{"id":324645,"date":"2025-05-14T11:50:00","date_gmt":"2025-05-14T03:50:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=324645"},"modified":"2025-05-14T11:50:00","modified_gmt":"2025-05-14T03:50:00","slug":"%e5%ba%b7%e9%9c%88cbl-514%e9%a0%86%e5%88%a9%e5%ae%8c%e6%88%90fda-eop2%e6%9c%83%e8%ad%b0","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=324645","title":{"rendered":"\u5eb7\u9708CBL-514\u9806\u5229\u5b8c\u6210FDA EOP2\u6703\u8b70"},"content":{"rendered":"
\n\n\n\n
<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u6709\u671b\u6210\u70ba\u5168\u7403\u9996\u6b3e\u300c\u6e1b\u5c11\u76ae\u4e0b\u8102\u80aa\u300d\u65b0\u85e5<\/b><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u5168\u7403\u9996\u6b3e\u5927\u7bc4\u570d\u5c40\u90e8\u6e1b\u8102\u65b0\u85e5CBL-514\uff0c\u4ee5505(b)(1)\u65b0\u85e5\u6cd5\u898f\u8def\u5f91\uff0c\u5df2\u5b8c\u6210\u8207\u7f8e\u570bFDA\u7684EOP2\u6703\u8b70\uff0c\u6b63\u5f0f\u53d6\u5f97\u66f8\u9762\u6703\u8b70\u7d00\u9304\uff0c\u96d9\u65b9\u5c31\u6a1e\u7d10\u4e09\u671f\u8a66\u9a57\u8a2d\u8a08\u8207\u672a\u4f86\u9069\u61c9\u75c7\u9054\u9ad8\u5ea6\u5171\u8b58\u3002<\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 FDA\u540c\u610fCBL-514\u672a\u4f86\u65b0\u85e5\u67e5\u9a57\u767b\u8a18\u7533\u8acb\uff08NDA\uff09\u4e4b\u9069\u61c9\u75c7\u70ba\u300c\u6e1b\u5c11\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u300d\uff0c<\/b>\u7a81\u7834\u904e\u5f80\u91ab\u7f8e\u7528\u85e5\u50c5\u6838\u51c6\u4ee5\u300c\u5916\u89c0\u6539\u5584\u300d\u4f5c\u70ba\u9069\u61c9\u75c7\u7684\u6846\u67b6\u3002<\/p>\n

\u65b0\u5317\u5e02<\/span>2025\u5e745\u670814\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — \u300a2025\u5e745\u670814\u65e5\u65b0\u5317\u5e02\u8a0a\u300b\u5eb7\u9708\u751f\u6280\uff086919\uff09\u4eca\u65e5\u5ba3\u5e03\uff0c\u65d7\u4e0b\u5168\u7403\u9996\u5275\u4e4b\u5927\u7bc4\u570d\u5c40\u90e8\u6e1b\u8102\u65b0\u85e5CBL-514\uff0c\u5df2\u65bc2025\u5e744\u6708\u5b8c\u6210\u8207\u7f8e\u570bFDA\uff08\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\uff0cFood and Drug Administration\uff09\u53ec\u958b\u7684\u4e8c\u671f\u81e8\u5e8a\u7d50\u675f\u6703\u8b70\uff08End-of-Phase 2 meeting\uff0c\u7c21\u7a31EOP2\uff09\uff0c\u4e26\u65bc\u8fd1\u671f\u6b63\u5f0f\u53d6\u5f97FDA\u6703\u5f8c\u66f8\u9762\u7d00\u9304\uff0c\u96d9\u65b9\u5c31\u672a\u4f86\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\uff08NDA\uff09\u6240\u9700\u7684\u6a1e\u7d10\u4e09\u671f\u7684\u8a66\u9a57\u8a2d\u8a08\u3001\u4e3b\u8981\u7642\u6548\u6307\u6a19\uff0c\u8207\u9069\u61c9\u75c7\u7b49\u8b70\u984c\u7686\u9054\u6210\u660e\u78ba\u5171\u8b58\u3002<\/p>\n

\n<\/p><\/div>\n

\u672c\u6b21\u6703\u8b70\u6700\u91cd\u8981\u7684\u7d50\u679c\u70baFDA\u540c\u610f\u4ee5\u300c\u6e1b\u5c11\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\uff08<\/b>Reduction of Abdominal Subcutaneous Fat<\/b>\uff09<\/b>\u300d\u4f5c\u70baCBL-514\u672a\u4f86\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\u7684\u64ec\u5b9a\u9069\u61c9\u75c7\uff0c\u6709\u6a5f\u6703\u7a81\u7834\u904e\u5f80\u91ab\u7f8e\u85e5\u54c1\u8207\u8a2d\u5099\u7686\u4ee5\u300c\u5916\u89c0\u6539\u5584\u300d\uff08Improvement in the Appearance\uff09\u70ba\u9069\u61c9\u75c7\u7684\u6163\u4f8b\uff0cCBL-514\u672a\u4f86\u6709\u671b\u6210\u70ba\u5168\u7403\u7b2c\u4e00\u500b\u7372FDA\u6838\u51c6\u4ee5\u300c\u6e1b\u5c11\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u300d\u70ba\u9069\u61c9\u75c7\u7684\u91ab\u7f8e\u85e5\u7269\uff0c\u82e5\u6210\u529f\u4e0a\u5e02\uff0c\u5c07\u53ef\u65bc\u4eff\u55ae\u4e2d\u8f09\u660e\u6b64\u7642\u6548\uff0c\u5728\u81e8\u5e8a\u50f9\u503c\u8207\u5e02\u5834\u6f5b\u529b\u4e0a\u5747\u5177\u91cd\u5927\u610f\u7fa9\u3002<\/p>\n

\u5eb7\u9708\u57f7\u884c\u9577\u51cc\u7389\u82b3\u8868\u793a\uff1a\u300c\u6b64\u6b21EOP2\u6703\u8b70\u8207FDA\u6e9d\u901a\u76f8\u7576\u9806\u5229\uff0c\u4e5f\u9054\u5230\u9ad8\u5ea6\u5171\u8b58\u3002FDA\u540c\u610f\u672a\u4f86\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\u4ee5\u300e\u6e1b\u5c11\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u300f\u4f5c\u70baCBL-514\u7684\u9069\u61c9\u75c7\uff0c\u4ee3\u8868\u6211\u5011\u6709\u6a5f\u6703\u6253\u7834\u904e\u53bb\u91ab\u7f8e\u85e5\u54c1\u9069\u61c9\u75c7\u50c5\u9650\u65bc\u300e\u5916\u89c0\u6539\u5584\u300f\u7684\u6846\u67b6\uff0c\u70ba\u6574\u500b\u7522\u696d\u5efa\u7acb\u65b0\u7684\u6a19\u6e96\uff0c\u4e5f\u958b\u555f\u66f4\u591a\u6f5b\u5728\u5e02\u5834\u6a5f\u6703\u3002\u300d<\/p>\n

\u5eb7\u9708\u9810\u8a08\u5c07\u65bc2025\u5e746\u6708\u5411\u7f8e\u570bFDA\u3001\u52a0\u62ff\u5927\u885b\u751f\u90e8\uff08Health Canada\uff09\u905e\u4ea4\u7b2c\u4e00\u9805\u5168\u7403\u6a1e\u7d10\u4e09\u671f\uff08CBL-0301\uff09\u7684\u81e8\u5e8a\u8a66\u9a57\u7533\u8acb\uff0c\u4e26\u5728Q3\u5411\u7f8e\u570bFDA\u3001\u52a0\u62ff\u5927\u885b\u751f\u90e8\uff08Health Canada\uff09\u53ca\u6fb3\u6d32HREC\u8207\u85e5\u7269\u7ba1\u7406\u5c40\uff08Therapeutic Goods Administration\uff09\u905e\u4ea4\u7b2c\u4e8c\u9805\u5168\u7403\u6a1e\u7d10\u4e09\u671f\uff08CBL-0302\uff09\u4e4b\u81e8\u5e8a\u8a66\u9a57\u7533\u8acb\u3002\u00a0<\/p>\n

\u900f\u904e\u6b64EOP2\u8996\u8a0a\u6703\u8b70\uff0c\u96d9\u65b9\u78ba\u8a8d\u4e86\u6a1e\u7d10\u4e09\u671f\u8a66\u9a57\u8a2d\u8a08\u3001\u4e3b\u8981\u7642\u6548\u6307\u6a19\u3001\u7522\u54c1\u9069\u61c9\u75c7\u8207\u898f\u683c\uff0c\u4ee5\u53caFDA\u5c0d\u65bc\u672a\u4f86\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\u7684\u91cd\u5927\u65b9\u5411\uff0c\u5f37\u5316\u516c\u53f8\u63a8\u9032\u5f8c\u7e8c\u4e09\u671f\u81e8\u5e8a\u8207\u85e5\u7269\u4e0a\u5e02\u7684\u4fe1\u5fc3\u3002<\/p>\n

*<\/b>\u95dc\u65bc<\/b>CBL-514 <\/b>
CBL-514\u6ce8\u5c04\u5291\u662f\u5eb7\u9708\u751f\u6280\u81ea\u884c\u7814\u767c\u7684505(b)(1)\u5168\u65b0\u5c0f\u5206\u5b50\u65b0\u85e5\uff0c\u662f\u5168\u7403\u9996\u5275\u900f\u904e\u8a98\u5c0e\u8102\u80aa\u7d30\u80de\u51cb\u4ea1\u4f86\u7cbe\u6e96\u6e1b\u5c11\u6ce8\u5c04\u90e8\u4f4d\u8102\u80aa\uff0c\u6839\u64da\u5176\u81e8\u5e8a\u8a66\u9a57\u7d50\u679c\uff0c\u7642\u6548\u512a\u7570\u8207\u624b\u8853\u76f8\u7576\u4e14\u5b89\u5168\u6027\u826f\u597d\uff0c\u4e0d\u6703\u9020\u6210\u5176\u4ed6\u7d30\u80de\u8207\u7d44\u7e54\u58de\u6b7b\u6216\u660e\u986f\u50b7\u5bb3\u3002\u00a0
CBL-514\u5177\u6709\u591a\u9805\u9069\u61c9\u75c7\uff0c\u76ee\u524d\u9069\u61c9\u75c7\u5305\u542b\u975e\u624b\u8853\u5c40\u90e8\u6e1b\u8102\uff08non-surgical fat reduction\uff09\u3001\u4e2d\/\u91cd\u5ea6\u6a58\u76ae\u7d44\u7e54\uff08cellulite\uff09\u53ca\u6539\u5584\u5fa9\u80d6\u7b49\uff0c\u540c\u6210\u4efd\u4e0d\u540c\u5291\u578b\u4e4b\u65b0\u85e5CBL-514D\u9069\u61c9\u75c7\u5305\u542b\u7f55\u898b\u75be\u75c5-\u7ac7\u6839\u6c0f\u75c7\uff08Dercum’s disease\uff09\u7b49\u3002\u622a\u81f32024\u5e7411\u6708\u5e95\uff0c\u5168\u7403\u5df2\u5171\u6709520\u540d\u53d7\u8a66\u8005\u53c3\u8207CBL-514\u76f8\u95dc\u81e8\u5e8a\u8a66\u9a57\uff1b\u6839\u64da\u76ee\u524d\u5df2\u5b8c\u6210\u4e26\u53d6\u5f97\u7d71\u8a08\u7d50\u679c\u4e4b10\u9805\u81e8\u5e8a\u8a66\u7684\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u91cd\u8981\u6b21\u8981\u7642\u6548\u6307\u6a19\u7686\u5168\u90e8\u9054\u6a19\uff0c\u4e14\u85e5\u54c1\u5b89\u5168\u6027\u8207\u8010\u53d7\u5ea6\u826f\u597d\u3002CBL-514\u5728\u4e0d\u540c\u9069\u61c9\u75c7\u7686\u5c55\u73fe\u4e86\u512a\u7570\u4e14\u7cbe\u6e96\u7684\u7642\u6548\u8207\u826f\u597d\u5b89\u5168\u6027\uff0c\u4e26\u5728ITT\u6216FAS\u5206\u6790\u65cf\u7fa4\u7642\u6548\u7686\u5177\u6709\u51fa\u8272\u7684\u7d71\u8a08\u986f\u8457\u6027\uff08p<0.00001\u6216p<0.0001\uff09\uff0c\u9810\u8a08\u5c07\u65bc2025\u5e74\u4e0b\u534a\u5e74\u555f\u52d5\u4e8c\u9805\u5c40\u90e8\u6e1b\u8102\u5168\u7403\u4e09\u671f\u6a1e\u7d10\u8a66\u9a57\u6536\u6848\u3002\u66f4\u591a\u95dc\u65bcCBL-514\u7684\u4ecb\u7d39\uff0c\u8acb\u62dc\u8a2a\u5eb7\u9708\u5b98\u7db2\uff1ahttps:\/\/www.caliwaybiopharma.com\/research\/15\/<\/a><\/p>\n

*<\/b>\u95dc\u65bc<\/b>AFRS<\/b>\uff08<\/b>Abdominal Fat Rating Scale<\/b>\uff09<\/b><\/p>\n

AFRS\u70ba\u5eb7\u9708\u4f9d\u7167\u7f8e\u570bFDA\u5efa\u8b70\u8207Patient-Reported Outcome Measures\u76f8\u95dc\u6cd5\u898f\u8981\u6c42\u6240\u958b\u767c\u4e26\u5b8c\u6210\u78ba\u6548\u7684\u4e00\u98051\u52305\u7d1a\u7684\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u8a55\u91cf\u8868\uff0c\u4e26\u5df2\u7d93\u904eFDA\u66f8\u9762\u5be9\u67e5\u3002\u7b49\u7d1a\u5206\u6578\u8d8a\u9ad8\u4ee3\u8868\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u8d8a\u56b4\u91cd\uff0c\u4e0d\u540c\u7b49\u7d1a\u5728\u81e8\u5e8a\u4e0a\u5177\u6709\u986f\u8457\u5dee\u7570\u3002Clinician Reported (CR-AFRS)\u8868\u793a\u7531\u8a66\u9a57\u91ab\u5e2b\u8a55\u4f30\u53d7\u8a66\u8005\u4e4b\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u7b49\u7d1a\uff1bPatient Reported (PR-AFRS)\u5247\u8868\u793a\u7531\u53d7\u8a66\u8005\u81ea\u8a55\u4e4b\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u7b49\u7d1a\u3002<\/b><\/p>\n

*<\/b>\u95dc\u65bc\u5eb7\u9708<\/b>
\u5eb7\u9708\u751f\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8\u65bc101\u5e74\u5275\u7acb\uff0c\u81f4\u529b\u65bc\u958b\u767c\u80fd\u8d85\u8d8a\u73fe\u6709\u7642\u6cd5\uff0c\u6539\u8b8a\u5e02\u5834\u5275\u65b0\u7684\u65b0\u85e5\u7522\u54c1\uff0c\u5c07\u53f0\u7063\u5145\u6c9b\u7684\u65b0\u85e5\u7814\u767c\u91cf\u80fd\u767c\u63ee\u65bc\u5168\u7403\u751f\u91ab\u8207\u91ab\u7f8e\u7522\u696d\uff0c\u5df2\u65bc113\u5e7410\u67082\u65e5\u6b63\u5f0f\u639b\u724c\u4e0a\u5e02\u3002<\/p>\n

*<\/b>\u8072\u660e<\/b>\u00a0\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":"

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disease\uff09\u7b49\u3002\u622a\u81f32024\u5e7411\u6708\u5e95\uff0c\u5168\u7403\u5df2\u5171\u6709520\u540d\u53d7\u8a66\u8005\u53c3\u8207CBL-514\u76f8\u95dc\u81e8\u5e8a\u8a66\u9a57\uff1b\u6839\u64da\u76ee\u524d\u5df2\u5b8c\u6210\u4e26\u53d6\u5f97\u7d71\u8a08\u7d50\u679c\u4e4b10\u9805\u81e8\u5e8a\u8a66\u7684\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u91cd\u8981\u6b21\u8981\u7642\u6548\u6307\u6a19\u7686\u5168\u90e8\u9054\u6a19\uff0c\u4e14\u85e5\u54c1\u5b89\u5168\u6027\u8207\u8010\u53d7\u5ea6\u826f\u597d\u3002CBL-514\u5728\u4e0d\u540c\u9069\u61c9\u75c7\u7686\u5c55\u73fe\u4e86\u512a\u7570\u4e14\u7cbe\u6e96\u7684\u7642\u6548\u8207\u826f\u597d\u5b89\u5168\u6027\uff0c\u4e26\u5728ITT\u6216FAS\u5206\u6790\u65cf\u7fa4\u7642\u6548\u7686\u5177\u6709\u51fa\u8272\u7684\u7d71\u8a08\u986f\u8457\u6027\uff08p<0.00001\u6216p<0.0001\uff09\uff0c\u9810\u8a08\u5c07\u65bc2025\u5e74\u4e0b\u534a\u5e74\u555f\u52d5\u4e8c\u9805\u5c40\u90e8\u6e1b\u8102\u5168\u7403\u4e09\u671f\u6a1e\u7d10\u8a66\u9a57\u6536\u6848\u3002\u66f4\u591a\u95dc\u65bcCBL-514\u7684\u4ecb\u7d39\uff0c\u8acb\u62dc\u8a2a\u5eb7\u9708\u5b98\u7db2\uff1ahttps:\/\/www.caliwaybiopharma.com\/research\/15\/ *\u95dc\u65bcAFRS\uff08Abdominal Fat Rating Scale\uff09 AFRS\u70ba\u5eb7\u9708\u4f9d\u7167\u7f8e\u570bFDA\u5efa\u8b70\u8207Patient-Reported Outcome Measures\u76f8\u95dc\u6cd5\u898f\u8981\u6c42\u6240\u958b\u767c\u4e26\u5b8c\u6210\u78ba\u6548\u7684\u4e00\u98051\u52305\u7d1a\u7684\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u8a55\u91cf\u8868\uff0c\u4e26\u5df2\u7d93\u904eFDA\u66f8\u9762\u5be9\u67e5\u3002\u7b49\u7d1a\u5206\u6578\u8d8a\u9ad8\u4ee3\u8868\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u8d8a\u56b4\u91cd\uff0c\u4e0d\u540c\u7b49\u7d1a\u5728\u81e8\u5e8a\u4e0a\u5177\u6709\u986f\u8457\u5dee\u7570\u3002Clinician Reported (CR-AFRS)\u8868\u793a\u7531\u8a66\u9a57\u91ab\u5e2b\u8a55\u4f30\u53d7\u8a66\u8005\u4e4b\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u7b49\u7d1a\uff1bPatient Reported (PR-AFRS)\u5247\u8868\u793a\u7531\u53d7\u8a66\u8005\u81ea\u8a55\u4e4b\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u7b49\u7d1a\u3002 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content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u5eb7\u9708CBL-514\u9806\u5229\u5b8c\u6210FDA EOP2\u6703\u8b70 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" content=\"\u6709\u671b\u6210\u70ba\u5168\u7403\u9996\u6b3e\u300c\u6e1b\u5c11\u76ae\u4e0b\u8102\u80aa\u300d\u65b0\u85e5 -\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u5168\u7403\u9996\u6b3e\u5927\u7bc4\u570d\u5c40\u90e8\u6e1b\u8102\u65b0\u85e5CBL-514\uff0c\u4ee5505(b)(1)\u65b0\u85e5\u6cd5\u898f\u8def\u5f91\uff0c\u5df2\u5b8c\u6210\u8207\u7f8e\u570bFDA\u7684EOP2\u6703\u8b70\uff0c\u6b63\u5f0f\u53d6\u5f97\u66f8\u9762\u6703\u8b70\u7d00\u9304\uff0c\u96d9\u65b9\u5c31\u6a1e\u7d10\u4e09\u671f\u8a66\u9a57\u8a2d\u8a08\u8207\u672a\u4f86\u9069\u61c9\u75c7\u9054\u9ad8\u5ea6\u5171\u8b58\u3002 -\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 FDA\u540c\u610fCBL-514\u672a\u4f86\u65b0\u85e5\u67e5\u9a57\u767b\u8a18\u7533\u8acb\uff08NDA\uff09\u4e4b\u9069\u61c9\u75c7\u70ba\u300c\u6e1b\u5c11\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u300d\uff0c\u7a81\u7834\u904e\u5f80\u91ab\u7f8e\u7528\u85e5\u50c5\u6838\u51c6\u4ee5\u300c\u5916\u89c0\u6539\u5584\u300d\u4f5c\u70ba\u9069\u61c9\u75c7\u7684\u6846\u67b6\u3002 \u65b0\u5317\u5e022025\u5e745\u670814\u65e5 \/\u7f8e\u901a\u793e\/ -- \u300a2025\u5e745\u670814\u65e5\u65b0\u5317\u5e02\u8a0a\u300b\u5eb7\u9708\u751f\u6280\uff086919\uff09\u4eca\u65e5\u5ba3\u5e03\uff0c\u65d7\u4e0b\u5168\u7403\u9996\u5275\u4e4b\u5927\u7bc4\u570d\u5c40\u90e8\u6e1b\u8102\u65b0\u85e5CBL-514\uff0c\u5df2\u65bc2025\u5e744\u6708\u5b8c\u6210\u8207\u7f8e\u570bFDA\uff08\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\uff0cFood and Drug Administration\uff09\u53ec\u958b\u7684\u4e8c\u671f\u81e8\u5e8a\u7d50\u675f\u6703\u8b70\uff08End-of-Phase 2 meeting\uff0c\u7c21\u7a31EOP2\uff09\uff0c\u4e26\u65bc\u8fd1\u671f\u6b63\u5f0f\u53d6\u5f97FDA\u6703\u5f8c\u66f8\u9762\u7d00\u9304\uff0c\u96d9\u65b9\u5c31\u672a\u4f86\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\uff08NDA\uff09\u6240\u9700\u7684\u6a1e\u7d10\u4e09\u671f\u7684\u8a66\u9a57\u8a2d\u8a08\u3001\u4e3b\u8981\u7642\u6548\u6307\u6a19\uff0c\u8207\u9069\u61c9\u75c7\u7b49\u8b70\u984c\u7686\u9054\u6210\u660e\u78ba\u5171\u8b58\u3002 \u672c\u6b21\u6703\u8b70\u6700\u91cd\u8981\u7684\u7d50\u679c\u70baFDA\u540c\u610f\u4ee5\u300c\u6e1b\u5c11\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\uff08Reduction of Abdominal Subcutaneous Fat\uff09\u300d\u4f5c\u70baCBL-514\u672a\u4f86\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\u7684\u64ec\u5b9a\u9069\u61c9\u75c7\uff0c\u6709\u6a5f\u6703\u7a81\u7834\u904e\u5f80\u91ab\u7f8e\u85e5\u54c1\u8207\u8a2d\u5099\u7686\u4ee5\u300c\u5916\u89c0\u6539\u5584\u300d\uff08Improvement in the Appearance\uff09\u70ba\u9069\u61c9\u75c7\u7684\u6163\u4f8b\uff0cCBL-514\u672a\u4f86\u6709\u671b\u6210\u70ba\u5168\u7403\u7b2c\u4e00\u500b\u7372FDA\u6838\u51c6\u4ee5\u300c\u6e1b\u5c11\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u300d\u70ba\u9069\u61c9\u75c7\u7684\u91ab\u7f8e\u85e5\u7269\uff0c\u82e5\u6210\u529f\u4e0a\u5e02\uff0c\u5c07\u53ef\u65bc\u4eff\u55ae\u4e2d\u8f09\u660e\u6b64\u7642\u6548\uff0c\u5728\u81e8\u5e8a\u50f9\u503c\u8207\u5e02\u5834\u6f5b\u529b\u4e0a\u5747\u5177\u91cd\u5927\u610f\u7fa9\u3002 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Canada\uff09\u905e\u4ea4\u7b2c\u4e00\u9805\u5168\u7403\u6a1e\u7d10\u4e09\u671f\uff08CBL-0301\uff09\u7684\u81e8\u5e8a\u8a66\u9a57\u7533\u8acb\uff0c\u4e26\u5728Q3\u5411\u7f8e\u570bFDA\u3001\u52a0\u62ff\u5927\u885b\u751f\u90e8\uff08Health Canada\uff09\u53ca\u6fb3\u6d32HREC\u8207\u85e5\u7269\u7ba1\u7406\u5c40\uff08Therapeutic Goods Administration\uff09\u905e\u4ea4\u7b2c\u4e8c\u9805\u5168\u7403\u6a1e\u7d10\u4e09\u671f\uff08CBL-0302\uff09\u4e4b\u81e8\u5e8a\u8a66\u9a57\u7533\u8acb\u3002\u00a0 \u900f\u904e\u6b64EOP2\u8996\u8a0a\u6703\u8b70\uff0c\u96d9\u65b9\u78ba\u8a8d\u4e86\u6a1e\u7d10\u4e09\u671f\u8a66\u9a57\u8a2d\u8a08\u3001\u4e3b\u8981\u7642\u6548\u6307\u6a19\u3001\u7522\u54c1\u9069\u61c9\u75c7\u8207\u898f\u683c\uff0c\u4ee5\u53caFDA\u5c0d\u65bc\u672a\u4f86\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\u7684\u91cd\u5927\u65b9\u5411\uff0c\u5f37\u5316\u516c\u53f8\u63a8\u9032\u5f8c\u7e8c\u4e09\u671f\u81e8\u5e8a\u8207\u85e5\u7269\u4e0a\u5e02\u7684\u4fe1\u5fc3\u3002 *\u95dc\u65bcCBL-514 CBL-514\u6ce8\u5c04\u5291\u662f\u5eb7\u9708\u751f\u6280\u81ea\u884c\u7814\u767c\u7684505(b)(1)\u5168\u65b0\u5c0f\u5206\u5b50\u65b0\u85e5\uff0c\u662f\u5168\u7403\u9996\u5275\u900f\u904e\u8a98\u5c0e\u8102\u80aa\u7d30\u80de\u51cb\u4ea1\u4f86\u7cbe\u6e96\u6e1b\u5c11\u6ce8\u5c04\u90e8\u4f4d\u8102\u80aa\uff0c\u6839\u64da\u5176\u81e8\u5e8a\u8a66\u9a57\u7d50\u679c\uff0c\u7642\u6548\u512a\u7570\u8207\u624b\u8853\u76f8\u7576\u4e14\u5b89\u5168\u6027\u826f\u597d\uff0c\u4e0d\u6703\u9020\u6210\u5176\u4ed6\u7d30\u80de\u8207\u7d44\u7e54\u58de\u6b7b\u6216\u660e\u986f\u50b7\u5bb3\u3002\u00a0CBL-514\u5177\u6709\u591a\u9805\u9069\u61c9\u75c7\uff0c\u76ee\u524d\u9069\u61c9\u75c7\u5305\u542b\u975e\u624b\u8853\u5c40\u90e8\u6e1b\u8102\uff08non-surgical fat reduction\uff09\u3001\u4e2d\/\u91cd\u5ea6\u6a58\u76ae\u7d44\u7e54\uff08cellulite\uff09\u53ca\u6539\u5584\u5fa9\u80d6\u7b49\uff0c\u540c\u6210\u4efd\u4e0d\u540c\u5291\u578b\u4e4b\u65b0\u85e5CBL-514D\u9069\u61c9\u75c7\u5305\u542b\u7f55\u898b\u75be\u75c5-\u7ac7\u6839\u6c0f\u75c7\uff08Dercum's disease\uff09\u7b49\u3002\u622a\u81f32024\u5e7411\u6708\u5e95\uff0c\u5168\u7403\u5df2\u5171\u6709520\u540d\u53d7\u8a66\u8005\u53c3\u8207CBL-514\u76f8\u95dc\u81e8\u5e8a\u8a66\u9a57\uff1b\u6839\u64da\u76ee\u524d\u5df2\u5b8c\u6210\u4e26\u53d6\u5f97\u7d71\u8a08\u7d50\u679c\u4e4b10\u9805\u81e8\u5e8a\u8a66\u7684\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u91cd\u8981\u6b21\u8981\u7642\u6548\u6307\u6a19\u7686\u5168\u90e8\u9054\u6a19\uff0c\u4e14\u85e5\u54c1\u5b89\u5168\u6027\u8207\u8010\u53d7\u5ea6\u826f\u597d\u3002CBL-514\u5728\u4e0d\u540c\u9069\u61c9\u75c7\u7686\u5c55\u73fe\u4e86\u512a\u7570\u4e14\u7cbe\u6e96\u7684\u7642\u6548\u8207\u826f\u597d\u5b89\u5168\u6027\uff0c\u4e26\u5728ITT\u6216FAS\u5206\u6790\u65cf\u7fa4\u7642\u6548\u7686\u5177\u6709\u51fa\u8272\u7684\u7d71\u8a08\u986f\u8457\u6027\uff08p<0.00001\u6216p<0.0001\uff09\uff0c\u9810\u8a08\u5c07\u65bc2025\u5e74\u4e0b\u534a\u5e74\u555f\u52d5\u4e8c\u9805\u5c40\u90e8\u6e1b\u8102\u5168\u7403\u4e09\u671f\u6a1e\u7d10\u8a66\u9a57\u6536\u6848\u3002\u66f4\u591a\u95dc\u65bcCBL-514\u7684\u4ecb\u7d39\uff0c\u8acb\u62dc\u8a2a\u5eb7\u9708\u5b98\u7db2\uff1ahttps:\/\/www.caliwaybiopharma.com\/research\/15\/ *\u95dc\u65bcAFRS\uff08Abdominal Fat Rating Scale\uff09 AFRS\u70ba\u5eb7\u9708\u4f9d\u7167\u7f8e\u570bFDA\u5efa\u8b70\u8207Patient-Reported Outcome Measures\u76f8\u95dc\u6cd5\u898f\u8981\u6c42\u6240\u958b\u767c\u4e26\u5b8c\u6210\u78ba\u6548\u7684\u4e00\u98051\u52305\u7d1a\u7684\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u8a55\u91cf\u8868\uff0c\u4e26\u5df2\u7d93\u904eFDA\u66f8\u9762\u5be9\u67e5\u3002\u7b49\u7d1a\u5206\u6578\u8d8a\u9ad8\u4ee3\u8868\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u8d8a\u56b4\u91cd\uff0c\u4e0d\u540c\u7b49\u7d1a\u5728\u81e8\u5e8a\u4e0a\u5177\u6709\u986f\u8457\u5dee\u7570\u3002Clinician Reported (CR-AFRS)\u8868\u793a\u7531\u8a66\u9a57\u91ab\u5e2b\u8a55\u4f30\u53d7\u8a66\u8005\u4e4b\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u7b49\u7d1a\uff1bPatient Reported (PR-AFRS)\u5247\u8868\u793a\u7531\u53d7\u8a66\u8005\u81ea\u8a55\u4e4b\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u7b49\u7d1a\u3002 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disease\uff09\u7b49\u3002\u622a\u81f32024\u5e7411\u6708\u5e95\uff0c\u5168\u7403\u5df2\u5171\u6709520\u540d\u53d7\u8a66\u8005\u53c3\u8207CBL-514\u76f8\u95dc\u81e8\u5e8a\u8a66\u9a57\uff1b\u6839\u64da\u76ee\u524d\u5df2\u5b8c\u6210\u4e26\u53d6\u5f97\u7d71\u8a08\u7d50\u679c\u4e4b10\u9805\u81e8\u5e8a\u8a66\u7684\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u91cd\u8981\u6b21\u8981\u7642\u6548\u6307\u6a19\u7686\u5168\u90e8\u9054\u6a19\uff0c\u4e14\u85e5\u54c1\u5b89\u5168\u6027\u8207\u8010\u53d7\u5ea6\u826f\u597d\u3002CBL-514\u5728\u4e0d\u540c\u9069\u61c9\u75c7\u7686\u5c55\u73fe\u4e86\u512a\u7570\u4e14\u7cbe\u6e96\u7684\u7642\u6548\u8207\u826f\u597d\u5b89\u5168\u6027\uff0c\u4e26\u5728ITT\u6216FAS\u5206\u6790\u65cf\u7fa4\u7642\u6548\u7686\u5177\u6709\u51fa\u8272\u7684\u7d71\u8a08\u986f\u8457\u6027\uff08p<0.00001\u6216p<0.0001\uff09\uff0c\u9810\u8a08\u5c07\u65bc2025\u5e74\u4e0b\u534a\u5e74\u555f\u52d5\u4e8c\u9805\u5c40\u90e8\u6e1b\u8102\u5168\u7403\u4e09\u671f\u6a1e\u7d10\u8a66\u9a57\u6536\u6848\u3002\u66f4\u591a\u95dc\u65bcCBL-514\u7684\u4ecb\u7d39\uff0c\u8acb\u62dc\u8a2a\u5eb7\u9708\u5b98\u7db2\uff1ahttps:\/\/www.caliwaybiopharma.com\/research\/15\/ *\u95dc\u65bcAFRS\uff08Abdominal Fat Rating Scale\uff09 AFRS\u70ba\u5eb7\u9708\u4f9d\u7167\u7f8e\u570bFDA\u5efa\u8b70\u8207Patient-Reported Outcome Measures\u76f8\u95dc\u6cd5\u898f\u8981\u6c42\u6240\u958b\u767c\u4e26\u5b8c\u6210\u78ba\u6548\u7684\u4e00\u98051\u52305\u7d1a\u7684\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u8a55\u91cf\u8868\uff0c\u4e26\u5df2\u7d93\u904eFDA\u66f8\u9762\u5be9\u67e5\u3002\u7b49\u7d1a\u5206\u6578\u8d8a\u9ad8\u4ee3\u8868\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u8d8a\u56b4\u91cd\uff0c\u4e0d\u540c\u7b49\u7d1a\u5728\u81e8\u5e8a\u4e0a\u5177\u6709\u986f\u8457\u5dee\u7570\u3002Clinician Reported (CR-AFRS)\u8868\u793a\u7531\u8a66\u9a57\u91ab\u5e2b\u8a55\u4f30\u53d7\u8a66\u8005\u4e4b\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u7b49\u7d1a\uff1bPatient Reported (PR-AFRS)\u5247\u8868\u793a\u7531\u53d7\u8a66\u8005\u81ea\u8a55\u4e4b\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u7b49\u7d1a\u3002 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FDA\u540c\u610fCBL-514\u672a\u4f86\u65b0\u85e5\u67e5\u9a57\u767b\u8a18\u7533\u8acb\uff08NDA\uff09\u4e4b\u9069\u61c9\u75c7\u70ba\u300c\u6e1b\u5c11\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u300d\uff0c\u7a81\u7834\u904e\u5f80\u91ab\u7f8e\u7528\u85e5\u50c5\u6838\u51c6\u4ee5\u300c\u5916\u89c0\u6539\u5584\u300d\u4f5c\u70ba\u9069\u61c9\u75c7\u7684\u6846\u67b6\u3002 \u65b0\u5317\u5e022025\u5e745\u670814\u65e5 \/\u7f8e\u901a\u793e\/ -- \u300a2025\u5e745\u670814\u65e5\u65b0\u5317\u5e02\u8a0a\u300b\u5eb7\u9708\u751f\u6280\uff086919\uff09\u4eca\u65e5\u5ba3\u5e03\uff0c\u65d7\u4e0b\u5168\u7403\u9996\u5275\u4e4b\u5927\u7bc4\u570d\u5c40\u90e8\u6e1b\u8102\u65b0\u85e5CBL-514\uff0c\u5df2\u65bc2025\u5e744\u6708\u5b8c\u6210\u8207\u7f8e\u570bFDA\uff08\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\uff0cFood and Drug Administration\uff09\u53ec\u958b\u7684\u4e8c\u671f\u81e8\u5e8a\u7d50\u675f\u6703\u8b70\uff08End-of-Phase 2 meeting\uff0c\u7c21\u7a31EOP2\uff09\uff0c\u4e26\u65bc\u8fd1\u671f\u6b63\u5f0f\u53d6\u5f97FDA\u6703\u5f8c\u66f8\u9762\u7d00\u9304\uff0c\u96d9\u65b9\u5c31\u672a\u4f86\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\uff08NDA\uff09\u6240\u9700\u7684\u6a1e\u7d10\u4e09\u671f\u7684\u8a66\u9a57\u8a2d\u8a08\u3001\u4e3b\u8981\u7642\u6548\u6307\u6a19\uff0c\u8207\u9069\u61c9\u75c7\u7b49\u8b70\u984c\u7686\u9054\u6210\u660e\u78ba\u5171\u8b58\u3002 \u672c\u6b21\u6703\u8b70\u6700\u91cd\u8981\u7684\u7d50\u679c\u70baFDA\u540c\u610f\u4ee5\u300c\u6e1b\u5c11\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\uff08Reduction of Abdominal Subcutaneous Fat\uff09\u300d\u4f5c\u70baCBL-514\u672a\u4f86\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\u7684\u64ec\u5b9a\u9069\u61c9\u75c7\uff0c\u6709\u6a5f\u6703\u7a81\u7834\u904e\u5f80\u91ab\u7f8e\u85e5\u54c1\u8207\u8a2d\u5099\u7686\u4ee5\u300c\u5916\u89c0\u6539\u5584\u300d\uff08Improvement in the Appearance\uff09\u70ba\u9069\u61c9\u75c7\u7684\u6163\u4f8b\uff0cCBL-514\u672a\u4f86\u6709\u671b\u6210\u70ba\u5168\u7403\u7b2c\u4e00\u500b\u7372FDA\u6838\u51c6\u4ee5\u300c\u6e1b\u5c11\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u300d\u70ba\u9069\u61c9\u75c7\u7684\u91ab\u7f8e\u85e5\u7269\uff0c\u82e5\u6210\u529f\u4e0a\u5e02\uff0c\u5c07\u53ef\u65bc\u4eff\u55ae\u4e2d\u8f09\u660e\u6b64\u7642\u6548\uff0c\u5728\u81e8\u5e8a\u50f9\u503c\u8207\u5e02\u5834\u6f5b\u529b\u4e0a\u5747\u5177\u91cd\u5927\u610f\u7fa9\u3002 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Canada\uff09\u905e\u4ea4\u7b2c\u4e00\u9805\u5168\u7403\u6a1e\u7d10\u4e09\u671f\uff08CBL-0301\uff09\u7684\u81e8\u5e8a\u8a66\u9a57\u7533\u8acb\uff0c\u4e26\u5728Q3\u5411\u7f8e\u570bFDA\u3001\u52a0\u62ff\u5927\u885b\u751f\u90e8\uff08Health Canada\uff09\u53ca\u6fb3\u6d32HREC\u8207\u85e5\u7269\u7ba1\u7406\u5c40\uff08Therapeutic Goods Administration\uff09\u905e\u4ea4\u7b2c\u4e8c\u9805\u5168\u7403\u6a1e\u7d10\u4e09\u671f\uff08CBL-0302\uff09\u4e4b\u81e8\u5e8a\u8a66\u9a57\u7533\u8acb\u3002\u00a0 \u900f\u904e\u6b64EOP2\u8996\u8a0a\u6703\u8b70\uff0c\u96d9\u65b9\u78ba\u8a8d\u4e86\u6a1e\u7d10\u4e09\u671f\u8a66\u9a57\u8a2d\u8a08\u3001\u4e3b\u8981\u7642\u6548\u6307\u6a19\u3001\u7522\u54c1\u9069\u61c9\u75c7\u8207\u898f\u683c\uff0c\u4ee5\u53caFDA\u5c0d\u65bc\u672a\u4f86\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\u7684\u91cd\u5927\u65b9\u5411\uff0c\u5f37\u5316\u516c\u53f8\u63a8\u9032\u5f8c\u7e8c\u4e09\u671f\u81e8\u5e8a\u8207\u85e5\u7269\u4e0a\u5e02\u7684\u4fe1\u5fc3\u3002 *\u95dc\u65bcCBL-514 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