{"id":3708,"date":"2025-04-18T12:30:11","date_gmt":"2025-04-18T09:30:11","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3708"},"modified":"2025-04-18T12:36:14","modified_gmt":"2025-04-18T09:36:14","slug":"belief-biomed-bbm-d101-gene-therapy-receives-ind-clearance-by-national-medical-products-administration-nmpa","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/belief-biomed-bbm-d101-gene-therapy-receives-ind-clearance-by-national-medical-products-administration-nmpa\/","title":{"rendered":"Belief BioMed BBM-D101\u57fa\u56e0\u7597\u6cd5\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u7684IND\u6279\u51c6"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u4e13\u6ce8\u4e8e\u5f00\u53d1\u5c16\u7aef\u57fa\u56e0\u7597\u6cd5\u7684\u521b\u65b0\u751f\u7269\u6280\u672f\u516c\u53f8Belief BioMed (BBM) \u4eca\u5929\u5ba3\u5e03\uff0c\u5176\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u57fa\u56e0\u7597\u6cd5\u5019\u9009\u836f\u7269 BBM-D101 \u7684\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u5df2\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (NMPA) \u6279\u51c6\u3002\u81f3\u6b64\uff0cBBM-D101 \u7684\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u5df2\u540c\u65f6\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u548c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) (FDA) \u7684\u6279\u51c6\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Belief BioMed\u8054\u5408\u521b\u59cb\u4eba\u3001\u8463\u4e8b\u957f\u517c\u9996\u5e2d\u79d1\u5b66\u5b98\u8096\u6f47\u535a\u58eb\u8868\u793a\uff1a\u201c\u6211\u4eec\u5f88\u9ad8\u5174\u4e0e\u5927\u5bb6\u5206\u4eabBBM-D101\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09IND\u6279\u51c6\u7684\u597d\u6d88\u606f\u3002\u6211\u4eec\u611f\u8c22NMPA\u5bf9\u8be5IND\u7684\u5ba1\u67e5\uff0c\u5e76\u671f\u5f85\u7ee7\u7eed\u4e0eNMPA\u5408\u4f5c\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u3002\u6b64\u524d\uff0cFDA\u5df2\u83b7\u5f97IND\u6279\u51c6\u3002\u6211\u4eec\u5c06\u52a0\u5feb\u4e34\u5e8a\u7814\u7a76\u8fdb\u5ea6\uff0c\u5c3d\u5feb\u4e3a\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08DMD\uff09\u60a3\u8005\u5e26\u6765\u65b0\u7684\u6cbb\u7597\u9009\u62e9\u3002\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u6b21\u4e34\u5e8a\u8bd5\u9a8c\u662f\u4e00\u9879\u5f00\u653e\u6807\u7b7e\u3001\u5355\u5242\u91cf\u4e34\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30\u5355\u6b21\u9759\u8109\u8f93\u6ce8\u6cbb\u75974-9\u5c81\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08DMD\uff09\u60a3\u8005\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u7531\u4e8eBBM-D101\u91c7\u7528\u5de5\u7a0b\u6539\u9020\u7684\u8863\u58f3\uff0c\u80fd\u591f\u66f4\u9ad8\u6548\u5730\u8f6c\u5bfc\u808c\u8089\u7ec4\u7ec7\uff0c\u56e0\u6b64\u62df\u5b9a\u7684\u4e34\u5e8a\u5242\u91cf\u4f4e\u4e8e\u5df2\u83b7\u6279\u7684\u540c\u7c7b\u817a\u76f8\u5173\u75c5\u6bd2\uff08AAV\uff09\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\uff0c\u4e14\u9884\u8ba1BBM-D101\u5177\u6709\u826f\u597d\u7684\u5b89\u5168\u6027\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u4ec0\u4e48\u662fBBM-D101\u57fa\u56e0\u6cbb\u7597\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">BBM-D101\u662fBBM\u62e5\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u57fa\u4e8e\u817a\u76f8\u5173\u75c5\u6bd2\uff08AAV\uff09\u7684\u57fa\u56e0\u7597\u6cd5\u3002\u8be5\u7597\u6cd5\u57fa\u4e8e\u57fa\u56e0\u5de5\u7a0b\u6539\u9020\u7684AAV\u8f7d\u4f53\uff0c\u901a\u8fc7\u5355\u6b21\u9759\u8109\u6ce8\u5c04\u5c06\u4f18\u5316\u540e\u7684\u57fa\u56e0\u9012\u9001\u81f3\u5168\u8eab\u808c\u8089\u7ec4\u7ec7\uff0c\u4ece\u800c\u5b9e\u73b0\u5bf9DMD\u7684\u201c\u4e00\u6b21\u7ed9\u836f\u3001\u957f\u671f\u6709\u6548\u201d\u6cbb\u7597\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4e86\u89e3\u66f4\u591a\uff1a<\/strong> <a href=\"https:\/\/dmdwarrior.com\/zh\/new-gene-therapies-for-duchenne-muscular-dystrophy\/\">\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u7684\u65b0\u57fa\u56e0\u7597\u6cd5<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">IND \u8bb8\u53ef\u662f\u4ec0\u4e48\u610f\u601d\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7 (IND) \u662f\u5411\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) (FDA) \u7533\u8bf7\u6388\u6743\uff0c\u7528\u4e8e\u4eba\u4f53\u8bd5\u9a8c\u836f\u7269\u6216\u751f\u7269\u5236\u54c1\u7684\u7533\u8bf7\u3002\uff08\u9605\u8bfb\u66f4\u591a\uff1a <a href=\"https:\/\/www.cc.nih.gov\/orcs\/ind\/what-is-an-ind\" target=\"_blank\" rel=\"noreferrer noopener\">IND \u6279\u51c6\u7684\u542b\u4e49<\/a>)<\/p>","protected":false},"excerpt":{"rendered":"<p>Belief BioMed (BBM), an innovative biotechnology company focused on developing cutting-edge gene therapies, today announced that it has received National Medical Products Administration (NMPA) clearance of an Investigational New Drug (IND) application for BBM-D101, the company\u2019s Duchenne Muscular Dystrophy (DMD) gene therapy candidate. Thus far, the IND for BBM-D101 has been approved by both NMPA [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3710,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[199,197,123,61,354],"class_list":["post-3708","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-bbm-d101","tag-belief-biomed","tag-china","tag-gene-therapy","tag-nmpa"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/3708","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=3708"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/3708\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/3710"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=3708"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=3708"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=3708"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}