{"id":3929,"date":"2025-06-17T16:48:33","date_gmt":"2025-06-17T13:48:33","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3929"},"modified":"2025-06-17T16:48:34","modified_gmt":"2025-06-17T13:48:34","slug":"capricor-therapeutics-announces-bmd-orphan-drug-designation-and-dmd-program-regulatory-development-for-deramiocel-cap-1002","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/capricor-therapeutics-announces-bmd-orphan-drug-designation-and-dmd-program-regulatory-development-for-deramiocel-cap-1002\/","title":{"rendered":"Capricor Therapeutics \u5ba3\u5e03\u83b7\u5f97 BMD \u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u5e76\u542f\u52a8 Deramiocel (CAP-1002) \u7684 DMD \u9879\u76ee\u76d1\u7ba1\u5f00\u53d1"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Capricor Therapeutics\u662f\u4e00\u5bb6\u81f4\u529b\u4e8e\u5f00\u53d1\u8f6c\u5316\u7ec6\u80de\u548c\u5916\u6ccc\u4f53\u7597\u6cd5\u6cbb\u7597\u7f55\u89c1\u75be\u75c5\u7684\u751f\u7269\u6280\u672f\u516c\u53f8\uff0c\u8be5\u516c\u53f8\u4eca\u65e5\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5df2\u6388\u4e88\u5176\u9886\u5148\u7684\u7ec6\u80de\u7597\u6cd5\u5019\u9009\u836f\u7269Deramiocel\uff08CAP-1002\uff09\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u7528\u4e8e\u6cbb\u7597\u8d1d\u514b\u5c14\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08BMD\uff09\u3002\u8be5\u8d44\u683c\u8ba4\u5b9a\u589e\u5f3a\u4e86Capricor\u7684\u6218\u7565\u5730\u4f4d\uff0c\u4f7f\u5176\u80fd\u591f\u63a8\u8fdb\u4e00\u4e2a\u9488\u5bf9\u808c\u8425\u517b\u4e0d\u826f\u75c7\u5fc3\u810f\u548c\u9aa8\u9abc\u5e76\u53d1\u75c7\u7684\u5168\u6574\u5408\u5e73\u53f0\uff0c\u5e76\u62d3\u5c55\u5176\u9886\u5148\u8d44\u4ea7\u7684\u5546\u4e1a\u6f5c\u529b\u3002 <a href=\"https:\/\/dmdwarrior.com\/zh\/what-is-deramiocel\/\">\u4ec0\u4e48\u662f Deramiocel\uff1fCAP-1002 \u6709\u4ec0\u4e48\u4f5c\u7528\uff1f<\/a> \u2013<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Capricor Therapeutics \u4fe1\u5fc3\u6ee1\u6000<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u7f8e\u56fd FDA \u6388\u4e88 Deramiocel \u5b64\u513f\u836f\u8d44\u683c\uff0c\u7528\u4e8e\u6cbb\u7597\u8d1d\u514b\u5c14\u578b\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff0c\u6269\u5927 Capricor \u5728\u795e\u7ecf\u808c\u8089\u75be\u75c5\u9886\u57df\u7684\u5e94\u7528\u8303\u56f4<\/strong><\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Capricor \u836f\u7269\u5728\u6210\u529f\u901a\u8fc7 FDA \u4e0a\u5e02\u524d\u68c0\u67e5\u540e\uff0c\u4ecd\u6709\u671b\u4e8e 2025 \u5e74 8 \u6708 31 \u65e5\uff08\u5373\u5904\u65b9\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u6cd5\u6848 (PDUFA) \u4e2d\u9488\u5bf9\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684 Deramiocel \u836f\u7269\u7684\u4e0a\u5e02\u65e5\u671f\uff09\u987a\u5229\u4e0a\u5e02<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u8d1d\u514b\u5c14\u578b\u808c\u8425\u517b\u4e0d\u826f\u75c7 (BMD) \u4e0e\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u7c7b\u4f3c\uff0c\u662f\u4e00\u79cd\u8fdb\u884c\u6027 X \u8fde\u9501\u795e\u7ecf\u808c\u8089\u75be\u75c5\uff0c\u968f\u7740\u65f6\u95f4\u7684\u63a8\u79fb\u4f1a\u5bfc\u81f4\u4e25\u91cd\u7684\u9aa8\u9abc\u808c\u548c\u5fc3\u808c\u529f\u80fd\u8870\u9000\u3002Deramiocel \u7684\u5f00\u53d1\u65e8\u5728\u89e3\u51b3\u8be5\u75be\u75c5\u75c5\u7406\u5b66\u7684\u4e24\u4e2a\u65b9\u9762\uff0c\u5305\u62ec\u5fc3\u808c\u75c5\u3002\u5fc3\u808c\u75c5\u662f BMD \u548c DMD \u60a3\u8005\u53d1\u75c5\u7387\u548c\u6b7b\u4ea1\u7387\u7684\u4e3b\u8981\u539f\u56e0\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Capricor \u9488\u5bf9 DMD \u4e2d\u7684 Deramiocel \u7684\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7 (BLA) \u4ecd\u5728\u4f18\u5148\u5ba1\u67e5\u4e2d\uff0cPDUFA \u76ee\u6807\u884c\u52a8\u65e5\u671f\u4e3a 2025 \u5e74 8 \u6708 31 \u65e5\u3002<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4e86\u89e3\u66f4\u591a<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/zh\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/\">Capricor Therapeutics\u5ba3\u5e03\u5b8c\u6210\u5ba1\u67e5\u4f1a\u8bae<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Capricor Therapeutics, a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Deramiocel (CAP-1002), the company\u2019s lead cell therapy candidate, for the potential treatment of Becker Muscular Dystrophy (BMD). This designation strengthens Capricor\u2019s strategic [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3931,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[361,90,86,87,89,85,117,362,88],"class_list":["post-3929","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-bmd","tag-cap-1002","tag-capricor","tag-capricor-therapeutics","tag-cardiomyopathy","tag-deramiocel","tag-dmd","tag-dmd-cardiomyopathy","tag-fda"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/3929","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=3929"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/3929\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/3931"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=3929"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=3929"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=3929"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}