{"id":101929,"date":"2023-11-30T18:16:00","date_gmt":"2023-11-30T10:16:00","guid":{"rendered":"https:\/\/gothe.tw\/?p=101929"},"modified":"2023-11-30T18:16:00","modified_gmt":"2023-11-30T10:16:00","slug":"%e5%ba%b7%e9%9c%88%e5%b7%b2%e5%90%91%e6%be%b3%e6%b4%b2-hrec-%e6%8f%90%e5%87%ba-cbl-514-%e5%b1%80%e9%83%a8%e6%b8%9b%e8%84%82%e5%a4%9a%e5%9c%8b%e5%a4%9a%e4%b8%ad%e5%bf%83%e4%b8%89%e6%9c%9f%e8%87%a8","status":"publish","type":"post","link":"https:\/\/gothe.tw\/?p=101929","title":{"rendered":"\u5eb7\u9708\u5df2\u5411\u6fb3\u6d32 HREC \u63d0\u51fa CBL-514 \u5c40\u90e8\u6e1b\u8102\u591a\u570b\u591a\u4e2d\u5fc3\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u7533\u8acb"},"content":{"rendered":"
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\u53f0\u5317<\/span>2023\u5e7411\u670830\u65e5<\/span> \/\u7f8e\u901a\u793e\/ \u2014 \u5eb7\u9708\u751f\u6280\uff08 6919-TW \uff09\u5df2\u65bc 11 \u6708 29 \u65e5\u5b8c\u6210\u5411\u6fb3\u6d32\u4e3b\u7ba1\u6a5f\u95dc Bellberry HREC \uff08\u4eba\u985e\u7814\u7a76\u502b\u7406\u59d4\u54e1\u6703\uff09\u905e\u4ea4 CBL-514 \u7528\u65bc\u65b0\u85e5\u67e5\u9a57\u767b\u8a18\u7533\u8acb\uff08 NDA \uff09\u4e4b\u591a\u570b\u591a\u4e2d\u5fc3\u975e\u624b\u8853\u5c40\u90e8\u6e1b\u8102\u81e8\u5e8a\u4e09\u671f\u6a1e\u7d10\u8a66\u9a57 \uff08 Pivotal Study \uff09 \u2013 CBL-0301 Phase 3 IND \u7533\u8acb\u3002<\/p>\n

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<\/a>
\u5eb7\u9708\u57f7\u884c\u9577\u51cc\u7389\u82b3<\/span><\/p>\n<\/div>\n

\u516c\u53f8\u5f8c\u7e8c\u5c07\u9678\u7e8c\u9032\u884c\u672c\u8a66\u9a57\u65bc\u7f8e\u570b FDA \u3001 \u6b50\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40\uff08 EMA \uff09\u53ca\u5176\u4ed6\u6536\u6848\u570b\u5bb6\u4e4b\u81e8\u5e8a\u8a66\u9a57\u7533\u8acb\uff0c\u4e26\u65bc\u7f8e\u570b FDA \u6838\u51c6\u57f7\u884c\u5f8c\u958b\u59cb\u6536\u6848\uff0c\u4e5f\u5c07\u540c\u6b65\u555f\u52d5\u53e6\u4e00\u9805\u591a\u570b\u591a\u4e2d\u5fc3\u81e8\u5e8a\u4e09\u671f\u6a1e\u7d10\u8a66\u9a57 CBL-0302 Phase 3 IND \u7533\u8acb\u3002<\/p>\n

CBL-514 <\/b> \u4e09\u671f\u81e8\u5e8a\u6a1e\u7d10\u8a66\u9a57\u9810\u8a08\u5c07\u7d0d\u5165 <\/b> 300 <\/b> \u4f4d\u53d7\u8a66\u8005\uff0c\u4ee5\u7f8e\u570b <\/b> FDA <\/b> \u5efa\u8b70\u4e4b\u7642\u6548\u6307\u6a19 <\/b> AFRS <\/b> \uff08 <\/b> Abdominal Fat Rating Scale <\/b> \uff09\u8a55\u4f30\u6e1b\u5c11\u76ae\u4e0b\u8102\u80aa\u7642\u6548 <\/b><\/p>\n

CBL-0301 Phase 3 \u8a66\u9a57\u70ba\u4e00\u9805\u7528\u65bc\u65b0\u85e5\u67e5\u9a57\u767b\u8a18\u7533\u8acb\uff08 NDA \uff09\u3001\u591a\u570b\u591a\u4e2d\u5fc3\u3001\u96d9\u76f2\u3001\u96a8\u6a5f\u5206\u914d\u7684\u81e8\u5e8a\u4e09\u671f\u6a1e\u7d10\u8a66\u9a57\uff0c\u9810\u8a08\u5c07\u7d0d\u5165 300 \u4f4d\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u4e2d\u5ea6\u6216\u91cd\u5ea6\u7684\u53d7\u8a66\u8005\uff08 AFRS \u8a55\u5206 Grade 3 \u6216 Grade 4) \uff0c\u4e26\u4ee5 2 \uff1a 1 \u96a8\u6a5f\u5206\u6d3e\u70ba CBL-514 \u7528\u85e5\u7d44\u8207\u5b89\u6170\u5291\u7d44\u5171 2 \u500b\u7d44\u5225\uff0c\u6839\u64da\u53d7\u8a66\u8005\u8179\u90e8\u76ae\u4e0b\u8102\u80aa\u5806\u7a4d\u7a0b\u5ea6\u7d66\u4e88\u6700\u591a 4 \u6b21 CBL-514 \u6216\u7b49\u9ad4\u7a4d\u7684\u5b89\u6170\u5291\u6ce8\u5c04\u6cbb\u7642\uff0c\u6bcf\u6b21\u5291\u91cf\u4e0d\u8d85\u904e 600 mg \uff1b\u6bcf\u6b21\u6cbb\u7642\u5c07\u9593\u9694 3 \u9031\uff0c\u4e26\u65bc\u5b8c\u6210\u6700\u5f8c\u4e00\u6b21\u6cbb\u7642\u5f8c\u7684 4 \u9031\u3001 8 \u9031\u548c 12 \u9031\u8ffd\u8e64\u8a55\u4f30\u7642\u6548\u8207\u5b89\u5168\u6027\u3002<\/p>\n

CBL-514 <\/b> \u4e8c\u671f\u81e8\u5e8a\u6578\u64da\u986f\u793a\u5176\u5c40\u90e8\u6e1b\u8102\u7642\u6548\u512a\u65bc\u62bd\u8102\u624b\u8853\u8207\u5176\u4ed6\u975e\u4fb5\u5165\u7642\u7a0b <\/b><\/p>\n

\u8fd1\u5e74\u71b1\u8ce3\u7684\u6e1b\u91cd\u85e5\u7269\u5982 Ozempic \u3001 Wegovy \u53ca Mounjaro \u7b49\u96d6\u80fd\u5feb\u901f\u6e1b\u8f15\u9ad4\u91cd\uff0c\u4f46\u540c\u6642\u4e5f\u6703\u5c0e\u81f4\u808c\u8089\u6d41\u5931\u8207\u76ae\u819a\u9b06\u5f1b\uff0c\u4e14\u7121\u6cd5\u6e1b\u5c11\u5c40\u90e8\u76ae\u4e0b\u8102\u80aa\uff0c\u8eab\u9ad4\u96d5\u5851\u5e02\u5834\u5546\u6a5f\u96a8\u4e4b\u64f4\u5927\u3002<\/p>\n

\u6709\u5225\u65bc\u6e1b\u91cd\uff0c\u82e5\u60f3\u6e1b\u5c11\u8eab\u9ad4\u7279\u5b9a\u90e8\u4f4d\u76ae\u4e0b\u8102\u80aa\uff0c\u5247\u9700\u900f\u904e\u5c40\u90e8\u6e1b\u8102\u7642\u7a0b\u6539\u5584\u3002\u7531\u65bc\u975e\u4fb5\u5165\u7684\u5c40\u90e8\u6e1b\u8102\u7642\u7a0b\u7642\u6548\u4e0d\u660e\u986f\uff0c\u76ee\u524d\u5c40\u90e8\u6e1b\u8102\u5e02\u5834 8 \u6210\u4ee5\u4e0a\u4ecd\u4ee5\u4fb5\u5165\u6027\u7684\u62bd\u8102\u624b\u8853\u70ba\u4e3b\u3002\u4f46\u6839\u64da ASJ \u7814\u7a76\uff0c\u8179\u90e8\u62bd\u8102\u624b\u8853\u5e73\u5747\u50c5\u80fd\u6e1b\u5c11 183 mL \u76ae\u4e0b\u8102\u80aa\uff0c\u4e14\u4f34\u96a8\u8457\u624b\u8853\u98a8\u96aa\u4ee5\u53ca\u8a31\u591a\u56b4\u91cd\u7684\u526f\u4f5c\u7528\u3002<\/p>\n

\u6839\u64da\u4eca\u5e74 9 \u6708\u516c\u5e03\u7684 CBL-514 \u975e\u624b\u8853\u5c40\u90e8\u6e1b\u8102 CBL-0202 \u4e8c\u671f\u81e8\u5e8a\u8a66\u9a57\u7b2c 2 \u968e\u6bb5\uff08 CBL-0202 Phase 2-Stage 2, NCT04897412) \u6700\u7d42\u81e8\u5e8a\u7d71\u8a08\u7d50\u679c\uff0c\u5176\u8a66\u9a57\u6240\u6709\u4e3b\u8981\u7642\u6548\u6307\u6a19\u8207\u6b21\u8981\u7642\u6548\u6307\u6a19\u5728 \u00a0ITT \u8207 \u00a0PP \u7d71\u8a08\u65cf\u7fa4\u7686\u9054\u5230\u81e8\u5e8a\u8207\u7d71\u8a08\u4e0a\u986f\u8457\u6709\u6548\u610f\u7fa9\uff0c\u4e26\u8207\u5b89\u6170\u5291\u7d44\u9054\u5230\u986f\u8457\u7d71\u8a08\u5dee\u7570\u3002 CBL-514 \u6cbb\u7642\u5f8c\uff0c 85.7% \u7684\u53d7\u8a66\u8005\u53ef\u6e1b\u5c11\u81f3\u5c11 150 mL \u6cbb\u7642\u90e8\u4f4d\u76ae\u4e0b\u8102\u80aa\uff0c 76.2% \u7684\u53d7\u8a66\u8005\u53ef\u6e1b\u5c11\u81f3\u5c11 200 mL \u6cbb\u7642\u90e8\u4f4d\u76ae\u4e0b\u8102\u80aa\uff1b CBL-514 \u6cbb\u7642\u5f8c\u5e73\u5747\u80fd\u6e1b\u5c11\u8d85\u904e 310 mL \u6cbb\u7642\u90e8\u4f4d\u76ae\u4e0b\u8102\u80aa\uff0c\u7642\u6548\u66f4\u52dd\u62bd\u8102\u624b\u8853\uff0c\u4e26\u5177\u6709\u826f\u597d\u7684\u5b89\u5168\u6027\u8207\u8010\u53d7\u6027\u3002 CBL-514 \u672a\u4f86\u4e0a\u5e02\u5f8c\u5c07\u53ef\u66f4\u5b89\u5168\u3001\u6709\u6548\u7684\u6e1b\u5c11\u5c40\u90e8\u76ae\u4e0b\u8102\u80aa\u4e26\u6709\u6a5f\u6703\u6210\u70ba\u4e3b\u8981\u7684\u6cbb\u7642\u65b9\u5f0f\u3002<\/p>\n

CBL-514 \u81e8\u5e8a\u8a66\u9a57\u51fa\u8272\u7684\u7642\u6548\u6578\u64da\u4e0d\u50c5\u5438\u5f15\u8a31\u591a\u570b\u969b\u85e5\u5ee0\u6d3d\u8ac7\u5408\u4f5c\uff0c\u4e5f\u5438\u5f15\u5317\u7f8e\u8207\u6fb3\u6d32\u6578\u5341\u4f4d\u5168\u7403\u77e5\u540d\u7684\u91ab\u7f8e\u6b0a\u5a01\u91ab\u5e2b\u52a0\u5165 CBL-514 \u7684\u76f8\u95dc\u81e8\u5e8a\u8a66\u9a57\u3002\u76ee\u524d CBL-514 \u7528\u65bc\u6e1b\u5c11\u76ae\u4e0b\u8102\u80aa\u5206\u5225\u6709\u4e8c\u9805 Phase 2b<\/span> \u81e8\u5e8a\u8a66\u9a57 CBL-0204 \uff08 NCT05736107 \uff09\u8207 CBL-0205 \uff08 NCT06005441 \uff09\u6b63\u65bc\u7f8e\u570b\u3001\u6fb3\u6d32\u8207\u7f8e\u570b\u3001\u52a0\u62ff\u5927\u9032\u884c\u6536\u6848\u4e2d\uff0c\u9810\u8a08\u5c07\u65bc 2024Q2 \u8207 2024Q3 \u5b8c\u6210\u8a66\u9a57\u3002<\/p>\n<\/div>\n

\n\u65b0\u805e\u4f86\u6e90\uff1aPR Newswire<\/p>\n

\u4ee5\u4e0a\u65b0\u805e\u6295\u7a3f\u5167\u5bb9\u7531PR Newswire \u7f8e\u901a\u793e\u5168\u6b0a\u81ea\u8ca0\u8cac\u4efb\uff0c\u82e5\u6709\u6d89\u53ca\u4efb\u4f55\u9055\u53cd\u6cd5\u4ee4\u3001\u9055\u53cd\u672c\u7db2\u7ad9\u6703\u54e1\u689d\u6b3e\u3001\u6709\u4fb5\u5bb3\u7b2c\u4e09\u4eba\u6b0a\u76ca\u4e4b\u865e\uff0c\u5c07\u4e00\u6982\u7531PR Newswire \u7f8e\u901a\u793e\u627f\u64d4\u6cd5\u5f8b\u53ca\u640d\u5bb3\u8ce0\u511f\u4e4b\u8cac\u4efb\uff0c\u8207\u65b0\u982d\u689dThehubnews\u7121\u95dc\u3002<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u53f0\u53172023\u5e7411\u670830\u65e5 \/\u7f8e\u901a\u793e\/ \u2014 <\/p>\n","protected":false},"author":6,"featured_media":101930,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[423],"class_list":["post-101929","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life","tag-423","two-columns"],"_links":{"self":[{"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/posts\/101929","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/gothe.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=101929"}],"version-history":[{"count":0,"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/posts\/101929\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gothe.tw\/index.php?rest_route=\/wp\/v2\/media\/101930"}],"wp:attachment":[{"href":"https:\/\/gothe.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=101929"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/gothe.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=101929"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gothe.tw\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=101929"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}