{"id":4357,"date":"2025-08-20T17:19:30","date_gmt":"2025-08-20T14:19:30","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4357"},"modified":"2025-08-20T17:21:43","modified_gmt":"2025-08-20T14:21:43","slug":"keros-announces-u-s-fda-orphan-drug-designation-granted-to-ker-065-for-the-treatment-of-duchenne-muscular-dystrophy","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/keros-announces-u-s-fda-orphan-drug-designation-granted-to-ker-065-for-the-treatment-of-duchenne-muscular-dystrophy\/","title":{"rendered":"Keros \u5ba3\u5e03\u7f8e\u56fd\u6388\u4e88 FDA \u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u7528\u4e8e\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Keros Therapeutics \u4eca\u5929\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08\u201cFDA\u201d\uff09\u6388\u4e88 KER-065 \u5b64\u513f\u836f\u8d44\u683c\uff0c\u7528\u4e8e\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08\u201cDMD\u201d\uff09\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u603b\u88c1\u517c\u9996\u5e2d\u6267\u884c\u5b98Jasbir S. Seehra\u8868\u793a\uff1a\u201cKER-065\u83b7\u5f97\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u51f8\u663e\u4e86\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08DMD\uff09\u60a3\u8005\u5c1a\u672a\u6ee1\u8db3\u7684\u5de8\u5927\u533b\u7597\u9700\u6c42\u3002\u6b64\u6b21\u8ba4\u5b9a\u5bf9Keros\u800c\u8a00\u662f\u4e00\u4e2a\u91cd\u8981\u7684\u91cc\u7a0b\u7891\uff0c\u6211\u4eec\u6b63\u5728\u63a8\u8fdbKER-065\u5728\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u60a3\u8005\u4e2d\u7684\u4e8c\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \u6388\u4e88\u5728\u7f8e\u56fd\u6cbb\u7597\u7f55\u89c1\u75be\u75c5\u6216\u75c5\u75c7\uff08\u5f71\u54cd\u4e0d\u5230 20 \u4e07\u4eba\uff09\u7684\u5728\u7814\u7597\u6cd5\u5b64\u513f\u836f\u8d44\u683c\u3002\u8be5\u8d44\u683c\u5c06\u5e26\u6765\u4e00\u4e9b\u6f5c\u5728\u76ca\u5904\uff0c\u5305\u62ec\u7b26\u5408\u6761\u4ef6\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7a0e\u6536\u62b5\u514d\u3001FDA \u7533\u8bf7\u8d39\u51cf\u514d\u6216\u90e8\u5206\u652f\u4ed8\uff0c\u4ee5\u53ca\uff08\u5982\u679c\u83b7\u5f97\u6279\u51c6\uff09\u4e03\u5e74\u7684\u5e02\u573a\u72ec\u5360\u6743\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u9605\u8bfb\u66f4\u591a<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/zh\/keros-therapeutics-announces-initial-topline-results-from-the-phase-1-clinical-trial-of-ker-065-in-healthy-volunteers\/\" target=\"_blank\" rel=\"noreferrer noopener\">KER-065\u5728\u5065\u5eb7\u5fd7\u613f\u8005\u4e2d\u8fdb\u884c\u76841\u671f\u4e34\u5e8a\u8bd5\u9a8c<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">KER-065\u662f\u4ec0\u4e48\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">KER-065 \u662f\u4e00\u79cd\u65b0\u578b\u914d\u4f53\u9677\u9631\uff0c\u7531\u6e90\u81ea\u6fc0\u6d3b\u7d20\u53d7\u4f53 IIA \u578b\u548c\u6fc0\u6d3b\u7d20\u53d7\u4f53 IIB \u578b\u7684\u4fee\u9970\u914d\u4f53\u7ed3\u5408\u57df\u7ec4\u6210\uff0c\u8be5\u57df\u4e0e\u4eba\u6e90\u6297\u4f53\u7684 Fc \u7ed3\u6784\u57df\u878d\u5408\u3002KER-065 \u65e8\u5728\u5145\u5f53\u914d\u4f53\u9677\u9631\uff0c\u6291\u5236\u808c\u751f\u957f\u6291\u5236\u7d20\u548c\u6fc0\u6d3b\u7d20 A\uff08\u4e24\u79cd\u901a\u8fc7\u6fc0\u6d3b\u7d20\u53d7\u4f53\u53d1\u51fa\u4fe1\u53f7\u7684\u914d\u4f53\uff09\u7684\u751f\u7269\u5b66\u6548\u5e94\uff0c\u4ece\u800c\u589e\u52a0\u9aa8\u9abc\u808c\u518d\u751f\u3001\u589e\u52a0\u808c\u8089\u5927\u5c0f\u548c\u529b\u91cf\u3001\u51cf\u5c11\u4f53\u8102\u3001\u51cf\u5c11\u9aa8\u9abc\u808c\u7ea4\u7ef4\u5316\u5e76\u589e\u52a0\u9aa8\u9abc\u5f3a\u5ea6\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>Keros Therapeutics today announced the U.S. Food and Drug Administration (\u201cFDA\u201d) granted Orphan Drug designation for KER-065 for the treatment of Duchenne muscular dystrophy (\u201cDMD\u201d). \u201cReceiving Orphan Drug designation for KER-065 highlights the significant unmet medical need for patients with DMD,\u201d said Jasbir S. Seehra, President and Chief Executive Officer. \u201cThis designation serves as a [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4360,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[337,336,195],"class_list":["post-4357","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-ker-065","tag-keros-therapeutics","tag-orphan-drug"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4357","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/comments?post=4357"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4357\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/4360"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=4357"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=4357"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=4357"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}