{"id":95309,"topic":"peptides","source":"中国医药创新促进会","title":"口服特立帕肽片即将启动3期临床 - 中国医药创新促进会","url":"https://www.phirda.com/artilce_42967.html?module=trackingCodeGenerator","url_hash":"44b5614fa3047a2ff0e3e95069d887ab44d45f37","author":"","summary":"<a href=\"https://news.google.com/rss/articles/CBMiekFVX3lxTE5yRi1DdTJFeDBrVkRwcldpSDhDVkN2dWJrWFoxbWo2aHJBQVVYTHhQM3l4RW0zVkJ0T2daOURaQVNsM21FRmJiZ3B0ekRwYXVfZ2dfQU9HanlWT214T1ZlaUN4cEp4a2VRQlVQMzcwNnJtclpVNFBsdmpn?oc=5\" target=\"_blank\">口服特立帕肽片即将启动3期临床</a>&nbsp;&nbsp;<font color=\"#6f6f6f\">中国医药创新促进会</font>","content":"6月22日(当地时间)，Enteral Bio宣布收到FDA对其口服特立帕肽(PTH(1-34))片剂EB613治疗骨质疏松3期临床的积极反馈。\n企业计划今年晚些时间启动这项随机、双盲、安慰剂对照的3期临床，计划招募750例绝经后骨质疏松女性患者，主要终点为12月BMD较基线变化。\nEB613是美国Entera Bio公司依托N-Tab™口服多肽递送技术开发的全球First-in-class口服PTH (1-34，特立帕肽) 片剂。\nN-Tab™口服多肽递送技术为专属口服大分子递送技术，旨在解决多肽类药物口服胃肠道酶解破坏、肠道膜通透性差难以入血的问题。\nN-Tab™双重核心作用机制：\n1. 多肽稳定保护体系(抗降解)：片剂内加入专属蛋白酶抑制剂+pH稳定辅料：\n在胃部、小肠内抑制胰蛋白酶、肽酶等水解酶活性，避免特立帕肽被分解失效;\n缓冲胃酸，维持多肽药物空间结构稳定，保证活性完整到达小肠吸收部位。\n2. 跨细胞渗透增强体系(促吸收，核心辅料SNAC)：采用水杨酸钠辛酯(SNAC)：\n不破坏肠道细胞紧密连接(安全性高，无肠道屏障损伤风险);\n可逆提升小肠上皮细胞膜流动性，让多肽通过跨细胞途径直接穿透肠壁进入血液循环;\n精准在小肠隐窝部位释放药物，大幅提升多肽系统暴露量，让口服血药浓度与皮下注射特立帕肽基本等效。\n原文：","image_url":null,"lang":"zh","published_at":"2026-06-29T07:00:00+00:00","fetched_at":"2026-10-04T03:15:12+00:00","status":"read","starred":0,"extract_state":"ok","summary_auto":"6月22日(当地时间)，Enteral Bio宣布收到FDA对其口服特立帕肽(PTH(1-34))片剂EB613治疗骨质疏松3期临床的积极反馈。\n企业计划今年晚些时间启动这项随机、双盲、安慰剂对照的3期临床，计划招募750例绝经后骨质疏松女性患者，主要终点为12月BMD较基线变化。\nEB613是美国Entera Bio公司依托N-Tab™口服多肽递送技术开发的全球First-in-class口服PTH (1-34，特立帕肽)…","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_42967.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 568 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":568,"summary_length":215,"usable_text_length":568,"source_field":"content"},"legacy_collapsed":false,"signals":{"extract_state":"ok","extract_error":null,"extract_retries":0,"content_length":568,"summary_length":215}},"news_item":{"id":95309,"canonical_url":"https://www.phirda.com/artilce_42967.html?module=trackingCodeGenerator","source_url":"https://www.phirda.com/artilce_42967.html?module=trackingCodeGenerator","title":"口服特立帕肽片即将启动3期临床 - 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