{"id":31162,"date":"2021-05-24T17:21:00","date_gmt":"2021-05-24T10:21:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2021052417210031162"},"modified":"2021-05-24T21:41:01","modified_gmt":"2021-05-24T13:41:01","slug":"%e8%8d%af%e7%9f%b3%e7%a7%91%e6%8a%80%e4%b8%8e%e9%a6%96%e8%8d%af%e6%8e%a7%e8%82%a1%e5%b0%b11%e7%b1%bb%e5%88%9b%e6%96%b0%e8%8d%afnda%e9%a1%b9%e7%9b%ae%e7%ad%be%e7%bd%b2%e5%bc%80%e5%8f%91%e7%94%9f","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2021052417210031162","title":{"rendered":"\u836f\u77f3\u79d1\u6280\u4e0e\u9996\u836f\u63a7\u80a1\u5c311\u7c7b\u521b\u65b0\u836fNDA\u9879\u76ee\u7b7e\u7f72\u5f00\u53d1\u751f\u4ea7\u5408\u4f5c\u534f\u8bae"},"content":{"rendered":"

\u5357\u4eac2021\u5e745\u670824\u65e5 \/\u7f8e\u901a\u793e\/ — 2021\u5e745\u670820\u65e5\uff0c\u5357\u4eac\u836f\u77f3\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u80a1\u7968\u4ee3\u7801\uff1a300725.SZ\uff0c \u7b80\u79f0\u201c\u836f\u77f3\u79d1\u6280\u201d\uff09\u4e0e\u9996\u836f\u63a7\u80a1\uff08\u5317\u4eac\uff09\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u7b80\u79f0\u201c\u9996\u836f\u63a7\u80a1\u201d\uff09\u7b7e\u7f721\u7c7b\u521b\u65b0\u836f\u5f00\u53d1\u751f\u4ea7\u5408\u4f5c\u534f\u8bae\uff0c\u53cc\u65b9\u5c06\u5c31\u7b2c\u4e8c\u4ee3ALK\u6291\u5236\u5242CT-707\u9879\u76ee\u7684\u539f\u6599\u836f\u5f00\u53d1\u751f\u4ea7\u53caNDA\uff08New Drug Application\uff0c\u65b0\u836f\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff09\u6ce8\u518c\u7533\u62a5\u7b49\u76f8\u5173\u5de5\u4f5c\u5f00\u5c55\u6df1\u5ea6\u6218\u7565\u5408\u4f5c\uff0c\u76f4\u81f3\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u3002<\/p>\n

CT-707\u662f\u9996\u836f\u63a7\u80a1\u81ea\u4e3b\u7814\u53d1\u3001\u5177\u6709\u5b8c\u5168\u77e5\u8bc6\u4ea7\u6743\u7684\u65b0\u4e00\u4ee3\u9ad8\u9009\u62e9\u6027\u3001\u9ad8\u6d3b\u6027ALK\/FAK\/IGF1R\u591a\u9776\u70b9\u6fc0\u9176\u6291\u5236\u5242\u3002\u5728\u4e34\u5e8a\u524d\u7684\u52a8\u7269\u6a21\u578b\u4e2d\uff0c\u53e3\u670d\u7ed9\u836fCT-707\u4e0d\u4ec5\u80fd\u591f\u4f7f\u52a8\u7269\u4f53\u5185\u7684\u80bf\u7624\u6d88\u5931\uff0c\u800c\u4e14\u80fd\u591f\u6291\u5236\u80bf\u7624\u5728\u80ba\u90e8\u7684\u8f6c\u79fb\u3002\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0cCT-707\u7684\u76ee\u6807\u4eba\u7fa4\u4e3b\u8981\u662fALK\u9633\u6027\u7684\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\uff08\u5305\u62ec\u521d\u6cbb\u548c\u514b\u5511\u66ff\u5c3c\u8010\u836f\uff09\u3002\u76ee\u524dCT-707\u6b63\u5904\u4e8e\u5173\u952e\u6027\u7684\u4e34\u5e8aII\/III\u671f\u7814\u7a76\uff0c\u57fa\u4e8e\u4e34\u5e8aI\u671f\u5353\u8d8a\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0cCT-707\u5df2\u83b7\u5f97CDE\u6279\u590d\u7684II\u671f\u6709\u6761\u4ef6\u6279\u51c6\u4e0a\u5e02\u8d44\u683c\u3002<\/p>\n

2014\u5e74\u81f3\u4eca\uff0c\u836f\u77f3\u79d1\u6280\u4e0e\u9996\u836f\u63a7\u80a1\u53ca\u5176\u5b50\u516c\u53f8\u5728\u521b\u65b0\u836f\u7269\u7814\u53d1\u3001\u751f\u4ea7\u670d\u52a1\u7b49\u65b9\u9762\u4fdd\u6301\u957f\u671f\u7a33\u5b9a\u7684\u5408\u4f5c\uff0c\u6b64\u6b21CT-707\u9879\u76ee\u7684\u7b7e\u7ea6\u4ee3\u8868\u4e86\u53cc\u65b9\u5168\u9762\u5408\u4f5c\u53d6\u5f97\u91cc\u7a0b\u7891\u7684\u7a81\u7834\u3002\u836f\u77f3\u79d1\u6280\u5c06\u6295\u5165\u6700\u5145\u8db3\u7684\u7814\u53d1\u53caGMP\u751f\u4ea7\u8d44\u6e90\uff0c\u5229\u7528\u521b\u65b0\u6280\u672f\u4f18\u52bf\uff0c\u52a9\u529b\u9996\u836f\u63a7\u80a1\u5168\u9762\u52a0\u901fCT-707\u9879\u76ee\u7684\u63a8\u8fdb\u548cNDA\u6ce8\u518c\u83b7\u6279\u3002<\/p>\n

\u9996\u836f\u63a7\u80a1\u8463\u4e8b\u957f\u674e\u6587\u519b\u8868\u793a\uff1a\u201c\u5728\u8fc7\u53bb\u591a\u5e74\u7684\u5408\u4f5c\u4e2d\uff0c\u836f\u77f3\u79d1\u6280\u5c55\u73b0\u51fa\u5353\u8d8a\u7684\u7814\u53d1\u548c\u751f\u4ea7\u4ea4\u4ed8\u80fd\u529b\uff0c\u5e2e\u52a9\u6211\u4eec\u89e3\u51b3\u4e86\u5f88\u591a\u9879\u76ee\u4e0a\u7684\u74f6\u9888\u95ee\u9898\uff0c\u662f\u9ad8\u5ea6\u4e13\u4e1a\u3001\u503c\u5f97\u4fe1\u8d56\u7684CMC\u5408\u4f5c\u4f19\u4f34\u3002\u6211\u4eec\u5e0c\u671b\u901a\u8fc7\u548c\u836f\u77f3\u79d1\u6280\u7684\u5408\u4f5c\uff0c\u8fdb\u4e00\u6b65\u52a0\u901fCT-707\u7684\u4e0a\u5e02\uff0c\u4e3a\u4e2d\u56fd\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u63d0\u4f9b\u66f4\u591a\u521b\u65b0\u6cbb\u7597\u65b9\u6848\u9009\u62e9\u3002\u671f\u5f85\u53cc\u65b9\u540e\u7eed\u6709\u8fdb\u4e00\u6b65\u5bc6\u5207\u5408\u4f5c\uff0c\u4e00\u8d77\u5b9e\u73b0\u6211\u4eec\u7684\u613f\u666f–\u9020\u4e2d\u56fd\u60a3\u8005\u80fd\u591f\u5403\u5f97\u8d77\u7684\u4e00\u7c7b\u65b0\u836f\u201d\u3002\u201d<\/p>\n

\u836f\u77f3\u79d1\u6280\u8463\u4e8b\u957f\u6768\u6c11\u6c11\u8868\u793a\uff1a\u201c\u9996\u836f\u63a7\u80a1\u662f\u6709\u6d3b\u529b\u3001\u6709\u60c5\u6000\u7684\u4e2d\u56fd\u521b\u65b0\u836f\u7814\u53d1\u4f01\u4e1a\uff0c\u6211\u4eec\u975e\u5e38\u8363\u5e78\u80fd\u76f4\u63a5\u53c2\u4e0e\u4e8c\u4ee3ALK\u6291\u5236\u5242\u836f\u7269\u7684\u7814\u53d1\u751f\u4ea7\u5de5\u4f5c\u3002\u836f\u77f3\u79d1\u6280\u5728\u8fc7\u53bb\u5341\u591a\u5e74\u4e2d\u6c89\u6dc0\u4e86\u6df1\u539a\u7684\u7814\u53d1\u6280\u672f\u5b9e\u529b\uff0c\u5728GMP\u751f\u4ea7\u3001\u6ce8\u518c\u7533\u62a5\u5de5\u4f5c\u4e2d\u4e5f\u79ef\u7d2f\u4e86\u4e30\u5bcc\u7ecf\u9a8c\uff0c\u6211\u4eec\u5e0c\u671b\u5145\u5206\u53d1\u6325\u6280\u672f\u548c\u56e2\u961f\u4f18\u52bf\uff0c\u63d0\u4f9b\u5168\u9762\u3001\u9ad8\u6548\u3001\u4f18\u8d28\u7684\u670d\u52a1\uff0c\u52a9\u529b\u5408\u4f5c\u4f19\u4f34\u52a0\u901f\u65b0\u836f\u7814\u53d1\u4ece\u4e34\u5e8a\u5230\u5546\u4e1a\u5316\u7684\u8fdb\u7a0b\uff0c\u9020\u798f\u60a3\u8005\uff01\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

\u5357\u4eac2021\u5e745\u670824\u65e5 \/\u7f8e\u901a\u793e\/ — 2021\u5e745\u670820\u65e5\uff0c\u5357\u4eac\u836f\u77f3\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u80a1\u7968\u4ee3\u7801\uff1a300725.SZ\uff0c \u7b80\u79f0\u201c\u836f\u77f3\u79d1\u6280\u201d\uff09\u4e0e\u9996\u836f\u63a7\u80a1\uff08\u5317\u4eac\uff09\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff08\u7b80\u79f0\u201c\u9996\u836f\u63a7\u80a1\u201d\uff09\u7b7e\u7f721\u7c7b\u521b\u65b0\u836f\u5f00\u53d1\u751f\u4ea7\u5408\u4f5c\u534f\u8bae\uff0c\u53cc\u65b9\u5c06\u5c31\u7b2c\u4e8c\u4ee3ALK\u6291\u5236\u5242CT-707\u9879\u76ee\u7684\u539f\u6599\u836f\u5f00\u53d1\u751f\u4ea7\u53caNDA\uff08New Drug Application\uff0c\u65b0\u836f\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff09\u6ce8\u518c\u7533\u62a5\u7b49\u76f8\u5173\u5de5\u4f5c\u5f00\u5c55\u6df1\u5ea6\u6218\u7565\u5408\u4f5c\uff0c\u76f4\u81f3\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u3002 CT-707\u662f\u9996\u836f\u63a7\u80a1\u81ea\u4e3b\u7814\u53d1\u3001\u5177\u6709\u5b8c\u5168\u77e5\u8bc6\u4ea7\u6743\u7684\u65b0\u4e00\u4ee3\u9ad8\u9009\u62e9\u6027\u3001\u9ad8\u6d3b\u6027ALK\/FAK\/IGF1R\u591a\u9776\u70b9\u6fc0\u9176\u6291\u5236\u5242\u3002\u5728\u4e34\u5e8a\u524d\u7684\u52a8\u7269\u6a21\u578b\u4e2d\uff0c\u53e3\u670d\u7ed9\u836fCT-707\u4e0d\u4ec5\u80fd\u591f\u4f7f\u52a8\u7269\u4f53\u5185\u7684\u80bf\u7624\u6d88\u5931\uff0c\u800c\u4e14\u80fd\u591f\u6291\u5236\u80bf\u7624\u5728\u80ba\u90e8\u7684\u8f6c\u79fb\u3002\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0cCT-707\u7684\u76ee\u6807\u4eba\u7fa4\u4e3b\u8981\u662fALK\u9633\u6027\u7684\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\uff08\u5305\u62ec\u521d\u6cbb\u548c\u514b\u5511\u66ff\u5c3c\u8010\u836f\uff09\u3002\u76ee\u524dCT-707\u6b63\u5904\u4e8e\u5173\u952e\u6027\u7684\u4e34\u5e8aII\/III\u671f\u7814\u7a76\uff0c\u57fa\u4e8e\u4e34\u5e8aI\u671f\u5353\u8d8a\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0cCT-707\u5df2\u83b7\u5f97CDE\u6279\u590d\u7684II\u671f\u6709\u6761\u4ef6\u6279\u51c6\u4e0a\u5e02\u8d44\u683c\u3002 2014\u5e74\u81f3\u4eca\uff0c\u836f\u77f3\u79d1\u6280\u4e0e\u9996\u836f\u63a7\u80a1\u53ca\u5176\u5b50\u516c\u53f8\u5728\u521b\u65b0\u836f\u7269\u7814\u53d1\u3001\u751f\u4ea7\u670d\u52a1\u7b49\u65b9\u9762\u4fdd\u6301\u957f\u671f\u7a33\u5b9a\u7684\u5408\u4f5c\uff0c\u6b64\u6b21CT-707\u9879\u76ee\u7684\u7b7e\u7ea6\u4ee3\u8868\u4e86\u53cc\u65b9\u5168\u9762\u5408\u4f5c\u53d6\u5f97\u91cc\u7a0b\u7891\u7684\u7a81\u7834\u3002\u836f\u77f3\u79d1\u6280\u5c06\u6295\u5165\u6700\u5145\u8db3\u7684\u7814\u53d1\u53caGMP\u751f\u4ea7\u8d44\u6e90\uff0c\u5229\u7528\u521b\u65b0\u6280\u672f\u4f18\u52bf\uff0c\u52a9\u529b\u9996\u836f\u63a7\u80a1\u5168\u9762\u52a0\u901fCT-707\u9879\u76ee\u7684\u63a8\u8fdb\u548cNDA\u6ce8\u518c\u83b7\u6279\u3002 \u9996\u836f\u63a7\u80a1\u8463\u4e8b\u957f\u674e\u6587\u519b\u8868\u793a\uff1a\u201c\u5728\u8fc7\u53bb\u591a\u5e74\u7684\u5408\u4f5c\u4e2d\uff0c\u836f\u77f3\u79d1\u6280\u5c55\u73b0\u51fa\u5353\u8d8a\u7684\u7814\u53d1\u548c\u751f\u4ea7\u4ea4\u4ed8\u80fd\u529b\uff0c\u5e2e\u52a9\u6211\u4eec\u89e3\u51b3\u4e86\u5f88\u591a\u9879\u76ee\u4e0a\u7684\u74f6\u9888\u95ee\u9898\uff0c\u662f\u9ad8\u5ea6\u4e13\u4e1a\u3001\u503c\u5f97\u4fe1\u8d56\u7684CMC\u5408\u4f5c\u4f19\u4f34\u3002\u6211\u4eec\u5e0c\u671b\u901a\u8fc7\u548c\u836f\u77f3\u79d1\u6280\u7684\u5408\u4f5c\uff0c\u8fdb\u4e00\u6b65\u52a0\u901fCT-707\u7684\u4e0a\u5e02\uff0c\u4e3a\u4e2d\u56fd\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u63d0\u4f9b\u66f4\u591a\u521b\u65b0\u6cbb\u7597\u65b9\u6848\u9009\u62e9\u3002\u671f\u5f85\u53cc\u65b9\u540e\u7eed\u6709\u8fdb\u4e00\u6b65\u5bc6\u5207\u5408\u4f5c\uff0c\u4e00\u8d77\u5b9e\u73b0\u6211\u4eec\u7684\u613f\u666f–\u9020\u4e2d\u56fd\u60a3\u8005\u80fd\u591f\u5403\u5f97\u8d77\u7684\u4e00\u7c7b\u65b0\u836f\u201d\u3002\u201d \u836f\u77f3\u79d1\u6280\u8463\u4e8b\u957f\u6768\u6c11\u6c11\u8868\u793a\uff1a\u201c\u9996\u836f\u63a7\u80a1\u662f\u6709\u6d3b\u529b\u3001\u6709\u60c5\u6000\u7684\u4e2d\u56fd\u521b\u65b0\u836f\u7814\u53d1\u4f01\u4e1a\uff0c\u6211\u4eec\u975e\u5e38\u8363\u5e78\u80fd\u76f4\u63a5\u53c2\u4e0e\u4e8c\u4ee3ALK\u6291\u5236\u5242\u836f\u7269\u7684\u7814\u53d1\u751f\u4ea7\u5de5\u4f5c\u3002\u836f\u77f3\u79d1\u6280\u5728\u8fc7\u53bb\u5341\u591a\u5e74\u4e2d\u6c89\u6dc0\u4e86\u6df1\u539a\u7684\u7814\u53d1\u6280\u672f\u5b9e\u529b\uff0c\u5728GMP\u751f\u4ea7\u3001\u6ce8\u518c\u7533\u62a5\u5de5\u4f5c\u4e2d\u4e5f\u79ef\u7d2f\u4e86\u4e30\u5bcc\u7ecf\u9a8c\uff0c\u6211\u4eec\u5e0c\u671b\u5145\u5206\u53d1\u6325\u6280\u672f\u548c\u56e2\u961f\u4f18\u52bf\uff0c\u63d0\u4f9b\u5168\u9762\u3001\u9ad8\u6548\u3001\u4f18\u8d28\u7684\u670d\u52a1\uff0c\u52a9\u529b\u5408\u4f5c\u4f19\u4f34\u52a0\u901f\u65b0\u836f\u7814\u53d1\u4ece\u4e34\u5e8a\u5230\u5546\u4e1a\u5316\u7684\u8fdb\u7a0b\uff0c\u9020\u798f\u60a3\u8005\uff01\u201d… Read More<\/a><\/p>\n","protected":false},"author":556,"featured_media":8278,"comment_status":"close","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1965],"tags":[],"class_list":["post-31162","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-partnerships"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/31162","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/users\/556"}],"replies":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/comments?post=31162"}],"version-history":[{"count":1,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/31162\/revisions"}],"predecessor-version":[{"id":31163,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/posts\/31162\/revisions\/31163"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/media\/8278"}],"wp:attachment":[{"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/media?parent=31162"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/categories?post=31162"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.xinwengao.com\/cn\/wp-json\/wp\/v2\/tags?post=31162"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}