{"id":4175,"date":"2025-07-23T17:17:54","date_gmt":"2025-07-23T14:17:54","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4175"},"modified":"2025-07-23T17:21:37","modified_gmt":"2025-07-23T14:21:37","slug":"roche-suspends-shipments-of-elevidys-gene-therapy-outside-of-the-united-states","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/roche-suspends-shipments-of-elevidys-gene-therapy-outside-of-the-united-states\/","title":{"rendered":"\u7f57\u6c0f\u6682\u505c\u5411\u7f8e\u56fd\u5883\u5916\u8fd0\u9001Elevidys\u57fa\u56e0\u7597\u6cd5"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u636e\u8fd9\u5bb6\u745e\u58eb\u5236\u836f\u516c\u53f8\u79f0\uff0c\u6b64\u6b21\u6682\u505c\u5c06\u4e8e 2025 \u5e74 7 \u6708 22 \u65e5\u751f\u6548\uff0c\u6db5\u76d6\u4f9d\u8d56\u5f53\u5730\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u7684\u7f8e\u56fd\u4ee5\u5916\u56fd\u5bb6\u7684 Elevidys \u65b0\u8ba2\u5355\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u4e0e\u5f53\u5730\u76d1\u7ba1\u673a\u6784\u534f\u5546\u540e\uff0c\u7f57\u6c0f\u516c\u53f8\u8868\u793a\u5c06\u7ee7\u7eed\u5411\u5176\u4ed6\u5df2\u83b7\u6279\u51c6\u7684\u56fd\u5bb6\u7684\u95e8\u8bca\u60a3\u8005\u63d0\u4f9b\u8be5\u7597\u6cd5\u3002\u2014\u2014\u9605\u8bfb\u66f4\u591a\uff1a <a href=\"https:\/\/dmdwarrior.com\/zh\/sarepta-therapeutics-announces-pause-of-elevidys-shipments-in-the-usa\/\" target=\"_blank\" rel=\"noreferrer noopener\">Sarepta Therapeutics \u5ba3\u5e03\u6682\u505c\u7f8e\u56fd\u5883\u5185 ELEVIDYS \u53d1\u8d27<\/a> \u2013<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u65e5\u672c\u3001\u5df4\u897f\u3001\u4ee5\u8272\u5217\u3001\u963f\u62c9\u4f2f\u8054\u5408\u914b\u957f\u56fd\u3001\u5361\u5854\u5c14\u548c\u79d1\u5a01\u7279\u7b49\u56fd\u5bb6\u5747\u5df2\u6279\u51c6 Elevidys\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636e\u7f57\u6c0f\u901a\u8fc7\u7535\u5b50\u90ae\u4ef6\u53d1\u51fa\u7684\u58f0\u660e\uff0c\u5bf9\u4e8e\u6240\u6709\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u60a3\u8005\u6765\u8bf4\uff0c\u65e0\u8bba\u5176\u884c\u8d70\u80fd\u529b\u5982\u4f55\uff0c\u6682\u505c\u884c\u8d70\u90fd\u662f\u6682\u65f6\u7684\u3001\u53ef\u9009\u7684\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5468\u4e00\u665a\u4e9b\u65f6\u5019\uff0c\u8428\u96f7\u666e\u5854\u5ba3\u5e03\u5c06\u9075\u5b88FDA\u7684\u8981\u6c42\uff0c\u505c\u6b62\u7f8e\u56fd\u5883\u5185\u6240\u6709Elevidys\u7684\u53d1\u8d27\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7ee7\u4eca\u5e74\u4e24\u540d\u63a5\u53d7Elevidys\u57fa\u56e0\u7597\u6cd5\u6cbb\u7597\u7684\u9752\u5c11\u5e74\u7537\u5b69\u6b7b\u4ea1\u540e\uff0c\u8428\u96f7\u666e\u5854\u516c\u53f8\u5468\u4e94\u5ba3\u5e03\uff0c\u53e6\u4e00\u540d\u63a5\u53d7\u5176\u5b9e\u9a8c\u6027\u57fa\u56e0\u7597\u6cd5\u7684\u60a3\u8005\u56e0\u6025\u6027\u809d\u8870\u7aed\u53bb\u4e16\u3002\u8fd9\u4fc3\u4f7fFDA\u57fa\u56e0\u7597\u6cd5\u7684\u7814\u7a76\u4eba\u5458\u7533\u8bf7\u4e86\u8be5\u7597\u6cd5\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7f57\u6c0f\u8868\u793a\uff0c\u6b63\u5728\u4e0e\u4e16\u754c\u5404\u5730\u7684\u536b\u751f\u5f53\u5c40\u6c9f\u901a\uff0c\u4ee5\u786e\u5b9a\u4e0b\u4e00\u6b65\u53ef\u80fd\u91c7\u53d6\u7684\u63aa\u65bd\uff0c\u5e76\u8bd5\u56fe\u67e5\u660e FDA \u63d0\u51fa\u8bf7\u6c42\u7684\u539f\u56e0\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2019 \u5e74\uff0c\u7f57\u6c0f\u516c\u53f8\u8d2d\u4e70\u4e86 Sarepta Elevidys \u5728\u7f8e\u56fd\u4ee5\u5916\u7684\u5546\u4e1a\u6743\u5229\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f6d\u535a\u65b0\u95fb\u793e\u6700\u521d\u62a5\u9053\u4e86\u8fd9\u4e00\u8fdb\u5c55\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e86\u89e3\u66f4\u591a\uff1a <a href=\"https:\/\/dmdwarrior.com\/zh\/frequently-asked-questions-about-elevidys-used-for-duchenne-muscular-dystrophy\/\">\u5173\u4e8e Elevidys \u7684\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>According to the Swiss pharmaceutical company, the halt, which goes into effect on 22nd July 2025 covers new Elevidys orders in non-US nations that rely on local approval from the Food and Drug Administration. After consulting with local regulatory bodies, Roche stated that it will keep shipping the therapy to ambulatory patients in other nations [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4177,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[282],"tags":[33,203,65],"class_list":["post-4175","post","type-post","status-publish","format-standard","has-post-thumbnail","category-editorials","tag-elevidys","tag-roche","tag-sarepta"],"subtitle":"\u4e0e\u7f8e\u56fd\u5408\u4f5c\u4f19\u4f34 Sarepta Therapeutics \u7684\u7c7b\u4f3c\u4e3e\u52a8\u76f8\u547c\u5e94\uff0c\u7f57\u6c0f\u516c\u53f8\u5468\u4e8c\u5ba3\u5e03\uff0c\u5df2\u6682\u505c\u5411\u4e00\u4e9b\u7f8e\u56fd\u4ee5\u5916\u7684\u56fd\u5bb6\u8fd0\u9001\u7528\u4e8e\u6cbb\u7597\u808c\u8089\u75be\u75c5\u7684\u57fa\u56e0\u7597\u6cd5 Elevidys\u3002","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4175","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=4175"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/4175\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/4177"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=4175"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=4175"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=4175"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}