{"id":3798,"date":"2025-05-05T15:47:58","date_gmt":"2025-05-05T12:47:58","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3798"},"modified":"2025-05-05T15:49:36","modified_gmt":"2025-05-05T12:49:36","slug":"capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/","title":{"rendered":"Capricor Therapeutics \u5ba3\u5e03\u5b8c\u6210\u4e0e FDA \u5c31 Deramiocel \u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u5fc3\u808c\u75c5\u7684\u4e2d\u671f\u5ba1\u67e5\u4f1a\u8bae"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Capricor Therapeutics \u662f\u4e00\u5bb6\u5f00\u53d1\u7528\u4e8e\u6cbb\u7597\u7f55\u89c1\u75be\u75c5\u7684\u8f6c\u5316\u7ec6\u80de\u548c\u5916\u6ccc\u4f53\u7597\u6cd5\u7684\u751f\u7269\u6280\u672f\u516c\u53f8\uff0c\u4eca\u5929\u5ba3\u5e03\u5df2\u5b8c\u6210\u4e0e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u4e2d\u671f\u5ba1\u67e5\u4f1a\u8bae\uff0c\u8be5\u4f1a\u8bae\u9488\u5bf9\u8be5\u516c\u53f8\u7684\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7 (BLA)\uff0c\u5bfb\u6c42\u5bf9\u7814\u7a76\u6027\u7ec6\u80de\u7597\u6cd5 deramiocel \u7684\u5168\u9762\u6279\u51c6\uff0c\u7528\u4e8e\u6cbb\u7597\u8bca\u65ad\u4e3a\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u5fc3\u808c\u75c5\u7684\u60a3\u8005\u3002<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u76ee\u5f55<\/h2><nav><ul><li><a href=\"#is-deramiocel-fda-approved\">Deramiocel FDA \u662f\u5426\u83b7\u5f97\u6279\u51c6\uff1f<\/a><\/li><li><a href=\"#what-is-deramiocel\">Deramiocel \u662f\u4ec0\u4e48\uff1f<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"is-deramiocel-fda-approved\">Deramiocel FDA \u662f\u5426\u83b7\u5f97\u6279\u51c6\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f1a\u8bae\u671f\u95f4\uff0cFDA \u8868\u793a\u5ba1\u67e5\u59d4\u5458\u4f1a\u672a\u53d1\u73b0\u4efb\u4f55\u91cd\u5927\u7f3a\u9677\uff0c\u5e76\u4e14\u8be5\u8ba1\u5212\u6709\u671b\u5728 2025 \u5e74 8 \u6708 31 \u65e5\u7684\u5904\u65b9\u836f\u7528\u6237\u4ed8\u8d39\u6cd5\u6848 (PDUFA) \u884c\u52a8\u65e5\u671f\u524d\u5b8c\u6210\u3002FDA \u8fd8\u786e\u8ba4\u4e86\u53ec\u5f00\u54a8\u8be2\u59d4\u5458\u4f1a\u4f1a\u8bae\u7684\u610f\u56fe\uff0c\u5c3d\u7ba1\u5c1a\u672a\u786e\u5b9a\u6b63\u5f0f\u65e5\u671f\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-deramiocel\">Deramiocel \u662f\u4ec0\u4e48\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Deramiocel (CAP-1002) \u7531\u540c\u79cd\u5f02\u4f53\u5fc3\u810f\u7403\u884d\u751f\u7ec6\u80de (CDC) \u7ec4\u6210\uff0cCDC \u662f\u4e00\u7c7b\u7a00\u6709\u7684\u5fc3\u810f\u7ec6\u80de\u7fa4\uff0c\u4e34\u5e8a\u524d\u548c\u4e34\u5e8a\u7814\u7a76\u8868\u660e\uff0c\u5b83\u4eec\u5728\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u7b49\u8425\u517b\u4e0d\u826f\u75c7\u60a3\u8005\u4e2d\uff0c\u53d1\u6325\u5f3a\u5927\u7684\u514d\u75ab\u8c03\u8282\u548c\u6297\u7ea4\u7ef4\u5316\u4f5c\u7528\uff0c\u6709\u52a9\u4e8e\u7ef4\u6301\u5fc3\u810f\u548c\u9aa8\u9abc\u808c\u529f\u80fd\u3002\u2014\u2014 \u9605\u8bfb\u66f4\u591a\uff1a <a href=\"https:\/\/dmdwarrior.com\/zh\/what-is-deramiocel\/\">\u4ec0\u4e48\u662f Deramiocel\uff1fCAP-1002 \u6709\u4ec0\u4e48\u4f5c\u7528\uff1f<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/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 the completion of a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for the Company\u2019s Biologics License Application (BLA) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3800,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[90,86,87,89,85,362,88],"class_list":["post-3798","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-cap-1002","tag-capricor","tag-capricor-therapeutics","tag-cardiomyopathy","tag-deramiocel","tag-dmd-cardiomyopathy","tag-fda"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/3798","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=3798"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/3798\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/3800"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=3798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=3798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=3798"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}