{"id":42762,"date":"2021-04-26T16:56:28","date_gmt":"2021-04-26T14:56:28","guid":{"rendered":"https:\/\/kymos.com\/news\/%e6%82%a8%e7%9a%84%e7%a8%b3%e5%ae%9a%e6%80%a7%e7%a0%94%e7%a9%b6%ef%bc%8c%e7%94%b1%e6%88%91%e4%bb%ac%e6%82%89%e5%bf%83%e5%ae%88%e6%8a%a4\/"},"modified":"2026-07-07T12:54:09","modified_gmt":"2026-07-07T10:54:09","slug":"%e6%82%a8%e7%9a%84%e7%a8%b3%e5%ae%9a%e6%80%a7%e7%a0%94%e7%a9%b6%ef%bc%8c%e7%94%b1%e6%88%91%e4%bb%ac%e6%82%89%e5%bf%83%e5%ae%88%e6%8a%a4","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/%e6%82%a8%e7%9a%84%e7%a8%b3%e5%ae%9a%e6%80%a7%e7%a0%94%e7%a9%b6%ef%bc%8c%e7%94%b1%e6%88%91%e4%bb%ac%e6%82%89%e5%bf%83%e5%ae%88%e6%8a%a4\/","title":{"rendered":"\u60a8\u7684\u7a33\u5b9a\u6027\u7814\u7a76\uff0c\u7531\u6211\u4eec\u6089\u5fc3\u5b88\u62a4"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container hundred-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-overflow:visible;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:calc( 100% + 0px ) !important;max-width:calc( 100% + 0px ) !important;margin-left: calc(-0px \/ 2 );margin-right: calc(-0px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column fusion-flex-align-self-flex-start fusion-column-no-min-height\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-spacing-right-small:0px;--awb-spacing-left-small:0px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-row\"><div class=\"fusion-text fusion-text-1\"><p class=\"Default\">\u8fd1\u5e74\u6765\uff0cKymos \u89c1\u8bc1\u4e86\u836f\u54c1\u5236\u9020\u5546\u5bf9\u7a33\u5b9a\u6027\u9879\u76ee\u53ef\u9760\u5916\u5305\u5408\u4f5c\u4f19\u4f34\u9700\u6c42\u7684\u6fc0\u589e\u3002\u4e3a\u6b64\uff0cKymos \u6295\u5165\u5de8\u8d44\u5728\u897f\u73ed\u7259\u548c\u610f\u5927\u5229\u7684\u7ad9\u70b9\u5efa\u9020\u4e86\u65b0\u7684\u6c14\u5019\u7bb1\uff0c\u76ee\u524d\u5b58\u50a8\u5bb9\u91cf\u5df2\u8fbe\u5230 100m\u00b3\uff0c\u6db5\u76d6\u4e86\u7b26\u5408 ICH II \u533a\u3001IVb \u533a\u7684\u6240\u6709\u6761\u4ef6\u4ee5\u53ca\u5176\u4ed6\u5b9a\u5236\u6761\u4ef6\u3002\u5df4\u585e\u7f57\u90a3\u548c\u5b89\u79d1\u7eb3\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u603b\u76d1 Damarih Valdes \u548c Francesco Spadoni \u5206\u522b\u89e3\u91ca\u4e86\u4e3a\u4ec0\u4e48\u6765\u81ea\u6b27\u6d32\u5404\u5730\u7684\u5ba2\u6237\u9009\u62e9\u4e0e\u4ed6\u4eec\u5408\u4f5c\u8fdb\u884c\u7a33\u5b9a\u6027\u6d4b\u8bd5\uff1a  <\/p>\n<p>Valdes \u535a\u58eb\u9996\u5148\u8bf4\u9053\uff1a<em>\u201c\u5728 Kymos\uff0c\u6211\u4eec\u627f\u8bfa\u5bf9\u5ba2\u6237\u8d1f\u8d23\u2014\u2014\u8fd9\u4e0d\u4ec5\u4ec5\u662f\u4e00\u53e5\u53e3\u53f7\uff0c\u800c\u662f\u6211\u4eec\u5207\u5b9e\u7684\u884c\u52a8\u3002\u201d<\/em> <em>\u201c\u5ba2\u6237\u975e\u5e38\u770b\u91cd\u6211\u4eec\u5728\u5904\u7406\u5404\u79cd\u836f\u7269\u4ea7\u54c1\u548c\u7269\u8d28\u65b9\u9762\u7684\u4e30\u5bcc\u7ecf\u9a8c\u3002\u6211\u4eec\u4e3a\u5236\u836f\u548c\u751f\u7269\u6280\u672f\u516c\u53f8\u5b58\u50a8\u7247\u5242\u548c\u6db2\u4f53\u5242\u578b\uff0c\u4e5f\u4e3a\u5316\u5986\u54c1\u884c\u4e1a\u5b58\u50a8\u4e73\u971c\uff0c\u5e76\u5f00\u5c55\u5404\u7c7b\u7814\u7a76\u3002\u57fa\u4e8e\u6211\u4eec\u5728\u7a33\u5b9a\u6027\u7814\u7a76\u548c\u5206\u6790\u65b9\u6cd5\u8f6c\u79fb\u65b9\u9762\u7684\u6df1\u539a\u7ecf\u9a8c\uff1a\u6211\u4eec\u53ef\u4ee5\u6839\u636e\u5ba2\u6237\u7684\u8981\u6c42\u8c03\u6574\u65b9\u6848\uff0c\u5e76\u5728\u5b9e\u9645\u9879\u76ee\u542f\u52a8\u524d\u63d0\u4f9b\u4e13\u5bb6\u5efa\u8bae\u3002\u201d<\/em> <\/p>\n<p>Francesco Spadoni \u5bf9 Damarih \u7684\u8bdd\u8868\u793a\u8d5e\u540c\uff1a<em> \u201c\u6211\u4eec\u4e0d\u4ec5\u6267\u884c\u6807\u51c6\u7684 ICH \u548c\u957f\u671f\u7a33\u5b9a\u6027\u7814\u7a76\uff0c\u8fd8\u8fdb\u884c\u4f7f\u7528\u4e2d\u7a33\u5b9a\u6027\u3001\u6301\u6709\u65f6\u95f4\u3001\u51bb\u878d\u3001\u8fd0\u8f93\u4ee5\u53ca\u5149\u7a33\u5b9a\u6027\u548c\u4e0d\u540c\u6761\u4ef6\u4e0b\u7684\u538b\u529b\u6d4b\u8bd5\u3002\u6211\u4eec\u5bf9\u5ba2\u6237\u7684\u627f\u8bfa\u4e0d\u6b62\u4e8e\u6b64\uff1a\u5728\u4e24\u4e2a\u4e0d\u540c\u7684\u7ad9\u70b9\u62e5\u6709\u9002\u7528\u4e8e\u6240\u6709\u6c14\u5019\u6761\u4ef6\u7684\u6d4b\u8bd5\u7bb1\uff0c\u4e92\u4e3a\u5907\u4efd\uff0c\u8fd9\u4f7f\u6211\u4eec\u80fd\u591f\u63d0\u4f9b\u66f4\u9ad8\u7684\u8fd0\u8425\u53ef\u9760\u6027\u3002\u201d Valdes \u535a\u58eb\u8865\u5145\u9053\uff1a\u201c\u5f97\u76ca\u4e8e\u6211\u4eec\u7684\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406\u7cfb\u7edf (LIMS)\uff0c\u6211\u4eec\u6240\u6709\u7684\u6d3b\u52a8\u90fd\u53d7\u5230\u8ddf\u8e2a\uff0c\u897f\u73ed\u7259\u548c\u610f\u5927\u5229\u7ad9\u70b9\u53ef\u4ee5\u5b8c\u7f8e\u534f\u4f5c\u3002\u751a\u81f3 GMP \u7ba1\u7406\u90e8\u95e8\u4e5f\u5bf9\u6211\u4eec LIMS \u7cfb\u7edf\u7684\u4e13\u4e1a\u6027\u7559\u4e0b\u4e86\u6df1\u523b\u5370\u8c61\u3002\u201d <\/em><\/p>\n<p>\u4f46\u636e\u4e24\u4f4d\u603b\u76d1\u6240\u8bf4\uff0c\u8fd9\u4e9b\u5e76\u4e0d\u662f\u5ba2\u6237\u559c\u6b22\u4e0e Kymos \u5408\u4f5c\u7684\u552f\u4e00\u539f\u56e0\u3002Francesco \u5f00\u59cb\u8bf4\u9053\uff1a<em>\u201c\u6211\u4eec\u7684\u5ba2\u6237\u8d5e\u8d4f\u6211\u4eec\u5bf9\u9879\u76ee\u7684\u4e13\u6ce8\u3002\u6211\u4eec\u7684\u6574\u4e2a\u56e2\u961f\u90fd\u81f4\u529b\u4e8e\u4e25\u683c\u9075\u5b88\u622a\u6b62\u65e5\u671f\u3001\u4fdd\u6301\u5b9a\u671f\u6c9f\u901a\u5e76\u968f\u65f6\u51c6\u5907\u8fdb\u884c\u8ba8\u8bba\u3002\u91cf\u8eab\u5b9a\u5236\u7684\u670d\u52a1\uff0c\u4f8b\u5982\u5bf9\u7814\u7a76\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u51fa\u73b0\u7684\u672a\u77e5\u76f8\u5173\u7269\u8d28\u8fdb\u884c\u8d28\u8c31 (MS) \u8868\u5f81\uff0c\u6b63\u662f\u6211\u4eec\u7aed\u8bda\u670d\u52a1\u5ba2\u6237\u7684\u4f53\u73b0\u3002\u201d<\/em> Damarih \u7ee7\u7eed\u8bf4\u9053\uff1a<em>\u201c\u6211\u4eec\u5df2\u7ecf\u966a\u4f34\u4e86\u4e00\u4e9b\u5ba2\u6237\u5341\u591a\u5e74\u3002\u957f\u671f\u6df1\u5165\u7684\u5408\u4f5c\u5173\u7cfb\u4e0d\u4ec5\u8ba9\u7533\u529e\u8005\u611f\u5230\u653e\u5fc3\u548c\u786e\u5b9a\uff0c\u4e5f\u7ed9\u4e86\u6211\u4eec\u5de8\u5927\u7684\u52a8\u529b\uff0c\u56e0\u4e3a\u8fd9\u8bc1\u660e\u4e86\u6211\u4eec\u7684\u5de5\u4f5c\u5353\u6709\u6210\u6548\u3002\u201d<\/em> <\/p>\n<p>Medichem\/Combino Pharm Ltd \u9a6c\u8033\u4ed6\u4e1a\u52a1\u8d1f\u8d23\u4eba\u3001Kymos \u7684\u4e3b\u8981\u957f\u671f\u5ba2\u6237\u4e4b\u4e00 Dino Mangion \u535a\u58eb\u5c31\u4ed6\u5728\u7a33\u5b9a\u6027\u90e8\u95e8\u7684\u5408\u4f5c\u7ecf\u5386\u8c08\u4e86\u51e0\u53e5\uff1a<em>\u201cCombino Pharm \u8fd1\u5e74\u6765\u7684\u4e1a\u52a1\u91cf\u5927\u5e45\u589e\u957f\uff0c\u201d<\/em> Mangion \u535a\u58eb\u8868\u793a\uff0c  <em>\u201c\u56e0\u6b64\u6211\u4eec\u51b3\u5b9a\u6709\u5fc5\u8981\u5c06\u4e00\u4e9b\u5927\u578b\u9879\u76ee\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u8fdb\u884c\u5916\u5305\u3002\u5f53\u7136\uff0c\u6211\u4eec\u5e0c\u671b\u786e\u4fdd\u6211\u4eec\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u80fd\u4ea4\u6258\u7ed9\u6700\u4e13\u4e1a\u7684\u56e2\u961f\uff0c\u5c31\u5728\u90a3\u65f6\u6211\u4eec\u9047\u5230\u4e86 Kymos\uff01Kymos \u901a\u8fc7\u6295\u8d44\u63d0\u5347\u5176\u7a33\u5b9a\u6027\u7814\u7a76\u80fd\u529b\u6765\u54cd\u5e94\u6211\u4eec\u7684\u9700\u6c42\uff0c\u8fd9\u7ed9\u6211\u4eec\u7559\u4e0b\u4e86\u6df1\u523b\u7684\u5370\u8c61\u3002\u73b0\u5728\u4e24\u5e74\u8fc7\u53bb\u4e86\uff0c\u9879\u76ee\u6b63\u5728\u5168\u9762\u63a8\u8fdb\uff0c\u6211\u53ef\u4ee5\u80af\u5b9a\u5730\u8bf4\uff0c\u6211\u4eec\u505a\u51fa\u4e86\u6b63\u786e\u7684\u9009\u62e9\u3002\u5728 Kymos\uff0c\u6211\u4eec\u627e\u5230\u4e86\u4e00\u4e2a\u53ef\u9760\u3001\u6295\u5165\u3001\u503c\u5f97\u4fe1\u8d56\u4e14\u4e13\u4e1a\u7684\u5408\u4f5c\u4f19\u4f34\u3002\u201d <\/em><\/p>\n<p>\u4e8b\u5b9e\u4e0a\uff0cDamarih Valdes\u3001Francesco Spadoni \u53ca\u5176\u56e2\u961f\u4e3a\u5ba2\u6237\u7684\u6ee1\u610f\u548c\u51fa\u8272\u5b8c\u6210\u7684\u5de5\u4f5c\u611f\u5230\u81ea\u8c6a\u3002\u9274\u4e8e\u65e5\u76ca\u5168\u7403\u5316\u7684\u4e16\u754c\u4e2d\u7a33\u5b9a\u6027\u9879\u76ee\u7684\u590d\u6742\u6027\u4e0d\u65ad\u589e\u52a0\uff0c\u4ed6\u4eec\u90fd\u9884\u89c1\u5230\uff0c\u50cf Medichem\/Combino Pharm \u8fd9\u6837\u5411\u591a\u4e2a\u56fd\u5bb6\u4f9b\u8d27\u5e76\u9700\u8981\u6d4b\u8bd5\u4e0d\u540c\u5730\u533a\u5b58\u50a8\u6761\u4ef6\u7684\u516c\u53f8\u7684\u5916\u5305\u9700\u6c42\u5c06\u7ee7\u7eed\u589e\u957f\u3002\u5df4\u585e\u7f57\u90a3\u548c\u5b89\u79d1\u7eb3\u7ad9\u70b9\u90fd\u5c06\u51c6\u5907\u597d\u8fce\u63a5\u8fd9\u4e00\u6311\u6218\u3002  <\/p>\n<p><a href=\"https:\/\/kymos.com\/zh-hans\/kymos\/\" data-wpel-link=\"internal\">Kymos<\/a> \u53ca\u5176\u610f\u5927\u5229\u5b50\u516c\u53f8 <a href=\"https:\/\/kymos.com\/zh-hans\/pharmaprogress\/\" data-wpel-link=\"internal\">PHARMAPROGRESS<\/a> \u662f\u7ecf EMA \u548c FDA \u68c0\u67e5\u7684\u6b27\u6d32\u5408\u540c\u5b9e\u9a8c\u5ba4\u7ec4\u7ec7\uff0c\u63d0\u4f9b\u7ecf\u8fc7 GMP \u8ba4\u8bc1\u7684\u4e13\u5bb6\u7ea7\u7a33\u5b9a\u6027\u7814\u7a76\u3002\u60a8\u53ef\u4ee5\u5728\u6b64\u5904\u67e5\u770b\u6709\u5173 Kymos \u7a33\u5b9a\u6027\u7814\u7a76\u3001\u65b9\u6cd5\u5f00\u53d1\u4e0e\u9a8c\u8bc1\u4ee5\u53ca\u8d28\u91cf\u63a7\u5236\u7684\u66f4\u591a\u4fe1\u606f\uff0c\u6216\u901a\u8fc7 <a href=\"mailto:info@kymos.com\" data-wpel-link=\"internal\">info@kymos.com<\/a> \u8054\u7cfb\u6211\u4eec\u3002 <\/p>\n<p>COMBINO PHARM (Malta) Ltd. \u96b6\u5c5e\u4e8e MEDICHEM \u96c6\u56e2\uff0c\u8fd9\u662f\u4e00\u5bb6\u5f00\u53d1\u548c\u751f\u4ea7\u539f\u6599\u836f (API) \u53ca\u5236\u5242\u7684\u897f\u73ed\u7259\u5236\u836f\u673a\u6784\u3002Combino Pharm (Malta) Ltd. \u4e13\u6ce8\u4e8e\u56fa\u4f53\u53e3\u670d\u836f\u7269\u4ea7\u54c1\u7684\u5f00\u53d1\u548c\u751f\u4ea7\u3002\u5b83\u62e5\u6709\u4e30\u5bcc\u7684\u81ea\u4e3b\u5f00\u53d1\u4ea7\u54c1\u7ec4\u5408\uff0c\u53ef\u4f9b\u5bf9\u5916\u8bb8\u53ef\uff0c\u5e76\u4e3a\u9876\u7ea7\u56fd\u9645\u5ba2\u6237\u63d0\u4f9b\u5408\u540c\u751f\u4ea7\u670d\u52a1\u3002\u5176\u4ea7\u54c1\u9500\u5f80\u5305\u62ec\u7f8e\u56fd\u5728\u5185\u7684\u5168\u7403\u5e02\u573a\u3002\u70b9\u51fb\u6b64\u5904\u4e86\u89e3\u66f4\u591a\u5173\u4e8e <strong><a href=\"https:\/\/www.medichem.es\/\" data-wpel-link=\"external\">MEDICHEM<\/a><\/strong> \u7684\u4fe1\u606f\u3002    <\/p>\n<p class=\"Default\">\u70b9\u51fb\u6b64\u5904\u4e86\u89e3\u66f4\u591a\u5173\u4e8e\u6211\u4eec\u7684 <a href=\"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/cmc-%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/%e7%a8%b3%e5%ae%9a%e6%80%a7%e7%a0%94%e7%a9%b6\/\" data-wpel-link=\"internal\"><b>\u7a33\u5b9a\u6027\u670d\u52a1<\/b><\/a>\u3001<b> <\/b>\u6211\u4eec\u7684 <b><span style=\"color: #82988c;\"><a href=\"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/cmc-%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/%e6%89%b9%e6%ac%a1%e6%a3%80%e6%b5%8b%e4%b8%8e%e6%89%b9%e6%ac%a1%e6%94%be%e8%a1%8c\/\" data-wpel-link=\"internal\">\u6279\u6b21\u6d4b\u8bd5\u4e0e\u653e\u884c\u670d\u52a1<\/a> <\/span><\/b>\u4ee5\u53ca\u6211\u4eec\u7684<b> <\/b><a href=\"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/cmc-%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/%e6%96%b9%e6%b3%95%e5%bc%80%e5%8f%91%e4%b8%8e%e9%aa%8c%e8%af%81\/\" rel=\"noopener\" 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