{"id":3996,"date":"2025-06-24T16:56:02","date_gmt":"2025-06-24T13:56:02","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3996"},"modified":"2025-06-24T16:56:03","modified_gmt":"2025-06-24T13:56:03","slug":"capricor-therapeutics-provides-regulatory-update-on-deramiocel-bla-for-duchenne-muscular-dystrophy","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/capricor-therapeutics-provides-regulatory-update-on-deramiocel-bla-for-duchenne-muscular-dystrophy\/","title":{"rendered":"Capricor Therapeutics \u4e3a\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u60a3\u8005\u63d0\u4f9b Deramiocel \u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7 (BLA) \u7684\u76d1\u7ba1\u66f4\u65b0"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u4f5c\u4e3aFDA\u6301\u7eed\u5ba1\u67e5\u7684\u4e00\u90e8\u5206\uff0c\u516c\u53f8\u5df2\u83b7\u6089\uff0c\u76ee\u524d\u5c1a\u4e0d\u9002\u5b9c\u53ec\u5f00\u54a8\u8be2\u59d4\u5458\u4f1a\u4f1a\u8bae\u3002\u8be5\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7\uff08BLA\uff09\u4ecd\u5904\u4e8e\u4f18\u5148\u5ba1\u67e5\u9636\u6bb5\uff0c\u5176\u5904\u65b9\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u6cd5\u6848\uff08PDUFA\uff09\u7684\u76ee\u6807\u884c\u52a8\u65e5\u671f\u4e3a2025\u5e748\u670831\u65e5\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA \u8868\u793a\u76ee\u524d\u4e0d\u9700\u8981\u53ec\u5f00\u54a8\u8be2\u59d4\u5458\u4f1a\u4f1a\u8bae\u3002<\/li>\n\n\n\n<li>\u8ba1\u5212\u4e8e 7 \u6708\u4e2d\u65ec\u4e3e\u884c\u9762\u5bf9\u9762\u7684\u540e\u671f\u5468\u671f\u5ba1\u67e5\u4f1a\u8bae\u3002<\/li>\n\n\n\n<li>\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7 (BLA) \u4ecd\u5904\u4e8e\u4f18\u5148\u5ba1\u67e5\u9636\u6bb5\uff0cPDUFA \u76ee\u6807\u884c\u52a8\u65e5\u671f\u4e3a 2025 \u5e74 8 \u6708 31 \u65e5\u3002<\/li>\n\n\n\n<li>PPMD 2025 \u4f1a\u8bae\u4e0a\u5c55\u793a\u7684\u56db\u5e74\u6570\u636e\u663e\u793a\u5fc3\u810f\u529f\u80fd\u6301\u7eed\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Capricor \u6700\u8fd1\u5728 2025 \u5e74\u5bb6\u957f\u9879\u76ee\u808c\u8425\u517b\u4e0d\u826f\u75c7 (PPMD) \u5927\u4f1a\u4e0a\u516c\u5e03\u4e86\u5176 HOPE-2 \u5f00\u653e\u6807\u7b7e\u6269\u5c55 (OLE) \u7814\u7a76\u7684\u56db\u5e74\u6570\u636e\uff0c\u8be5\u6570\u636e\u662f DMD \u9886\u57df\u8fd0\u884c\u65f6\u95f4\u6700\u957f\u7684\u6cbb\u7597\u6570\u636e\u96c6\u4e4b\u4e00\uff0c\u6db5\u76d6\u4e86\u5fc3\u810f\u548c\u9aa8\u9abc\u808c\u529f\u80fd\u7684\u6307\u6807\u3002\u6570\u636e\u663e\u793a\uff0c\u957f\u671f Deramiocel \u6cbb\u7597\u53ef\u6301\u7eed\u4fdd\u6301\u5fc3\u810f\u529f\u80fd\uff0c\u5e76\u5e26\u6765\u6301\u7eed\u7684\u4e34\u5e8a\u76ca\u5904\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9605\u8bfb\u66f4\u591a\uff1a <a href=\"https:\/\/dmdwarrior.com\/zh\/capricor-therapeutics-announces-positive-4-year-data-of-deramiocel-cap-1002-in-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Capricor Therapeutics \u5ba3\u5e03 Deramiocel (CAP-1002) \u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684 4 \u5e74\u79ef\u6781\u6570\u636e<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Capricor \u80a1\u4ef7\u4e3a\u4f55\u4e0b\u8dcc\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Capricor Therapeutics \u80a1\u4ef7\u5468\u4e00\u4e0b\u8dcc\u3002FDA \u8868\u793a\uff0c\u76ee\u524d\u8be5\u516c\u53f8\u9488\u5bf9\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684\u7ec6\u80de\u7597\u6cd5\u65e0\u9700\u53ec\u5f00\u54a8\u8be2\u59d4\u5458\u4f1a\u4f1a\u8bae\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4eca\u5e746\u6708\uff0c\u8be5\u516c\u53f8\u5ba3\u5e03FDA\u5df2\u5bf9\u5176\u751f\u4ea7\u8bbe\u65bd\u8fdb\u884c\u68c0\u67e5\uff0c\u672a\u53d1\u73b0\u91cd\u5927\u95ee\u9898\u3002\u7136\u800c\uff0c\u6700\u8fd1\u7684\u4e8b\u6001\u53d1\u5c55\u5f15\u53d1\u4e86\u4eba\u4eec\u5bf9\u8be5\u5904\u7406\u65b9\u6cd5\u6709\u6548\u6027\u7684\u8d28\u7591\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u53d7\u6b64\u6d88\u606f\u5f71\u54cd\uff0c\u81ea\u4e0a\u5468\u4e94\u4ee5\u6765\uff0cCapricor \u80a1\u4ef7\u5df2\u4e0b\u8dcc\u7ea6 30%\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e00\u4e2a\u81f4\u529b\u4e8e\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u9886\u57df\u7684\u5021\u5bfc\u7ec4\u7ec7\u5f3a\u8c03\u4e86\u8be5\u9886\u57df\u76d1\u7ba1\u51b3\u7b56\u548c\u4e34\u5e8a\u8bd5\u9a8c\u7684\u91cd\u8981\u6027\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Capricor \u80a1\u7968\u4ea4\u6613\u4ef7\u4e3a $7.30\uff0c\u5468\u4e00\u4e0b\u8dcc 11.6%\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>As part of the FDA\u2019s ongoing review, the Company has been informed that an Advisory Committee meeting is not indicated at this time. The BLA remains under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of August 31, 2025. Capricor recently presented four-year data from its HOPE-2 Open-Label Extension (OLE) [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3998,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[90,86,87,89,85,362,301],"class_list":["post-3996","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-hope-2"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/3996","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=3996"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/3996\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/3998"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=3996"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=3996"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=3996"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}