{"id":964,"slug":"克罗恩病复杂性肛瘘-alofisel-达伐妥赛-在欧盟被撤市了-韩国的cupistem是同一个东西吗","question":"克罗恩病复杂性肛瘘：Alofisel（达伐妥赛）在欧盟被撤市了，韩国的Cupistem是同一个东西吗？","intent":"comparison","language":"zh","url":"https://worldwiki.io/q/克罗恩病复杂性肛瘘-alofisel-达伐妥赛-在欧盟被撤市了-韩国的cupistem是同一个东西吗","entity":{"slug":"adipose-derived-stem-cell","name":"Adipose-derived Stem Cell","url":"https://worldwiki.io/entity/adipose-derived-stem-cell"},"answer":{"short_answer":"不是同一个产品。Alofisel（达伐妥赛）是异体脂肪来源产品，2018年3月23日获欧盟批准用于克罗恩病复杂性肛周瘘，其上市许可于2024年12月13日应持有人申请撤回。Cupistem是Anterogen的自体产品，2012年获韩国MFDS批准用于克罗恩病肛瘘，两者的细胞来源（异体/自体）和批准辖区都不同。撤市本身不等同于对自体产品的结论。[5][6][7]","detailed_answer":"<p>欧盟方面：达伐妥赛为异体脂肪来源细胞产品，2018年3月23日获批用于克罗恩病复杂性肛周瘘；2024年12月13日应上市许可持有人申请，该许可被撤回。[6]</p><p>关于撤回的背景，持有企业武田自己发布的说明称，III期确证性试验ADMIRE-CD II纳入568例患者，24周联合缓解的主要终点未达到，次要终点亦无统计学差异。这是企业方的陈述，应按企业声明理解。[7]</p><p>韩国方面：Cupistem（Anterogen）为自体脂肪来源干细胞产品，2012年获MFDS批准用于克罗恩病肛瘘；同一企业的Queencell于2010年获批用于皮下组织缺损。[5]</p><p>就诊前可核对的要点：产品是自体还是异体、在哪个国家获批、获批适应症与你的病情是否一致。</p>","format":"paragraph","confidence":75,"verified_at":null,"updated_at":"2026-09-20 17:11:10"},"sources":[{"id":101,"title":"Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World (Fernández-Garza LE, et al., Pharmaceuticals 16(9):1334)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10536665/","publisher":"Pharmaceuticals (MDPI)","type":"journal","accessed_at":"2026-09-19 18:01:27"},{"id":102,"title":"Alofisel: EPAR","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/alofisel","publisher":"European Medicines Agency","type":"government","accessed_at":"2026-09-19 18:01:28"},{"id":246,"title":"Takeda Update on Alofisel (darvadstrocel)","url":"https://www.takeda.com/newsroom/statements/2024/takeda-alofisel-update-2024/","publisher":"Takeda Pharmaceutical Company","type":"industry","accessed_at":"2026-09-19 18:00:19"}],"published_at":"2026-09-20 08:11:10"}