{"id":42986,"date":"2025-09-02T12:10:01","date_gmt":"2025-09-02T10:10:01","guid":{"rendered":"https:\/\/kymos.com\/news\/%e4%b8%ad%e5%92%8c%e6%8a%97%e4%bd%93%ef%bc%9a%e7%94%9f%e7%89%a9%e5%88%b6%e5%93%81%e7%9a%84%e6%a3%80%e6%b5%8b%e3%80%81%e6%8c%87%e5%8d%97%e5%8f%8a%e5%bd%b1%e5%93%8d\/"},"modified":"2026-07-07T13:03:46","modified_gmt":"2026-07-07T11:03:46","slug":"%e4%b8%ad%e5%92%8c%e6%8a%97%e4%bd%93%ef%bc%9a%e7%94%9f%e7%89%a9%e5%88%b6%e5%93%81%e7%9a%84%e6%a3%80%e6%b5%8b%e3%80%81%e6%8c%87%e5%8d%97%e5%8f%8a%e5%bd%b1%e5%93%8d","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/%e4%b8%ad%e5%92%8c%e6%8a%97%e4%bd%93%ef%bc%9a%e7%94%9f%e7%89%a9%e5%88%b6%e5%93%81%e7%9a%84%e6%a3%80%e6%b5%8b%e3%80%81%e6%8c%87%e5%8d%97%e5%8f%8a%e5%bd%b1%e5%93%8d\/","title":{"rendered":"\u4e2d\u548c\u6297\u4f53\uff1a\u751f\u7269\u5236\u54c1\u7684\u68c0\u6d4b\u3001\u6307\u5357\u53ca\u5f71\u54cd"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 1170px + 20px );margin-left: calc(-20px \/ 2 );margin-right: calc(-20px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-size: 14pt;\"><strong>\u751f\u7269\u5236\u54c1\u548c\u5148\u8fdb\u6cbb\u7597\u836f\u7269 (ATMPs)<\/strong> \u6b63\u5728\u5f7b\u5e95\u6539\u53d8\u533b\u5b66\u7684\u672a\u6765\uff0c\u5176\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u662f\u91cd\u4e2d\u4e4b\u91cd\u3002\u8fd9\u4e00\u8fc7\u7a0b\u7684\u4e00\u4e2a\u5173\u952e\u65b9\u9762\u662f<strong>\u5b83\u4eec\u53ef\u80fd\u5f15\u53d1\u7684\u514d\u75ab\u53cd\u5e94<\/strong>\uff0c\u7279\u522b\u662f<strong>\u4e2d\u548c\u6297\u4f53 (NAbs) \u7684\u4ea7\u751f<\/strong>\u3002\u8fd9\u4e9b\u6297\u4f53\u5bf9\u836f\u7269\u6027\u80fd\u6709\u91cd\u8981\u5f71\u54cd\uff1b\u5b83\u4eec\u53ef\u80fd\u6539\u53d8\u751a\u81f3\u6291\u5236\u5176\u6cbb\u7597\u4f5c\u7528\uff1b\u56e0\u6b64\uff0c\u514d\u75ab\u539f\u6027\u68c0\u6d4b\u662f\u751f\u7269\u5236\u54c1\u548c ATMPs \u5f00\u53d1\u7684\u4e00\u4e2a\u81f3\u5173\u91cd\u8981\u7684\u73af\u8282  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5728\u672c\u6587\u4e2d\uff0c\u6211\u4eec\u7efc\u8ff0\u4e86<strong>\u4ec0\u4e48\u662f\u4e2d\u548c\u6297\u4f53<\/strong>\u3001\u4e3a\u4ec0\u4e48\u8981\u5bf9\u5176\u8fdb\u884c\u68c0\u6d4b\u3001<strong>\u5982\u4f55\u68c0\u6d4b\u5b83\u4eec<\/strong>\u3001\u76ee\u524d\u68c0\u6d4b\u9700\u9075\u5faa\u7684<strong>\u6307\u5357<\/strong>\uff0c\u4ee5\u53ca <strong>Kymos \u5982\u4f55\u652f\u6301\u60a8\u7684 NAb \u68c0\u6d4b<\/strong>\u9700\u6c42\u3002<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u4ec0\u4e48\u662f\u4e2d\u548c\u6297\u4f53\uff1f<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>\u4e2d\u548c\u6297\u4f53\u662f\u4e00\u79cd\u7279\u5b9a\u7c7b\u578b\u7684\u6297\u836f\u7269\u6297\u4f53 (ADAs)<\/strong>\u3002\u7ed3\u5408\u578b ADAs \u4e0e\u6cbb\u7597\u5206\u5b50\u7ed3\u5408\u4f46\u4e0d\u4e00\u5b9a\u635f\u5bb3\u5176\u529f\u80fd\uff0c\u800c <strong>NAbs \u4f1a\u963b\u65ad\u836f\u7269\u7684\u751f\u7269\u6d3b\u6027\uff0c\u4ece\u800c\u53ef\u80fd\u6539\u53d8\u5176\u7597\u6548<\/strong>\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5b83\u4eec\u7684\u5b58\u5728\u53ef\u80fd\u5bfc\u81f4\u6cbb\u7597\u53cd\u5e94\u964d\u4f4e\u3001\u6cbb\u7597\u5931\u8d25\uff0c\u751a\u81f3\u4ea7\u751f\u4e0d\u826f\u53cd\u5e94\uff0c\u7279\u522b\u662f\u5728\u957f\u671f\u6216\u91cd\u590d\u7ed9\u836f\u65b9\u6848\u4e2d\u3002\u51fa\u4e8e\u8fd9\u4e9b\u539f\u56e0\uff0c<strong>\u5728\u836f\u7269\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u8bc6\u522b\u548c\u8868\u5f81 NAbs \u81f3\u5173\u91cd\u8981<\/strong>\u3002 <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u4f55\u65f6\u9700\u8981\u8fdb\u884c NAb \u68c0\u6d4b\uff1f<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">NAb \u68c0\u6d4b\u901a\u5e38<strong>\u9488\u5bf9\u4efb\u4f55\u5177\u6709\u8bf1\u5bfc\u514d\u75ab\u53cd\u5e94\u6f5c\u529b\u7684\u4ea7\u54c1<\/strong>\uff0c\u5305\u62ec\uff1a<\/span><\/p>\n<ul>\n<li><strong><span style=\"font-size: 14pt;\">\u5355\u514b\u9686\u6297\u4f53 (mAbs)<\/span><\/strong><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u6cbb\u7597\u6027\u86cb\u767d\u8d28<\/strong>\uff0c\u5982\u9176\u3001\u6fc0\u7d20\u6216\u7ec6\u80de\u56e0\u5b50<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u57fa\u56e0\u7597\u6cd5<\/strong>\u548c<strong>\u57fa\u4e8e\u5be1\u6838\u82f7\u9178\u7684\u7597\u6cd5<\/strong><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u6eb6\u7624\u75c5\u6bd2<\/strong>\u548c<strong>\u57fa\u4e8e\u75c5\u6bd2\u8f7d\u4f53\u7684\u7597\u6cd5<\/strong><\/span><\/li>\n<li><strong><span style=\"font-size: 14pt;\">\u751f\u7269\u7c7b\u4f3c\u836f<\/span><\/strong><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u75ab\u82d7<\/strong>\uff08\u4fa7\u91cd\u4e8e\u514d\u75ab\u4fdd\u62a4\u53cd\u5e94\uff09<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u4e9b\u6cbb\u7597\u6a21\u5f0f\u65e5\u76ca\u589e\u52a0\u7684\u590d\u6742\u6027\u4f7f\u5f97 NAb \u68c0\u6d4b\u53d8\u5f97\u66f4\u52a0\u91cd\u8981\uff0c\u5e76\u4e14\u5728\u672a\u6765\u51e0\u5e74\u5c06\u7ee7\u7eed\u589e\u957f\u3002<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u5982\u4f55\u68c0\u6d4b\u4e2d\u548c\u6297\u4f53\uff1f<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>NAb \u68c0\u6d4b\u901a\u5e38\u9075\u5faa\u66f4\u5e7f\u6cdb\u7684\u514d\u75ab\u539f\u6027\u68c0\u6d4b\u6846\u67b6\u5185\u7684\u591a\u6b65\u7b56\u7565<\/strong>\u3002\u8be5\u8fc7\u7a0b\u901a\u5e38\u5305\u62ec\uff1a <\/span><\/p>\n<ol>\n<li><span style=\"font-size: 14pt;\"> <strong>\u4f7f\u7528\u6865\u63a5\u914d\u4f53\u7ed3\u5408\u8bd5\u9a8c\uff08\u5982 ELISA \u6216 ECLA\uff09\u7b5b\u9009 ADAs<\/strong>\u3002\u5728\u6b64\u9636\u6bb5\u4f1a\u68c0\u6d4b\u5230\u7ed3\u5408\u6297\u4f53\u548c\u4e2d\u548c\u6297\u4f53\uff0c\u4f46\u4e0d\u4f1a\u8fdb\u884c\u533a\u5206 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u9633\u6027\u6837\u672c\u7684\u786e\u8ba4\u8bd5\u9a8c<\/strong>\uff0c\u4f7f\u7528\u7ade\u4e89\u6027\u914d\u4f53\u7ed3\u5408\u8bd5\u9a8c\u786e\u5b9a\u5bf9\u6cbb\u7597\u5206\u5b50\u7684\u7279\u5f02\u6027\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u6ef4\u5b9a\u6cd5\uff0c\u901a\u8fc7\u914d\u4f53\u7ed3\u5408\u8bd5\u9a8c\u534a\u5b9a\u91cf\u8bc4\u4f30 ADA \u6d53\u5ea6<\/strong>\u3002<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u4ec5\u5bf9\u786e\u8ba4\u7684 ADA \u9633\u6027\u6837\u672c\u8fdb\u884c NAb \u68c0\u6d4b\uff0c\u4ee5\u786e\u5b9a\u5176\u5bf9\u836f\u7269\u7684\u529f\u80fd\u5f71\u54cd<\/strong>\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c<strong>NAb \u68c0\u6d4b\u91c7\u7528\u4e24\u79cd\u901a\u7528\u7684\u5206\u6790\u683c\u5f0f<\/strong>\uff1a <\/span><\/li>\n<\/ol>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\u57fa\u4e8e\u7ec6\u80de\u7684\u5206\u6790 (CBAs)\uff1a <\/strong><\/span><span style=\"font-size: 14pt;\">\u8fd9\u7c7b\u5206\u6790\u88ab\u8ba4\u4e3a\u662f<strong>\u91d1\u6807\u51c6\uff0c\u56e0\u4e3a\u5b83\u4eec\u63d0\u4f9b\u4e86\u5728\u7ec6\u80de\u7cfb\u7edf\u4e2d\u5bf9\u836f\u7269\u751f\u7269\u6d3b\u6027\u529f\u80fd\u6291\u5236\u7684\u5b9a\u91cf\u8bc4\u4f30<\/strong>\uff08\u4f8b\u5982\u7ec6\u80de\u751f\u957f\u3001\u51cb\u4ea1\u6216\u62a5\u544a\u57fa\u56e0\u5206\u6790\uff09\u3002\u5b83\u4eec\u7684\u751f\u7406\u76f8\u5173\u6027\u4f7f\u5176\u6210\u4e3a\u5927\u591a\u6570\u76d1\u7ba1\u673a\u6784\u7684\u9996\u9009\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u914d\u4f53\u7ed3\u5408\u5206\u6790 (LBAs)\uff1a<\/strong>\u8fd9\u4e9b\u662f\u975e\u7ec6\u80de\u57fa\u7684\uff0c<strong>\u901a\u5e38\u5728 CBAs \u4e0d\u53ef\u884c\u65f6\u4f7f\u7528<\/strong>\u3002LBAs \u901a\u5e38\u662f\u7ade\u4e89\u6027\u7ed3\u5408\u5206\u6790\uff0c\u867d\u7136\u6267\u884c\u901f\u5ea6\u66f4\u5feb\uff0c\u4f46<strong>\u5bf9\u4f53\u5185\u4e2d\u548c\u6d3b\u6027\u7684\u9884\u6d4b\u6027\u53ef\u80fd\u8f83\u4f4e<\/strong>\u3002 <\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2><span style=\"font-size: 18pt;\"><strong>\u54ea\u4e9b\u6307\u5357\u9002\u7528\u4e8e NAb \u6d4b\u5b9a\uff1f<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u4e2d\u548c\u6297\u4f53\u68c0\u6d4b\u53d7\u65e2\u5b9a\u7684\u76d1\u7ba1\u6846\u67b6\u548c\u6307\u5357\u7ba1\u8f96\u3002\u6700\u76f8\u5173\u7684\u5305\u62ec\uff1a <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>FDA (2019)<\/strong> \u2013 <em>\u6cbb\u7597\u6027\u86cb\u767d\u4ea7\u54c1\u7684\u514d\u75ab\u539f\u6027\u68c0\u6d4b<\/em>\uff1a<strong>\u5efa\u8bae\u91c7\u7528\u57fa\u4e8e\u98ce\u9669\u7684\u65b9\u6cd5\uff0c\u5e76\u652f\u6301\u5c06 CBAs \u4f5c\u4e3a\u9996\u9009\u65b9\u6cd5<\/strong>\u3002\u8be5\u6307\u5357\u5efa\u8bae\u8fdb\u884c <strong>CBA \u9a8c\u8bc1\uff0c<\/strong>\u5305\u62ec\u7075\u654f\u5ea6\u3001\u7279\u5f02\u6027\u548c\u836f\u7269\u8010\u53d7\u6027\u3002 <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>EMA (2017)<\/strong> \u2013 <em>\u751f\u7269\u6280\u672f\u884d\u751f\u6cbb\u7597\u6027\u86cb\u767d\u514d\u75ab\u539f\u6027\u8bc4\u4f30\u6307\u5357<\/em>\uff1a\u5f3a\u8c03\u4e86 NAb \u6d4b\u5b9a\u5728\u836f\u7269\u4f5c\u7528\u673a\u5236\u4e2d\u7684\u91cd\u8981\u6027\u3002<strong>\u8be5\u6307\u5357\u8981\u6c42\uff0c\u5982\u679c\u68c0\u6d4b\u5230 ADAs \u4e14\u8ba4\u4e3a\u5177\u6709\u6f5c\u5728\u4e34\u5e8a\u76f8\u5173\u6027\uff0c\u5219\u5fc5\u987b\u8fdb\u884c NAb \u68c0\u6d4b\u3002<\/strong><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>ICH S6(R1) (2011)<\/strong> \u2013 \u4fa7\u91cd\u4e8e<strong>\u4e34\u5e8a\u524d\u514d\u75ab\u539f\u6027\u8003\u8651<\/strong>\uff0c\u5e76\u652f\u6301<strong>\u5728\u65e9\u671f\u5f00\u53d1\u9636\u6bb5\u8fdb\u884c\u57fa\u4e8e\u98ce\u9669\u7684\u8bc4\u4f30\u3002<\/strong><\/span><\/li>\n<\/ul>\n<h2><span style=\"font-size: 18pt;\"><strong>\u7ed3\u8bba\uff1a\u751f\u7269\u5236\u54c1\u5f00\u53d1\u4e2d\u7684\u5173\u952e\u5de5\u5177<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>NAb \u6d4b\u5b9a<\/strong>\u662f\u751f\u7269\u7597\u6cd5\u5f00\u53d1\u548c\u76d1\u6d4b\u4e2d\u7684\u5173\u952e\u6b65\u9aa4\uff0c\u662f<strong>\u786e\u4fdd\u751f\u7269\u7597\u6cd5\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u548c\u6cbb\u7597\u4e00\u81f4\u6027<\/strong>\u7684\u5de5\u5177\u3002\u968f\u7740\u57fa\u56e0\u548c\u7ec6\u80de\u6cbb\u7597\u7b49\u65b0\u6a21\u5f0f\u7597\u6cd5\u7684\u5174\u8d77\uff0c\u7406\u89e3\u548c\u51cf\u8f7b\u514d\u75ab\u539f\u6027\u5bf9\u4e8e<strong>\u836f\u7269\u7597\u6548\u548c\u60a3\u8005\u5b89\u5168<\/strong>\u81f3\u5173\u91cd\u8981\uff0c\u4e14\u5c06\u4e00\u76f4\u5982\u6b64\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\u5728\u5f00\u53d1\u65e9\u671f\u6574\u5408\u7a33\u5065\u7684\u514d\u75ab\u539f\u6027\u7b56\u7565<\/strong>\uff08\u5e76\u5728\u540e\u671f\u9636\u6bb5\u8fdb\u884c\u5b8c\u5584\uff09\u53ef\u4ee5\u663e\u8457<strong>\u964d\u4f4e\u540e\u671f\u5931\u8d25\u7684\u98ce\u9669\uff0c\u7f29\u77ed\u4e0a\u5e02\u65f6\u95f4\uff0c\u5e76\u652f\u6301\u76d1\u7ba1\u5ba1\u6279<\/strong>\u3002\u56e0\u6b64\uff0c\u62e5\u6709\u4e00\u4e2a\u503c\u5f97\u4fe1\u8d56\u7684\u5408\u4f5c\u4f19\u4f34\u81f3\u5173\u91cd\u8981\u3002 <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Kymos \u5982\u4f55\u652f\u6301\u60a8\u7684\u514d\u75ab\u539f\u6027\u7814\u7a76\uff1f<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\u5728 Kymos \u96c6\u56e2\uff0c<strong>\u6211\u4eec\u4e3a\u6240\u6709\u5f00\u53d1\u9636\u6bb5\u7684\u514d\u75ab\u539f\u6027\u68c0\u6d4b\u63d0\u4f9b\u5168\u9762\u652f\u6301<\/strong>\uff0c\u4ece\u65e9\u671f\u7814\u53d1\u5230\u5173\u952e\u4e34\u5e8a\u9636\u6bb5\u3002\u968f\u7740\u6211\u4eec\u5728<strong>\u5fb7\u56fd\u65b0\u5f00\u8bbe\u7684 GLP \u57fa\u4e8e\u7ec6\u80de\u7684\u5206\u6790\u5b9e\u9a8c\u5ba4<\/strong>\uff0c\u6211\u4eec\u663e\u8457\u6269\u5c55\u4e86\u5728\u751f\u7269\u5236\u54c1\u9886\u57df\u7684\u80fd\u529b\uff0c\u5305\u62ec\uff1a <\/span><\/p>\n<ul>\n<li><strong><span style=\"font-size: 14pt;\">\u5b8c\u6574\u7684\u514d\u75ab\u539f\u6027\u5206\u6790\uff1a<\/span><\/strong>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u7ed3\u5408\u578b\u6297\u836f\u7269\u6297\u4f53 (<strong>ADAs<\/strong>)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u4e2d\u548c\u6297\u4f53 (<strong>NAbs<\/strong>)<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u4e13\u4e1a\u77e5\u8bc6\u6db5\u76d6<\/strong>\uff1a<\/span>\n<ul>\n<li><strong><span style=\"font-size: 14pt;\">\u521b\u65b0\u5355\u514b\u9686\u6297\u4f53<\/span><\/strong><\/li>\n<li><strong><span style=\"font-size: 14pt;\">\u751f\u7269\u7c7b\u4f3c\u836f<\/span><\/strong><\/li>\n<li><strong><span style=\"font-size: 14pt;\">\u6cbb\u7597\u6027\u591a\u80bd<\/span><\/strong><\/li>\n<li><strong><span style=\"font-size: 14pt;\">\u5be1\u6838\u82f7\u9178<\/span><\/strong><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\u75c5\u6bd2\u8f7d\u4f53<\/strong>\u548c<strong>\u6eb6\u7624\u75c5\u6bd2<\/strong><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u6211\u4eec<strong>\u5728\u5fb7\u56fd\u548c\u897f\u73ed\u7259\u7684\u56e2\u961f<\/strong>\u53ef\u4ee5\u652f\u6301\u65b9\u6cd5<strong>\u5b9e\u65bd<\/strong>\u3001<strong>\u9a8c\u8bc1<\/strong>\u6216\u4ece\u96f6\u5f00\u59cb\u7684\u5b8c\u6574\u5206\u6790<strong>\u5f00\u53d1<\/strong>\uff0c\u6240\u6709\u5de5\u4f5c\u5747<strong>\u7b26\u5408 EMA \u548c FDA \u7684\u751f\u7269\u5206\u6790\u6307\u5357<\/strong>\u3002\u65e0\u8bba\u60a8\u7684\u7814\u7a76\u9700\u8981\u9002\u7528\u6027\u63a2\u7d22\u8fd8\u662f <strong>GLP \u6761\u4ef6\u4e0b<\/strong>\u7684\u5b8c\u5168\u76d1\u7ba1\u5408\u89c4\uff0cKymos \u90fd\u80fd\u5728\u6b27\u6d32\u8303\u56f4\u5185\u63d0\u4f9b\u91cf\u8eab\u5b9a\u5236\u7684\u3001\u79d1\u5b66\u9a71\u52a8\u7684\u89e3\u51b3\u65b9\u6848\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u4e86\u89e3\u66f4\u591a\u5173\u4e8e\u6211\u4eec\u7684\u514d\u75ab\u539f\u6027\u53ca\u4e2d\u548c\u6297\u4f53\u670d\u52a1\uff1a<\/span><a href=\"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/%e4%b8%b4%e5%ba%8a%e5%89%8d%e5%92%8c%e4%b8%b4%e5%ba%8a%e6%9c%8d%e5%8a%a1\/%e7%94%9f%e7%89%a9%e5%88%b6%e5%93%81%e4%b8%8e%e7%94%9f%e7%89%a9%e7%b1%bb%e4%bc%bc%e8%8d%af%e7%9a%84%e7%94%9f%e7%89%a9%e5%88%86%e6%9e%90%e4%b8%8e%e5%85%8d%e7%96%ab%e5%8e%9f%e6%80%a7\/\" data-wpel-link=\"internal\"><span style=\"font-size: 14pt;\"> https:\/\/kymos.com\/services\/pre-clinical-clinical-services\/bioanalysis-immunogenicity-of-biologics-biosimilars\/<\/span><\/a><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\u53c2\u8003\u6587\u732e<\/strong><\/span><\/h2>\n<ol>\n<li><span style=\"font-size: 14pt;\">\u7f8e\u56fd\u536b\u751f\u4e0e\u516c\u4f17\u670d\u52a1\u90e8\uff0c\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff0c\u836f\u54c1\u5ba1\u8bc4\u4e0e\u7814\u7a76\u4e2d\u5fc3 (CDER)\uff0c\u751f\u7269\u5236\u54c1\u5ba1\u8bc4\u4e0e\u7814\u7a76\u4e2d\u5fc3 (CBER)<strong>\u3002<\/strong> <strong>\u6cbb\u7597\u6027\u86cb\u767d\u4ea7\u54c1\u7684\u514d\u75ab\u539f\u6027\u68c0\u6d4b\u2014\u2014\u6297\u836f\u7269\u6297\u4f53\u68c0\u6d4b\u5206\u6790\u7684\u5f00\u53d1\u4e0e\u9a8c\u8bc1\u3002\u884c\u4e1a\u6307\u5357 (2019) <\/strong>\u3002 <a href=\"https:\/\/www.fda.gov\/media\/119788\/download\" data-wpel-link=\"external\">https:\/\/www.fda.gov\/media\/119788\/download<\/a><\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a (CHMP)\u3002<strong>\u6cbb\u7597\u6027\u86cb\u767d\u514d\u75ab\u539f\u6027\u8bc4\u4f30\u6307\u5357 (2017)<\/strong>\u3002<em><u>EMEA\/CHMP\/BMWP\/14327\/2006 Rev 1<\/u><\/em>\u3002<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf\" data-wpel-link=\"external\">https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf<\/a><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"> <strong> ICH \u6307\u5357 S6 (R1) \u2013 \u751f\u7269\u6280\u672f\u884d\u751f\u836f\u7269\u7684\u4e34\u5e8a\u524d\u5b89\u5168\u6027\u8bc4\u4ef7 (2011) <\/strong><em><u>EMA\/CHMP\/ICH\/731268\/1998\u3002<\/u><\/em><\/span><\/li>\n<\/ol>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":42987,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[383],"tags":[67],"class_list":["post-42986","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-383","tag-carles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - 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