{"id":250316,"date":"2018-12-31T20:02:38","date_gmt":"2019-01-01T04:02:38","guid":{"rendered":"https:\/\/nai500.com\/?p=250316"},"modified":"2018-12-31T20:02:38","modified_gmt":"2019-01-01T04:02:38","slug":"%e4%b8%ad%e5%9b%bd%e7%bb%bf%e5%8f%b6%e5%88%b6%e8%8d%af%e5%90%af%e5%8a%a8%e5%88%a9%e5%9f%b9%e9%85%ae%e5%be%ae%e7%90%83%e5%85%a8%e7%90%83nda%e6%b3%a8%e5%86%8c","status":"publish","type":"post","link":"https:\/\/nai500.com\/zh-hans\/blog\/2018\/12\/%e4%b8%ad%e5%9b%bd%e7%bb%bf%e5%8f%b6%e5%88%b6%e8%8d%af%e5%90%af%e5%8a%a8%e5%88%a9%e5%9f%b9%e9%85%ae%e5%be%ae%e7%90%83%e5%85%a8%e7%90%83nda%e6%b3%a8%e5%86%8c\/","title":{"rendered":"\u4e2d\u56fd\u7eff\u53f6\u5236\u836f\u542f\u52a8\u5229\u57f9\u916e\u5fae\u7403\u5168\u7403NDA\u6ce8\u518c"},"content":{"rendered":"<p>\u7eff\u53f6\u5236\u836f\u96c6\u56e2\u8fd1\u65e5\u5ba3\u5e03\uff0c\u7eff\u53f6\u5236\u836f\u6cbb\u7597\u7cbe\u795e\u5206\u88c2\u75c7\u548c\u53cc\u76f8\u60c5\u611f\u969c\u788d\u7684\u521b\u65b0\u836f\u7269 &#8212; \u6ce8\u5c04\u7528\u5229\u57f9\u916e\u7f13\u91ca\u5fae\u7403\uff08LY03004\uff09\u5df2\u8fdb\u5165\u65b0\u836f\uff09\u7533\u62a5\uff08NDA\uff09\u51c6\u5907\u7684\u6700\u540e\u9636\u6bb5\u3002<\/p>\n<p>\u76ee\u524d\uff0cFDA \u5df2\u6279\u51c6 LY03004 \u7684\u5546\u54c1\u540d\u4e3a Rykindo\u00ae\u3002LY03004 \u7528\u4e8e\u6cbb\u7597\u7cbe\u795e\u5206\u88c2\u75c7\u548c\u53cc\u5411\u60c5\u611f\u969c\u788d\u3002\u7eff\u53f6\u5236\u836f\u5df2\u5411 FDA \u7533\u8bf7\u4e86 LY03004 \u7684 NDA \u7f16\u53f7\uff0c\u5e76\u5df2\u83b7\u5f97 FDA \u5206\u914d\u7684 NDA \u7533\u8bf7\u53f7212849\u3002LY03004 \u7684 NDA \u7533\u62a5\u6750\u6599\u5df2\u51c6\u5907\u5b8c\u6210\u5e76\u6839\u636e FDA \u8981\u6c42\u6b63\u5728\u5236\u4f5c\u6210\u7535\u5b50\u901a\u7528\u6280\u672f\u6587\u4ef6\uff08eCTD\uff09\u683c\u5f0f\u3002\u65e9\u5728\u4eca\u5e74\u4e8c\u6708\uff0cFDA \u5df2\u6279\u51c6\u8be5\u836f\u7269\u5728\u7533\u8bf7 NDA \u65f6\uff0c\u65e0\u9700\u63d0\u4ea4\u4efb\u4f55\u513f\u79d1\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u3002<\/p>\n<p>\u4e0e\u6b64\u540c\u65f6\uff0cLY03004 \u5728\u6b27\u76df\u3001\u4e2d\u56fd\u3001\u65e5\u672c\u7684\u6ce8\u518c\u4e5f\u5728\u540c\u6b65\u987a\u5229\u63a8\u8fdb\u4e2d\uff0c\u4f7f\u7eff\u53f6\u5236\u836f\u671d\u7740\u4ee5\u521b\u65b0\u836f\u7814\u53d1\u4e3a\u9a71\u52a8\u7684\u56fd\u9645\u5316\u5236\u836f\u516c\u53f8\uff0c\u53c8\u8fc8\u8fd1\u4e86\u575a\u5b9e\u7684\u4e00\u6b65\u3002<\/p>\n<p>\u7eff\u53f6\u5236\u836f\u96c6\u56e2\u7ba1\u7406\u5c42\u8868\u793a\uff1a\u201c\u6211\u4eec\u4e00\u76f4\u5728\u79ef\u6781\u63a8\u8fdb LY03004 \u7684\u5404\u9879\u7533\u62a5\u6750\u6599\u7684\u51c6\u5907\u5de5\u4f5c\uff0c\u5305\u62ec\u6cd5\u89c4\u3001\u836f\u5b66\uff08CMC\uff09\u3001\u975e\u4e34\u5e8a\u548c\u4e34\u5e8a\u90e8\u5206\u7684\u8d44\u6599\u51c6\u5907\u3002\u76ee\u524d\uff0c\u6211\u4eec\u6b63\u5728\u6309\u7167\u9884\u671f\u7684\u65f6\u95f4\u8868\u6709\u5e8f\u63a8\u8fdb\u8be5\u836f\u7269\u7684 FDA \u7533\u62a5\u4e0a\u5e02\u5de5\u4f5c\u3002LY03004 \u6709\u671b\u4e8e2019\u5e74\u5e95\u4ee5\u524d\u5728\u7f8e\u56fd\u548c\u4e2d\u56fd\u4e0a\u5e02\u3002\u201d<\/p>\n<p>\u82f1\u6587\u6765\u6e90\uff1aprnewswire.com<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u7eff\u53f6\u5236\u836f\u96c6\u56e2\u8fd1\u65e5\u5ba3\u5e03\uff0c\u7eff\u53f6\u5236\u836f\u6cbb\u7597\u7cbe\u795e\u5206\u88c2\u75c7\u548c\u53cc\u76f8\u60c5\u611f\u969c\u788d\u7684\u521b\u65b0\u836f\u7269 &#8212; \u6ce8\u5c04\u7528\u5229\u57f9\u916e\u7f13\u91ca\u5fae\u7403\uff08L [&hellip;]<\/p>\n","protected":false},"author":9,"featured_media":250313,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[427],"tags":[820,513,455,747,925,459],"class_list":["post-250316","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-market-news-zh-hans","tag-820","tag-513","tag-455","tag-747","tag-925","tag-459","sectors-life-science-zh-hans","locations-china-zh-hans"],"acf":[],"_links":{"self":[{"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/posts\/250316","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=250316"}],"version-history":[{"count":0,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/posts\/250316\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/media\/250313"}],"wp:attachment":[{"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=250316"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=250316"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nai500.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=250316"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}