{"id":5152,"date":"2022-05-17T00:52:47","date_gmt":"2022-05-17T00:52:47","guid":{"rendered":"\/\/smallcapscn.x5view.co\/?p=5152"},"modified":"2023-08-29T17:54:05","modified_gmt":"2023-08-29T17:54:05","slug":"incannex-meets-us-fda-ihl-42x-treat-obstructive-sleep-apnoea","status":"publish","type":"post","link":"https:\/\/smallcapscn.x5view.co\/?p=5152","title":{"rendered":"Incannex \u4e0e\u7f8e\u56fd FDA \u5c31\u5f00\u53d1 IHL-42X \u6cbb\u7597\u963b\u585e\u6027\u7761\u7720\u547c\u5438\u6682\u505c\u4f1a\u9762"},"content":{"rendered":"

\u4e34\u5e8a\u9636\u6bb5\u5927\u9ebb\u7d20\u836f\u7269\u5f00\u53d1\u516c\u53f8 Incannex Healthcare (ASX: IHL) \u5df2\u5b8c\u6210\u4e0e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u8c03\u67e5\u524d\u65b0\u836f\u7533\u8bf7 (pre-IND) \u4f1a\u8bae\uff0c\u8ba8\u8bba\u5176\u5019\u9009\u836f\u7269 IHL-42X \u7684\u5f00\u53d1.<\/p>\n

\u8be5\u836f\u7269\u662f\u5c48\u5927\u9ebb\u915a\u548c\u4e59\u9170\u5511\u80fa\u7684\u56fa\u5b9a\u5242\u91cf\u7ec4\u5408\uff0c\u88ab\u8bbe\u8ba1\u4e3a\u7528\u4e8e\u6cbb\u7597\u6210\u4eba\u963b\u585e\u6027\u7761\u7720\u547c\u5438\u6682\u505c (OSA) \u7684\u7247\u5242\u3002<\/p>\n

Incannex \u5728 2 \u6708\u4efd\u63d0\u4ea4\u4e86 IND \u524d\u4f1a\u8bae\u6587\u4ef6\u548c\u8bf7\u6c42\uff0c\u5176\u4e2d\u5305\u62ec\u5f00\u53d1\u8ba1\u5212\u7684\u6982\u8ff0\u4ee5\u53ca\u4e0e\u5f00\u653e\u7814\u7a76\u6027\u65b0\u836f (IND) \u7533\u8bf7\u7684\u76d1\u7ba1\u8981\u6c42\u6709\u5173\u7684\u5177\u4f53\u95ee\u9898\u3002<\/p>\n

\u5728\u7f8e\u56fd\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u9700\u8981 IND\uff0c\u5e76\u786e\u4fdd\u8bd5\u9a8c\u65e8\u5728\u6ee1\u8db3 FDA \u8425\u9500\u6279\u51c6\u6240\u9700\u7684\u6570\u636e\u8981\u6c42\u3002<\/p>\n

\u5efa\u8bbe\u6027\u548c\u652f\u6301\u6027<\/h2>\n

Incannex \u8868\u793a\uff0c\u4e66\u9762\u7b54\u590d\u4ee5\u53ca\u5728\u4e0e FDA \u4ee3\u8868\u7684\u7535\u8bdd\u4f1a\u8bae\u4e2d\u63d0\u4f9b\u7684\u7b54\u590d\u662f\u201c\u5efa\u8bbe\u6027\u7684\u548c\u652f\u6301\u6027\u7684\u201d\uff0c\u8be5\u9879\u76ee\u7684\u5174\u8da3\u662f\u7531\u5927\u91cf\u88ab\u8bca\u65ad\u60a3\u6709 OSA \u7684\u4eba\u7fa4\u548c\u7f3a\u4e4f\u836f\u7269\u6cbb\u7597\u89e3\u51b3\u65b9\u6848\u6240\u652f\u6491\u7684\u3002<\/p>\n

\u5e02\u573a\u4e0a\u6ca1\u6709\u6cbb\u7597 OSA \u7684\u6ce8\u518c\u836f\u7269\uff0c\u76ee\u524d\u6700\u597d\u7684\u6cbb\u7597\u9009\u62e9\u662f CPAP \u673a\u5668\uff0c\u4f46\u7531\u4e8e\u5305\u62ec\u4e0d\u9002\u5728\u5185\u7684\u5404\u79cd\u56e0\u7d20\uff0c\u60a3\u8005\u7684\u4f9d\u4ece\u6027\u8f83\u4f4e\u3002<\/p>\n

FDA \u5c31\u516c\u53f8\u7684\u957f\u671f\u53d1\u5c55\u6218\u7565\u63d0\u4f9b\u4e86\u6307\u5bfc\uff0c\u5305\u62ec\u5728 2 \u671f\u548c 3 \u671f\u5173\u952e\u7814\u7a76\u4e2d\u8bc1\u660e\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u5177\u4f53\u53c2\u6570\u3002<\/p>\n

Incannex \u5df2\u8868\u793a\u5c06\u4f7f\u7528\u8be5\u6307\u5357\u8c03\u6574\u5176\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\uff0c\u4ee5\u751f\u6210\u65b0\u836f\u7533\u8bf7 (NDA) \u6240\u9700\u7684\u6570\u636e\u3002<\/p>\n

\u6ca1\u6709\u52a8\u7269\u7814\u7a76<\/h2>\n

\u5728\u4e00\u9879\u5c06\u8282\u7701 Incannex \u65f6\u95f4\u548c\u6210\u672c\u7684\u51b3\u5b9a\u4e2d\uff0cFDA \u540c\u610f\u8be5\u516c\u53f8\u4e0d\u9700\u8981\u5728\u52a8\u7269\u8eab\u4e0a\u8fdb\u884c\u7814\u7a76\u3002<\/p>\n

\u7279\u522b\u662f\uff0c\u5b83\u8bc1\u5b9e\u4e86\u4e3a IHL-42X \u6253\u5f00 IND \u4e0d\u9700\u8981\u52a8\u7269\u6bd2\u7406\u5b66\u548c\u52a8\u7269\u836f\u4ee3\u52a8\u529b\u5b66 (PK) \u7814\u7a76\u3002<\/p>\n

Incannex \u8868\u793a\uff0c\u5f00\u53d1 IHL-42X \u7684\u4e0b\u4e00\u6b65\u5c06\u662f\u8c03\u6574\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u5b89\u6392\u4e0e FDA \u5f00\u7acb IND \u6240\u9700\u7684\u64cd\u4f5c\u8981\u6c42\u3002<\/p>\n

\u6f5c\u5728\u7597\u6cd5<\/h2>\n

Incannex \u9996\u5e2d\u79d1\u5b66\u5b98 Mark Bleackley \u535a\u58eb\u8868\u793a\uff0cFDA \u5bf9 IHL-42X \u4f5c\u4e3a\u4e00\u79cd\u6f5c\u5728\u7684 OSA \u7597\u6cd5\u7684\u5174\u8da3\u4f7f\u516c\u53f8\u53d7\u5230\u9f13\u821e\u3002<\/p>\n

\u201c\u5c31\u603b\u4f53\u62df\u8bae\u5f00\u53d1\u8ba1\u5212\u63d0\u4f9b\u7684\u53cd\u9988\u662f\u79ef\u6781\u7684\uff0c[FDA] \u5bf9\u6211\u4eec\u63d0\u51fa\u7684\u5177\u4f53\u95ee\u9898\u7684\u56de\u5e94\u5c06\u4f7f\u6211\u4eec\u80fd\u591f\u4fee\u6539\u6211\u4eec\u7684\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\uff0c\u4ee5\u786e\u4fdd\u6211\u4eec\u8fdb\u884c\u9ad8\u6548\u7684\u7814\u7a76\uff0c\u751f\u6210 FDA \u7684\u6570\u636e\u7c7b\u578b\u548c\u6570\u91cf\u5c06\u9700\u8981\u5728\u672a\u6765\u7684\u8425\u9500\u5e94\u7528\u7a0b\u5e8f\u4e2d\uff0c\u201c\u4ed6\u8bf4\u3002<\/p>\n

\u201cIND \u524d\u4f1a\u8bae\u7684\u7ed3\u679c\u5c06\u5728\u672a\u6765\u51e0\u4e2a\u6708\u5185\u5851\u9020 IHL-42X \u5f00\u53d1\u8ba1\u5212\u3002\u201d<\/p>\n

\u6982\u5ff5\u9a8c\u8bc1\u8bd5\u9a8c<\/h2>\n

\u53bb\u5e74\uff0cIncannex \u5b8c\u6210\u4e86\u4e00\u9879 2 \u671f\u6982\u5ff5\u9a8c\u8bc1\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u8bc4\u4f30 OSA \u60a3\u8005\u7684 IHL-42X<\/a>\u3002<\/p>\n

\u521d\u6b65\u7ed3\u679c\u8868\u660e\uff0c\u4e0e\u57fa\u7ebf\u76f8\u6bd4\uff0c60% \u7684\u8bd5\u9a8c\u53c2\u4e0e\u8005\u5728\u81f3\u5c11\u4e00\u6b21\u6cbb\u7597\u671f\u95f4\u7684\u547c\u5438\u6682\u505c\u4f4e\u901a\u6c14\u6307\u6570 (AHI) \u964d\u4f4e\u4e86 55% \u4ee5\u4e0a\u3002<\/p>\n

\u5927\u7ea6 20% \u7684\u53c2\u4e0e\u8005\u7ecf\u5386\u4e86\u8d85\u8fc7 80% \u7684 AHI \u964d\u4f4e\u3002<\/p>\n

Incannex \u9884\u8ba1\u5b8c\u6574\u7684\u4e34\u5e8a\u7814\u7a76\u62a5\u544a\u5c06\u4e8e\u4e0b\u4e2a\u6708\u53d1\u5e03\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

\u4e34\u5e8a\u9636\u6bb5\u5927\u9ebb\u7d20\u836f\u7269\u5f00\u53d1\u516c\u53f8 Incannex Healthcare (ASX: IHL) \u5df2\u5b8c\u6210\u4e0e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u8c03\u67e5\u524d\u65b0\u836f\u7533\u8bf7 (pre-IND) \u4f1a\u8bae\uff0c\u8ba8\u8bba\u5176\u5019\u9009\u836f\u7269 IHL-42X \u7684\u5f00\u53d1. \u8be5\u836f\u7269\u662f\u5c48\u5927\u9ebb\u915a\u548c\u4e59\u9170\u5511\u80fa\u7684\u56fa\u5b9a\u5242\u91cf\u7ec4\u5408\uff0c\u88ab\u8bbe\u8ba1\u4e3a\u7528\u4e8e\u6cbb\u7597\u6210\u4eba\u963b\u585e\u6027\u7761\u7720\u547c\u5438\u6682\u505c (OSA) \u7684\u7247\u5242\u3002 Incannex \u5728 2 \u6708\u4efd\u63d0\u4ea4\u4e86 IND \u524d\u4f1a\u8bae\u6587\u4ef6\u548c\u8bf7\u6c42\uff0c\u5176\u4e2d\u5305\u62ec\u5f00\u53d1\u8ba1\u5212\u7684\u6982\u8ff0\u4ee5\u53ca\u4e0e\u5f00\u653e\u7814\u7a76\u6027\u65b0\u836f (IND) \u7533\u8bf7\u7684\u76d1\u7ba1\u8981\u6c42\u6709\u5173\u7684\u5177\u4f53\u95ee\u9898\u3002 \u5728\u7f8e\u56fd\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u9700\u8981 IND\uff0c\u5e76\u786e\u4fdd\u8bd5\u9a8c\u65e8\u5728\u6ee1\u8db3 FDA \u8425\u9500\u6279\u51c6\u6240\u9700\u7684\u6570\u636e\u8981\u6c42\u3002 \u5efa\u8bbe\u6027\u548c\u652f\u6301\u6027 Incannex \u8868\u793a\uff0c\u4e66\u9762\u7b54\u590d\u4ee5\u53ca\u5728\u4e0e FDA \u4ee3\u8868\u7684\u7535\u8bdd\u4f1a\u8bae\u4e2d\u63d0\u4f9b\u7684\u7b54\u590d\u662f\u201c\u5efa\u8bbe\u6027\u7684\u548c\u652f\u6301\u6027\u7684\u201d\uff0c\u8be5\u9879\u76ee\u7684\u5174\u8da3\u662f\u7531\u5927\u91cf\u88ab\u8bca\u65ad\u60a3\u6709 OSA \u7684\u4eba\u7fa4\u548c\u7f3a\u4e4f\u836f\u7269\u6cbb\u7597\u89e3\u51b3\u65b9\u6848\u6240\u652f\u6491\u7684\u3002 \u5e02\u573a\u4e0a\u6ca1\u6709\u6cbb\u7597 OSA \u7684\u6ce8\u518c\u836f\u7269\uff0c\u76ee\u524d\u6700\u597d\u7684\u6cbb\u7597\u9009\u62e9\u662f CPAP \u673a\u5668\uff0c\u4f46\u7531\u4e8e\u5305\u62ec\u4e0d\u9002\u5728\u5185\u7684\u5404\u79cd\u56e0\u7d20\uff0c\u60a3\u8005\u7684\u4f9d\u4ece\u6027\u8f83\u4f4e\u3002 FDA \u5c31\u516c\u53f8\u7684\u957f\u671f\u53d1\u5c55\u6218\u7565\u63d0\u4f9b\u4e86\u6307\u5bfc\uff0c\u5305\u62ec\u5728 2 \u671f\u548c 3 \u671f\u5173\u952e\u7814\u7a76\u4e2d\u8bc1\u660e\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u5177\u4f53\u53c2\u6570\u3002 Incannex \u5df2\u8868\u793a\u5c06\u4f7f\u7528\u8be5\u6307\u5357\u8c03\u6574\u5176\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\uff0c\u4ee5\u751f\u6210\u65b0\u836f\u7533\u8bf7 (NDA) \u6240\u9700\u7684\u6570\u636e\u3002 \u6ca1\u6709\u52a8\u7269\u7814\u7a76 \u5728\u4e00\u9879\u5c06\u8282\u7701 Incannex \u65f6\u95f4\u548c\u6210\u672c\u7684\u51b3\u5b9a\u4e2d\uff0cFDA \u540c\u610f\u8be5\u516c\u53f8\u4e0d\u9700\u8981\u5728\u52a8\u7269\u8eab\u4e0a\u8fdb\u884c\u7814\u7a76\u3002 \u7279\u522b\u662f\uff0c\u5b83\u8bc1\u5b9e\u4e86\u4e3a… Continue reading Incannex \u4e0e\u7f8e\u56fd FDA \u5c31\u5f00\u53d1 IHL-42X \u6cbb\u7597\u963b\u585e\u6027\u7761\u7720\u547c\u5438\u6682\u505c\u4f1a\u9762<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":17251,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[3],"tags":[33],"yoast_head":"\nIncannex \u4e0e\u7f8e\u56fd FDA \u5c31\u5f00\u53d1 IHL-42X \u6cbb\u7597\u963b\u585e\u6027\u7761\u7720\u547c\u5438\u6682\u505c\u4f1a\u9762<\/title>\n<meta name=\"description\" content=\"\u4e34\u5e8a\u9636\u6bb5\u5927\u9ebb\u7d20\u836f\u7269\u5f00\u53d1\u516c\u53f8 Incannex Healthcare (ASX: IHL) \u5df2\u5b8c\u6210\u4e0e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u8c03\u67e5\u524d\u65b0\u836f\u7533\u8bf7 (pre-IND) \u4f1a\u8bae\uff0c\u8ba8\u8bba\u5176\u5019\u9009\u836f\u7269 IHL-42X \u7684\u5f00\u53d1.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Incannex \u4e0e\u7f8e\u56fd FDA \u5c31\u5f00\u53d1 IHL-42X \u6cbb\u7597\u963b\u585e\u6027\u7761\u7720\u547c\u5438\u6682\u505c\u4f1a\u9762\" \/>\n<meta property=\"og:description\" content=\"\u4e34\u5e8a\u9636\u6bb5\u5927\u9ebb\u7d20\u836f\u7269\u5f00\u53d1\u516c\u53f8 Incannex Healthcare (ASX: IHL) \u5df2\u5b8c\u6210\u4e0e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u8c03\u67e5\u524d\u65b0\u836f\u7533\u8bf7 (pre-IND) \u4f1a\u8bae\uff0c\u8ba8\u8bba\u5176\u5019\u9009\u836f\u7269 IHL-42X \u7684\u5f00\u53d1.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/smallcapscn.x5view.co\/incannex-meets-us-fda-ihl-42x-treat-obstructive-sleep-apnoea\/\" \/>\n<meta property=\"og:site_name\" content=\"smallcapsCN\" \/>\n<meta property=\"article:published_time\" content=\"2022-05-17T00:52:47+00:00\" \/>\n<meta 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