6170\u5242\u5bf9\u7167\u6cbb\u7597\u671f\u95f4\uff0c\u60a3\u8005\u968f\u673a\u63a5\u53d7\u5b89\u6170\u5242\u6216\u4e24\u79cdlemborexant<\/span>\u6cbb\u7597\u65b9\u6848\u4e2d\u7684\u4e00\u79cd\uff08lemborexant 5mg <\/span>\u6216 lemborexant 10mg\uff09\u3002\u5728\u4ec5\u6d3b\u6027\u836f\u7269\u6cbb\u7597\u671f\u95f4\uff0c\u5728\u7b2c\u4e00\u9636\u6bb5\u4f7f\u7528\u5b89\u6170\u5242\u7684\u60a3\u8005\u88ab\u91cd\u65b0\u968f\u673a\u5316\u5206\u914d\uff0c\u63a5\u53d75mg<\/span>\u621610mg<\/span>\u7684lemborexant<\/span>\u6cbb\u7597\u3002\u5728\u7b2c\u4e00\u9636\u6bb5\u63a5\u53d7\u6d3b\u6027\u836f\u7269\u6cbb\u7597\u7684\u60a3\u8005\u7ee7\u7eed\u63a5\u53d7\u6700\u521d\u7684\u968f\u673a\u6cbb\u7597\u3002<\/p>\n \u4e3b\u8981\u76ee\u6807\u662f\u6839\u636e\u60a3\u8005\u4e3b\u89c2\u62a5\u544a\u7684\u7761\u7720\u65e5\u8bb0\u8bc4\u4f30\u57286<\/span>\u4e2a\u6708\u7684\u5b89\u6170\u5242\u5bf9\u7167\u6cbb\u7597\u540e\u4e3b\u89c2\u5165\u7761\u6f5c\u4f0f\u671f\u76f8\u5bf9\u4e8e\u57fa\u7ebf\u7684\u53d8\u5316\u3002\u5173\u952e\u6b21\u8981\u7ec8\u70b9\u662f\u6839\u636e\u60a3\u8005\u62a5\u544a\u7684\u4e3b\u89c2\u7761\u7720\u65e5\u8bb0\u8bc4\u4f30\u5728\u5b89\u6170\u5242\u5bf9\u7167\u6cbb\u75976<\/span>\u4e2a\u6708\u540e\uff0c\u670d\u7528\u4e24\u79cd\u5242\u91cf\u7684lemborexant<\/span>\u540e\u60a3\u8005\u4e3b\u89c2\u7761\u7720\u6548\u7387\u548c\u4e3b\u89c2\u5165\u7761\u540e\u89c9\u9192\uff08sWASO<\/span>\uff09\u76f8\u5bf9\u4e8e\u57fa\u7ebf\u7684\u53d8\u5316\u3002<\/p>\n \u00a0<\/span><\/p>\n 4.\u00a0<\/span>\u5173\u4e8e\u7761\u7720\u969c\u788d<\/strong><\/p>\n \u4eba\u53e3\u7814\u7a76\u8868\u660e\uff0c\u5168\u4e16\u754c\u53d7\u7761\u7720\u969c\u788d\u5f71\u54cd\u7684\u4eba\u6570\u6bd4\u5148\u524d\u8ba4\u4e3a\u7684\u8981\u591a\u30024<\/sup><\/span>\u00a0<\/span>\u5931\u7720\u75c7\u662f\u6700\u5e38\u89c1\u7684\u7761\u7720\u969c\u788d\uff0c\u5168\u4e16\u754c\u7ea630<\/span>\uff05\u7684\u6210\u5e74\u4eba\u53d7\u5176\u5f71\u54cd\u30024,5<\/sup><\/span>\u00a0<\/span>\u5931\u7720\u75c7\u7684\u7279\u70b9\u662f\u62e5\u6709\u8db3\u591f\u7684\u7761\u7720\u673a\u4f1a\u5374\u5165\u7761\u56f0\u96be\uff0c\u4e0d\u80fd\u7ef4\u6301\u7761\u7720\u6216\u4e24\u8005\u517c\u800c\u6709\u4e4b\u3002\u8fd9\u53ef\u80fd\u4f1a\u5bfc\u81f4\u4e00\u4e9b\u767d\u5929\u75c7\u72b6\uff0c\u5982\u75b2\u52b3\uff0c\u6ce8\u610f\u529b\u4e0d\u96c6\u4e2d\u548c\u70e6\u8e81\u4e0d\u5b89\u7b49\u30023,6<\/sup><\/span><\/p>\n \u826f\u597d\u7684\u7761\u7720\u5bf9\u5305\u62ec\u5927\u8111\u5065\u5eb7\u5728\u5185\u7684\u8eab\u4f53\u5065\u5eb7\u81f3\u5173\u91cd\u8981\u3002\u7761\u7720\u4e0d\u4f73\u53ef\u5bfc\u81f4\u591a\u79cd\u5065\u5eb7\u95ee\u9898\uff0c\u5982\u9ad8\u8840\u538b\u3001\u610f\u5916\u4f24\u5bb3\u3001\u7cd6\u5c3f\u75c5\u3001\u80a5\u80d6\u3001\u6291\u90c1\u3001\u5fc3\u810f\u75c5\u3001\u4e2d\u98ce\u548c\u75f4\u5446\u75c7\u98ce\u9669\u589e\u52a0\u7b49\uff0c\u5e76\u53ef\u80fd\u5bf9\u60c5\u7eea\u548c\u884c\u4e3a\u4ea7\u751f\u4e0d\u826f\u5f71\u54cd\u30023,7<\/sup><\/span><\/p>\n \u52a8\u7269\u548c\u4eba\u7c7b\u7684\u5b9e\u9a8c\u7814\u7a76\u90fd\u63d0\u4f9b\u4e86\u7761\u7720\u540c\u75be\u75c5\u98ce\u9669\u56e0\u7d20\u3001\u75be\u75c5\u53ca\u6b7b\u4ea1\u7387\u76f8\u5173\u7684\u8bc1\u636e\u30028<\/sup><\/span>\u7814\u7a76\u8868\u660e\uff0c\u6700\u4f73\u7761\u7720\u65f6\u957f\u4e3a7<\/span>\u52308<\/span>\u5c0f\u65f6\u30029<\/sup><\/span><\/p>\n \u5973\u6027\u7f79\u60a3\u5931\u7720\u75c7\u7684\u53ef\u80fd\u6027\u662f\u7537\u6027\u76841.4<\/span>\u500d\u300210<\/sup><\/span>\u00a0\u8001\u5e74\u4eba\u5931\u7720\u7684\u60a3\u75c5\u7387\u4e5f\u8f83\u9ad8;<\/span>\u8870\u8001\u7684\u8fdb\u7a0b\u5f80\u5f80\u4f34\u968f\u7740\u7761\u7720\u6a21\u5f0f\u7684\u53d8\u5316\uff0c\u5305\u62ec\u7761\u7720\u4e2d\u65ad\u3001\u9891\u7e41\u9192\u6765\u548c\u65e9\u9192\u800c\u5bfc\u81f4\u7684\u7761\u7720\u65f6\u95f4\u51cf\u5c11\u300211<\/sup><\/span><\/p>\n \u00a0<\/span><\/p>\n 5.\u00a0<\/span>\u5173\u4e8e\u536b\u6750\u682a\u5f0f\u4f1a\u793e<\/strong><\/p>\n \u536b\u6750\u682a\u5f0f\u4f1a\u793e\u662f\u4e00\u5bb6\u9886\u5148\u7684\u4ee5\u7814\u53d1\u4e3a\u4e3b\u7684\u8de8\u56fd\u533b\u836f\u516c\u53f8\uff0c\u603b\u90e8\u4f4d\u4e8e\u65e5\u672c\u3002\u6211\u4eec\u7684\u516c\u53f8\u4f7f\u547d\u4e3a\u201c<\/span>\u5c06\u60a3\u8005\u53ca\u5bb6\u5c5e\u7684\u5229\u76ca\u653e\u5728\u9996\u4f4d\uff0c\u4e3a\u63d0\u5347\u5176\u798f\u7949\u505a\u51fa\u8d21\u732e\u201d<\/span>\uff0c\u5373hhc<\/span><\/i><\/span>\u7406\u5ff5\u3002\u536b\u6750\u62e5\u6709\u8d85\u8fc710,000<\/span>\u540d\u5458\u5de5\uff0c\u5de5\u4f5c\u5728\u516c\u53f8\u904d\u5e03\u5168\u7403\u7684\u7814\u53d1\u4e2d\u5fc3\u3001\u751f\u4ea7\u57fa\u5730\u548c\u8425\u9500\u5b50\u516c\u53f8\u4e2d\u3002\u6211\u4eec\u81f4\u529b\u4e8e\u901a\u8fc7\u7814\u53d1\u521b\u65b0\u4ea7\u54c1\u6765\u6ee1\u8db3\u5404\u79cd\u6cbb\u7597\u9886\u57df\u7684\u672a\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\uff0c\u7279\u522b\u662f\u80bf\u7624\u5b66\u548c\u795e\u7ecf\u75c5\u5b66\u9886\u57df\uff0c\u4ee5\u6b64\u6765\u5b9e\u73b0\u6211\u4eec\u7684hhc<\/span><\/em>\u7406\u5ff5\u3002\u6b64\u5916\uff0c\u6211\u4eec\u6295\u8d44\u5e76\u53c2\u4e0e\u82e5\u5e72\u57fa\u4e8e\u4f19\u4f34\u5173\u7cfb\u7684\u9879\u76ee\uff0c\u4ee5\u6539\u5584\u53d1\u5c55\u4e2d\u56fd\u5bb6\u548c\u65b0\u5174\u56fd\u5bb6\u836f\u54c1\u7f3a\u4e4f\u7684\u72b6\u51b5\u3002\u6709\u5173\u536b\u6750\u682a\u5f0f\u4f1a\u793e\u7684\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee\u00a0www.eisai.com<\/span><\/a>\u00a0<\/span>\u3002<\/p>\n \u00a0<\/span><\/p>\n 6.\u00a0<\/span>\u5173\u4e8eImbrium Therapeutics<\/span><\/strong><\/p>\n Imbrium<\/span>\u662f\u4e00\u5bb6\u4e13\u6ce8\u4e34\u5e8a\u9636\u6bb5\u7684\u751f\u7269\u5236\u836f\u516c\u53f8\uff0c\u81f4\u529b\u4e8e\u5f00\u53d1\u91cd\u91cf\u7ea7\u65b0\u836f\u548c\u751f\u7269\u7597\u6cd5\u6765\u63a8\u52a8\u533b\u836f\u79d1\u5b66\u7684\u53d1\u5c55\u3002\u6211\u4eec\u6b63\u5728\u5bfb\u6c42\u6cbb\u7597\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u75be\u75c5\u3001\u80bf\u7624\u5316\u7597\u548c\u7528\u975e\u963f\u7247\u7c7b\u836f\u7269\u6cbb\u7597\u75bc\u75db\u7684\u65b9\u6cd5\u3002\u4f5c\u4e3a\u666e\u5ea6\u5236\u836f\u7684\u8fd0\u8425\u5b50\u516c\u53f8\uff0cImbrium<\/span>\u81f4\u529b\u4e8e\u5f00\u53d1\u5e76\u63a8\u51fa\u65b0\u836f\uff0c\u4ee5\u6ee1\u8db3\u5168\u7403\u60a3\u8005\u3001\u533b\u751f\u548c\u536b\u751f\u7cfb\u7edf\u7684\u9700\u6c42\u7f3a\u53e3\u3002\u6211\u4eec\u5df2\u7ecf\u5efa\u7acb\u4e86\u5f3a\u5927\u4e14\u591a\u6837\u5316\u7684\u5019\u9009\u8bd5\u9a8c\u836f\u7ba1\u7ebf\uff0c\u79ef\u6781\u4e0e\u884c\u4e1a\u548c\u5b66\u672f\u4f19\u4f34\u5408\u4f5c\uff0c\u4ee5\u786e\u5b9a\u548c\u63a8\u8fdb\u5728\u672a\u6765\u4f1a\u4ea7\u751f\u5f71\u54cd\u529b\u7684\u836f\u7269\u3002\u6b32\u4e86\u89e3\u8be5\u516c\u53f8\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee\u00a0www.imbriumthera.com<\/a>\u00a0<\/span>\u3002<\/p>\n <\/p>\n <\/span><\/p>\n \u53c2\u8003\u6587\u732e
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\n<\/span><\/p>\n
\n<\/span><\/p>\n
\n\u536b\u6750\u682a\u5f0f\u4f1a\u793e\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0\u00a0 \u00a0 Imbrium Therapeutics L.P.
\n\u516c\u5171\u5173\u7cfb\u90e8\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0 \u00a0 \u00a0\u00a0\u00a0 \u00a0 media@imbriumthera.com
\n+81-(0)3-3817-5120<\/span><\/p>\n
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\n<\/b>1<\/sup>\u00a0Eisai Inc. A multicenter, randomized, double-blind, placebo-conrolled, active comparator, parallel-group study of the efficacy and safety of lemborexant in subjects 55 years and older with insomnia disorder. (E2006-G000-304). (Clinicaltrials.gov Identifier NCT02783729). 2018. Unpublished data on file.
\n2<\/sup>\u00a0Eisai Inc. A long-term multicenter, randomized, double-blind, controlled, parallel-group study of the safety and efficacy of lemborexant in subjects with insomnia disorder (E2006-G000-303). (Clinicaltrials.gov Identifier NCT02952820). 2018. Unpublished data on file.
\n3<\/sup>\u00a0Institute of Medicine. Sleep disorders and sleep deprivation: An unmet public health problem. Washington, DC: National Academies Press. 2006.
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