{"id":259203,"date":"2024-09-03T14:42:00","date_gmt":"2024-09-03T06:42:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=259203"},"modified":"2024-09-03T14:42:00","modified_gmt":"2024-09-03T06:42:00","slug":"%e5%ba%b7%e9%9c%88%e6%96%b0%e8%97%a5cbl-514%e4%b9%8b%e7%bd%95%e7%97%85%e7%ab%87%e6%a0%b9%e6%b0%8f%e7%97%87phase-2b%e9%96%8b%e5%a7%8b%e6%94%b6%e6%a1%88-%e9%a0%90%e8%a8%882025-q4%e5%8f%96%e5%be%97","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=259203","title":{"rendered":"\u5eb7\u9708\u65b0\u85e5CBL-514\u4e4b\u7f55\u75c5\u7ac7\u6839\u6c0f\u75c7Phase 2b\u958b\u59cb\u6536\u6848 \u9810\u8a082025 Q4\u53d6\u5f97\u89e3\u76f2\u7d50\u679c"},"content":{"rendered":"<div>\n<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\">\u65b0\u5317\u5e02<\/span><span class=\"legendSpanClass\">2024\u5e749\u67083\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212; \u5eb7\u9708\u751f\u6280 (6919-TW) \u81ea\u4e3b\u7814\u767c\u4e4b\u5e02\u5834\u9996\u898b (First-in-class)\u5019\u9078\u65b0\u85e5CBL-514\u4e4b\u7f55\u75c5\u9069\u61c9\u75c7\u2014\u7ac7\u6839\u6c0f\u75c7Phase <span class=\"xn-money\">2b<\/span> \u81e8\u5e8a\u8a66\u9a57 (CBL-0202DD Phase <span class=\"xn-money\">2b<\/span> Study, NCT06303570)\u5df2\u958b\u59cb\u9032\u884c\u6536\u6848\uff0c\u9810\u8a08\u5c07\u65bc 2025\u5e74 Q4 \u53d6\u5f97\u81e8\u5e8a\u8a66\u9a57\u7d71\u8a08\u6578\u64da\uff0c\u5be6\u969b\u6642\u7a0b\u5c07\u4f9d\u57f7\u884c\u9032\u5ea6\u8abf\u6574\u3002<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<\/p><\/div>\n<p>\u672c\u8a66\u9a57\u70ba\u4e00\u9805\u7d93\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\u00a0(U.S. FDA) \u6838\u51c6\u57f7\u884c\u7684\u5b89\u6170\u5291\u7d44\u5c0d\u7167Phase 2b\u81e8\u5e8a\u8a66\u9a57\uff0c\u9810\u8a08\u5c07\u7d0d\u516530\u4f4d\u5177\u67094\u523010\u9846\u75db\u6027\u8102\u80aa\u7624\u7684\u7ac7\u6839\u6c0f\u75c7\u60a3\u8005\uff0c\u5206\u70baCBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d442\u500b\u7d44\u5225\uff0c\u7d66\u4e88\u81f3\u5c111\u6b21\u3001\u81f3\u591a5\u6b21\u4e4bCBL-514\u6cbb\u7642\u6216\u540c\u9ad4\u7a4d\u7684\u5b89\u6170\u5291\uff0c\u4ee5\u8a55\u4f30CBL-514\u6ce8\u5c04\u5291\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u7642\u6548\u3001\u5b89\u5168\u6027\u8207\u8010\u53d7\u5ea6\uff0c\u4e26\u6bd4\u8f03CBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d44\u5728\u6e1b\u5c11\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8207\u75bc\u75db\u7a0b\u5ea6\u7b49\u7642\u6548\u662f\u5426\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570\u00a0(p&lt;0.05\u70ba\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570)\u3002<\/p>\n<p>\u8207CBL-514 \u5df2\u5b8c\u6210\u4e4bPhase 2\u7ac7\u6839\u6c0f\u75c7\u81e8\u5e8a\u8a66\u9a57(CBL-0201DD) 4<span id=\"spanHghltc042\">\u9031<\/span>\u7642\u7a0b\u7684\u8a66\u9a57\u8a2d\u8a08\u76f8\u8f03\uff0c\u6b64\u6b21Phase 2b\u8a66\u9a57\u5c07\u5ef6\u9577\u6cbb\u7642\u6642\u9593\u81f316\u9031\uff0c\u65bc\u958b\u59cb\u6cbb\u7642\u5f8c4\u9031\u523024\u9031\u6bcf\u6b21\u56de\u8a3a\u8a55\u4f30\u7642\u6548\uff0c\u4e26\u4e14\u63a1\u7b2c\u4e09\u65b9\u4e2d\u7acb\u6a5f\u69cb\u4ee5\u8d85\u97f3\u6ce2\u8a55\u4f30\u8102\u80aa\u7624\u5927\u5c0f\u7684\u8b8a\u5316\u3002\u9664\u6b64\u4e4b\u5916\uff0c\u76f8\u6bd4\u4e8c\u671fPhase2\u4e3b\u8981\u7642\u6548\u6307\u6a19\u2014\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8b8a\u5316\uff0c\u672c\u8a66\u9a57\u7684\u4e3b\u8981\u7642\u6548\u6307\u6a19\u70ba\uff1a\u8207\u5b89\u6170\u5291\u7d44\u76f8\u6bd4\uff0c\u7d93CBL-514\u6cbb\u7642\u5f8c\u7684\u75db\u6027\u8102\u80aa\u7624<b>\u5b8c\u5168\u6e05\u9664\u7684\u767e\u5206\u6bd4<\/b>\u00a0(Complete Response, CR)\uff1b\u6b21\u8981\u7642\u6548\u6307\u6a19\u5247\u5305\u542b\uff1a\u75db\u6027\u8102\u80aa\u7624<b>\u90e8\u5206\u7de9\u89e3<\/b><b>\u00a0(Partial Response) <\/b><b>\u7684\u767e\u5206\u6bd4\u8207\u75bc\u75db\u5206\u6578\u7684\u6539\u5584<\/b>\u7b49\u3002\u4ea6\u5373\u672c\u6b21\u7ac7\u6839\u6c0f\u75c72b\u81e8\u5e8a\u8a66\u9a57\u7d0d\u5165\u75c5\u60a3\u66f4\u591a\u3001\u6cbb\u7642\u6642\u9593\u66f4\u9577\u800c\u4e14\u671f\u7d42\u7642\u6548\u6307\u6a19\u66f4\u5177\u6311\u6230\u6027\uff1b\u82e5\u6b64\u8a66\u9a57\u9054\u6a19\uff0c\u5c07\u5c55\u958b\u6a1e\u7d10\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u7684\u7533\u8acb\u8207\u6536\u6848\u3002<\/p>\n<p>CBL-514\u70ba\u76ee\u524d\u5168\u7403\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u85e5\u7269\u4e2d\uff0c\u81e8\u5e8a\u958b\u767c\u901f\u5ea6\u6700\u524d\u6cbf\uff0c\u540c\u6642\u4e5f\u662f\u552f\u4e00\u81e8\u5e8a\u7642\u6548\u53d6\u5f97\u7d71\u8a08\u986f\u8457\u610f\u7fa9\u7684\u85e5\u7269\uff0c\u672a\u4f86\u5c07\u6709\u6a5f\u6703\u6210\u70ba\u5168\u7403\u7b2c\u4e00\u500b\u6838\u51c6\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u4e4b\u85e5\u7269\u3002\u503c\u5f97\u4e00\u63d0\u7684\u662f\uff0cCBL-514\u4e5f\u662f\u76ee\u524d\u552f\u4e00\u7372\u7f8e\u570bFDA\u540c\u6642\u6388\u4e88\u300c\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Orphan Drug Designation, ODD) \u53ca\u300c\u5feb\u901f\u5be9\u67e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Fast Track Designation) \u96d9\u8cc7\u683c\u8a8d\u5b9a\u4e4b\u7ac7\u6839\u6c0f\u75c7\u65b0\u85e5\uff0c\u5c07\u6709\u5229\u65bc\u52a0\u901fCBL-514\u7684\u81e8\u5e8a\u958b\u767c\uff0c\u4e26\u589e\u52a0\u7522\u54c1\u4e0a\u5e02\u5f8c\u4e4b\u512a\u52e2\u3002<\/p>\n<p><b>\u95dc\u65bc\u7ac7\u6839\u6c0f\u75c7<\/b><b>\u00a0(Dercum&#8217;s Disease)<\/b><\/p>\n<p>\u7ac7\u6839\u6c0f\u75c7\u70ba\u4e00\u7a2e\u6162\u6027\u4e14\u5fa9\u767c\u6027\u5f37\u7684\u56b4\u91cd\u7f55\u898b\u75be\u75c5\uff0c\u60a3\u8005\u8ec0\u5e79\u53ca\u56db\u80a2\u6703\u6709\u76ae\u4e0b\u8102\u80aa\u7570\u5e38\u5806\u7a4d\u6240\u5f62\u6210\u7684\u826f\u6027\u7684\u75db\u6027\u8102\u80aa\u7624\u6216\u8102\u80aa\u816b\u584a\uff0c\u4e26\u4f34\u96a8\u8a72\u90e8\u4f4d\u81ea\u767c\u6027\u5287\u70c8\u75bc\u75db\uff0c\u4e26\u6703\u6709\u6301\u7e8c\u8d85\u904e3\u500b\u6708\u7684\u707c\u75db\u8207\u707c\u71b1\u611f\uff0c\u9032\u800c\u56b4\u91cd\u5e72\u64fe\u60a3\u8005\u6b63\u5e38\u751f\u6d3b\u3002\u7ac7\u6839\u6c0f\u75c7\u75c7\u72c0\u4e26\u4e0d\u6703\u81ea\u767c\u6027\u7de9\u89e3\u6216\u6d88\u5931\uff0c\u4e14\u5176\u75db\u6027\u8102\u80aa\u7624\u6709\u53ef\u80fd\u5728\u77ed\u6642\u9593\u8b8a\u5927\u6216\u6578\u91cf\u589e\u52a0\u3002\u76ee\u524d\u81f4\u75c5\u6a5f\u8f49\u5c1a\u4e0d\u660e\uff0c\u4f46\u6709\u7814\u7a76\u6307\u51fa\u53ef\u80fd\u8207\u8102\u80aa\u7d44\u7e54\u4ee3\u8b1d\u969c\u7919\u76f8\u95dc\u3002<\/p>\n<p>\u76ee\u524d\u5168\u7403\u5c1a\u7121\u6838\u51c6\u7684\u7ac7\u6839\u6c0f\u75c7\u85e5\u7269\u53ef\u6cbb\u7642\uff0c\u73fe\u4eca\u4f7f\u7528\u4e4b\u7de9\u89e3\u7642\u6cd5\u5305\u542b\u624b\u8853\u5207\u9664\u8102\u80aa\u7624\u3001\u62bd\u8102\u3001\u9ebb\u9189\/\u6b62\u75db\u85e5\u3001\u514d\u75ab\u8abf\u7bc0\u5291\u3001\u96fb\u7642\u53ca\u91dd\u7078\u7b49\uff0c\u7136\u800c\u5176\u7642\u6548\u591a\u4e0d\u4f73\u4e14\u50c5\u80fd\u77ed\u66ab\u7de9\u89e3\u75bc\u75db\uff0c\u4e26\u4f34\u96a8\u591a\u7a2e\u526f\u4f5c\u7528\u3002<\/p>\n<p>\u6839\u64da\u00a0Global Dercum&#8217;s Disease Market Research Report Future 2023\u5e02\u5834\u5831\u544a\u6307\u51fa\uff0c2021\u5e74\u7ac7\u6839\u6c0f\u75c7\u5168\u7403\u5e02\u5834\u70ba113\u5104\u7f8e\u5143\uff0c\u4f9d\u64da\u5e74\u8907\u5408\u6210\u9577\u7387(CAGR) 6.76%\u63a8\u4f302032\u5e74\u5168\u7403\u5e02\u5834\u70ba227\u5104\u7f8e\u5143\u3002<\/p>\n<p><b>CBL-514<\/b><b>\u7522\u54c1\u7814\u767c\u73fe\u6cc1<\/b><\/p>\n<p>CBL-514\u6ce8\u5c04\u5291\u662f\u5168\u7403\u9996\u5275\u7684505(b)(1)\u5168\u65b0\u5c0f\u5206\u5b50\u65b0\u85e5\uff0c\u900f\u904e\u8a98\u5c0e\u8102\u80aa\u7d30\u80de\u51cb\u4ea1\u4f86\u6e1b\u5c11\u6ce8\u5c04\u90e8\u4f4d\u8102\u80aa\u3002CBL-514\u6cbb\u7642\u7f55\u898b\u75be\u75c5\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum&#8217;s Disease) \u4e4bCBL-0201DD Phase 2\u81e8\u5e8a\u8a66\u9a57\u00a0(NCT05387733) \u5df2\u65bc2023\u5e744\u6708\u5b8c\u6210\u8a66\u9a57\uff0c\u5176\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u6b21\u8981\u7642\u6548\u6307\u6a19\u5728ITT\u8207PP\u7686\u9054\u5230\u81e8\u5e8a\u53ca\u7d71\u8a08\u4e0a\u986f\u8457\u6709\u6548\u610f\u7fa9(p&lt;0.0001)\uff1b\u7ac7\u6839\u6c0f\u75c7CBL-0202DD Phase <span class=\"xn-money\">2b<\/span> IND\u5df2\u65bc2024\u5e741\u6708\u53d6\u5f97\u7f8e\u570bFDA\u6838\u51c6\u57f7\u884c\uff0c\u4e26\u65bc2024\u5e748\u6708\u958b\u59cb\u6536\u6848\uff0c\u9810\u8a082025\u5e74Q4\u53d6\u5f97\u81e8\u5e8a\u7d71\u8a08\u7d50\u679c\u3002<\/p>\n<p><b>\u8072\u660e<\/b><br \/>\u672c\u6587\u7ae0\u53ca\u7db2\u7ad9\u4e2d\u6240\u767c\u4f48\u4e4b\u76f8\u95dc\u8cc7\u6599\u542b\u6709\u9810\u6e2c\u6027\u6558\u8ff0\uff0c\u6b64\u985e\u6558\u8ff0\u662f\u57fa\u65bc\u73fe\u6cc1\u7684\u9810\u6e2c\u548c\u8a55\u4f30\u3002\u9019\u4e9b\u9810\u6e2c\u6027\u6558\u8ff0\u5c07\u53d7\u4e0d\u78ba\u5b9a\u6027\u3001\u98a8\u96aa\u8207\u5176\u4ed6\u975e\u672c\u516c\u53f8\u6240\u80fd\u638c\u63a7\u7b49\u56e0\u7d20\u5f71\u97ff\u3002\u60df\u4ecd\u5b58\u6709\u8a31\u591a\u56e0\u7d20\u53ef\u80fd\u4f7f\u4e8b\u4ef6\u7684\u767c\u5c55\u6216\u5176\u5be6\u969b\u7d50\u679c\u8207\u9810\u6e2c\u6027\u6558\u8ff0\u6709\u91cd\u5927\u5dee\u7570\u3002\u672c\u516c\u53f8\u4e0d\u8ca0\u4efb\u4f55\u66f4\u65b0\u6216\u4fee\u8a02\u4e4b\u8cac\u4efb\u3002<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u65b0\u5317\u5e022024\u5e749\u67083\u65e5 \/\u7f8e&#8230;<\/p>\n","protected":false},"author":16,"featured_media":259204,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[40567],"tags":[],"class_list":["post-259203","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-40567"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u5eb7\u9708\u65b0\u85e5CBL-514\u4e4b\u7f55\u75c5\u7ac7\u6839\u6c0f\u75c7Phase 2b\u958b\u59cb\u6536\u6848 \u9810\u8a082025 Q4\u53d6\u5f97\u89e3\u76f2\u7d50\u679c - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831<\/title>\n<meta name=\"description\" content=\"\u65b0\u5317\u5e022024\u5e749\u67083\u65e5 \/\u7f8e\u901a\u793e\/ -- \u5eb7\u9708\u751f\u6280 (6919-TW) \u81ea\u4e3b\u7814\u767c\u4e4b\u5e02\u5834\u9996\u898b (First-in-class)\u5019\u9078\u65b0\u85e5CBL-514\u4e4b\u7f55\u75c5\u9069\u61c9\u75c7\u2014\u7ac7\u6839\u6c0f\u75c7Phase 2b \u81e8\u5e8a\u8a66\u9a57 (CBL-0202DD Phase 2b Study, NCT06303570)\u5df2\u958b\u59cb\u9032\u884c\u6536\u6848\uff0c\u9810\u8a08\u5c07\u65bc 2025\u5e74 Q4 \u53d6\u5f97\u81e8\u5e8a\u8a66\u9a57\u7d71\u8a08\u6578\u64da\uff0c\u5be6\u969b\u6642\u7a0b\u5c07\u4f9d\u57f7\u884c\u9032\u5ea6\u8abf\u6574\u3002     \u672c\u8a66\u9a57\u70ba\u4e00\u9805\u7d93\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\u00a0(U.S. FDA) \u6838\u51c6\u57f7\u884c\u7684\u5b89\u6170\u5291\u7d44\u5c0d\u7167Phase 2b\u81e8\u5e8a\u8a66\u9a57\uff0c\u9810\u8a08\u5c07\u7d0d\u516530\u4f4d\u5177\u67094\u523010\u9846\u75db\u6027\u8102\u80aa\u7624\u7684\u7ac7\u6839\u6c0f\u75c7\u60a3\u8005\uff0c\u5206\u70baCBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d442\u500b\u7d44\u5225\uff0c\u7d66\u4e88\u81f3\u5c111\u6b21\u3001\u81f3\u591a5\u6b21\u4e4bCBL-514\u6cbb\u7642\u6216\u540c\u9ad4\u7a4d\u7684\u5b89\u6170\u5291\uff0c\u4ee5\u8a55\u4f30CBL-514\u6ce8\u5c04\u5291\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u7642\u6548\u3001\u5b89\u5168\u6027\u8207\u8010\u53d7\u5ea6\uff0c\u4e26\u6bd4\u8f03CBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d44\u5728\u6e1b\u5c11\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8207\u75bc\u75db\u7a0b\u5ea6\u7b49\u7642\u6548\u662f\u5426\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570\u00a0(p&lt;0.05\u70ba\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570)\u3002 \u8207CBL-514 \u5df2\u5b8c\u6210\u4e4bPhase 2\u7ac7\u6839\u6c0f\u75c7\u81e8\u5e8a\u8a66\u9a57(CBL-0201DD) 4\u9031\u7642\u7a0b\u7684\u8a66\u9a57\u8a2d\u8a08\u76f8\u8f03\uff0c\u6b64\u6b21Phase 2b\u8a66\u9a57\u5c07\u5ef6\u9577\u6cbb\u7642\u6642\u9593\u81f316\u9031\uff0c\u65bc\u958b\u59cb\u6cbb\u7642\u5f8c4\u9031\u523024\u9031\u6bcf\u6b21\u56de\u8a3a\u8a55\u4f30\u7642\u6548\uff0c\u4e26\u4e14\u63a1\u7b2c\u4e09\u65b9\u4e2d\u7acb\u6a5f\u69cb\u4ee5\u8d85\u97f3\u6ce2\u8a55\u4f30\u8102\u80aa\u7624\u5927\u5c0f\u7684\u8b8a\u5316\u3002\u9664\u6b64\u4e4b\u5916\uff0c\u76f8\u6bd4\u4e8c\u671fPhase2\u4e3b\u8981\u7642\u6548\u6307\u6a19\u2014\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8b8a\u5316\uff0c\u672c\u8a66\u9a57\u7684\u4e3b\u8981\u7642\u6548\u6307\u6a19\u70ba\uff1a\u8207\u5b89\u6170\u5291\u7d44\u76f8\u6bd4\uff0c\u7d93CBL-514\u6cbb\u7642\u5f8c\u7684\u75db\u6027\u8102\u80aa\u7624\u5b8c\u5168\u6e05\u9664\u7684\u767e\u5206\u6bd4\u00a0(Complete Response, CR)\uff1b\u6b21\u8981\u7642\u6548\u6307\u6a19\u5247\u5305\u542b\uff1a\u75db\u6027\u8102\u80aa\u7624\u90e8\u5206\u7de9\u89e3\u00a0(Partial Response) \u7684\u767e\u5206\u6bd4\u8207\u75bc\u75db\u5206\u6578\u7684\u6539\u5584\u7b49\u3002\u4ea6\u5373\u672c\u6b21\u7ac7\u6839\u6c0f\u75c72b\u81e8\u5e8a\u8a66\u9a57\u7d0d\u5165\u75c5\u60a3\u66f4\u591a\u3001\u6cbb\u7642\u6642\u9593\u66f4\u9577\u800c\u4e14\u671f\u7d42\u7642\u6548\u6307\u6a19\u66f4\u5177\u6311\u6230\u6027\uff1b\u82e5\u6b64\u8a66\u9a57\u9054\u6a19\uff0c\u5c07\u5c55\u958b\u6a1e\u7d10\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u7684\u7533\u8acb\u8207\u6536\u6848\u3002 CBL-514\u70ba\u76ee\u524d\u5168\u7403\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u85e5\u7269\u4e2d\uff0c\u81e8\u5e8a\u958b\u767c\u901f\u5ea6\u6700\u524d\u6cbf\uff0c\u540c\u6642\u4e5f\u662f\u552f\u4e00\u81e8\u5e8a\u7642\u6548\u53d6\u5f97\u7d71\u8a08\u986f\u8457\u610f\u7fa9\u7684\u85e5\u7269\uff0c\u672a\u4f86\u5c07\u6709\u6a5f\u6703\u6210\u70ba\u5168\u7403\u7b2c\u4e00\u500b\u6838\u51c6\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u4e4b\u85e5\u7269\u3002\u503c\u5f97\u4e00\u63d0\u7684\u662f\uff0cCBL-514\u4e5f\u662f\u76ee\u524d\u552f\u4e00\u7372\u7f8e\u570bFDA\u540c\u6642\u6388\u4e88\u300c\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Orphan Drug Designation, ODD) \u53ca\u300c\u5feb\u901f\u5be9\u67e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Fast Track Designation) \u96d9\u8cc7\u683c\u8a8d\u5b9a\u4e4b\u7ac7\u6839\u6c0f\u75c7\u65b0\u85e5\uff0c\u5c07\u6709\u5229\u65bc\u52a0\u901fCBL-514\u7684\u81e8\u5e8a\u958b\u767c\uff0c\u4e26\u589e\u52a0\u7522\u54c1\u4e0a\u5e02\u5f8c\u4e4b\u512a\u52e2\u3002 \u95dc\u65bc\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum&#039;s Disease) \u7ac7\u6839\u6c0f\u75c7\u70ba\u4e00\u7a2e\u6162\u6027\u4e14\u5fa9\u767c\u6027\u5f37\u7684\u56b4\u91cd\u7f55\u898b\u75be\u75c5\uff0c\u60a3\u8005\u8ec0\u5e79\u53ca\u56db\u80a2\u6703\u6709\u76ae\u4e0b\u8102\u80aa\u7570\u5e38\u5806\u7a4d\u6240\u5f62\u6210\u7684\u826f\u6027\u7684\u75db\u6027\u8102\u80aa\u7624\u6216\u8102\u80aa\u816b\u584a\uff0c\u4e26\u4f34\u96a8\u8a72\u90e8\u4f4d\u81ea\u767c\u6027\u5287\u70c8\u75bc\u75db\uff0c\u4e26\u6703\u6709\u6301\u7e8c\u8d85\u904e3\u500b\u6708\u7684\u707c\u75db\u8207\u707c\u71b1\u611f\uff0c\u9032\u800c\u56b4\u91cd\u5e72\u64fe\u60a3\u8005\u6b63\u5e38\u751f\u6d3b\u3002\u7ac7\u6839\u6c0f\u75c7\u75c7\u72c0\u4e26\u4e0d\u6703\u81ea\u767c\u6027\u7de9\u89e3\u6216\u6d88\u5931\uff0c\u4e14\u5176\u75db\u6027\u8102\u80aa\u7624\u6709\u53ef\u80fd\u5728\u77ed\u6642\u9593\u8b8a\u5927\u6216\u6578\u91cf\u589e\u52a0\u3002\u76ee\u524d\u81f4\u75c5\u6a5f\u8f49\u5c1a\u4e0d\u660e\uff0c\u4f46\u6709\u7814\u7a76\u6307\u51fa\u53ef\u80fd\u8207\u8102\u80aa\u7d44\u7e54\u4ee3\u8b1d\u969c\u7919\u76f8\u95dc\u3002 \u76ee\u524d\u5168\u7403\u5c1a\u7121\u6838\u51c6\u7684\u7ac7\u6839\u6c0f\u75c7\u85e5\u7269\u53ef\u6cbb\u7642\uff0c\u73fe\u4eca\u4f7f\u7528\u4e4b\u7de9\u89e3\u7642\u6cd5\u5305\u542b\u624b\u8853\u5207\u9664\u8102\u80aa\u7624\u3001\u62bd\u8102\u3001\u9ebb\u9189\/\u6b62\u75db\u85e5\u3001\u514d\u75ab\u8abf\u7bc0\u5291\u3001\u96fb\u7642\u53ca\u91dd\u7078\u7b49\uff0c\u7136\u800c\u5176\u7642\u6548\u591a\u4e0d\u4f73\u4e14\u50c5\u80fd\u77ed\u66ab\u7de9\u89e3\u75bc\u75db\uff0c\u4e26\u4f34\u96a8\u591a\u7a2e\u526f\u4f5c\u7528\u3002 \u6839\u64da\u00a0Global Dercum&#039;s Disease Market Research Report Future 2023\u5e02\u5834\u5831\u544a\u6307\u51fa\uff0c2021\u5e74\u7ac7\u6839\u6c0f\u75c7\u5168\u7403\u5e02\u5834\u70ba113\u5104\u7f8e\u5143\uff0c\u4f9d\u64da\u5e74\u8907\u5408\u6210\u9577\u7387(CAGR) 6.76%\u63a8\u4f302032\u5e74\u5168\u7403\u5e02\u5834\u70ba227\u5104\u7f8e\u5143\u3002 CBL-514\u7522\u54c1\u7814\u767c\u73fe\u6cc1 CBL-514\u6ce8\u5c04\u5291\u662f\u5168\u7403\u9996\u5275\u7684505(b)(1)\u5168\u65b0\u5c0f\u5206\u5b50\u65b0\u85e5\uff0c\u900f\u904e\u8a98\u5c0e\u8102\u80aa\u7d30\u80de\u51cb\u4ea1\u4f86\u6e1b\u5c11\u6ce8\u5c04\u90e8\u4f4d\u8102\u80aa\u3002CBL-514\u6cbb\u7642\u7f55\u898b\u75be\u75c5\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum&#039;s Disease) \u4e4bCBL-0201DD Phase 2\u81e8\u5e8a\u8a66\u9a57\u00a0(NCT05387733) \u5df2\u65bc2023\u5e744\u6708\u5b8c\u6210\u8a66\u9a57\uff0c\u5176\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u6b21\u8981\u7642\u6548\u6307\u6a19\u5728ITT\u8207PP\u7686\u9054\u5230\u81e8\u5e8a\u53ca\u7d71\u8a08\u4e0a\u986f\u8457\u6709\u6548\u610f\u7fa9(p&lt;0.0001)\uff1b\u7ac7\u6839\u6c0f\u75c7CBL-0202DD Phase 2b IND\u5df2\u65bc2024\u5e741\u6708\u53d6\u5f97\u7f8e\u570bFDA\u6838\u51c6\u57f7\u884c\uff0c\u4e26\u65bc2024\u5e748\u6708\u958b\u59cb\u6536\u6848\uff0c\u9810\u8a082025\u5e74Q4\u53d6\u5f97\u81e8\u5e8a\u7d71\u8a08\u7d50\u679c\u3002 \u8072\u660e\u672c\u6587\u7ae0\u53ca\u7db2\u7ad9\u4e2d\u6240\u767c\u4f48\u4e4b\u76f8\u95dc\u8cc7\u6599\u542b\u6709\u9810\u6e2c\u6027\u6558\u8ff0\uff0c\u6b64\u985e\u6558\u8ff0\u662f\u57fa\u65bc\u73fe\u6cc1\u7684\u9810\u6e2c\u548c\u8a55\u4f30\u3002\u9019\u4e9b\u9810\u6e2c\u6027\u6558\u8ff0\u5c07\u53d7\u4e0d\u78ba\u5b9a\u6027\u3001\u98a8\u96aa\u8207\u5176\u4ed6\u975e\u672c\u516c\u53f8\u6240\u80fd\u638c\u63a7\u7b49\u56e0\u7d20\u5f71\u97ff\u3002\u60df\u4ecd\u5b58\u6709\u8a31\u591a\u56e0\u7d20\u53ef\u80fd\u4f7f\u4e8b\u4ef6\u7684\u767c\u5c55\u6216\u5176\u5be6\u969b\u7d50\u679c\u8207\u9810\u6e2c\u6027\u6558\u8ff0\u6709\u91cd\u5927\u5dee\u7570\u3002\u672c\u516c\u53f8\u4e0d\u8ca0\u4efb\u4f55\u66f4\u65b0\u6216\u4fee\u8a02\u4e4b\u8cac\u4efb\u3002\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pingtungtimes.com.tw\/?p=259203\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u5eb7\u9708\u65b0\u85e5CBL-514\u4e4b\u7f55\u75c5\u7ac7\u6839\u6c0f\u75c7Phase 2b\u958b\u59cb\u6536\u6848 \u9810\u8a082025 Q4\u53d6\u5f97\u89e3\u76f2\u7d50\u679c - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" content=\"\u65b0\u5317\u5e022024\u5e749\u67083\u65e5 \/\u7f8e\u901a\u793e\/ -- \u5eb7\u9708\u751f\u6280 (6919-TW) \u81ea\u4e3b\u7814\u767c\u4e4b\u5e02\u5834\u9996\u898b (First-in-class)\u5019\u9078\u65b0\u85e5CBL-514\u4e4b\u7f55\u75c5\u9069\u61c9\u75c7\u2014\u7ac7\u6839\u6c0f\u75c7Phase 2b \u81e8\u5e8a\u8a66\u9a57 (CBL-0202DD Phase 2b Study, NCT06303570)\u5df2\u958b\u59cb\u9032\u884c\u6536\u6848\uff0c\u9810\u8a08\u5c07\u65bc 2025\u5e74 Q4 \u53d6\u5f97\u81e8\u5e8a\u8a66\u9a57\u7d71\u8a08\u6578\u64da\uff0c\u5be6\u969b\u6642\u7a0b\u5c07\u4f9d\u57f7\u884c\u9032\u5ea6\u8abf\u6574\u3002     \u672c\u8a66\u9a57\u70ba\u4e00\u9805\u7d93\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\u00a0(U.S. FDA) \u6838\u51c6\u57f7\u884c\u7684\u5b89\u6170\u5291\u7d44\u5c0d\u7167Phase 2b\u81e8\u5e8a\u8a66\u9a57\uff0c\u9810\u8a08\u5c07\u7d0d\u516530\u4f4d\u5177\u67094\u523010\u9846\u75db\u6027\u8102\u80aa\u7624\u7684\u7ac7\u6839\u6c0f\u75c7\u60a3\u8005\uff0c\u5206\u70baCBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d442\u500b\u7d44\u5225\uff0c\u7d66\u4e88\u81f3\u5c111\u6b21\u3001\u81f3\u591a5\u6b21\u4e4bCBL-514\u6cbb\u7642\u6216\u540c\u9ad4\u7a4d\u7684\u5b89\u6170\u5291\uff0c\u4ee5\u8a55\u4f30CBL-514\u6ce8\u5c04\u5291\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u7642\u6548\u3001\u5b89\u5168\u6027\u8207\u8010\u53d7\u5ea6\uff0c\u4e26\u6bd4\u8f03CBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d44\u5728\u6e1b\u5c11\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8207\u75bc\u75db\u7a0b\u5ea6\u7b49\u7642\u6548\u662f\u5426\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570\u00a0(p&lt;0.05\u70ba\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570)\u3002 \u8207CBL-514 \u5df2\u5b8c\u6210\u4e4bPhase 2\u7ac7\u6839\u6c0f\u75c7\u81e8\u5e8a\u8a66\u9a57(CBL-0201DD) 4\u9031\u7642\u7a0b\u7684\u8a66\u9a57\u8a2d\u8a08\u76f8\u8f03\uff0c\u6b64\u6b21Phase 2b\u8a66\u9a57\u5c07\u5ef6\u9577\u6cbb\u7642\u6642\u9593\u81f316\u9031\uff0c\u65bc\u958b\u59cb\u6cbb\u7642\u5f8c4\u9031\u523024\u9031\u6bcf\u6b21\u56de\u8a3a\u8a55\u4f30\u7642\u6548\uff0c\u4e26\u4e14\u63a1\u7b2c\u4e09\u65b9\u4e2d\u7acb\u6a5f\u69cb\u4ee5\u8d85\u97f3\u6ce2\u8a55\u4f30\u8102\u80aa\u7624\u5927\u5c0f\u7684\u8b8a\u5316\u3002\u9664\u6b64\u4e4b\u5916\uff0c\u76f8\u6bd4\u4e8c\u671fPhase2\u4e3b\u8981\u7642\u6548\u6307\u6a19\u2014\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8b8a\u5316\uff0c\u672c\u8a66\u9a57\u7684\u4e3b\u8981\u7642\u6548\u6307\u6a19\u70ba\uff1a\u8207\u5b89\u6170\u5291\u7d44\u76f8\u6bd4\uff0c\u7d93CBL-514\u6cbb\u7642\u5f8c\u7684\u75db\u6027\u8102\u80aa\u7624\u5b8c\u5168\u6e05\u9664\u7684\u767e\u5206\u6bd4\u00a0(Complete Response, CR)\uff1b\u6b21\u8981\u7642\u6548\u6307\u6a19\u5247\u5305\u542b\uff1a\u75db\u6027\u8102\u80aa\u7624\u90e8\u5206\u7de9\u89e3\u00a0(Partial Response) \u7684\u767e\u5206\u6bd4\u8207\u75bc\u75db\u5206\u6578\u7684\u6539\u5584\u7b49\u3002\u4ea6\u5373\u672c\u6b21\u7ac7\u6839\u6c0f\u75c72b\u81e8\u5e8a\u8a66\u9a57\u7d0d\u5165\u75c5\u60a3\u66f4\u591a\u3001\u6cbb\u7642\u6642\u9593\u66f4\u9577\u800c\u4e14\u671f\u7d42\u7642\u6548\u6307\u6a19\u66f4\u5177\u6311\u6230\u6027\uff1b\u82e5\u6b64\u8a66\u9a57\u9054\u6a19\uff0c\u5c07\u5c55\u958b\u6a1e\u7d10\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u7684\u7533\u8acb\u8207\u6536\u6848\u3002 CBL-514\u70ba\u76ee\u524d\u5168\u7403\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u85e5\u7269\u4e2d\uff0c\u81e8\u5e8a\u958b\u767c\u901f\u5ea6\u6700\u524d\u6cbf\uff0c\u540c\u6642\u4e5f\u662f\u552f\u4e00\u81e8\u5e8a\u7642\u6548\u53d6\u5f97\u7d71\u8a08\u986f\u8457\u610f\u7fa9\u7684\u85e5\u7269\uff0c\u672a\u4f86\u5c07\u6709\u6a5f\u6703\u6210\u70ba\u5168\u7403\u7b2c\u4e00\u500b\u6838\u51c6\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u4e4b\u85e5\u7269\u3002\u503c\u5f97\u4e00\u63d0\u7684\u662f\uff0cCBL-514\u4e5f\u662f\u76ee\u524d\u552f\u4e00\u7372\u7f8e\u570bFDA\u540c\u6642\u6388\u4e88\u300c\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Orphan Drug Designation, ODD) \u53ca\u300c\u5feb\u901f\u5be9\u67e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Fast Track Designation) \u96d9\u8cc7\u683c\u8a8d\u5b9a\u4e4b\u7ac7\u6839\u6c0f\u75c7\u65b0\u85e5\uff0c\u5c07\u6709\u5229\u65bc\u52a0\u901fCBL-514\u7684\u81e8\u5e8a\u958b\u767c\uff0c\u4e26\u589e\u52a0\u7522\u54c1\u4e0a\u5e02\u5f8c\u4e4b\u512a\u52e2\u3002 \u95dc\u65bc\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum&#039;s Disease) \u7ac7\u6839\u6c0f\u75c7\u70ba\u4e00\u7a2e\u6162\u6027\u4e14\u5fa9\u767c\u6027\u5f37\u7684\u56b4\u91cd\u7f55\u898b\u75be\u75c5\uff0c\u60a3\u8005\u8ec0\u5e79\u53ca\u56db\u80a2\u6703\u6709\u76ae\u4e0b\u8102\u80aa\u7570\u5e38\u5806\u7a4d\u6240\u5f62\u6210\u7684\u826f\u6027\u7684\u75db\u6027\u8102\u80aa\u7624\u6216\u8102\u80aa\u816b\u584a\uff0c\u4e26\u4f34\u96a8\u8a72\u90e8\u4f4d\u81ea\u767c\u6027\u5287\u70c8\u75bc\u75db\uff0c\u4e26\u6703\u6709\u6301\u7e8c\u8d85\u904e3\u500b\u6708\u7684\u707c\u75db\u8207\u707c\u71b1\u611f\uff0c\u9032\u800c\u56b4\u91cd\u5e72\u64fe\u60a3\u8005\u6b63\u5e38\u751f\u6d3b\u3002\u7ac7\u6839\u6c0f\u75c7\u75c7\u72c0\u4e26\u4e0d\u6703\u81ea\u767c\u6027\u7de9\u89e3\u6216\u6d88\u5931\uff0c\u4e14\u5176\u75db\u6027\u8102\u80aa\u7624\u6709\u53ef\u80fd\u5728\u77ed\u6642\u9593\u8b8a\u5927\u6216\u6578\u91cf\u589e\u52a0\u3002\u76ee\u524d\u81f4\u75c5\u6a5f\u8f49\u5c1a\u4e0d\u660e\uff0c\u4f46\u6709\u7814\u7a76\u6307\u51fa\u53ef\u80fd\u8207\u8102\u80aa\u7d44\u7e54\u4ee3\u8b1d\u969c\u7919\u76f8\u95dc\u3002 \u76ee\u524d\u5168\u7403\u5c1a\u7121\u6838\u51c6\u7684\u7ac7\u6839\u6c0f\u75c7\u85e5\u7269\u53ef\u6cbb\u7642\uff0c\u73fe\u4eca\u4f7f\u7528\u4e4b\u7de9\u89e3\u7642\u6cd5\u5305\u542b\u624b\u8853\u5207\u9664\u8102\u80aa\u7624\u3001\u62bd\u8102\u3001\u9ebb\u9189\/\u6b62\u75db\u85e5\u3001\u514d\u75ab\u8abf\u7bc0\u5291\u3001\u96fb\u7642\u53ca\u91dd\u7078\u7b49\uff0c\u7136\u800c\u5176\u7642\u6548\u591a\u4e0d\u4f73\u4e14\u50c5\u80fd\u77ed\u66ab\u7de9\u89e3\u75bc\u75db\uff0c\u4e26\u4f34\u96a8\u591a\u7a2e\u526f\u4f5c\u7528\u3002 \u6839\u64da\u00a0Global Dercum&#039;s Disease Market Research Report Future 2023\u5e02\u5834\u5831\u544a\u6307\u51fa\uff0c2021\u5e74\u7ac7\u6839\u6c0f\u75c7\u5168\u7403\u5e02\u5834\u70ba113\u5104\u7f8e\u5143\uff0c\u4f9d\u64da\u5e74\u8907\u5408\u6210\u9577\u7387(CAGR) 6.76%\u63a8\u4f302032\u5e74\u5168\u7403\u5e02\u5834\u70ba227\u5104\u7f8e\u5143\u3002 CBL-514\u7522\u54c1\u7814\u767c\u73fe\u6cc1 CBL-514\u6ce8\u5c04\u5291\u662f\u5168\u7403\u9996\u5275\u7684505(b)(1)\u5168\u65b0\u5c0f\u5206\u5b50\u65b0\u85e5\uff0c\u900f\u904e\u8a98\u5c0e\u8102\u80aa\u7d30\u80de\u51cb\u4ea1\u4f86\u6e1b\u5c11\u6ce8\u5c04\u90e8\u4f4d\u8102\u80aa\u3002CBL-514\u6cbb\u7642\u7f55\u898b\u75be\u75c5\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum&#039;s Disease) \u4e4bCBL-0201DD Phase 2\u81e8\u5e8a\u8a66\u9a57\u00a0(NCT05387733) \u5df2\u65bc2023\u5e744\u6708\u5b8c\u6210\u8a66\u9a57\uff0c\u5176\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u6b21\u8981\u7642\u6548\u6307\u6a19\u5728ITT\u8207PP\u7686\u9054\u5230\u81e8\u5e8a\u53ca\u7d71\u8a08\u4e0a\u986f\u8457\u6709\u6548\u610f\u7fa9(p&lt;0.0001)\uff1b\u7ac7\u6839\u6c0f\u75c7CBL-0202DD Phase 2b IND\u5df2\u65bc2024\u5e741\u6708\u53d6\u5f97\u7f8e\u570bFDA\u6838\u51c6\u57f7\u884c\uff0c\u4e26\u65bc2024\u5e748\u6708\u958b\u59cb\u6536\u6848\uff0c\u9810\u8a082025\u5e74Q4\u53d6\u5f97\u81e8\u5e8a\u7d71\u8a08\u7d50\u679c\u3002 \u8072\u660e\u672c\u6587\u7ae0\u53ca\u7db2\u7ad9\u4e2d\u6240\u767c\u4f48\u4e4b\u76f8\u95dc\u8cc7\u6599\u542b\u6709\u9810\u6e2c\u6027\u6558\u8ff0\uff0c\u6b64\u985e\u6558\u8ff0\u662f\u57fa\u65bc\u73fe\u6cc1\u7684\u9810\u6e2c\u548c\u8a55\u4f30\u3002\u9019\u4e9b\u9810\u6e2c\u6027\u6558\u8ff0\u5c07\u53d7\u4e0d\u78ba\u5b9a\u6027\u3001\u98a8\u96aa\u8207\u5176\u4ed6\u975e\u672c\u516c\u53f8\u6240\u80fd\u638c\u63a7\u7b49\u56e0\u7d20\u5f71\u97ff\u3002\u60df\u4ecd\u5b58\u6709\u8a31\u591a\u56e0\u7d20\u53ef\u80fd\u4f7f\u4e8b\u4ef6\u7684\u767c\u5c55\u6216\u5176\u5be6\u969b\u7d50\u679c\u8207\u9810\u6e2c\u6027\u6558\u8ff0\u6709\u91cd\u5927\u5dee\u7570\u3002\u672c\u516c\u53f8\u4e0d\u8ca0\u4efb\u4f55\u66f4\u65b0\u6216\u4fee\u8a02\u4e4b\u8cac\u4efb\u3002\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pingtungtimes.com.tw\/?p=259203\" \/>\n<meta property=\"og:site_name\" content=\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/pingtungnews\" \/>\n<meta property=\"article:published_time\" content=\"2024-09-03T06:42:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/Caliway_Biopharmaceuticals_Logo.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"400\" \/>\n\t<meta property=\"og:image:height\" content=\"118\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"\u7f8e\u901a\u793e\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005:\" \/>\n\t<meta name=\"twitter:data1\" content=\"\u7f8e\u901a\u793e\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"NewsArticle\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=259203#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=259203\"},\"author\":{\"name\":\"\u7f8e\u901a\u793e\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/person\\\/683b937f29ec1537972f6c41e22a2cf3\"},\"headline\":\"\u5eb7\u9708\u65b0\u85e5CBL-514\u4e4b\u7f55\u75c5\u7ac7\u6839\u6c0f\u75c7Phase 2b\u958b\u59cb\u6536\u6848 \u9810\u8a082025 Q4\u53d6\u5f97\u89e3\u76f2\u7d50\u679c\",\"datePublished\":\"2024-09-03T06:42:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=259203\"},\"wordCount\":87,\"publisher\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=259203#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/Caliway_Biopharmaceuticals_Logo.jpg\",\"articleSection\":[\"\u7f8e\u901a\u793e\"],\"inLanguage\":\"zh-TW\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=259203\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=259203\",\"name\":\"\u5eb7\u9708\u65b0\u85e5CBL-514\u4e4b\u7f55\u75c5\u7ac7\u6839\u6c0f\u75c7Phase 2b\u958b\u59cb\u6536\u6848 \u9810\u8a082025 Q4\u53d6\u5f97\u89e3\u76f2\u7d50\u679c - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=259203#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=259203#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/Caliway_Biopharmaceuticals_Logo.jpg\",\"datePublished\":\"2024-09-03T06:42:00+00:00\",\"description\":\"\u65b0\u5317\u5e022024\u5e749\u67083\u65e5 \\\/\u7f8e\u901a\u793e\\\/ -- \u5eb7\u9708\u751f\u6280 (6919-TW) \u81ea\u4e3b\u7814\u767c\u4e4b\u5e02\u5834\u9996\u898b (First-in-class)\u5019\u9078\u65b0\u85e5CBL-514\u4e4b\u7f55\u75c5\u9069\u61c9\u75c7\u2014\u7ac7\u6839\u6c0f\u75c7Phase 2b \u81e8\u5e8a\u8a66\u9a57 (CBL-0202DD Phase 2b Study, NCT06303570)\u5df2\u958b\u59cb\u9032\u884c\u6536\u6848\uff0c\u9810\u8a08\u5c07\u65bc 2025\u5e74 Q4 \u53d6\u5f97\u81e8\u5e8a\u8a66\u9a57\u7d71\u8a08\u6578\u64da\uff0c\u5be6\u969b\u6642\u7a0b\u5c07\u4f9d\u57f7\u884c\u9032\u5ea6\u8abf\u6574\u3002 \u672c\u8a66\u9a57\u70ba\u4e00\u9805\u7d93\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\u00a0(U.S. FDA) \u6838\u51c6\u57f7\u884c\u7684\u5b89\u6170\u5291\u7d44\u5c0d\u7167Phase 2b\u81e8\u5e8a\u8a66\u9a57\uff0c\u9810\u8a08\u5c07\u7d0d\u516530\u4f4d\u5177\u67094\u523010\u9846\u75db\u6027\u8102\u80aa\u7624\u7684\u7ac7\u6839\u6c0f\u75c7\u60a3\u8005\uff0c\u5206\u70baCBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d442\u500b\u7d44\u5225\uff0c\u7d66\u4e88\u81f3\u5c111\u6b21\u3001\u81f3\u591a5\u6b21\u4e4bCBL-514\u6cbb\u7642\u6216\u540c\u9ad4\u7a4d\u7684\u5b89\u6170\u5291\uff0c\u4ee5\u8a55\u4f30CBL-514\u6ce8\u5c04\u5291\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u7642\u6548\u3001\u5b89\u5168\u6027\u8207\u8010\u53d7\u5ea6\uff0c\u4e26\u6bd4\u8f03CBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d44\u5728\u6e1b\u5c11\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8207\u75bc\u75db\u7a0b\u5ea6\u7b49\u7642\u6548\u662f\u5426\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570\u00a0(p&lt;0.05\u70ba\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570)\u3002 \u8207CBL-514 \u5df2\u5b8c\u6210\u4e4bPhase 2\u7ac7\u6839\u6c0f\u75c7\u81e8\u5e8a\u8a66\u9a57(CBL-0201DD) 4\u9031\u7642\u7a0b\u7684\u8a66\u9a57\u8a2d\u8a08\u76f8\u8f03\uff0c\u6b64\u6b21Phase 2b\u8a66\u9a57\u5c07\u5ef6\u9577\u6cbb\u7642\u6642\u9593\u81f316\u9031\uff0c\u65bc\u958b\u59cb\u6cbb\u7642\u5f8c4\u9031\u523024\u9031\u6bcf\u6b21\u56de\u8a3a\u8a55\u4f30\u7642\u6548\uff0c\u4e26\u4e14\u63a1\u7b2c\u4e09\u65b9\u4e2d\u7acb\u6a5f\u69cb\u4ee5\u8d85\u97f3\u6ce2\u8a55\u4f30\u8102\u80aa\u7624\u5927\u5c0f\u7684\u8b8a\u5316\u3002\u9664\u6b64\u4e4b\u5916\uff0c\u76f8\u6bd4\u4e8c\u671fPhase2\u4e3b\u8981\u7642\u6548\u6307\u6a19\u2014\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8b8a\u5316\uff0c\u672c\u8a66\u9a57\u7684\u4e3b\u8981\u7642\u6548\u6307\u6a19\u70ba\uff1a\u8207\u5b89\u6170\u5291\u7d44\u76f8\u6bd4\uff0c\u7d93CBL-514\u6cbb\u7642\u5f8c\u7684\u75db\u6027\u8102\u80aa\u7624\u5b8c\u5168\u6e05\u9664\u7684\u767e\u5206\u6bd4\u00a0(Complete Response, CR)\uff1b\u6b21\u8981\u7642\u6548\u6307\u6a19\u5247\u5305\u542b\uff1a\u75db\u6027\u8102\u80aa\u7624\u90e8\u5206\u7de9\u89e3\u00a0(Partial Response) \u7684\u767e\u5206\u6bd4\u8207\u75bc\u75db\u5206\u6578\u7684\u6539\u5584\u7b49\u3002\u4ea6\u5373\u672c\u6b21\u7ac7\u6839\u6c0f\u75c72b\u81e8\u5e8a\u8a66\u9a57\u7d0d\u5165\u75c5\u60a3\u66f4\u591a\u3001\u6cbb\u7642\u6642\u9593\u66f4\u9577\u800c\u4e14\u671f\u7d42\u7642\u6548\u6307\u6a19\u66f4\u5177\u6311\u6230\u6027\uff1b\u82e5\u6b64\u8a66\u9a57\u9054\u6a19\uff0c\u5c07\u5c55\u958b\u6a1e\u7d10\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u7684\u7533\u8acb\u8207\u6536\u6848\u3002 CBL-514\u70ba\u76ee\u524d\u5168\u7403\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u85e5\u7269\u4e2d\uff0c\u81e8\u5e8a\u958b\u767c\u901f\u5ea6\u6700\u524d\u6cbf\uff0c\u540c\u6642\u4e5f\u662f\u552f\u4e00\u81e8\u5e8a\u7642\u6548\u53d6\u5f97\u7d71\u8a08\u986f\u8457\u610f\u7fa9\u7684\u85e5\u7269\uff0c\u672a\u4f86\u5c07\u6709\u6a5f\u6703\u6210\u70ba\u5168\u7403\u7b2c\u4e00\u500b\u6838\u51c6\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u4e4b\u85e5\u7269\u3002\u503c\u5f97\u4e00\u63d0\u7684\u662f\uff0cCBL-514\u4e5f\u662f\u76ee\u524d\u552f\u4e00\u7372\u7f8e\u570bFDA\u540c\u6642\u6388\u4e88\u300c\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Orphan Drug Designation, ODD) \u53ca\u300c\u5feb\u901f\u5be9\u67e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Fast Track Designation) \u96d9\u8cc7\u683c\u8a8d\u5b9a\u4e4b\u7ac7\u6839\u6c0f\u75c7\u65b0\u85e5\uff0c\u5c07\u6709\u5229\u65bc\u52a0\u901fCBL-514\u7684\u81e8\u5e8a\u958b\u767c\uff0c\u4e26\u589e\u52a0\u7522\u54c1\u4e0a\u5e02\u5f8c\u4e4b\u512a\u52e2\u3002 \u95dc\u65bc\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum's Disease) \u7ac7\u6839\u6c0f\u75c7\u70ba\u4e00\u7a2e\u6162\u6027\u4e14\u5fa9\u767c\u6027\u5f37\u7684\u56b4\u91cd\u7f55\u898b\u75be\u75c5\uff0c\u60a3\u8005\u8ec0\u5e79\u53ca\u56db\u80a2\u6703\u6709\u76ae\u4e0b\u8102\u80aa\u7570\u5e38\u5806\u7a4d\u6240\u5f62\u6210\u7684\u826f\u6027\u7684\u75db\u6027\u8102\u80aa\u7624\u6216\u8102\u80aa\u816b\u584a\uff0c\u4e26\u4f34\u96a8\u8a72\u90e8\u4f4d\u81ea\u767c\u6027\u5287\u70c8\u75bc\u75db\uff0c\u4e26\u6703\u6709\u6301\u7e8c\u8d85\u904e3\u500b\u6708\u7684\u707c\u75db\u8207\u707c\u71b1\u611f\uff0c\u9032\u800c\u56b4\u91cd\u5e72\u64fe\u60a3\u8005\u6b63\u5e38\u751f\u6d3b\u3002\u7ac7\u6839\u6c0f\u75c7\u75c7\u72c0\u4e26\u4e0d\u6703\u81ea\u767c\u6027\u7de9\u89e3\u6216\u6d88\u5931\uff0c\u4e14\u5176\u75db\u6027\u8102\u80aa\u7624\u6709\u53ef\u80fd\u5728\u77ed\u6642\u9593\u8b8a\u5927\u6216\u6578\u91cf\u589e\u52a0\u3002\u76ee\u524d\u81f4\u75c5\u6a5f\u8f49\u5c1a\u4e0d\u660e\uff0c\u4f46\u6709\u7814\u7a76\u6307\u51fa\u53ef\u80fd\u8207\u8102\u80aa\u7d44\u7e54\u4ee3\u8b1d\u969c\u7919\u76f8\u95dc\u3002 \u76ee\u524d\u5168\u7403\u5c1a\u7121\u6838\u51c6\u7684\u7ac7\u6839\u6c0f\u75c7\u85e5\u7269\u53ef\u6cbb\u7642\uff0c\u73fe\u4eca\u4f7f\u7528\u4e4b\u7de9\u89e3\u7642\u6cd5\u5305\u542b\u624b\u8853\u5207\u9664\u8102\u80aa\u7624\u3001\u62bd\u8102\u3001\u9ebb\u9189\\\/\u6b62\u75db\u85e5\u3001\u514d\u75ab\u8abf\u7bc0\u5291\u3001\u96fb\u7642\u53ca\u91dd\u7078\u7b49\uff0c\u7136\u800c\u5176\u7642\u6548\u591a\u4e0d\u4f73\u4e14\u50c5\u80fd\u77ed\u66ab\u7de9\u89e3\u75bc\u75db\uff0c\u4e26\u4f34\u96a8\u591a\u7a2e\u526f\u4f5c\u7528\u3002 \u6839\u64da\u00a0Global Dercum's Disease Market Research Report Future 2023\u5e02\u5834\u5831\u544a\u6307\u51fa\uff0c2021\u5e74\u7ac7\u6839\u6c0f\u75c7\u5168\u7403\u5e02\u5834\u70ba113\u5104\u7f8e\u5143\uff0c\u4f9d\u64da\u5e74\u8907\u5408\u6210\u9577\u7387(CAGR) 6.76%\u63a8\u4f302032\u5e74\u5168\u7403\u5e02\u5834\u70ba227\u5104\u7f8e\u5143\u3002 CBL-514\u7522\u54c1\u7814\u767c\u73fe\u6cc1 CBL-514\u6ce8\u5c04\u5291\u662f\u5168\u7403\u9996\u5275\u7684505(b)(1)\u5168\u65b0\u5c0f\u5206\u5b50\u65b0\u85e5\uff0c\u900f\u904e\u8a98\u5c0e\u8102\u80aa\u7d30\u80de\u51cb\u4ea1\u4f86\u6e1b\u5c11\u6ce8\u5c04\u90e8\u4f4d\u8102\u80aa\u3002CBL-514\u6cbb\u7642\u7f55\u898b\u75be\u75c5\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum's Disease) \u4e4bCBL-0201DD Phase 2\u81e8\u5e8a\u8a66\u9a57\u00a0(NCT05387733) \u5df2\u65bc2023\u5e744\u6708\u5b8c\u6210\u8a66\u9a57\uff0c\u5176\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u6b21\u8981\u7642\u6548\u6307\u6a19\u5728ITT\u8207PP\u7686\u9054\u5230\u81e8\u5e8a\u53ca\u7d71\u8a08\u4e0a\u986f\u8457\u6709\u6548\u610f\u7fa9(p&lt;0.0001)\uff1b\u7ac7\u6839\u6c0f\u75c7CBL-0202DD Phase 2b IND\u5df2\u65bc2024\u5e741\u6708\u53d6\u5f97\u7f8e\u570bFDA\u6838\u51c6\u57f7\u884c\uff0c\u4e26\u65bc2024\u5e748\u6708\u958b\u59cb\u6536\u6848\uff0c\u9810\u8a082025\u5e74Q4\u53d6\u5f97\u81e8\u5e8a\u7d71\u8a08\u7d50\u679c\u3002 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\u6838\u51c6\u57f7\u884c\u7684\u5b89\u6170\u5291\u7d44\u5c0d\u7167Phase 2b\u81e8\u5e8a\u8a66\u9a57\uff0c\u9810\u8a08\u5c07\u7d0d\u516530\u4f4d\u5177\u67094\u523010\u9846\u75db\u6027\u8102\u80aa\u7624\u7684\u7ac7\u6839\u6c0f\u75c7\u60a3\u8005\uff0c\u5206\u70baCBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d442\u500b\u7d44\u5225\uff0c\u7d66\u4e88\u81f3\u5c111\u6b21\u3001\u81f3\u591a5\u6b21\u4e4bCBL-514\u6cbb\u7642\u6216\u540c\u9ad4\u7a4d\u7684\u5b89\u6170\u5291\uff0c\u4ee5\u8a55\u4f30CBL-514\u6ce8\u5c04\u5291\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u7642\u6548\u3001\u5b89\u5168\u6027\u8207\u8010\u53d7\u5ea6\uff0c\u4e26\u6bd4\u8f03CBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d44\u5728\u6e1b\u5c11\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8207\u75bc\u75db\u7a0b\u5ea6\u7b49\u7642\u6548\u662f\u5426\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570\u00a0(p&lt;0.05\u70ba\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570)\u3002 \u8207CBL-514 \u5df2\u5b8c\u6210\u4e4bPhase 2\u7ac7\u6839\u6c0f\u75c7\u81e8\u5e8a\u8a66\u9a57(CBL-0201DD) 4\u9031\u7642\u7a0b\u7684\u8a66\u9a57\u8a2d\u8a08\u76f8\u8f03\uff0c\u6b64\u6b21Phase 2b\u8a66\u9a57\u5c07\u5ef6\u9577\u6cbb\u7642\u6642\u9593\u81f316\u9031\uff0c\u65bc\u958b\u59cb\u6cbb\u7642\u5f8c4\u9031\u523024\u9031\u6bcf\u6b21\u56de\u8a3a\u8a55\u4f30\u7642\u6548\uff0c\u4e26\u4e14\u63a1\u7b2c\u4e09\u65b9\u4e2d\u7acb\u6a5f\u69cb\u4ee5\u8d85\u97f3\u6ce2\u8a55\u4f30\u8102\u80aa\u7624\u5927\u5c0f\u7684\u8b8a\u5316\u3002\u9664\u6b64\u4e4b\u5916\uff0c\u76f8\u6bd4\u4e8c\u671fPhase2\u4e3b\u8981\u7642\u6548\u6307\u6a19\u2014\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8b8a\u5316\uff0c\u672c\u8a66\u9a57\u7684\u4e3b\u8981\u7642\u6548\u6307\u6a19\u70ba\uff1a\u8207\u5b89\u6170\u5291\u7d44\u76f8\u6bd4\uff0c\u7d93CBL-514\u6cbb\u7642\u5f8c\u7684\u75db\u6027\u8102\u80aa\u7624\u5b8c\u5168\u6e05\u9664\u7684\u767e\u5206\u6bd4\u00a0(Complete Response, CR)\uff1b\u6b21\u8981\u7642\u6548\u6307\u6a19\u5247\u5305\u542b\uff1a\u75db\u6027\u8102\u80aa\u7624\u90e8\u5206\u7de9\u89e3\u00a0(Partial Response) \u7684\u767e\u5206\u6bd4\u8207\u75bc\u75db\u5206\u6578\u7684\u6539\u5584\u7b49\u3002\u4ea6\u5373\u672c\u6b21\u7ac7\u6839\u6c0f\u75c72b\u81e8\u5e8a\u8a66\u9a57\u7d0d\u5165\u75c5\u60a3\u66f4\u591a\u3001\u6cbb\u7642\u6642\u9593\u66f4\u9577\u800c\u4e14\u671f\u7d42\u7642\u6548\u6307\u6a19\u66f4\u5177\u6311\u6230\u6027\uff1b\u82e5\u6b64\u8a66\u9a57\u9054\u6a19\uff0c\u5c07\u5c55\u958b\u6a1e\u7d10\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u7684\u7533\u8acb\u8207\u6536\u6848\u3002 CBL-514\u70ba\u76ee\u524d\u5168\u7403\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u85e5\u7269\u4e2d\uff0c\u81e8\u5e8a\u958b\u767c\u901f\u5ea6\u6700\u524d\u6cbf\uff0c\u540c\u6642\u4e5f\u662f\u552f\u4e00\u81e8\u5e8a\u7642\u6548\u53d6\u5f97\u7d71\u8a08\u986f\u8457\u610f\u7fa9\u7684\u85e5\u7269\uff0c\u672a\u4f86\u5c07\u6709\u6a5f\u6703\u6210\u70ba\u5168\u7403\u7b2c\u4e00\u500b\u6838\u51c6\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u4e4b\u85e5\u7269\u3002\u503c\u5f97\u4e00\u63d0\u7684\u662f\uff0cCBL-514\u4e5f\u662f\u76ee\u524d\u552f\u4e00\u7372\u7f8e\u570bFDA\u540c\u6642\u6388\u4e88\u300c\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Orphan Drug Designation, ODD) \u53ca\u300c\u5feb\u901f\u5be9\u67e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Fast Track Designation) \u96d9\u8cc7\u683c\u8a8d\u5b9a\u4e4b\u7ac7\u6839\u6c0f\u75c7\u65b0\u85e5\uff0c\u5c07\u6709\u5229\u65bc\u52a0\u901fCBL-514\u7684\u81e8\u5e8a\u958b\u767c\uff0c\u4e26\u589e\u52a0\u7522\u54c1\u4e0a\u5e02\u5f8c\u4e4b\u512a\u52e2\u3002 \u95dc\u65bc\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum's Disease) \u7ac7\u6839\u6c0f\u75c7\u70ba\u4e00\u7a2e\u6162\u6027\u4e14\u5fa9\u767c\u6027\u5f37\u7684\u56b4\u91cd\u7f55\u898b\u75be\u75c5\uff0c\u60a3\u8005\u8ec0\u5e79\u53ca\u56db\u80a2\u6703\u6709\u76ae\u4e0b\u8102\u80aa\u7570\u5e38\u5806\u7a4d\u6240\u5f62\u6210\u7684\u826f\u6027\u7684\u75db\u6027\u8102\u80aa\u7624\u6216\u8102\u80aa\u816b\u584a\uff0c\u4e26\u4f34\u96a8\u8a72\u90e8\u4f4d\u81ea\u767c\u6027\u5287\u70c8\u75bc\u75db\uff0c\u4e26\u6703\u6709\u6301\u7e8c\u8d85\u904e3\u500b\u6708\u7684\u707c\u75db\u8207\u707c\u71b1\u611f\uff0c\u9032\u800c\u56b4\u91cd\u5e72\u64fe\u60a3\u8005\u6b63\u5e38\u751f\u6d3b\u3002\u7ac7\u6839\u6c0f\u75c7\u75c7\u72c0\u4e26\u4e0d\u6703\u81ea\u767c\u6027\u7de9\u89e3\u6216\u6d88\u5931\uff0c\u4e14\u5176\u75db\u6027\u8102\u80aa\u7624\u6709\u53ef\u80fd\u5728\u77ed\u6642\u9593\u8b8a\u5927\u6216\u6578\u91cf\u589e\u52a0\u3002\u76ee\u524d\u81f4\u75c5\u6a5f\u8f49\u5c1a\u4e0d\u660e\uff0c\u4f46\u6709\u7814\u7a76\u6307\u51fa\u53ef\u80fd\u8207\u8102\u80aa\u7d44\u7e54\u4ee3\u8b1d\u969c\u7919\u76f8\u95dc\u3002 \u76ee\u524d\u5168\u7403\u5c1a\u7121\u6838\u51c6\u7684\u7ac7\u6839\u6c0f\u75c7\u85e5\u7269\u53ef\u6cbb\u7642\uff0c\u73fe\u4eca\u4f7f\u7528\u4e4b\u7de9\u89e3\u7642\u6cd5\u5305\u542b\u624b\u8853\u5207\u9664\u8102\u80aa\u7624\u3001\u62bd\u8102\u3001\u9ebb\u9189\/\u6b62\u75db\u85e5\u3001\u514d\u75ab\u8abf\u7bc0\u5291\u3001\u96fb\u7642\u53ca\u91dd\u7078\u7b49\uff0c\u7136\u800c\u5176\u7642\u6548\u591a\u4e0d\u4f73\u4e14\u50c5\u80fd\u77ed\u66ab\u7de9\u89e3\u75bc\u75db\uff0c\u4e26\u4f34\u96a8\u591a\u7a2e\u526f\u4f5c\u7528\u3002 \u6839\u64da\u00a0Global Dercum's Disease Market Research Report Future 2023\u5e02\u5834\u5831\u544a\u6307\u51fa\uff0c2021\u5e74\u7ac7\u6839\u6c0f\u75c7\u5168\u7403\u5e02\u5834\u70ba113\u5104\u7f8e\u5143\uff0c\u4f9d\u64da\u5e74\u8907\u5408\u6210\u9577\u7387(CAGR) 6.76%\u63a8\u4f302032\u5e74\u5168\u7403\u5e02\u5834\u70ba227\u5104\u7f8e\u5143\u3002 CBL-514\u7522\u54c1\u7814\u767c\u73fe\u6cc1 CBL-514\u6ce8\u5c04\u5291\u662f\u5168\u7403\u9996\u5275\u7684505(b)(1)\u5168\u65b0\u5c0f\u5206\u5b50\u65b0\u85e5\uff0c\u900f\u904e\u8a98\u5c0e\u8102\u80aa\u7d30\u80de\u51cb\u4ea1\u4f86\u6e1b\u5c11\u6ce8\u5c04\u90e8\u4f4d\u8102\u80aa\u3002CBL-514\u6cbb\u7642\u7f55\u898b\u75be\u75c5\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum's Disease) \u4e4bCBL-0201DD Phase 2\u81e8\u5e8a\u8a66\u9a57\u00a0(NCT05387733) \u5df2\u65bc2023\u5e744\u6708\u5b8c\u6210\u8a66\u9a57\uff0c\u5176\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u6b21\u8981\u7642\u6548\u6307\u6a19\u5728ITT\u8207PP\u7686\u9054\u5230\u81e8\u5e8a\u53ca\u7d71\u8a08\u4e0a\u986f\u8457\u6709\u6548\u610f\u7fa9(p&lt;0.0001)\uff1b\u7ac7\u6839\u6c0f\u75c7CBL-0202DD Phase 2b IND\u5df2\u65bc2024\u5e741\u6708\u53d6\u5f97\u7f8e\u570bFDA\u6838\u51c6\u57f7\u884c\uff0c\u4e26\u65bc2024\u5e748\u6708\u958b\u59cb\u6536\u6848\uff0c\u9810\u8a082025\u5e74Q4\u53d6\u5f97\u81e8\u5e8a\u7d71\u8a08\u7d50\u679c\u3002 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2b\u958b\u59cb\u6536\u6848 \u9810\u8a082025 Q4\u53d6\u5f97\u89e3\u76f2\u7d50\u679c - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","og_description":"\u65b0\u5317\u5e022024\u5e749\u67083\u65e5 \/\u7f8e\u901a\u793e\/ -- \u5eb7\u9708\u751f\u6280 (6919-TW) \u81ea\u4e3b\u7814\u767c\u4e4b\u5e02\u5834\u9996\u898b (First-in-class)\u5019\u9078\u65b0\u85e5CBL-514\u4e4b\u7f55\u75c5\u9069\u61c9\u75c7\u2014\u7ac7\u6839\u6c0f\u75c7Phase 2b \u81e8\u5e8a\u8a66\u9a57 (CBL-0202DD Phase 2b Study, NCT06303570)\u5df2\u958b\u59cb\u9032\u884c\u6536\u6848\uff0c\u9810\u8a08\u5c07\u65bc 2025\u5e74 Q4 \u53d6\u5f97\u81e8\u5e8a\u8a66\u9a57\u7d71\u8a08\u6578\u64da\uff0c\u5be6\u969b\u6642\u7a0b\u5c07\u4f9d\u57f7\u884c\u9032\u5ea6\u8abf\u6574\u3002     \u672c\u8a66\u9a57\u70ba\u4e00\u9805\u7d93\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\u00a0(U.S. FDA) \u6838\u51c6\u57f7\u884c\u7684\u5b89\u6170\u5291\u7d44\u5c0d\u7167Phase 2b\u81e8\u5e8a\u8a66\u9a57\uff0c\u9810\u8a08\u5c07\u7d0d\u516530\u4f4d\u5177\u67094\u523010\u9846\u75db\u6027\u8102\u80aa\u7624\u7684\u7ac7\u6839\u6c0f\u75c7\u60a3\u8005\uff0c\u5206\u70baCBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d442\u500b\u7d44\u5225\uff0c\u7d66\u4e88\u81f3\u5c111\u6b21\u3001\u81f3\u591a5\u6b21\u4e4bCBL-514\u6cbb\u7642\u6216\u540c\u9ad4\u7a4d\u7684\u5b89\u6170\u5291\uff0c\u4ee5\u8a55\u4f30CBL-514\u6ce8\u5c04\u5291\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u7642\u6548\u3001\u5b89\u5168\u6027\u8207\u8010\u53d7\u5ea6\uff0c\u4e26\u6bd4\u8f03CBL-514\u7d44\u8207\u5b89\u6170\u5291\u7d44\u5728\u6e1b\u5c11\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8207\u75bc\u75db\u7a0b\u5ea6\u7b49\u7642\u6548\u662f\u5426\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570\u00a0(p&lt;0.05\u70ba\u5177\u6709\u7d71\u8a08\u986f\u8457\u5dee\u7570)\u3002 \u8207CBL-514 \u5df2\u5b8c\u6210\u4e4bPhase 2\u7ac7\u6839\u6c0f\u75c7\u81e8\u5e8a\u8a66\u9a57(CBL-0201DD) 4\u9031\u7642\u7a0b\u7684\u8a66\u9a57\u8a2d\u8a08\u76f8\u8f03\uff0c\u6b64\u6b21Phase 2b\u8a66\u9a57\u5c07\u5ef6\u9577\u6cbb\u7642\u6642\u9593\u81f316\u9031\uff0c\u65bc\u958b\u59cb\u6cbb\u7642\u5f8c4\u9031\u523024\u9031\u6bcf\u6b21\u56de\u8a3a\u8a55\u4f30\u7642\u6548\uff0c\u4e26\u4e14\u63a1\u7b2c\u4e09\u65b9\u4e2d\u7acb\u6a5f\u69cb\u4ee5\u8d85\u97f3\u6ce2\u8a55\u4f30\u8102\u80aa\u7624\u5927\u5c0f\u7684\u8b8a\u5316\u3002\u9664\u6b64\u4e4b\u5916\uff0c\u76f8\u6bd4\u4e8c\u671fPhase2\u4e3b\u8981\u7642\u6548\u6307\u6a19\u2014\u75db\u6027\u8102\u80aa\u7624\u5927\u5c0f\u8b8a\u5316\uff0c\u672c\u8a66\u9a57\u7684\u4e3b\u8981\u7642\u6548\u6307\u6a19\u70ba\uff1a\u8207\u5b89\u6170\u5291\u7d44\u76f8\u6bd4\uff0c\u7d93CBL-514\u6cbb\u7642\u5f8c\u7684\u75db\u6027\u8102\u80aa\u7624\u5b8c\u5168\u6e05\u9664\u7684\u767e\u5206\u6bd4\u00a0(Complete Response, CR)\uff1b\u6b21\u8981\u7642\u6548\u6307\u6a19\u5247\u5305\u542b\uff1a\u75db\u6027\u8102\u80aa\u7624\u90e8\u5206\u7de9\u89e3\u00a0(Partial Response) \u7684\u767e\u5206\u6bd4\u8207\u75bc\u75db\u5206\u6578\u7684\u6539\u5584\u7b49\u3002\u4ea6\u5373\u672c\u6b21\u7ac7\u6839\u6c0f\u75c72b\u81e8\u5e8a\u8a66\u9a57\u7d0d\u5165\u75c5\u60a3\u66f4\u591a\u3001\u6cbb\u7642\u6642\u9593\u66f4\u9577\u800c\u4e14\u671f\u7d42\u7642\u6548\u6307\u6a19\u66f4\u5177\u6311\u6230\u6027\uff1b\u82e5\u6b64\u8a66\u9a57\u9054\u6a19\uff0c\u5c07\u5c55\u958b\u6a1e\u7d10\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u7684\u7533\u8acb\u8207\u6536\u6848\u3002 CBL-514\u70ba\u76ee\u524d\u5168\u7403\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u7684\u85e5\u7269\u4e2d\uff0c\u81e8\u5e8a\u958b\u767c\u901f\u5ea6\u6700\u524d\u6cbf\uff0c\u540c\u6642\u4e5f\u662f\u552f\u4e00\u81e8\u5e8a\u7642\u6548\u53d6\u5f97\u7d71\u8a08\u986f\u8457\u610f\u7fa9\u7684\u85e5\u7269\uff0c\u672a\u4f86\u5c07\u6709\u6a5f\u6703\u6210\u70ba\u5168\u7403\u7b2c\u4e00\u500b\u6838\u51c6\u7528\u65bc\u6cbb\u7642\u7ac7\u6839\u6c0f\u75c7\u4e4b\u85e5\u7269\u3002\u503c\u5f97\u4e00\u63d0\u7684\u662f\uff0cCBL-514\u4e5f\u662f\u76ee\u524d\u552f\u4e00\u7372\u7f8e\u570bFDA\u540c\u6642\u6388\u4e88\u300c\u5b64\u5152\u85e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Orphan Drug Designation, ODD) \u53ca\u300c\u5feb\u901f\u5be9\u67e5\u8cc7\u683c\u8a8d\u5b9a\u300d(Fast Track Designation) \u96d9\u8cc7\u683c\u8a8d\u5b9a\u4e4b\u7ac7\u6839\u6c0f\u75c7\u65b0\u85e5\uff0c\u5c07\u6709\u5229\u65bc\u52a0\u901fCBL-514\u7684\u81e8\u5e8a\u958b\u767c\uff0c\u4e26\u589e\u52a0\u7522\u54c1\u4e0a\u5e02\u5f8c\u4e4b\u512a\u52e2\u3002 \u95dc\u65bc\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum's Disease) \u7ac7\u6839\u6c0f\u75c7\u70ba\u4e00\u7a2e\u6162\u6027\u4e14\u5fa9\u767c\u6027\u5f37\u7684\u56b4\u91cd\u7f55\u898b\u75be\u75c5\uff0c\u60a3\u8005\u8ec0\u5e79\u53ca\u56db\u80a2\u6703\u6709\u76ae\u4e0b\u8102\u80aa\u7570\u5e38\u5806\u7a4d\u6240\u5f62\u6210\u7684\u826f\u6027\u7684\u75db\u6027\u8102\u80aa\u7624\u6216\u8102\u80aa\u816b\u584a\uff0c\u4e26\u4f34\u96a8\u8a72\u90e8\u4f4d\u81ea\u767c\u6027\u5287\u70c8\u75bc\u75db\uff0c\u4e26\u6703\u6709\u6301\u7e8c\u8d85\u904e3\u500b\u6708\u7684\u707c\u75db\u8207\u707c\u71b1\u611f\uff0c\u9032\u800c\u56b4\u91cd\u5e72\u64fe\u60a3\u8005\u6b63\u5e38\u751f\u6d3b\u3002\u7ac7\u6839\u6c0f\u75c7\u75c7\u72c0\u4e26\u4e0d\u6703\u81ea\u767c\u6027\u7de9\u89e3\u6216\u6d88\u5931\uff0c\u4e14\u5176\u75db\u6027\u8102\u80aa\u7624\u6709\u53ef\u80fd\u5728\u77ed\u6642\u9593\u8b8a\u5927\u6216\u6578\u91cf\u589e\u52a0\u3002\u76ee\u524d\u81f4\u75c5\u6a5f\u8f49\u5c1a\u4e0d\u660e\uff0c\u4f46\u6709\u7814\u7a76\u6307\u51fa\u53ef\u80fd\u8207\u8102\u80aa\u7d44\u7e54\u4ee3\u8b1d\u969c\u7919\u76f8\u95dc\u3002 \u76ee\u524d\u5168\u7403\u5c1a\u7121\u6838\u51c6\u7684\u7ac7\u6839\u6c0f\u75c7\u85e5\u7269\u53ef\u6cbb\u7642\uff0c\u73fe\u4eca\u4f7f\u7528\u4e4b\u7de9\u89e3\u7642\u6cd5\u5305\u542b\u624b\u8853\u5207\u9664\u8102\u80aa\u7624\u3001\u62bd\u8102\u3001\u9ebb\u9189\/\u6b62\u75db\u85e5\u3001\u514d\u75ab\u8abf\u7bc0\u5291\u3001\u96fb\u7642\u53ca\u91dd\u7078\u7b49\uff0c\u7136\u800c\u5176\u7642\u6548\u591a\u4e0d\u4f73\u4e14\u50c5\u80fd\u77ed\u66ab\u7de9\u89e3\u75bc\u75db\uff0c\u4e26\u4f34\u96a8\u591a\u7a2e\u526f\u4f5c\u7528\u3002 \u6839\u64da\u00a0Global Dercum's Disease Market Research Report Future 2023\u5e02\u5834\u5831\u544a\u6307\u51fa\uff0c2021\u5e74\u7ac7\u6839\u6c0f\u75c7\u5168\u7403\u5e02\u5834\u70ba113\u5104\u7f8e\u5143\uff0c\u4f9d\u64da\u5e74\u8907\u5408\u6210\u9577\u7387(CAGR) 6.76%\u63a8\u4f302032\u5e74\u5168\u7403\u5e02\u5834\u70ba227\u5104\u7f8e\u5143\u3002 CBL-514\u7522\u54c1\u7814\u767c\u73fe\u6cc1 CBL-514\u6ce8\u5c04\u5291\u662f\u5168\u7403\u9996\u5275\u7684505(b)(1)\u5168\u65b0\u5c0f\u5206\u5b50\u65b0\u85e5\uff0c\u900f\u904e\u8a98\u5c0e\u8102\u80aa\u7d30\u80de\u51cb\u4ea1\u4f86\u6e1b\u5c11\u6ce8\u5c04\u90e8\u4f4d\u8102\u80aa\u3002CBL-514\u6cbb\u7642\u7f55\u898b\u75be\u75c5\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum's Disease) \u4e4bCBL-0201DD Phase 2\u81e8\u5e8a\u8a66\u9a57\u00a0(NCT05387733) \u5df2\u65bc2023\u5e744\u6708\u5b8c\u6210\u8a66\u9a57\uff0c\u5176\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u6b21\u8981\u7642\u6548\u6307\u6a19\u5728ITT\u8207PP\u7686\u9054\u5230\u81e8\u5e8a\u53ca\u7d71\u8a08\u4e0a\u986f\u8457\u6709\u6548\u610f\u7fa9(p&lt;0.0001)\uff1b\u7ac7\u6839\u6c0f\u75c7CBL-0202DD Phase 2b IND\u5df2\u65bc2024\u5e741\u6708\u53d6\u5f97\u7f8e\u570bFDA\u6838\u51c6\u57f7\u884c\uff0c\u4e26\u65bc2024\u5e748\u6708\u958b\u59cb\u6536\u6848\uff0c\u9810\u8a082025\u5e74Q4\u53d6\u5f97\u81e8\u5e8a\u7d71\u8a08\u7d50\u679c\u3002 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\u53d6\u5f97\u81e8\u5e8a\u8a66\u9a57\u7d71\u8a08\u6578\u64da\uff0c\u5be6\u969b\u6642\u7a0b\u5c07\u4f9d\u57f7\u884c\u9032\u5ea6\u8abf\u6574\u3002 \u672c\u8a66\u9a57\u70ba\u4e00\u9805\u7d93\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\u00a0(U.S. FDA) \u6838\u51c6\u57f7\u884c\u7684\u5b89\u6170\u5291\u7d44\u5c0d\u7167Phase 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\u95dc\u65bc\u7ac7\u6839\u6c0f\u75c7\u00a0(Dercum's Disease) 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