{"id":738,"date":"2026-07-23T23:21:00","date_gmt":"2026-07-23T14:21:00","guid":{"rendered":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-07-23-lipfendra-oral-pcsk9-fda-2026-zh\/"},"modified":"2026-07-23T23:21:00","modified_gmt":"2026-07-23T14:21:00","slug":"2026-07-23-lipfendra-oral-pcsk9-fda-2026-zh","status":"publish","type":"briefing","link":"https:\/\/onepress.co.kr\/index.php\/briefing\/2026-07-23-lipfendra-oral-pcsk9-fda-2026-zh\/","title":{"rendered":"\u9996\u4e2a\u53e3\u670dPCSK9\u6291\u5236\u5242\u83b7\u6279\uff0cLDL-C\u6cbb\u7597\u9009\u62e9\u6539\u53d8"},"content":{"rendered":"<p><strong>2026-07-23 23:18 KST<\/strong><\/p>\n<p>FDA\u79f0\uff0c2026\u5e747\u670817\u65e5\u6279\u51c6Lipfendra\uff08enlicitide\uff09\u4f5c\u4e3a\u996e\u98df\u548c\u8fd0\u52a8\u8f85\u52a9\u6cbb\u7597\uff0c\u7528\u4e8e\u964d\u4f4e\u6210\u4eba\u9ad8\u80c6\u56fa\u9187\u8840\u75c7\u60a3\u8005\u7684LDL-C\u3002\u5173\u952e\u53d8\u5316\u662f\uff0c\u4ee5\u6ce8\u5c04\u5242\u4e3a\u4e3b\u7684PCSK9\u6291\u5236\u5242\u7c7b\u522b\u9996\u6b21\u52a0\u5165\u53e3\u670d\u836f\uff0c\u800c\u4e0d\u662f\u8bc1\u660e\u5b83\u5df2\u964d\u4f4e\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u3002<\/p>\n<h2>\u8c01\u4f1a\u53d7\u5f71\u54cd<\/h2>\n<p>\u6279\u51c6\u5bf9\u8c61\u662f\u9700\u8981\u5728\u996e\u98df\u548c\u8fd0\u52a8\u57fa\u7840\u4e0a\u964d\u4f4eLDL-C\u7684\u6210\u4eba\u9ad8\u80c6\u56fa\u9187\u8840\u75c7\u60a3\u8005\uff0c\u5305\u62echeterozygous familial hypercholesterolemia\u60a3\u8005\u3002FDA\u79f0\uff0c\u8fd9\u662f\u4e3a\u5df2\u6709\u6cbb\u7597\u540e\u4ecd\u9700\u8fdb\u4e00\u6b65\u964d\u4f4eLDL-C\u7684\u6210\u4eba\u63d0\u4f9b\u989d\u5916\u9009\u62e9\u3002\u4e2a\u4eba\u4e0d\u5e94\u81ea\u884c\u542f\u52a8\u7528\u836f\uff0c\u533b\u751f\u4ecd\u9700\u6bd4\u8f83statin\u3001ezetimibe\u3001\u6ce8\u5c04\u578bPCSK9\u7597\u6cd5\u548c\u603b\u4f53\u98ce\u9669\u3002<\/p>\n<h2>\u6539\u53d8\u4e86\u4ec0\u4e48<\/h2>\n<p>Lipfendra\u662f\u6bcf\u65e5\u4e00\u6b21\u53e3\u670dPCSK9\u6291\u5236\u5242\u3002FDA\u79f0\uff0c\u6b64\u524dPCSK9\u6291\u5236\u5242\u53ea\u6709\u6ce8\u5c04\u7597\u6cd5\uff0c\u5e76\u5c06Lipfendra\u63cf\u8ff0\u4e3a\u9996\u4e2a\u963b\u65adPCSK9\u7684\u53e3\u670d\u836f\u3002Merck\u79f0\u83b7\u6279\u7247\u5242\u4e3a20 mg\u3002\u8303\u56f4\u662f\u7f8e\u56fdFDA\u6279\u51c6\uff0c\u5176\u4ed6\u56fd\u5bb6\u6279\u51c6\u548c\u652f\u4ed8\u653f\u7b56\u9700\u8981\u53e6\u884c\u786e\u8ba4\u3002<\/p>\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/onepress.co.kr\/wp-content\/uploads\/2026\/07\/lipfendra-oral-pcsk9-fda-2026-zh.png\" alt=\"\u5fc3\u5185\u79d1\u54a8\u8be2\u4e2d\u89e3\u91caLDL\u68c0\u6d4b\u548c\u53e3\u670d\u6cbb\u7597\u9009\u62e9\u7684\u56fe\u7247\" loading=\"eager\" \/><figcaption class=\"op-briefing-image-caption\">\u5236\u4f5c\u56fe\u7247\uff1aONEPRESS\u7528\u8bf4\u660e\u6027\u753b\u9762\u5448\u73b0LDL\u68c0\u6d4b\u3001\u5fc3\u8840\u7ba1\u98ce\u9669\u54a8\u8be2\u548c\u53e3\u670dPCSK9\u6cbb\u7597\u9009\u62e9\u6982\u5ff5\u3002\u5b83\u4e0d\u662f\u7279\u5b9a\u4ea7\u54c1\u5ba3\u4f20\u56fe\u3002<\/figcaption><\/figure>\n<h2>\u8bc1\u636e\u662f\u4ec0\u4e48<\/h2>\n<p>FDA human-drug\u9875\u9762\u79f0\uff0c\u7597\u6548\u548c\u5b89\u5168\u6027\u6765\u81ea\u4e24\u4e2arandomized, double-blind, placebo-controlled trials\uff0cNCT05952856\u548cNCT05952869\uff0c\u51713,207\u540d\u6210\u4eba\u3002\u7b2c24\u5468\u65f6\uff0c\u7b2c\u4e00\u4e2a\u8bd5\u9a8cLDL-C\u76f8\u5bf9placebo\u53d8\u5316\u4e3a-56%\uff0cHeFH\u8bd5\u9a8c\u4e3a-59%\u3002Merck\u5c06\u652f\u6301\u7814\u7a76\u79f0\u4e3aCORALreef Lipids\u548cCORALreef HeFH\u3002<\/p>\n<h2>\u9650\u5236\u548c\u6ce8\u610f<\/h2>\n<p>\u91cd\u8981\u9650\u5236\u662f\uff0c\u8fd9\u662f\u4e00\u9879\u964d\u4f4eLDL-C\u7684\u6279\u51c6\u3002\u5df2\u6838\u67e5\u7684\u6279\u51c6\u8d44\u6599\u6ca1\u6709\u8bc1\u660e\u5b83\u964d\u4f4e\u5fc3\u808c\u6897\u6b7b\u3001\u4e2d\u98ce\u6216\u6b7b\u4ea1\u3002FDA\u63d0\u5230\uff0cHeFH\u6210\u4eba\u4e2ddiarrhea\u548cdizziness\u6bd4placebo\u66f4\u5e38\u89c1\u3002\u9ad8\u80c6\u56fa\u9187\u5e38\u65e0\u75c7\u72b6\uff0c\u56e0\u6b64\u8840\u6db2\u68c0\u6d4b\u548c\u5b8c\u6574\u5fc3\u8840\u7ba1\u98ce\u9669\u8bc4\u4f30\u5e94\u5148\u8fdb\u884c\u3002<\/p>\n<h2>\u5b98\u65b9\u6838\u67e5\u8def\u5f84<\/h2>\n<p>FDA\u53d1\u5e03\u5185\u5bb9\u53ef\u6838\u67e5\u6279\u51c6\u65e5\u671f\u3001\u9002\u5e94\u75c7\u548c\u9996\u4e2a\u53e3\u670dPCSK9\u8303\u56f4\u3002FDA human-drug\u9875\u9762\u53ef\u6838\u67e5\u8bd5\u9a8c\u89c4\u6a21\u3001\u8bd5\u9a8c\u7f16\u53f7\u300124\u5468LDL-C\u4e0b\u964d\u548c\u5b89\u5168\u6027\u3002Merck\u53d1\u5e03\u5185\u5bb9\u53ef\u5bf9\u7167\u7247\u5242\u5242\u91cf\u548cCORALreef\u8bd5\u9a8c\u540d\u79f0\u3002<\/p>\n<h2>\u5b98\u65b9\u6765\u6e90<\/h2>\n<p><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol\" target=\"_blank\" rel=\"noopener noreferrer\">FDA\u53d1\u5e03\uff1a\u6279\u51c6\u65e5\u671f\u3001\u9002\u5e94\u75c7\u548c\u9996\u4e2a\u53e3\u670dPCSK9\u8303\u56f4<\/a><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fda-approves-first-oral-therapy-inhibits-proprotein-convertase-subtilisinkexin-type-9-pcsk9-lower\" target=\"_blank\" rel=\"noopener noreferrer\">FDA human-drug\u9875\u9762\uff1a\u8bd5\u9a8c\u89c4\u6a21\u300124\u5468LDL-C\u4e0b\u964d\u548c\u5b89\u5168\u6027<\/a><\/p>\n<p><a href=\"https:\/\/www.merck.com\/news\/mercks-lipfendra-enlicitide-is-the-first-and-only-once-daily-oral-pcsk9-inhibitor-approved-by-the-u-s-fda-to-reduce-ldl-c-in-adults-with-hypercholesterolemia\/\" target=\"_blank\" rel=\"noopener noreferrer\">Merck\u53d1\u5e03\uff1a\u7247\u5242\u5242\u91cf\u548cCORALreef\u8bd5\u9a8c\u540d\u79f0<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA\u79f0\uff0c2026\u5e747\u670817\u65e5\u6279\u51c6Lipfendra\uff08enlicitide\uff09\u4f5c\u4e3a\u996e\u98df\u548c\u8fd0\u52a8\u8f85\u52a9\u6cbb\u7597\uff0c\u7528\u4e8e\u964d\u4f4e\u6210\u4eba\u9ad8\u80c6\u56fa\u9187\u8840\u75c7\u60a3\u8005\u7684LDL-C\u3002\u5173\u952e\u53d8\u5316\u662f\uff0c\u4ee5\u6ce8\u5c04\u5242\u4e3a\u4e3b\u7684PCSK9\u6291\u5236\u5242\u7c7b\u522b\u9996\u6b21\u52a0\u5165\u53e3\u670d\u836f\uff0c\u800c\u4e0d\u662f\u8bc1\u660e\u5b83\u5df2\u964d\u4f4e\u5fc3\u8840\u7ba1\u4e8b\u4ef6\u3002<\/p>\n","protected":false},"featured_media":0,"template":"","meta":[],"class_list":["post-738","briefing","type-briefing","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/briefing\/738","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/briefing"}],"about":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/types\/briefing"}],"wp:attachment":[{"href":"https:\/\/onepress.co.kr\/index.php\/wp-json\/wp\/v2\/media?parent=738"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}