{"id":91577,"topic":"peptides","source":"phirda.com","title":"产业新闻 | FDA批准强生口服多肽疗法！ - phirda.com","url":"https://www.phirda.com/artilce_41979.html?module=trackingCodeGenerator","url_hash":"2e2c3923be0492538772c91bcc61da607714030a","author":"","summary":"<a href=\"https://news.google.com/rss/articles/CBMiekFVX3lxTE9odzl1YnJDVUxvRUJ2bWNhMDFkRWp3S0piaHVPaUZ2M2ZzNm5mSGVqcWp1c1BYUGJTMXd2TWIxaTJIemhvcFNMTXAyc0c5cjJyY2E4bGEtdEw5WEg1MlB5akFFbWFEdmhRcWJIS2tzbkI1OE4zcENYdnV3?oc=5\" target=\"_blank\">产业新闻 | FDA批准强生口服多肽疗法！</a>&nbsp;&nbsp;<font color=\"#6f6f6f\">phirda.com</font>","content":"强生(Johnson & Johnson)今日宣布，美国FDA已批准口服多肽疗法Icotyde(icotrokinra)，用于一线治疗中重度斑块状银屑病(PsO)成人患者，以及12岁及以上、体重至少40 kg，且适合接受全身治疗或光疗的儿童患者。根据新闻稿，Icotyde是首个能够精准阻断IL-23受体的靶向口服多肽药物。\n斑块状银屑病是一种免疫介导的疾病，可导致皮肤细胞过度生成，从而引起炎症、鳞屑性斑块，可能会发痒或疼痛。据估计，全球有超过1.25亿人患有该疾病，且近四分之一的斑块状银屑病患者属于中度至重度病例。斑块状银屑病除了影响身体健康以外，还会成为包括情绪健康、人际关系和日常生活的压力源，尤其当皮损出现在可见或敏感部位时，会显著影响患者的身体舒适感和生活质量。对于许多中重度患者而言，靶向全身治疗至关重要。这也与国际银屑病委员会的指导建议一致，即在连续接受两个周期(每周期4周)外用药物治疗仍未获得显著改善的情况下，应考虑转向全身治疗。\n本次获批基于ICONIC临床开发项目所积累的证据，该项目同时在成人和青少年人群中开展评估，并覆盖头皮、生殖器等高影响部位的银屑病，同时还包括与活性对照药物进行的多项头对头比较试验。在涵盖约2500名患者的四项3期临床研究中，Icotyde达到了所有主要疗效终点，并显示出良好的安全性特征。在优效性头对头研究中，约70%的患者在第16周达到皮损清除或几乎清除(IGA 0/1)，55%的患者达到银屑病面积和严重程度指数(PASI)90应答。至第16周，Icotyde治疗组的不良反应发生率与安慰剂组差异在1.1%以内，且至第52周未发现新的安全性信号。\nIcotyde是一款“first-in-class”的靶向口服多肽，能够选择性阻断IL-23受体(IL-23R)。IL-23在中度至重度斑块状PsO的致病性T细胞活化中起着关键作用，是PsO和其他皮肤病、风湿病和IL-23介导的胃肠道疾病中炎症反应的基础。Icotyde能够以个位数的皮摩尔亲和力与IL-23R结合，并对人类T细胞中的IL-23信号转导产生强效的选择性抑制作用。","image_url":null,"lang":"zh","published_at":"2026-03-23T07:00:00+00:00","fetched_at":"2026-09-28T03:15:11+00:00","status":"read","starred":0,"extract_state":"ok","summary_auto":"强生(Johnson & Johnson)今日宣布，美国FDA已批准口服多肽疗法Icotyde(icotrokinra)，用于一线治疗中重度斑块状银屑病(PsO)成人患者，以及12岁及以上、体重至少40…","cluster_id":null,"extract_retries":0,"extract_error":null,"contract_version":"news_item.v1","format_contract_version":"news_item_formats.v1","dedup_url":"https://www.phirda.com/artilce_41979.html?module=trackingCodeGenerator","quality_profile":{"profile_version":"extraction_quality.v2","bucket":"high","confidence":0.9,"failure_kind":"none","retryable":false,"retry_after_attempts":0,"reason":"High confidence: full text extraction produced 892 characters.","operator_guidance":{"severity":"ok","recommended_action":"trust_full_text","next_step":"Use the extracted full text as the primary article source.","operator_label":"Ready","can_retry":false,"can_use_summary":false,"diagnostics_required":false},"content_depth":{"contract_version":"content_depth.v1","category":"full_text","label":"Full text","has_full_text":true,"has_summary":true,"content_length":892,"summary_length":102,"usable_text_length":892,"source_field":"content"},"legacy_collapsed":false,"signals":{"extract_state":"ok","extract_error":null,"extract_retries":0,"content_length":892,"summary_length":102}},"news_item":{"id":91577,"canonical_url":"https://www.phirda.com/artilce_41979.html?module=trackingCodeGenerator","source_url":"https://www.phirda.com/artilce_41979.html?module=trackingCodeGenerator","title":"产业新闻 | FDA批准强生口服多肽疗法！ - 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