{"id":6533,"date":"2023-03-13T01:22:31","date_gmt":"2023-03-13T01:22:31","guid":{"rendered":"\/\/smallcapscn.x5view.co\/?p=6533"},"modified":"2023-08-29T17:57:14","modified_gmt":"2023-08-29T17:57:14","slug":"neuren-pharmaceuticals-receives-fda-approval-world-first-drug-treat-rett-syndrome","status":"publish","type":"post","link":"https:\/\/smallcapscn.x5view.co\/?p=6533","title":{"rendered":"Neuren Pharmaceuticals \u83b7\u5f97 FDA \u6279\u51c6\u4e16\u754c\u9996\u6b3e\u6cbb\u7597\u96f7\u7279\u7efc\u5408\u5f81\u7684\u836f\u7269"},"content":{"rendered":"

\u603b\u90e8\u4f4d\u4e8e\u58a8\u5c14\u672c\u7684 Neuren Pharmaceuticals (ASX: NEU) \u5ba3\u5e03\u5176\u5317\u7f8e\u5408\u4f5c\u4f19\u4f34 Acadia Pharmaceuticals (NASDAQ: ACAD) \u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u6279\u51c6\uff0cNeuren \u7684\u4e3b\u8981\u5019\u9009\u836f\u7269 Daybue (trofinetide) \u7528\u4e8e\u6cbb\u7597\u60a3\u96f7\u7279\u7efc\u5408\u5f81\u7684\u6210\u4eba\u548c\u513f\u7ae5\u3002<\/p>\n

\u8be5\u836f\u7269\u662f\u4e16\u754c\u4e0a\u7b2c\u4e00\u4e2a\u4e5f\u662f\u552f\u4e00\u4e00\u4e2a\u83b7\u6279\u7684\u96f7\u7279\u7efc\u5408\u5f81\u6cbb\u7597\u836f\u7269\uff0c\u9884\u8ba1\u5c06\u4e8e 4 \u6708\u5e95\u4ee5\u53e3\u670d\u6eb6\u6db2\u7684\u5f62\u5f0f\u6295\u653e\u7f8e\u56fd\u5e02\u573a\u3002<\/p>\n

Trofinetide \u7684\u4f5c\u7528\u662f\u51cf\u5c11\u5927\u8111\u4e2d\u7684\u708e\u75c7\uff0c\u963b\u6b62\u67d0\u4e9b\u7c7b\u578b\u7684\u7ec6\u80de\u53d8\u5f97\u8fc7\u5ea6\u6d3b\u8dc3\uff0c\u5e76\u589e\u52a0\u5929\u7136\u5b58\u5728\u7684 IGF-1 \u86cb\u767d\u7684\u6570\u91cf\u3002<\/p>\n

\u5728\u7814\u7a76\u4e2d\uff0c\u670d\u7528\u66f2\u975e\u5948\u80bd\u7684\u53c2\u4e0e\u8005\u5728\u51e0\u4e2a\u5173\u952e\u9886\u57df\u90fd\u6709\u6539\u5584\uff0c\u5305\u62ec\u793e\u4ea4\u6c9f\u901a\u3001\u5c0f\u808c\u8089\u8fd0\u52a8\u6280\u80fd\u548c\u547c\u5438\u3002<\/p>\n

\u91cd\u8981\u91cc\u7a0b\u7891<\/h2>\n

Acadia \u9996\u5e2d\u6267\u884c\u5b98 Steve Davis \u8868\u793a\uff0c\u6b64\u6b21\u6279\u51c6\u662f\u96f7\u7279\u7efc\u5408\u5f81\u793e\u533a\u7684\u4e00\u4e2a\u91cd\u8981\u91cc\u7a0b\u7891\u3002<\/p>\n

\u4ed6\u8bf4\uff1a\u201c\u4f5c\u4e3a FDA \u6279\u51c6\u7684\u7b2c\u4e00\u79cd\u6cbb\u7597\u96f7\u7279\u7efc\u5408\u5f81\u7684\u836f\u7269\uff0cDaybue \u6709\u53ef\u80fd\u4e3a\u60a3\u8005\u53ca\u5176\u5bb6\u4eba\u7684\u751f\u6d3b\u5e26\u6765\u6709\u610f\u4e49\u7684\u6539\u53d8\uff0c\u56e0\u4e3a\u4ed6\u4eec\u7f3a\u4e4f\u6cbb\u7597\u5404\u79cd\u4f7f\u4eba\u8870\u5f31\u7684\u75c7\u72b6\u7684\u9009\u62e9\u3002\u201d<\/p>\n

\u201c\u6211\u4eec\u611f\u8c22\u6240\u6709\u4e3a\u4f7f\u4eca\u5929\u6210\u4e3a\u73b0\u5b9e\u505a\u51fa\u8d21\u732e\u7684\u96f7\u7279\u7efc\u5408\u5f81\u60a3\u8005\u3001\u62a4\u7406\u4eba\u5458\u548c\u4e34\u5e8a\u7814\u7a76\u4eba\u5458\uff0c\u6211\u4eec\u671f\u5f85\u5c3d\u5feb\u5c06 Daybue \u5e26\u7ed9\u60a3\u8005\u3002\u201d<\/p>\n

\u671d\u7740\u6b63\u786e\u7684\u65b9\u5411\u8fc8\u8fdb<\/h2>\n

Neuren \u9996\u5e2d\u6267\u884c\u5b98 Jon Pilcher \u8868\u793a\uff0cFDA \u7684\u6279\u51c6\u662f\u671d\u7740\u6b63\u786e\u65b9\u5411\u8fc8\u51fa\u7684\u4e00\u6b65\u3002<\/p>\n

\u201c\u8bb8\u591a\u4eba\u5728\u5b9e\u73b0\u8fd9\u4e00\u5386\u53f2\u6027\u6210\u679c\u7684\u6f2b\u957f\u65c5\u7a0b\u4e2d\u8868\u73b0\u51fa\u4e86\u6781\u5927\u7684\u51b3\u5fc3\u2026\u2026\u96f7\u7279\u7efc\u5408\u75c7\u793e\u533a\u8868\u73b0\u51fa\u4e86\u6700\u5927\u7684\u51b3\u5fc3\uff0c\u6211\u4e3a\u4ed6\u4eec\u611f\u5230\u9ad8\u5174\uff0c\u201d\u4ed6\u8bf4\u3002<\/p>\n

\u201c\u8fd9\u662f\u4e00\u4e2a\u8f6c\u578b\u91cc\u7a0b\u7891\uff0c\u5b83\u4f7f\u6211\u4eec\u80fd\u591f\u5145\u5206\u5229\u7528\u672a\u6765\u7684\u673a\u4f1a\uff0c\u56e0\u4e3a\u6211\u4eec\u6b63\u5728\u52aa\u529b\u6539\u53d8\u5176\u4ed6\u56db\u79cd\u795e\u7ecf\u53d1\u80b2\u969c\u788d\u3002\u201d<\/p>\n

Neuren \u6b63\u5728\u5bf9\u7b2c\u4e8c\u4e2a\u5019\u9009\u836f\u7269 NNZ-2591 \u8fdb\u884c\u7b2c\u4e8c\u9636\u6bb5\u8bd5\u9a8c\uff0c\u7528\u4e8e\u6cbb\u7597 Phelan-McDermid\u3001Angelman\u3001Pitt Hopkins \u548c Prader-Willi \u7efc\u5408\u5f81\u3002<\/p>\n

\u6240\u6709\u9879\u76ee\u5747\u5df2\u5728\u7f8e\u56fd\u83b7\u5f97\u5b64\u513f\u836f\u79f0\u53f7\uff0c\u8be5\u79f0\u53f7\u627f\u8ba4\u7f55\u89c1\u548c\u4e25\u91cd\u75be\u75c5\u7684\u8feb\u5207\u672a\u6ee1\u8db3\u4e34\u5e8a\u9700\u6c42\uff0c\u5e76\u63d0\u4f9b\u6fc0\u52b1\u63aa\u65bd\u4ee5\u9f13\u52b1\u5f00\u53d1\u65b0\u7597\u6cd5\u3002<\/p>\n

\u8bb8\u53ef\u534f\u8bae<\/h2>\n

2018 \u5e74\uff0cNeuren \u548c Acadia \u7b7e\u8ba2\u4e86\u72ec\u5bb6\u8bb8\u53ef\u534f\u8bae\uff0c\u7531 Acadia \u5728\u7f8e\u56fd\u3001\u52a0\u62ff\u5927\u548c\u58a8\u897f\u54e5\u5f00\u53d1\u548c\u5546\u4e1a\u5316 trofinetide\uff0c\u7528\u4e8e\u6cbb\u7597\u96f7\u7279\u7efc\u5408\u75c7\u548c\u5176\u4ed6\u9002\u5e94\u75c7\u3002<\/p>\n

Neuren \u4fdd\u7559\u5317\u7f8e\u4ee5\u5916\u56fd\u5bb6\u5bf9\u8be5\u836f\u7269\u7684\u6240\u6709\u6743\u5229\uff0c\u5e76\u62e5\u6709\u5728\u8fd9\u4e9b\u5730\u533a\u4f7f\u7528 Acadia \u751f\u6210\u7684\u6240\u6709\u6570\u636e\u7684\u5168\u989d\u652f\u4ed8\u3001\u4e0d\u53ef\u64a4\u9500\u7684\u8bb8\u53ef\u3002<\/p>\n

Neuren \u6253\u7b97\u901a\u8fc7\u5408\u4f5c\u4f19\u4f34\u8fdb\u884c trofinetide \u7684\u6ce8\u518c\u548c\u5546\u4e1a\u5316\uff0c\u76ee\u524d\u6b63\u5728\u63a8\u8fdb\u4e0e\u8bb8\u591a\u7b2c\u4e09\u65b9\u7684\u8ba8\u8bba\u3002<\/p>\n

\u8be5\u516c\u53f8\u6ca1\u6709\u5fc5\u8981\u7684\u6279\u51c6\u6216\u53ef\u7528\u7684\u836f\u7269\u4f9b\u5e94\u6765\u542f\u7528\u4efb\u4f55\u540c\u60c5\u4f7f\u7528\u6216\u6307\u5b9a\u60a3\u8005\u8ba1\u5212\u3002<\/p>\n

Neuren \u5df2\u83b7\u5f97\u4e0e FDA \u6279\u51c6\u76f8\u5173\u7684\u7f55\u89c1\u513f\u79d1\u75be\u75c5\u4f18\u5148\u5ba1\u67e5\u51ed\u8bc1\uff0c\u8fd9\u4f7f\u8be5\u516c\u53f8\u6709\u6743\u5728\u516d\u4e2a\u6708\u800c\u4e0d\u662f\u6807\u51c6\u7684 10 \u4e2a\u6708\u5185\u5bf9 Daybue \u8fdb\u884c\u76d1\u7ba1\u5ba1\u67e5\u3002<\/p>\n

\u7f55\u89c1\u75be\u75c5<\/h2>\n

\u96f7\u7279\u7efc\u5408\u75c7\u662f\u4e00\u79cd\u590d\u6742\u4e14\u7f55\u89c1\u7684\u795e\u7ecf\u53d1\u80b2\u969c\u788d\uff0c\u901a\u5e38\u7531 MECP2 \u57fa\u56e0\u7684\u57fa\u56e0\u7a81\u53d8\u5f15\u8d77\uff0c\u8be5\u57fa\u56e0\u5bf9\u795e\u7ecf\u7ec6\u80de\u7684\u6b63\u5e38\u529f\u80fd\u81f3\u5173\u91cd\u8981\u3002<\/p>\n

\u8be5\u75c5\u75c7\u7684\u7279\u70b9\u662f\u5728 6 \u81f3 18 \u4e2a\u6708\u5927\u4e4b\u524d\u6709\u4e00\u6bb5\u6b63\u5e38\u53d1\u80b2\u671f\uff0c\u968f\u540e\u968f\u7740\u83b7\u5f97\u7684\u6c9f\u901a\u6280\u5de7\u548c\u6709\u76ee\u7684\u7684\u624b\u90e8\u4f7f\u7528\u7684\u4e27\u5931\u800c\u51fa\u73b0\u663e\u7740\u7684\u53d1\u80b2\u5012\u9000\u3002<\/p>\n

\u75c7\u72b6\u8fd8\u53ef\u80fd\u5305\u62ec\u51fa\u73b0\u624b\u90e8\u523b\u677f\u5370\u8c61\uff08\u5982\u62e7\u624b\u548c\u62cd\u624b\uff09\u548c\u6b65\u6001\u5f02\u5e38\u3002<\/p>\n

\u636e\u4fe1\uff0c\u96f7\u7279\u7efc\u5408\u5f81\u5728\u7f8e\u56fd\u5f71\u54cd\u4e86\u591a\u8fbe 9,000 \u540d\u60a3\u8005\uff0c\u786e\u8bca\u4eba\u6570\u7ea6\u4e3a 4,500 \u540d\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

\u603b\u90e8\u4f4d\u4e8e\u58a8\u5c14\u672c\u7684 Neuren Pharmaceuticals (ASX: NEU) \u5ba3\u5e03\u5176\u5317\u7f8e\u5408\u4f5c\u4f19\u4f34 Acadia Pharmaceuticals (NASDAQ: ACAD) \u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u6279\u51c6\uff0cNeuren \u7684\u4e3b\u8981\u5019\u9009\u836f\u7269 Daybue (trofinetide) \u7528\u4e8e\u6cbb\u7597\u60a3\u96f7\u7279\u7efc\u5408\u5f81\u7684\u6210\u4eba\u548c\u513f\u7ae5\u3002 \u8be5\u836f\u7269\u662f\u4e16\u754c\u4e0a\u7b2c\u4e00\u4e2a\u4e5f\u662f\u552f\u4e00\u4e00\u4e2a\u83b7\u6279\u7684\u96f7\u7279\u7efc\u5408\u5f81\u6cbb\u7597\u836f\u7269\uff0c\u9884\u8ba1\u5c06\u4e8e 4 \u6708\u5e95\u4ee5\u53e3\u670d\u6eb6\u6db2\u7684\u5f62\u5f0f\u6295\u653e\u7f8e\u56fd\u5e02\u573a\u3002 Trofinetide \u7684\u4f5c\u7528\u662f\u51cf\u5c11\u5927\u8111\u4e2d\u7684\u708e\u75c7\uff0c\u963b\u6b62\u67d0\u4e9b\u7c7b\u578b\u7684\u7ec6\u80de\u53d8\u5f97\u8fc7\u5ea6\u6d3b\u8dc3\uff0c\u5e76\u589e\u52a0\u5929\u7136\u5b58\u5728\u7684 IGF-1 \u86cb\u767d\u7684\u6570\u91cf\u3002 \u5728\u7814\u7a76\u4e2d\uff0c\u670d\u7528\u66f2\u975e\u5948\u80bd\u7684\u53c2\u4e0e\u8005\u5728\u51e0\u4e2a\u5173\u952e\u9886\u57df\u90fd\u6709\u6539\u5584\uff0c\u5305\u62ec\u793e\u4ea4\u6c9f\u901a\u3001\u5c0f\u808c\u8089\u8fd0\u52a8\u6280\u80fd\u548c\u547c\u5438\u3002 \u91cd\u8981\u91cc\u7a0b\u7891 Acadia \u9996\u5e2d\u6267\u884c\u5b98 Steve Davis \u8868\u793a\uff0c\u6b64\u6b21\u6279\u51c6\u662f\u96f7\u7279\u7efc\u5408\u5f81\u793e\u533a\u7684\u4e00\u4e2a\u91cd\u8981\u91cc\u7a0b\u7891\u3002 \u4ed6\u8bf4\uff1a\u201c\u4f5c\u4e3a FDA \u6279\u51c6\u7684\u7b2c\u4e00\u79cd\u6cbb\u7597\u96f7\u7279\u7efc\u5408\u5f81\u7684\u836f\u7269\uff0cDaybue \u6709\u53ef\u80fd\u4e3a\u60a3\u8005\u53ca\u5176\u5bb6\u4eba\u7684\u751f\u6d3b\u5e26\u6765\u6709\u610f\u4e49\u7684\u6539\u53d8\uff0c\u56e0\u4e3a\u4ed6\u4eec\u7f3a\u4e4f\u6cbb\u7597\u5404\u79cd\u4f7f\u4eba\u8870\u5f31\u7684\u75c7\u72b6\u7684\u9009\u62e9\u3002\u201d \u201c\u6211\u4eec\u611f\u8c22\u6240\u6709\u4e3a\u4f7f\u4eca\u5929\u6210\u4e3a\u73b0\u5b9e\u505a\u51fa\u8d21\u732e\u7684\u96f7\u7279\u7efc\u5408\u5f81\u60a3\u8005\u3001\u62a4\u7406\u4eba\u5458\u548c\u4e34\u5e8a\u7814\u7a76\u4eba\u5458\uff0c\u6211\u4eec\u671f\u5f85\u5c3d\u5feb\u5c06 Daybue \u5e26\u7ed9\u60a3\u8005\u3002\u201d \u671d\u7740\u6b63\u786e\u7684\u65b9\u5411\u8fc8\u8fdb Neuren \u9996\u5e2d\u6267\u884c\u5b98 Jon Pilcher \u8868\u793a\uff0cFDA \u7684\u6279\u51c6\u662f\u671d\u7740\u6b63\u786e\u65b9\u5411\u8fc8\u51fa\u7684\u4e00\u6b65\u3002 \u201c\u8bb8\u591a\u4eba\u5728\u5b9e\u73b0\u8fd9\u4e00\u5386\u53f2\u6027\u6210\u679c\u7684\u6f2b\u957f\u65c5\u7a0b\u4e2d\u8868\u73b0\u51fa\u4e86\u6781\u5927\u7684\u51b3\u5fc3\u2026\u2026\u96f7\u7279\u7efc\u5408\u75c7\u793e\u533a\u8868\u73b0\u51fa\u4e86\u6700\u5927\u7684\u51b3\u5fc3\uff0c\u6211\u4e3a\u4ed6\u4eec\u611f\u5230\u9ad8\u5174\uff0c\u201d\u4ed6\u8bf4\u3002 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