{"id":1448,"date":"2023-05-22T11:11:59","date_gmt":"2023-05-22T03:11:59","guid":{"rendered":"http:\/\/yunjiamed.cn\/?post_type=news&#038;p=1448"},"modified":"2023-05-22T11:12:00","modified_gmt":"2023-05-22T03:12:00","slug":"%e5%88%9b%e6%96%b0%e8%8d%af%e5%9f%ba%e6%9c%ac%e5%bc%80%e5%8f%91%e6%b5%81%e7%a8%8b","status":"publish","type":"news","link":"http:\/\/yunjiamed.cn\/news\/%e5%88%9b%e6%96%b0%e8%8d%af%e5%9f%ba%e6%9c%ac%e5%bc%80%e5%8f%91%e6%b5%81%e7%a8%8b\/","title":{"rendered":"\u521b\u65b0\u836f\u57fa\u672c\u5f00\u53d1\u6d41\u7a0b"},"content":{"rendered":"\n<p class=\"has-text-align-center\"><strong><em>\u524d\u8a00<\/em><\/strong><\/p>\n\n\n\n<p>\u521b\u65b0\u836f\uff0c\u4e5f\u79f0\u4e3a\u539f\u7814\u836f\uff0c\u662f\u4e00\u4e2a\u76f8\u5bf9\u4e8e\u4eff\u5236\u836f\u7684\u6982\u5ff5\uff0c\u6307\u7684\u662f\u4ece\u673a\u7406\u5f00\u59cb\u6e90\u5934\u7814\u53d1\uff0c\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\uff0c\u5177\u5907\u5b8c\u6574\u5145\u5206\u7684\u5b89\u5168\u6027\u6709\u6548\u6027\u6570\u636e\u4f5c\u4e3a\u4e0a\u5e02\u4f9d\u636e\uff0c\u9996\u6b21\u83b7\u51c6\u4e0a\u5e02\u7684\u836f\u7269\u3002\u6309\u7167\u836f\u7269\u7814\u53d1\u7684\u5e38\u89c4\u6d41\u7a0b\uff0c\u4e00\u6b3e\u836f\u7269\u4ece\u786e\u5b9a\u9776\u70b9\u5230\u6700\u540e\u5ba1\u6279\u4e0a\u5e02\u7684\u6574\u4e2a\u7814\u53d1\u5468\u671f\u901a\u5e38\u8017\u65f6\u5341\u6570\u5e74\u7684\u65f6\u95f4\u3002\u4e13\u5229\u4fdd\u62a4\u671f\u8fc7\u540e\uff0c\u5c31\u4f1a\u88ab\u5927\u91cf\u4eff\u5236\u3002\u5728\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u8bc4\u5ba1\u6807\u51c6\u4e2d\uff0c\u65b0\u5206\u5b50\u5b9e\u4f53\uff08New &nbsp;Moleculer &nbsp;Entity\uff0cNME\uff09\u548c\u83b7\u5f97\u65b0\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7684\u836f\u7269\uff08Biologic &nbsp;License &nbsp;Application\uff0cBLA\uff09\u5747\u5c5e\u4e8e\u521b\u65b0\u836f\u3002\u6839\u636eCFDA\u9881\u5e03\u7684\u6ce8\u518c\u5206\u7c7b\uff0c\u5206\u4e3a\u4e94\u5927\u7c7b\u3002\u672c\u6587\u4e2d\u7684\u65b0\u836f\u7279\u63071\u7c7b\u65b0\u836f\u3002<br><\/p>\n\n\n\n<p class=\"has-text-align-center\"><em><strong>\u65b0\u836f\u7814\u53d1\u6a21\u5f0f<\/strong><\/em><\/p>\n\n\n\n<p>1\u7c7b\u65b0\u836f\u5927\u81f4\u53ef\u5206\u4e3a\u4ee5\u4e0b\u51e0\u7c7b\uff08\u56fe1\uff09\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" width=\"1080\" height=\"626\" data-echo=\"http:\/\/yunjiamed.cn\/assets\/uploads\/2023\/05\/640-3.png\"  alt=\"\" class=\"wp-image-1450\"\/>\n<noscript><img loading=\"lazy\" width=\"1080\" height=\"626\" src=\"http:\/\/yunjiamed.cn\/assets\/uploads\/2023\/05\/640-3.png\" alt=\"\" class=\"wp-image-1450\"\/><\/noscript><\/figure>\n\n\n\n<p class=\"has-text-align-center\">\u25b2\u00a0\u56fe1-\u65b0\u836f\u7814\u53d1\u6a21\u5f0f<br><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p class=\"has-text-align-left\"><strong>\u201cFirst in Class\u201d<\/strong>\u5373\u4e3a\u9996\u521b\u65b0\u836f\u3002\u4e00\u822c\u6307\u80fd\u6cbb\u7597\u67d0\u79cd\u75be\u75c5\u7684\u65b0\u9776\u70b9\u3001\u65b0\u673a\u7406\u836f\u7269\uff1b<br><strong>\u201cme-too\u201d<\/strong>\u610f\u4e3a\u4e0eFIC\u5177\u6709\u76f8\u4f3c\u7684\u4f5c\u7528\u673a\u7406\u548c\u6cbb\u7597\u6548\u679c\u7684\u836f\u7269\uff0c\uff1b<\/p>\n\n\n\n<p class=\"has-text-align-left\"><strong>\u201cme-better\u201d<\/strong>\u7ed3\u6784\u53ef\u80fd\u5177\u6709\u8f83\u5927\u4f18\u5316\uff0c\u5728\u6d3b\u6027\u3001\u4ee3\u8c22\u548c\/\u6216\u6bd2\u6027\u7b49\u5404\u65b9\u9762\u4f18\u4e8e&#8221;me-too&#8221;\u836f\uff1b<\/p>\n\n\n\n<p class=\"has-text-align-left\"><strong>\u201cme-best\u201d<\/strong>\u5373\u5728\u540c\u7c7b\u521b\u65b0\u836f\u91cc\u6700\u597d\uff1b<\/p>\n\n\n\n<p class=\"has-text-align-left\"><strong>\u201cme-worse\u201d<\/strong>\u5219\u662f\u76f8\u6bd4\u201cme-too\u201d\u800c\u8a00\u5728\u7597\u6548\u66f4\u5dee\u6216\u6bd2\u526f\u4f5c\u7528\u66f4\u5f3a\u3002<strong>\u201cfast-follow\u201d<\/strong>\u6307\u5feb\u901f\u8ffd\u8e2a\u65b0\u836f\u7684\u6a21\u5f0f\uff0c\u4ee5\u6700\u5feb\u901f\u5ea6\u5bf9\u201cfirst in class\u201d\u836f\u7269\u5206\u5b50\u8fdb\u884c\u6539\u9020\uff0c\u4e5f\u88ab\u79f0\u4e3a\u201c\u7ad9\u5728\u5de8\u4eba\u7684\u80a9\u8180\u4e0a\u4f9d\u846b\u82a6\u753b\u74e2\u201d\uff1b<strong>\u201clicense-in\u201d<\/strong>\u6307\u8d2d\u4e70\u6388\u6743\u8bb8\u53ef\uff1b<\/p>\n\n\n\n<p class=\"has-text-align-left\"><strong>\u201clicense-out\u201d<\/strong>\u6307\u51fa\u552e\u6388\u6743\u8bb8\u53ef\u3002<br><strong><a rel=\"noreferrer noopener\" target=\"_blank\" href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzIwOTcwODA3OA==&amp;mid=2247536163&amp;idx=5&amp;sn=b0d587f71796eb8cbb134db09ee2e216&amp;chksm=976dbb62a01a3274a349ddb89e42abaaab12087950c3cfceebc7d3c5077606b0c696def296f2&amp;token=1081818151&amp;lang=zh_CN&amp;scene=21#wechat_redirect\"><\/a><\/strong><\/p>\n\n\n\n<p class=\"has-text-align-center\"><em><strong>\u836f\u7269\u53d1\u73b0\u9636\u6bb5<\/strong><\/em><\/p>\n\n\n\n<p>\u5728\u751f\u7269\u533b\u836f\u7814\u53d1\u9886\u57df\uff0c\u65b0\u836f\u7814\u53d1\u5177\u6709<strong>\u957f\u5468\u671f\u3001\u9ad8\u6210\u672c\u3001\u9ad8\u98ce\u9669<\/strong>\u7684\u7279\u70b9\u3002\u4e1a\u5185\u4eba\u5e38\u8bf4\u7684<strong>\u201c\u53cc\u5341\u5b9a\u5f8b\u201d<\/strong>\u5373\u6210\u529f\u7814\u53d1\u4e00\u6b3e\u65b0\u836f\uff0c\u5373\u4f7f\u8fc7\u7a0b\u6bd4\u8f83\u987a\u5229\uff0c\u4e5f\u9700\u8981\u8017\u65f6\u5341\u5e74\u3001\u6295\u8d44\u5341\u4ebf\u7f8e\u91d1\uff0c\u751a\u81f3\u66f4\u4e45\u66f4\u591a\u3002<\/p>\n\n\n\n<p><strong>1\u3001\u75be\u75c5\u9776\u6807\u9009\u62e9\u4e0e\u786e\u8bc1\uff08Target\uff09\u3002<\/strong><\/p>\n\n\n\n<p><strong>2\u3001\u82d7\u5934\u5316\u5408\u7269\u7684\u7b5b\u9009\uff08Hit\uff09\u3002<\/strong><\/p>\n\n\n\n<p><strong>3\u3001\u5148\u5bfc\u5316\u5408\u7269\u7684\u53d1\u73b0\uff08Lead\uff09\u3002<\/strong><\/p>\n\n\n\n<p><strong>4\u3001\u5148\u5bfc\u5316\u5408\u7269\u7684\u4f18\u5316\uff08Lead Optimization\uff09\u3002<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" width=\"1080\" height=\"336\" data-echo=\"http:\/\/yunjiamed.cn\/assets\/uploads\/2023\/05\/640-4.png\"  alt=\"\" class=\"wp-image-1451\"\/>\n<noscript><img loading=\"lazy\" width=\"1080\" height=\"336\" src=\"http:\/\/yunjiamed.cn\/assets\/uploads\/2023\/05\/640-4.png\" alt=\"\" class=\"wp-image-1451\"\/><\/noscript><\/figure>\n\n\n\n<p class=\"has-text-align-center\">\u25b2\u00a0\u56fe2-\u65b0\u836f\u5f00\u53d1\u57fa\u672c\u6d41\u7a0b<a rel=\"noreferrer noopener\" target=\"_blank\" href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzIwOTcwODA3OA==&amp;mid=2247535825&amp;idx=2&amp;sn=8ab4a18ecb41866fbbf9a19d6e605ced&amp;chksm=976db990a01a3086484a960e05b603a5faca657a5d6fcf39f0a0b25931d93211cdf0e166ca3e&amp;token=1880177211&amp;lang=zh_CN&amp;scene=21#wechat_redirect\"><\/a><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p class=\"has-text-align-center\"><em><strong>IND\u7533\u62a5\u53ca\u5ba1\u6279<\/strong><\/em><\/p>\n\n\n\n<p>\u5728\u5019\u9009\u836f\u7269\u5b8c\u6210\u4e34\u5e8a\u524d\u7814\u7a76\u540e\uff0c\u4fbf\u53ef\u5411\u836f\u54c1\u8bc4\u5ba1\u4e2d\u5fc3\uff08Center for Drug Evaluation,CDE\uff09(\u7f8e\u56fd\u4e3aFDA\uff09\u63d0\u51fa\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff08Investigational New Drug\uff0cIND\uff09<strong>\u4e00\u822c\u4ee5IND\u4f5c\u4e3a\u65b0\u836f\u7814\u53d1\u7684\u7b2c\u4e8c\u4e2a\u5173\u952e\u8282\u70b9\u3002&nbsp;<\/strong><\/p>\n\n\n\n<p>1\u3001\u8d44\u6599\u51c6\u5907\u9636\u6bb5\u3002\u5305\u62ec\u4e34\u5e8a\u524d\u7814\u7a76\u7684\u8d28\u91cf\u7814\u7a76\u548c\u5b89\u5168\u6027\u8bc4\u4ef7\u8d44\u6599\u3001\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u3001\u836f\u6548\u5b66\/\u836f\u4ee3\u52a8\u529b\u5b66\/\u6bd2\u7406\u5b66\u8d44\u6599\u7b49\uff08\u56fe3\uff09\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" width=\"1080\" height=\"592\" data-echo=\"http:\/\/yunjiamed.cn\/assets\/uploads\/2023\/05\/640-5.png\"  alt=\"\" class=\"wp-image-1452\"\/>\n<noscript><img loading=\"lazy\" width=\"1080\" height=\"592\" src=\"http:\/\/yunjiamed.cn\/assets\/uploads\/2023\/05\/640-5.png\" alt=\"\" class=\"wp-image-1452\"\/><\/noscript><\/figure>\n\n\n\n<p class=\"has-text-align-center\">\u25b2\u00a0\u56fe3-IND\u7533\u62a5\u6d41\u7a0b<\/p>\n\n\n\n<p>2\u3001Pre-IND\u4f1a\u8bae\u3002\u5728\u6b63\u5f0f\u5411CDE\u63d0\u4ea4IND\u4e4b\u524d\uff0c\u7533\u8bf7\u4eba\u53ef\u81ea\u613f\u9009\u62e9\u662f\u5426\u8fdb\u884cPre-IND\u4f1a\u8bae\uff08\u65e0\u507f\uff09\uff0c\u5411\u76d1\u7ba1\u673a\u6784\u63d0\u4ea4\u4ea7\u54c1\u7684\u57fa\u672c\u4fe1\u606f\u3001\u5f00\u53d1\u8ba1\u5212\uff0c\u6240\u9700\u6c9f\u901a\u4ea4\u6d41\u95ee\u9898\u7684\u80cc\u666f\u548c\u6570\u636e\uff0c\u5e76\u63d0\u51fa\u62df\u89e3\u51b3\u95ee\u9898\u7684\u5efa\u8bae\u548c\u60f3\u6cd5\u7b49\u3002\u5bf9\u4e8e\u7f3a\u4e4f\u65b0\u836f\u6ce8\u518c\u7684\u4f01\u4e1a\u6765\u8bf4\uff0c\u8fd9\u662f\u4fdd\u8bc1\u6210\u529f\u7684\u5fc5\u8981\u4e00\u6b65\u3002<\/p>\n\n\n\n<p>3\u3001IND\u5ba1\u6279\u3002CDE\u4f1a\u572860\u5929\u5185\u901a\u77e5\u7533\u8bf7\u4eba\u8be5\u65b0\u836f\u7269\u79cd\u662f\u5426\u53ef\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u82e560\u5929\u5185\u672a\u7ed9\u51fa\u610f\u89c1\uff0c\u5219\u9ed8\u8ba4\u53ef\u4ee5\u5f00\u59cb\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n\n\n\n<p>4\u3001\u4f26\u7406\u5ba1\u67e5\u3002<\/p>\n\n\n\n<p>5\u3001\u7b7e\u8ba2\u5408\u540c\u3002<\/p>\n\n\n\n<p>6\u3001\u4e2d\u5fc3\u542f\u52a8\u4f1a\u3002\u4e34\u5e8a\u8bd5\u9a8c\u6b63\u5f0f\u5f00\u59cb\u524d\uff0c\u5fc5\u987b\u5728\u7814\u7a76\u79d1\u5ba4\u53ec\u5f00\u4e34\u5e8a\u8bd5\u9a8c\u542f\u52a8\u4f1a\uff0c\u5176\u76ee\u7684\u4e86\u8ba9\u6240\u6709\u53c2\u4e0e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4eba\u5458\u719f\u6089\u8bd5\u9a8c\u65b9\u6848\u53ca\u5177\u4f53\u64cd\u4f5c\u6d41\u7a0b\u3002\u53c2\u4e0e\u4eba\u5458\u4e3b\u8981\u5305\u62ec\uff1a\u7814\u7a76\u8005\u3001\u7533\u529e\u65b9\u3001\u673a\u6784\u4eba\u5458\u3001CRA\u548cCRC\u7b49\u3002\u7ecf\u8fc7\u542f\u52a8\u4f1a\u7684\u5f53\u5929\u51c6\u5907\u3001\u53ec\u5f00\uff0c\u5f85\u542f\u52a8\u4f1a\u7ed3\u675f\u540e\uff0c\u5373\u53ef\u6b63\u5f0f\u5f00\u5c55I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/p>\n\n\n\n<p><strong><a target=\"_blank\" href=\"https:\/\/mp.weixin.qq.com\/s?__biz=MzIwOTcwODA3OA==&amp;mid=2247536197&amp;idx=8&amp;sn=ad92528abcc3f64095c28a50225e2a2b&amp;chksm=976dbb04a01a3212d8733e9140f9076226cf318b02393959c16f3c2eab9659ad4bcda1074b19&amp;token=1585551566&amp;lang=zh_CN&amp;scene=21#wechat_redirect\" rel=\"noreferrer noopener\"><\/a><\/strong><\/p>\n\n\n\n<p class=\"has-text-align-center\"><em><strong>\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c<\/strong><\/em><\/p>\n\n\n\n<p>\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u5171\u5206\u4e3a\u56db\u671f\uff0c\u5176\u4e2d\uff0cI-III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e3a\u4e0a\u5e02\u524d\uff0c\u4e14\u6bcf\u4e00\u9636\u6bb5\u4e34\u5e8a\u8bd5\u9a8c\u90fd\u4f1a\u9884\u8bbe\u4e34\u5e8a\u7ec8\u70b9\uff0c\u8fbe\u5230\u4e34\u5e8a\u7ec8\u70b9\u65b9\u53ef\u5f00\u5c55\u4e0b\u4e00\u9636\u6bb5\u7684\u8bd5\u9a8c\uff1bIV\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e3a\u4e0a\u5e02\u540e\u7814\u7a76\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" width=\"1080\" height=\"433\" data-echo=\"http:\/\/yunjiamed.cn\/assets\/uploads\/2023\/05\/640-6.png\"  alt=\"\" class=\"wp-image-1453\"\/>\n<noscript><img loading=\"lazy\" width=\"1080\" height=\"433\" src=\"http:\/\/yunjiamed.cn\/assets\/uploads\/2023\/05\/640-6.png\" alt=\"\" class=\"wp-image-1453\"\/><\/noscript><\/figure>\n\n\n\n<p class=\"has-text-align-center\">\u00a0\u25b2\u00a0\u56fe4-\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c<br>1\u3001I\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u53d7\u8bd5\u8005\u4e3a\u5065\u5eb7\u4eba\u3002\u4e3b\u8981\u76ee\u7684\u662f\uff1a1\uff09\u5bf9\u836f\u7269\u7684\u5b89\u5168\u6027\u53ca\u5728\u4eba\u4f53\u7684\u8010\u53d7\u6027\u8fdb\u884c\u7814\u7a76\uff0c\u8003\u5bdf\u836f\u7269\u526f\u4f5c\u7528\u4e0e\u836f\u7269\u5242\u91cf\u9012\u589e\u4e4b\u95f4\u7684\u5173\u7cfb\uff1b2\uff09\u8003\u5bdf\u836f\u7269\u7684\u4f53\u5185\u836f\u4ee3\u52a8\u529b\u5b66\u6027\u8d28\uff0c\u5305\u62ec\u4ee3\u8c22\u4ea7\u7269\u53ca\u4ee3\u8c22\u9014\u5f84\u7b49\u3002\u6309\u7167\u8bd5\u9a8c\u9636\u6bb5\u53ef\u5206\u4e3aIa\u671f\u548cIb\u671f\u3002Ia\u671f\u4e5f\u79f0\u4e3a\u5355\u6b21\u5242\u91cf\u9012\u589e\uff08SAD,Single ascending 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