SOR-102(SOR-102) - 药物靶点：IL-23 x IL-23p19 x TNF-α_在研适应症：溃疡性结肠炎，克罗恩病_专利_临床

概要

基本信息

药物类型

双特异性抗体

别名

SOR 102、SOR102

靶点

IL-23 x IL-23p19 x TNF-α

作用方式

抑制剂

作用机制

IL-23抑制剂(白细胞介素-23复合体抑制剂)、IL-23p19抑制剂(白细胞介素-23亚单位p19抑制剂)、TNF-α抑制剂(肿瘤坏死因子α抑制剂)

治疗领域

免疫系统疾病消化系统疾病

在研适应症

溃疡性结肠炎克罗恩病

非在研适应症-

原研机构

Sorriso Pharmaceuticals, Inc.

在研机构

Sorriso Pharmaceuticals, Inc.

非在研机构-

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

1

项与 SOR-102 相关的临床试验

NCT06080048

/ Completed临床1期

A Ph I Randomized Double-Blind First-in-Human Single Ascending Dose & Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Severe Ulcerative Colitis

SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).

开始日期2023-10-24

申办/合作机构

Sorriso Pharmaceuticals, Inc.

100 项与 SOR-102 相关的临床结果

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100 项与 SOR-102 相关的转化医学

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100 项与 SOR-102 相关的专利（医药）

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1

项与 SOR-102 相关的文献（医药）

2026-01-01·Lancet Gastroenterology & Hepatology

Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial

Article

作者: Sattler, Carlos ; Jairath, Vipul ; Roberts, Kevin J ; Gaemers, Ingrid ; Barbat, Sara ; Sands, Bruce E ; Wedel, Pamela ; Feagan, Brian G ; Benson, Jacqueline M ; Westfall, Matt ; Terry, Allyson Q ; Danese, Silvio ; Peyrin-Biroulet, Laurent ; D'Haens, Geert R

BACKGROUND:

SOR102 is an oral bispecific antibody comprised of single domain antibodies targeting TNF and interleukin (IL)-23p19. We aimed to assess the safety, pharmacokinetics, clinical, and biological activity of SOR102 in healthy participants and in patients with active ulcerative colitis.

METHODS:

This phase 1 first-in-human, double-blind, randomised, placebo-controlled, trial was done in the UK, Ukraine, and Georgia in clinical research centres. Central randomisation was by an interactive web response system and a randomisation scheme produced by an unmasked, independent statistician. In part 1, healthy participants were randomly assigned (6:2) to single ascending doses of SOR102 or placebo. In part 2, healthy participants were randomly assigned (8:2) to SOR102 or placebo twice daily for 7 days. In part 3, patients with mildly-to-severely active ulcerative colitis were randomly assigned (1:1:1) to once-daily or twice-daily SOR102 or placebo for 42 days. The primary objective was to evaluate the safety and tolerability of SOR102. Safety analyses were done on all participants or patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT06080048 and is complete.

FINDINGS:

From Oct 9, 2023, to Oct 16, 2024, 157 participants were assessed for eligibility, of whom 93 were excluded and 64 were randomly assigned to either SOR102 (n=48) or placebo (n=16) across all three parts of the study. In part 1, six participants were randomly assigned to receive SOR102 135 mg, six to receive SOR102 405 mg, six to receive SOR102 1215 mg, six to receive SOR102 3645 mg, and eight to receive placebo. In part 2, eight participants were randomly assigned to receive SOR102 1215 mg twice-daily and two to receive placebo. In part 3, seven patients with ulcerative colitis were randomly assigned to receive SOR102 810 mg once-daily, nine to receive the same dose twice-daily, and six to receive placebo. In part 1, treatment-emergent adverse events (TEAEs) occurred in three (13%) of 24 participants who received SOR102 (two in the SOR102 135 mg dose group and one in the SOR102 405 mg dose group; mild diarrhoea and moderate dysmenorrhoea both in a single participant in the SOR102 135 mg group and mild flatulence in a second participant in same group; mild dysmenorrhoea in one participant in the SOR102 405 mg group) compared with two (25%) of eight participants who received placebo (mild catheter site pain; mild headache). Only the TEAE of mild diarrhoea was deemed treatment-related. No TEAEs occurred in part 2. In part 3, at least one TEAE occurred in seven (44%) of 16 patients who received SOR102 (five in the SOR102 810 mg twice-daily dose group and two in the SOR102 810 mg once-daily dose group) and three (50%) of six patients who received placebo. Two patients in the SOR102 twice-daily group had TEAEs of worsening of ulcerative colitis (one of which was severe [the only serious TEAE reported] but not deemed treatment related), leading to study discontinuation. All other TEAEs were mild to moderate in nature. No clinically significant effect of SOR102 on electrocardiogram, vital signs, physical examination, or laboratory parameters was observed at any dose, or frequency of dosing, in any part of the study, and no deaths occurred. In part 3, by day 42, three (43%) of seven participants in the SOR102 once-daily group, five (56%) of nine patients in the SOR102 twice-daily group, and one (17%) of six patients in the placebo group had achieved a Mayo score clinical response, while two (29%) patients in the once-daily group, six (67%) in the twice-daily group, and two (33%) in the placebo group achieved a modified Mayo score clinical response. Three (43%) patients in the once-daily group, five (56%) in the twice-daily group, and none in the placebo group achieved symptomatic remission by day 42.

INTERPRETATION:

The favourable safety profile and preliminary evidence for efficacy support development of SOR102 for treatment of ulcerative colitis.

FUNDING:

Sorriso Pharmaceuticals.

26

项与 SOR-102 相关的新闻（医药）

2026-02-17

·北京医学感染与传染研究

柳叶刀胃肠病学与肝病学 11卷 1-3期

THE LANCET Gastroenterology & Hepatology. Volume 11Number1 柳叶刀胃肠病学与肝病学 11卷 1期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 Accelerating MASH trials: from biopsy to biomarkers 加速MASH（代谢障碍相关脂肪性肝炎）试验：从活检到生物标志物 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p1 COMMENT（述评） 2 Optimising treatment in Crohn's disease: is the main issue early versus late or biologic naive versus biologic experienced? 优化克罗恩病的治疗：主要问题在于早期治疗与晚期治疗，还是生物制剂初治患者与生物制剂经治患者？ Marte Lie Høivik The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p2 3 Ileal bile acid transporter inhibitors for cholestatic pruritus in primary biliary cholangitis 针对原发性胆汁性胆管炎中胆汁淤积性瘙痒的回肠胆汁酸转运蛋白抑制剂 Ansgar W Lohse,David N Assis The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p3 4 Dual targeting of TNF and IL-23 by a bispecific antibody in ulcerative colitis 双特异性抗体在溃疡性结肠炎中同时靶向TNF和IL-23 Raja Atreya,Markus F Neurath The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p5 5 The essential medicines list for inflammatory bowel disease: time to raise the standards of global care 炎症性肠病基本药物清单：是时候提高全球护理标准了 Nanne K de Boer,Richard B Gearry,Charles N Bernstein,Rupa Banerjee,David T Rubin,Gilaad G Kaplanon behalf of the Globalization Cluster of the International Organization of IBD The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p7 NEWS（新闻） 6 The Liver Meeting 2025 2025年肝脏会议 Rob Brierley The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p10 IN FOCUS（焦点） 7 Food Matters 食物很重要 Dietary management of constipation: time for clinical guidelines to catch up with evidence 便秘的饮食治疗：是时候让临床指南跟上证据的步伐了 Eirini Dimidi,Kevin Whelan The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p11 ARTICLES（论著） 8 Vedolizumab in early and late Crohn's disease (LOVE-CD): a phase 4 open-label cohort study 维多珠单抗在早期和晚期克罗恩病中的应用（LOVE-CD）：一项4期开放性队列研究 Geert R D'Haens,Mark Löwenberg,Filip Baert,Peter Bossuyt,Tamás Molnár,Frank Hoentjen,Esmé Clasquin,Krisztina B Gecse,Melanie S Hulshoff,Gert De Hertogh,Matthias Lenfant,Lotte Oldenburg,Séverine Vermeire The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p12 9 Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): 利尼西巴特治疗原发性胆汁性胆管炎和胆汁淤积性瘙痒患者（GLISTEN）：一项随机、多中心、双盲、安慰剂对照的3期试验 a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial Gideon M Hirschfield,Christopher L Bowlus,David E J Jones,Andreas E Kremer,Marlyn J Mayo,Atsushi Tanaka,Pietro Andreone,Jidong Jia,Qinglong Jin,Ricardo U Macías-Rodríguez,Alexander R Cobitz,Brooke M Currie,Ciara Gorey,Ivana Lazic,Danielle Podmore,Andrea Ribeiro,Jennifer B Shannon,Brandon Swift,Megan M McLaughlin,Cynthia Levyfor the GLISTEN Study Group The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p22 10 Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial SOR102（一种口服双特异性肿瘤坏死因子和白细胞介素-23抑制剂）在健康受试者和溃疡性结肠炎患者中的安全性和药代动力学：一项首次人体、双盲、随机、安慰剂对照的1期试验 Vipul Jairath,Silvio Danese,Geert R D’Haens,Brian G Feagan,Laurent Peyrin-Biroulet,Bruce E Sands,Ingrid Gaemers,Matt Westfall,Allyson Q Terry,Kevin J Roberts,Sara Barbat,Pamela Wedel,Jacqueline M Benson,Carlos Sattler The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p34 11 Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial 西洛芬酸在非肝硬化原发性硬化性胆管炎中的应用（PRIMIS）：一项随机、双盲、多中心、安慰剂对照的3期试验 Michael Trauner,Cynthia Levy,Atsushi Tanaka,Zachary Goodman,Douglas Thorburn,Deepak Joshi,Kimmo Salminen,Kidist Yimam,Hiroyuki Isayama,Aldo J Montano-Loza,Stephen Caldwell,Mark Danta,Martti Farkkila,Juan F Gallegos-Orozco,Stuart C Gordon,Holger Hinrichsen,Pietro Invernizzi,Raj Vuppalanchi,Kaiyi Zhu,Jun Xu,Xiangyu Liu,Xiaomin Lu,Gerald Crans,Shahla Bolbolan,Lisa Boyette,Muhsen Alani,William T Barchuk,Timothy R Watkins,Mark C Genovese,Christopher L Bowlus The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p46 REVIEW（综述） 12 Age-related changes of the gastrointestinal tract 胃肠道的年龄相关变化 Alberto Pilotto,Carlo Custodero,Lucilla Crudele,Wanda Morganti,Nicola Veronese,Marilisa Franceschi The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p59 13 Fatigue in people with primary biliary cholangitis: a position paper from the European Reference Network for Rare Liver Diseases 原发性胆汁性胆管炎患者的疲劳问题：欧洲罕见肝病参考网络立场文件 Ozgur M Koc,Anne-Kristin Toussaint,Aurelie Untas,Piotr Milkiewicz,Henriette Ytting,Laura Buck,David E Jones,Gideon Hirschfield,Angela Leburgue,Christoph Schramm,Frederik Nevens,Adriaan J van der Meer,Alessio Gerussi,Jef Verbeek The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p71 THE LANCET Gastroenterology & Hepatology. Volume 11Number2 柳叶刀胃肠病学与肝病学 11卷 2期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 ACIP's HBV birth-dose vaccine recommendations: a fiasco 美国免疫接种咨询委员会（ACIP）的乙肝疫苗出生剂量推荐：一场闹剧 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p87 COMMENT（述评） 2 Expanding the therapeutic arsenal for paediatric ulcerative colitis 扩充儿童溃疡性结肠炎的治疗武器库 Stephanie A Vuijk,Esmée H Boute,Lissy de Ridder The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p88 3 Closing the Middle East and north Africa representation gap in clinical trials in inflammatory bowel disease 缩小炎症性肠病临床试验中中东和北非地区代表不足的差距 Mohammad Shebab,Ahmed Al-Hindawi,Shane W Goodwin,Yuhong Yuan,Talat Bessissow,Laurent Peyrin-Biroulet,Vipul Jairath The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p89 4 Colorectal cancer screening in LGBTQIA+ people: an urgent call for equity 对LGBTQIA+人群进行结直肠癌筛查：迫切呼吁公平 Vidhi Singh,Jayraan Badiee,Alexander Goldowsky,David Russo,Folasade P May The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p91 CORRESPONDENCE（读者来信） 5 Efficacy differentiation of sterile faecal filtrates in Clostridioides difficile infection 无菌粪便滤液在艰难梭菌感染中的疗效差异 Stefan Schreiber,Philip Rosenstiel,Stephan J Ott,Georg H Waetzig The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p94 6 Efficacy differentiation of sterile faecal filtrates in Clostridioides difficile infection – Authors’ reply 无菌粪便滤液在艰难梭菌感染中的疗效差异——作者回复 Dina Kao,Huiping Xu,Thomas Louie The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p94 7 Endoscopic palliation of malignant gastric outlet obstruction: harmonising outcomes 恶性胃出口梗阻的内镜下姑息治疗：统一疗效标准 Zachary L Smith The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p95 8 Clinical remission in ulcerative colitis: restoring precision in trial terminology 溃疡性结肠炎的临床缓解：恢复试验术语的精确性 Sailish Honap,Vipul Jairath,Fernando Magro,Silvio Danese,Laurent Peyrin-Biroulet The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p96 CORRECTIONS（更正） 9 Correction to Lancet Gastroenterol Hepatol 2019; 4: 364–75 对《柳叶刀-胃肠病学与肝病学》2019年；4卷：364-75页的更正 The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：e1 10 Correction to Lancet Gastroenterol Hepatol 2025; 10: 431–41 对《柳叶刀-胃肠病学与肝病学》2025年；10卷：431-41页的更正 The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：e1 NEWS（新闻） 11 Research in Brief 研究简讯 Holly Baker The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p98 IN FOCUS（焦点） 12 Patient Perspectives 患者视角 The label of a diagnosis 诊断标签 Cheryl Reeves The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p99 ARTICLES（论著） 13 Efficacy and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis (SHINE-1): a multicentre, open-label, non-randomised phase 2 trial Mirikizumab治疗中重度活动性溃疡性结肠炎儿童患者的疗效和安全性（SHINE-1）：一项多中心、开放标签、非随机2期试验 Jess L Kaplan,Athos Bousvaros,Dan Turner,Marla Dubinsky,Amy Larkin,Jordan Johns,Yuki Otani,Wallace Crandall,Wendy J Komocsar,Jeffrey S Hyams The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p100 14 Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials Glecirasib联合或不联合西妥昔单抗治疗既往接受过治疗的KRASG12C突变局部晚期或转移性结直肠癌（JAB-21822-1002和JAB-21822-1007）：两项开放标签、非随机1/2期试验 Jian Li,Zhenghang Wang,Jing Huang,Yi Ba,Baoshan Cao,Suxia Luo,Wenhua Li,Chunmei Bai,Zhengbo Song,Jianping Xiong,Liangjun Zhu,Guangyu An,Yanqiao Zhang,Zhihua Li,Yongsheng Li,Yanhong Gu,Changlu Hu,Xingya Li,Chenghui Huang,Qihan Fu,Xianli Yin,Xinjun Liang,Diansheng Zhong,Huaqiu Shi,Xiaoyan Li,Zhen Li,Lian Liu,Feng Wang,Rong Liang,Guohao Xia,Zhen Wang,Andrea Wang-Gillam,Yuli Ding,Zhiyue Rao,Wenhui Pan,Shuang Lu,Xin Sun,Lin Shen The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p110 15 Adjuvant camrelizumab combined with capecitabine in patients with intrahepatic cholangiocarcinoma after surgical resection in China (ACC): a single-arm, single-centre, open-label, phase 2 trial 卡瑞利珠单抗联合卡培他滨辅助治疗中国肝内胆管癌术后患者（ACC）：一项单臂、单中心、开放标签、2期试验 Zheng Wang,Lixing Li,Peiran Huang,Honghu Tu,Xiangyu Zhang,Lei Yu,Fei Liang,Cheng Huang,Shuangjian Qiu,Qinghai Ye,Zhenbin Ding,Xiaowu Huang,Yinghong Shi,Kang Song,Huichuan Sun,Xiaoying Wang,Yongfeng Xu,Yao Yu,Qiang Gao,Lan Zhang,Jia Fan,Jian Zhou The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p124 16 Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial Tinengotinib治疗晚期或转移性胆管癌成人患者：一项多中心、开放标签、2期试验 Milind Javle,Christos Fountzilas,Chih-Yi Liao,Meredith Pelster,Daneng Li,Dustin Deming,Vaibhav Sahai,Lionel Kankeu Fonkoua,Allen Cohn,Parvez Mantry,Donald Richards,Edwin Kingsley,Frank Wu,Peng Peng,Katie Hennessy,Hui Wang,Caixia Sun,Shumao Ni,Jean Fan,Amit Mahipal The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p137 REVIEW（综述） 17 Current and emerging therapeutic landscape for metabolic dysfunction-associated steatohepatitis 代谢功能障碍相关脂肪性肝炎当前及新兴治疗格局 Wenhao Li,William Alazawi,Rohit Loomba The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p150 VIEWPOINT（观点） 18 Ulcerative colitis: moving beyond the mucosal dogma 溃疡性结肠炎：超越黏膜教条 Elisabeth Eggermont,Krisztina Gecse,Noa Krugliak Cleveland,Frauke Petersen,João Sabino,AndréD'Hoore,Torsten Kucharzik,Mariangela Allocca,Gabriele Bislenghi,Kerri Novak,Gert De Hertogh,Christian Maaser,Bram Verstockt The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p163 THE LANCET Gastroenterology & Hepatology. Volume 11Number3 柳叶刀胃肠病学与肝病学 11卷 3期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 Alcohol guidance in US dietary guidelines: a step backwards 美国膳食指南中的酒精建议：倒退的一步 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p175 2 Thanks to our peer reviewers and contributors 感谢我们的同行评审专家和投稿者 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p175 COMMENT（述评） 3 Appendicectomy: a disease-modifying treatment for ulcerative colitis? 阑尾切除术：溃疡性结肠炎的一种疾病修饰疗法？ Alexandra Damasio Todescatto,Paulo Gustavo Kotze The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p176 4 Cyclic exclusive enteral nutrition: a novel approach to maintaining remission in paediatric Crohn's disease 循环全肠内营养：维持儿童克罗恩病缓解的新方法 Anissa M Armet,Eytan Wine The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p177 5 Viral hepatitis in Roma communities: vulnerabilities and improving care access 罗姆人社区中的病毒性肝炎：易感性及改善医疗可及性 Pavol Kristian,Ivana Hockickova,Monika Halanova,Sylvia Drazilova,Ondrej Zahornacky,Peter Jarcuska The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p179 6 Thank you to The Lancet Gastroenterology & Hepatology's statistical and peer reviewers in 2025 感谢《柳叶刀 - 胃肠病学和肝病学》2025 年的统计学和同行评审专家 The Lancet Gastroenterology & Hepatology's Editors The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e2 CORRESPONDENCE（读者来信） 7 Antipruritic effects of the ileal bile acid transporter inhibitor linerixibat 回肠胆汁酸转运体抑制剂利那西巴特的抗瘙痒作用 Gideon M Hirschfield,Andreas E Kremer,Cynthia Levy The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p182 8 Vedolizumab treatment outcomes in early versus late Crohn's disease 维多珠单抗治疗早期与晚期克罗恩病的疗效 Nurulamin M Noor,Ailsa L Hart,James C Lee,Miles Parkes The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p182 9 Vedolizumab treatment outcomes in early versus late Crohn's disease 维多珠单抗治疗早期与晚期克罗恩病的疗效 Rirong Chen,Kenneth Croitoru,Sun-Ho Lee The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p183 10 Vedolizumab treatment outcomes in early versus late Crohn's disease – Authors' reply 维多珠单抗治疗早期与晚期克罗恩病的疗效——作者回复 Geert R D'Haens,Lotte Oldenburg,Melanie S Hulshoffon behalf of the LOVE-CD collaborators The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p184 11 Global perspectives on sustainable IBD care 全球视角下的可持续炎症性肠病（IBD）诊疗 Olga M Nardone,Silvio Danese,Beatriz Gros,Tommaso L Parigion behalf of the Sustainable IBD Study Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p185 12 The impact of 2025 US NIDDK funding cuts 2025 年美国国家糖尿病、消化及肾脏疾病研究所（NIDDK）经费削减的影响 Rogelio Perez,Christopher W Chan,Aakash Reddy,David T Zhu The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p186 CORRECTIONS（更正） 13 Correction to Lancet Gastroenterol Hepatol 2026; 11: 34–45 对《柳叶刀 - 胃肠病学和肝病学》2026 年；11卷：34 - 45 页的更正 The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e5 14 Correction to Lancet Gastroenterol Hepatol 2026; 11: 89–91 对《柳叶刀 - 胃肠病学和肝病学》2026 年；11卷：89 - 91 页的更正 The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e5 NEWS（新闻） 15 ASCO Gastrointestinal Cancers Symposium 2026 2026 年美国临床肿瘤学会（ASCO）胃肠道肿瘤研讨会 Rob Brierley The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p188 IN FOCUS（焦点） Book（书籍） 16 Stoma: life saver, not a barrier 造口：救命手段，而非障碍 Lucy Mae Spurgeon The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p189 ARTICLES（论著） 17 Appendicectomy versus switching to a JAK inhibitor in inducing remission in patients with active ulcerative colitis after biologic therapy failure (COSTA): 1-year results of a multicentre, prospective, cohort study 生物制剂治疗失败后，阑尾切除术与换用 JAK 抑制剂诱导活动期溃疡性结肠炎患者缓解的对比（COSTA）：一项多中心、前瞻性、队列研究的 1 年结果 Eva Visser,Maud A Reijntjes,Lianne Heuthorst,Merle E Stellingwerf,Rachel West,Koen van Dongen,Rogier M P H Crolla,Susan van Dieren,Jarmila D W van der Bilt,Willem A Bemelman,Geert R D'Haens,Christianne J Buskensfor the COSTA Study Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p190 18 Cyclic exclusive enteral nutrition versus partial enteral nutrition to maintain long-term drug-free remission in paediatric Crohn's disease (CD-HOPE): an open-label, endpoint-blinded, randomised controlled trial 循环全肠内营养与部分肠内营养维持儿童克罗恩病长期无药物缓解的对比（CD - HOPE）：一项开放标签、终点盲法、随机对照试验 Bénédicte Pigneur,Christine Martinez-Vinson,Aurélie Bourmaud,Alain Dabadie,Rémi Duclaux-Loras,Jean-Pierre Hugot,Céline Roman,Clémentine Dumant,Claire Spyckerelle,Vincent Guinard-Samuel,Stéphanie Willot,Claire Dupont,Anne Breton,Nicolas Caron,Emilie Chaillou,Laurent Rebouissoux,Valérie Bertrand,Valérie Triolo,Justine Pages,Djamal Djeddi,Marjorie Bonneton,Stéphanie Uhlen,Natacha Catteau,Stéphanie Coopman,Patricia Lepage,Jérôme Viala,Frank M Ruemmele The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p204 19 ALG-000184 (pevifoscorvir sodium) monotherapy in participants with chronic HBV infection: a phase 1, multicentre, randomised, dose escalation trial ALG - 000184（佩维福司科韦钠）单药治疗慢性乙型肝炎病毒感染者：一项 1 期、多中心、随机、剂量递增试验 Man-Fung Yuen,Kosh Agarwal,Alina Jucov,Jinlin Hou,Junqi Niu,Yanhua Ding,Alexei Haceatrean,Xie'er Liang,Jia Xu,Min Wu,Kha Le,Tse-I Lin,Lawrence Blatt,Sushmita Chanda,John Fry,Ed Gane The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p218 20 Best buys for metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis: a global Delphi study 代谢功能障碍相关脂肪性肝病和代谢功能障碍相关脂肪性肝炎的最佳干预措施：一项全球德尔菲研究 Jeffrey V Lazarus,Leire Agirre-Garrido,Trenton M White,Anish K Arora,Melina I Manolas,Luis Antonio Diaz,Juan Pablo Arab,Shira Zelber-Sagi,Naim Alkhouri,C Wendy Spearman,Jörn M Schattenberg,Loreta A Kondili,Patrizia Carrieri,Holly F Lofton,Priya Jaisinghani,Sonal Kumar,Ajay Duseja,Mohamed El-Kassas,Hirokazu Takahasi,Debbie L Shawcross,Jonathan G Stine,Marcela Villota-Rivas,Juan Emilio Miralles-Sanchez,Silvana Pannain,Paul N BrennanMASLD/MASH Collaborators The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p232 REVIEW（综述） 21 Definitions, diagnosis, management, and outcomes of upper gastrointestinal Crohn's disease: an international, expert RAND/UCLA appropriateness study 上消化道克罗恩病的定义、诊断、治疗和转归：一项国际专家兰德/加州大学洛杉矶分校适用性研究 Nathaniel A Cohen,Dominik Bettenworth,Neta Sror,Raneem Khedraki,Qijun Yang,Maria T Abreu,Raja Atreya,Badr Al-Bawardy,Susan J Connor,Geert D'Haens,Iris Dotan,Axel Dignass,Sara El Ouali,Brian Feagan,Roger Feakins,Richard Gearry,Ilyssa O Gordon,Charlotte R H Hedin,Cristian Hernandez-Rocha,Taku Kobayashi,Haim Leibovitzh,Cathy Lu,Nitsan Maharshak,Maliha Naseer,Jacob Ollech,David T Rubin,Shaji Sebastian,Britta Siegmund,Mark S Silverberg,Flavio Steinwurz,Joana Torres,Gill Watermeyer,Tina Aswani Omprakash,Lior Frenkel,Paige Gurizzian,Alexa Silfen,Roie Tzadok,Katherine Falloon,Florian Riederon behalf of the Study of Upper Gastrointestinal Manifestations and Management of Crohn's Disease (SUMM-CD) Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p243 22 Mechanisms and pathophysiology leading to development of small intestinal microbial dysbiosis 导致小肠微生物群失调的机制和病理生理学 John A Damianos,Xiao Jing Wang,Michael Camilleri The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p256

临床3期临床2期临床结果

2026-02-13

·北京医学感染与传染研究

柳叶刀胃肠病学与肝病学 11卷 1-3期（2026年2月13日更新）

THE LANCET Gastroenterology & Hepatology. Volume 11Number1 柳叶刀胃肠病学与肝病学 11卷 1期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 Accelerating MASH trials: from biopsy to biomarkers 加速MASH（代谢障碍相关脂肪性肝炎）试验：从活检到生物标志物 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p1 COMMENT（述评） 2 Optimising treatment in Crohn's disease: is the main issue early versus late or biologic naive versus biologic experienced? 优化克罗恩病的治疗：主要问题在于早期治疗与晚期治疗，还是生物制剂初治患者与生物制剂经治患者？ Marte Lie Høivik The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p2 3 Ileal bile acid transporter inhibitors for cholestatic pruritus in primary biliary cholangitis 针对原发性胆汁性胆管炎中胆汁淤积性瘙痒的回肠胆汁酸转运蛋白抑制剂 Ansgar W Lohse,David N Assis The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p3 4 Dual targeting of TNF and IL-23 by a bispecific antibody in ulcerative colitis 双特异性抗体在溃疡性结肠炎中同时靶向TNF和IL-23 Raja Atreya,Markus F Neurath The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p5 5 The essential medicines list for inflammatory bowel disease: time to raise the standards of global care 炎症性肠病基本药物清单：是时候提高全球护理标准了 Nanne K de Boer,Richard B Gearry,Charles N Bernstein,Rupa Banerjee,David T Rubin,Gilaad G Kaplanon behalf of the Globalization Cluster of the International Organization of IBD The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p7 NEWS（新闻） 6 The Liver Meeting 2025 2025年肝脏会议 Rob Brierley The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p10 IN FOCUS（焦点） 7 Food Matters 食物很重要 Dietary management of constipation: time for clinical guidelines to catch up with evidence 便秘的饮食治疗：是时候让临床指南跟上证据的步伐了 Eirini Dimidi,Kevin Whelan The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p11 ARTICLES（论著） 8 Vedolizumab in early and late Crohn's disease (LOVE-CD): a phase 4 open-label cohort study 维多珠单抗在早期和晚期克罗恩病中的应用（LOVE-CD）：一项4期开放性队列研究 Geert R D'Haens,Mark Löwenberg,Filip Baert,Peter Bossuyt,Tamás Molnár,Frank Hoentjen,Esmé Clasquin,Krisztina B Gecse,Melanie S Hulshoff,Gert De Hertogh,Matthias Lenfant,Lotte Oldenburg,Séverine Vermeire The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p12 9 Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): 利尼西巴特治疗原发性胆汁性胆管炎和胆汁淤积性瘙痒患者（GLISTEN）：一项随机、多中心、双盲、安慰剂对照的3期试验 a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial Gideon M Hirschfield,Christopher L Bowlus,David E J Jones,Andreas E Kremer,Marlyn J Mayo,Atsushi Tanaka,Pietro Andreone,Jidong Jia,Qinglong Jin,Ricardo U Macías-Rodríguez,Alexander R Cobitz,Brooke M Currie,Ciara Gorey,Ivana Lazic,Danielle Podmore,Andrea Ribeiro,Jennifer B Shannon,Brandon Swift,Megan M McLaughlin,Cynthia Levyfor the GLISTEN Study Group The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p22 10 Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial SOR102（一种口服双特异性肿瘤坏死因子和白细胞介素-23抑制剂）在健康受试者和溃疡性结肠炎患者中的安全性和药代动力学：一项首次人体、双盲、随机、安慰剂对照的1期试验 Vipul Jairath,Silvio Danese,Geert R D’Haens,Brian G Feagan,Laurent Peyrin-Biroulet,Bruce E Sands,Ingrid Gaemers,Matt Westfall,Allyson Q Terry,Kevin J Roberts,Sara Barbat,Pamela Wedel,Jacqueline M Benson,Carlos Sattler The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p34 11 Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial 西洛芬酸在非肝硬化原发性硬化性胆管炎中的应用（PRIMIS）：一项随机、双盲、多中心、安慰剂对照的3期试验 Michael Trauner,Cynthia Levy,Atsushi Tanaka,Zachary Goodman,Douglas Thorburn,Deepak Joshi,Kimmo Salminen,Kidist Yimam,Hiroyuki Isayama,Aldo J Montano-Loza,Stephen Caldwell,Mark Danta,Martti Farkkila,Juan F Gallegos-Orozco,Stuart C Gordon,Holger Hinrichsen,Pietro Invernizzi,Raj Vuppalanchi,Kaiyi Zhu,Jun Xu,Xiangyu Liu,Xiaomin Lu,Gerald Crans,Shahla Bolbolan,Lisa Boyette,Muhsen Alani,William T Barchuk,Timothy R Watkins,Mark C Genovese,Christopher L Bowlus The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p46 REVIEW（综述） 12 Age-related changes of the gastrointestinal tract 胃肠道的年龄相关变化 Alberto Pilotto,Carlo Custodero,Lucilla Crudele,Wanda Morganti,Nicola Veronese,Marilisa Franceschi The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p59 13 Fatigue in people with primary biliary cholangitis: a position paper from the European Reference Network for Rare Liver Diseases 原发性胆汁性胆管炎患者的疲劳问题：欧洲罕见肝病参考网络立场文件 Ozgur M Koc,Anne-Kristin Toussaint,Aurelie Untas,Piotr Milkiewicz,Henriette Ytting,Laura Buck,David E Jones,Gideon Hirschfield,Angela Leburgue,Christoph Schramm,Frederik Nevens,Adriaan J van der Meer,Alessio Gerussi,Jef Verbeek The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p71 THE LANCET Gastroenterology & Hepatology. Volume 11Number2 柳叶刀胃肠病学与肝病学 11卷 2期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 ACIP's HBV birth-dose vaccine recommendations: a fiasco 美国免疫接种咨询委员会（ACIP）的乙肝疫苗出生剂量推荐：一场闹剧 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p87 COMMENT（述评） 2 Expanding the therapeutic arsenal for paediatric ulcerative colitis 扩充儿童溃疡性结肠炎的治疗武器库 Stephanie A Vuijk,Esmée H Boute,Lissy de Ridder The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p88 3 Closing the Middle East and north Africa representation gap in clinical trials in inflammatory bowel disease 缩小炎症性肠病临床试验中中东和北非地区代表不足的差距 Mohammad Shebab,Ahmed Al-Hindawi,Shane W Goodwin,Yuhong Yuan,Talat Bessissow,Laurent Peyrin-Biroulet,Vipul Jairath The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p89 4 Colorectal cancer screening in LGBTQIA+ people: an urgent call for equity 对LGBTQIA+人群进行结直肠癌筛查：迫切呼吁公平 Vidhi Singh,Jayraan Badiee,Alexander Goldowsky,David Russo,Folasade P May The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p91 CORRESPONDENCE（读者来信） 5 Efficacy differentiation of sterile faecal filtrates in Clostridioides difficile infection 无菌粪便滤液在艰难梭菌感染中的疗效差异 Stefan Schreiber,Philip Rosenstiel,Stephan J Ott,Georg H Waetzig The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p94 6 Efficacy differentiation of sterile faecal filtrates in Clostridioides difficile infection – Authors’ reply 无菌粪便滤液在艰难梭菌感染中的疗效差异——作者回复 Dina Kao,Huiping Xu,Thomas Louie The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p94 7 Endoscopic palliation of malignant gastric outlet obstruction: harmonising outcomes 恶性胃出口梗阻的内镜下姑息治疗：统一疗效标准 Zachary L Smith The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p95 8 Clinical remission in ulcerative colitis: restoring precision in trial terminology 溃疡性结肠炎的临床缓解：恢复试验术语的精确性 Sailish Honap,Vipul Jairath,Fernando Magro,Silvio Danese,Laurent Peyrin-Biroulet The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p96 CORRECTIONS（更正） 9 Correction to Lancet Gastroenterol Hepatol 2019; 4: 364–75 对《柳叶刀-胃肠病学与肝病学》2019年；4卷：364-75页的更正 The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：e1 10 Correction to Lancet Gastroenterol Hepatol 2025; 10: 431–41 对《柳叶刀-胃肠病学与肝病学》2025年；10卷：431-41页的更正 The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：e1 NEWS（新闻） 11 Research in Brief 研究简讯 Holly Baker The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p98 IN FOCUS（焦点） 12 Patient Perspectives 患者视角 The label of a diagnosis 诊断标签 Cheryl Reeves The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p99 ARTICLES（论著） 13 Efficacy and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis (SHINE-1): a multicentre, open-label, non-randomised phase 2 trial Mirikizumab治疗中重度活动性溃疡性结肠炎儿童患者的疗效和安全性（SHINE-1）：一项多中心、开放标签、非随机2期试验 Jess L Kaplan,Athos Bousvaros,Dan Turner,Marla Dubinsky,Amy Larkin,Jordan Johns,Yuki Otani,Wallace Crandall,Wendy J Komocsar,Jeffrey S Hyams The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p100 14 Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials Glecirasib联合或不联合西妥昔单抗治疗既往接受过治疗的KRASG12C突变局部晚期或转移性结直肠癌（JAB-21822-1002和JAB-21822-1007）：两项开放标签、非随机1/2期试验 Jian Li,Zhenghang Wang,Jing Huang,Yi Ba,Baoshan Cao,Suxia Luo,Wenhua Li,Chunmei Bai,Zhengbo Song,Jianping Xiong,Liangjun Zhu,Guangyu An,Yanqiao Zhang,Zhihua Li,Yongsheng Li,Yanhong Gu,Changlu Hu,Xingya Li,Chenghui Huang,Qihan Fu,Xianli Yin,Xinjun Liang,Diansheng Zhong,Huaqiu Shi,Xiaoyan Li,Zhen Li,Lian Liu,Feng Wang,Rong Liang,Guohao Xia,Zhen Wang,Andrea Wang-Gillam,Yuli Ding,Zhiyue Rao,Wenhui Pan,Shuang Lu,Xin Sun,Lin Shen The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p110 15 Adjuvant camrelizumab combined with capecitabine in patients with intrahepatic cholangiocarcinoma after surgical resection in China (ACC): a single-arm, single-centre, open-label, phase 2 trial 卡瑞利珠单抗联合卡培他滨辅助治疗中国肝内胆管癌术后患者（ACC）：一项单臂、单中心、开放标签、2期试验 Zheng Wang,Lixing Li,Peiran Huang,Honghu Tu,Xiangyu Zhang,Lei Yu,Fei Liang,Cheng Huang,Shuangjian Qiu,Qinghai Ye,Zhenbin Ding,Xiaowu Huang,Yinghong Shi,Kang Song,Huichuan Sun,Xiaoying Wang,Yongfeng Xu,Yao Yu,Qiang Gao,Lan Zhang,Jia Fan,Jian Zhou The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p124 16 Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial Tinengotinib治疗晚期或转移性胆管癌成人患者：一项多中心、开放标签、2期试验 Milind Javle,Christos Fountzilas,Chih-Yi Liao,Meredith Pelster,Daneng Li,Dustin Deming,Vaibhav Sahai,Lionel Kankeu Fonkoua,Allen Cohn,Parvez Mantry,Donald Richards,Edwin Kingsley,Frank Wu,Peng Peng,Katie Hennessy,Hui Wang,Caixia Sun,Shumao Ni,Jean Fan,Amit Mahipal The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p137 REVIEW（综述） 17 Current and emerging therapeutic landscape for metabolic dysfunction-associated steatohepatitis 代谢功能障碍相关脂肪性肝炎当前及新兴治疗格局 Wenhao Li,William Alazawi,Rohit Loomba The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p150 VIEWPOINT（观点） 18 Ulcerative colitis: moving beyond the mucosal dogma 溃疡性结肠炎：超越黏膜教条 Elisabeth Eggermont,Krisztina Gecse,Noa Krugliak Cleveland,Frauke Petersen,João Sabino,AndréD'Hoore,Torsten Kucharzik,Mariangela Allocca,Gabriele Bislenghi,Kerri Novak,Gert De Hertogh,Christian Maaser,Bram Verstockt The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p163 THE LANCET Gastroenterology & Hepatology. Volume 11Number3 柳叶刀胃肠病学与肝病学 11卷 3期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 Alcohol guidance in US dietary guidelines: a step backwards 美国膳食指南中的酒精建议：倒退的一步 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p175 2 Thanks to our peer reviewers and contributors 感谢我们的同行评审专家和投稿者 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p175 COMMENT（述评） 3 Appendicectomy: a disease-modifying treatment for ulcerative colitis? 阑尾切除术：溃疡性结肠炎的一种疾病修饰疗法？ Alexandra Damasio Todescatto,Paulo Gustavo Kotze The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p176 4 Cyclic exclusive enteral nutrition: a novel approach to maintaining remission in paediatric Crohn's disease 循环全肠内营养：维持儿童克罗恩病缓解的新方法 Anissa M Armet,Eytan Wine The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p177 5 Viral hepatitis in Roma communities: vulnerabilities and improving care access 罗姆人社区中的病毒性肝炎：易感性及改善医疗可及性 Pavol Kristian,Ivana Hockickova,Monika Halanova,Sylvia Drazilova,Ondrej Zahornacky,Peter Jarcuska The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p179 6 Thank you to The Lancet Gastroenterology & Hepatology's statistical and peer reviewers in 2025 感谢《柳叶刀 - 胃肠病学和肝病学》2025 年的统计学和同行评审专家 The Lancet Gastroenterology & Hepatology's Editors The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e2 CORRESPONDENCE（读者来信） 7 Antipruritic effects of the ileal bile acid transporter inhibitor linerixibat 回肠胆汁酸转运体抑制剂利那西巴特的抗瘙痒作用 Gideon M Hirschfield,Andreas E Kremer,Cynthia Levy The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p182 8 Vedolizumab treatment outcomes in early versus late Crohn's disease 维多珠单抗治疗早期与晚期克罗恩病的疗效 Nurulamin M Noor,Ailsa L Hart,James C Lee,Miles Parkes The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p182 9 Vedolizumab treatment outcomes in early versus late Crohn's disease 维多珠单抗治疗早期与晚期克罗恩病的疗效 Rirong Chen,Kenneth Croitoru,Sun-Ho Lee The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p183 10 Vedolizumab treatment outcomes in early versus late Crohn's disease – Authors' reply 维多珠单抗治疗早期与晚期克罗恩病的疗效——作者回复 Geert R D'Haens,Lotte Oldenburg,Melanie S Hulshoffon behalf of the LOVE-CD collaborators The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p184 11 Global perspectives on sustainable IBD care 全球视角下的可持续炎症性肠病（IBD）诊疗 Olga M Nardone,Silvio Danese,Beatriz Gros,Tommaso L Parigion behalf of the Sustainable IBD Study Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p185 12 The impact of 2025 US NIDDK funding cuts 2025 年美国国家糖尿病、消化及肾脏疾病研究所（NIDDK）经费削减的影响 Rogelio Perez,Christopher W Chan,Aakash Reddy,David T Zhu The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p186 CORRECTIONS（更正） 13 Correction to Lancet Gastroenterol Hepatol 2026; 11: 34–45 对《柳叶刀 - 胃肠病学和肝病学》2026 年；11卷：34 - 45 页的更正 The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e5 14 Correction to Lancet Gastroenterol Hepatol 2026; 11: 89–91 对《柳叶刀 - 胃肠病学和肝病学》2026 年；11卷：89 - 91 页的更正 The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e5 NEWS（新闻） 15 ASCO Gastrointestinal Cancers Symposium 2026 2026 年美国临床肿瘤学会（ASCO）胃肠道肿瘤研讨会 Rob Brierley The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p188 IN FOCUS（焦点） Book（书籍） 16 Stoma: life saver, not a barrier 造口：救命手段，而非障碍 Lucy Mae Spurgeon The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p189 ARTICLES（论著） 17 Appendicectomy versus switching to a JAK inhibitor in inducing remission in patients with active ulcerative colitis after biologic therapy failure (COSTA): 1-year results of a multicentre, prospective, cohort study 生物制剂治疗失败后，阑尾切除术与换用 JAK 抑制剂诱导活动期溃疡性结肠炎患者缓解的对比（COSTA）：一项多中心、前瞻性、队列研究的 1 年结果 Eva Visser,Maud A Reijntjes,Lianne Heuthorst,Merle E Stellingwerf,Rachel West,Koen van Dongen,Rogier M P H Crolla,Susan van Dieren,Jarmila D W van der Bilt,Willem A Bemelman,Geert R D'Haens,Christianne J Buskensfor the COSTA Study Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p190 18 Cyclic exclusive enteral nutrition versus partial enteral nutrition to maintain long-term drug-free remission in paediatric Crohn's disease (CD-HOPE): an open-label, endpoint-blinded, randomised controlled trial 循环全肠内营养与部分肠内营养维持儿童克罗恩病长期无药物缓解的对比（CD - HOPE）：一项开放标签、终点盲法、随机对照试验 Bénédicte Pigneur,Christine Martinez-Vinson,Aurélie Bourmaud,Alain Dabadie,Rémi Duclaux-Loras,Jean-Pierre Hugot,Céline Roman,Clémentine Dumant,Claire Spyckerelle,Vincent Guinard-Samuel,Stéphanie Willot,Claire Dupont,Anne Breton,Nicolas Caron,Emilie Chaillou,Laurent Rebouissoux,Valérie Bertrand,Valérie Triolo,Justine Pages,Djamal Djeddi,Marjorie Bonneton,Stéphanie Uhlen,Natacha Catteau,Stéphanie Coopman,Patricia Lepage,Jérôme Viala,Frank M Ruemmele The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p204 19 ALG-000184 (pevifoscorvir sodium) monotherapy in participants with chronic HBV infection: a phase 1, multicentre, randomised, dose escalation trial ALG - 000184（佩维福司科韦钠）单药治疗慢性乙型肝炎病毒感染者：一项 1 期、多中心、随机、剂量递增试验 Man-Fung Yuen,Kosh Agarwal,Alina Jucov,Jinlin Hou,Junqi Niu,Yanhua Ding,Alexei Haceatrean,Xie'er Liang,Jia Xu,Min Wu,Kha Le,Tse-I Lin,Lawrence Blatt,Sushmita Chanda,John Fry,Ed Gane The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p218 20 Best buys for metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis: a global Delphi study 代谢功能障碍相关脂肪性肝病和代谢功能障碍相关脂肪性肝炎的最佳干预措施：一项全球德尔菲研究 Jeffrey V Lazarus,Leire Agirre-Garrido,Trenton M White,Anish K Arora,Melina I Manolas,Luis Antonio Diaz,Juan Pablo Arab,Shira Zelber-Sagi,Naim Alkhouri,C Wendy Spearman,Jörn M Schattenberg,Loreta A Kondili,Patrizia Carrieri,Holly F Lofton,Priya Jaisinghani,Sonal Kumar,Ajay Duseja,Mohamed El-Kassas,Hirokazu Takahasi,Debbie L Shawcross,Jonathan G Stine,Marcela Villota-Rivas,Juan Emilio Miralles-Sanchez,Silvana Pannain,Paul N BrennanMASLD/MASH Collaborators The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p232 REVIEW（综述） 21 Definitions, diagnosis, management, and outcomes of upper gastrointestinal Crohn's disease: an international, expert RAND/UCLA appropriateness study 上消化道克罗恩病的定义、诊断、治疗和转归：一项国际专家兰德/加州大学洛杉矶分校适用性研究 Nathaniel A Cohen,Dominik Bettenworth,Neta Sror,Raneem Khedraki,Qijun Yang,Maria T Abreu,Raja Atreya,Badr Al-Bawardy,Susan J Connor,Geert D'Haens,Iris Dotan,Axel Dignass,Sara El Ouali,Brian Feagan,Roger Feakins,Richard Gearry,Ilyssa O Gordon,Charlotte R H Hedin,Cristian Hernandez-Rocha,Taku Kobayashi,Haim Leibovitzh,Cathy Lu,Nitsan Maharshak,Maliha Naseer,Jacob Ollech,David T Rubin,Shaji Sebastian,Britta Siegmund,Mark S Silverberg,Flavio Steinwurz,Joana Torres,Gill Watermeyer,Tina Aswani Omprakash,Lior Frenkel,Paige Gurizzian,Alexa Silfen,Roie Tzadok,Katherine Falloon,Florian Riederon behalf of the Study of Upper Gastrointestinal Manifestations and Management of Crohn's Disease (SUMM-CD) Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p243 22 Mechanisms and pathophysiology leading to development of small intestinal microbial dysbiosis 导致小肠微生物群失调的机制和病理生理学 John A Damianos,Xiao Jing Wang,Michael Camilleri The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p256

2026-02-06

·药研网

TNF-α：攻克自身免疫疾病的新钥匙

自身免疫疾病作为全球第二大慢性病领域，患者群体庞大且治疗需求迫切，推动靶向药物市场高速增长。TNF-a抑制剂作为首个靶向生物制剂，凭借明确的抗炎机制和广泛适应症，成为自免治疗领域的核心赛道。近期，Sorriso Pharmaceuticals 推出的一项进展再次引发关注：其口服双抗SOR102靶向TNF-α和IL-23p19，用于溃疡性结肠炎，I期临床显示良好安全性和初步疗效（56%患者达临床应答），计划II期。新兴管线的推进，使业内对 TNF-α 这一成熟靶点的价值重新聚焦。 01 TNF靶点概述肿瘤坏死因子（Tumor Necrosis Factor，TNF）是一种炎性细胞因子，可以协同调节其它细胞因子的产生、细胞存活和死亡来协调组织的稳态。 TNF分为两种类型，分别是TNF-α和TNF-β。虽然TNF-α与TNF-β仅有约30%的同源性，但它们却拥有共同的受体。TNF-α的生物学活性占TNF总活性的70%～95%，因此目前常说的TNF多指TNF-α。 TNF-α（Tumor Necrosis Factor α）是一种由157个氨基酸组成的同型三聚体蛋白，主要由由活化的巨噬细胞和其他类型的细胞如CD4+ T细胞、中性粒细胞、肥大细胞等释放产生，能够诱导炎症反应和细胞凋亡，它在免疫应答、炎症反应和细胞凋亡等多个生理过程中发挥重要作用。图1. TNF-α的结构示意图 02 经典 TNF 通路 TNF 的生物功能依赖与其受体结合后激活下游信号通路。TNF 的主要受体包括 TNFR1（TNF Receptor 1）和 TNFR2（TNF Receptor 2），二者在结构、表达分布以及调控功能上存在显著差异。图2. TNF-α的受体信号传导其中，TNFR1主要介导促炎症的作用。当细胞受到炎性刺激或压力时，TNFR1表达会增加，与其结合的TNF-α会激活一系列信号传导通路，引发细胞凋亡、炎症反应等生物学过程。基于此机制，通过结合TNFR1及配体TNF而阻断TNF-TNFR1信号通路已成为炎症性疾病治疗的重要策略。相比之下，TNFR2 主要在免疫调节和组织修复中发挥作用。它高度表达于免疫细胞如调节性 T 细胞（Tregs）和内皮细胞表面，与 TNF-α 结合后倾向激活 PI3K/Akt 通路，促进细胞存活、增殖、免疫耐受及组织修复。在慢性炎症状态下，TNFR2 的促炎作用也会显著增强，显示其功能具有条件依赖性。 03 TNF-α重磅上市药物盘点自 1998 年首个抗 TNF-α 单抗英夫利昔单抗获批上市以来，该靶点已催生多款「超级重磅药物」。阿达木单抗作为全球销售规模最大的TNF-α抑制剂生物药品，其在多种疾病治疗中表现出色，如类风湿关节炎、强直性脊柱炎、银屑病等。在此基础上，TNF-α抑制剂的研发围绕多方向推进，如：长效化与给药便捷化，全人源单抗戈利木单抗具有较长的半衰期，仅需每月一次皮下注射，显著提升了患者用药依从性；适应症拓展方面，逐步覆盖幼年特发性关节炎、葡萄膜炎等罕见病领域，为 TNF-α 抑制剂开辟更广泛的应用空间。为满足靶向TNF/TNFR药物研发需求，吉满生物提供稳定过表达细胞系、报告基因细胞系及抗体、蛋白产品，全方位助力项目推进。欢迎垂询吉满生物客服，联系电话与微信：18916119826！ 04 靶向TNF/TNFR的药物研发进展目前，市场上已经有多种TNF/TNFR在研药物，药物类型涵盖单抗、双抗、ADC融合蛋白等，主要针对类风湿关节炎（RA）、强银屑病等多种自免类疾病。 Sorriso Pharmaceuticals 在口服抗体领域同时布局了两款靶向 TNF-α 的创新产品，分别为单抗 SOR-101 与双抗 SOR102，涵盖不同机制与适应症。 SOR-101 是由 Sorriso Pharmaceuticals 研发的一款口服抗 TNF-α 单抗（抗体片段/Vorabody）药物，目前处于临床 II 期开发阶段，主要开发用于结肠炎等炎症性肠病。该分子设计为经口给药后能到达肠道炎症部位并有效与 TNF-α 结合，从而局部抑制炎症反应。与传统注射/输注型抗 TNF 药物不同，SOR-101 旨在实现肠道局部靶向抑制 TNF-α，有望提高安全性和患者依从性。 SOR102通过工程化改造和特殊的制剂设计，实现了在肠道的特异性释放，成为首个进入临床的口服双特异性抗体药物。近期，该药的临床结果首次发表于《柳叶刀》，显示出良好疗效。在第三部分研究中，第 42 天时，SOR102 每日一次、每日两次给药组的Mayo 评分临床应答率分别为 43%（3/7）和 56%（5/9）；改良 Mayo 应答率为 29%（2/7）和 67%（6/9）；症状缓解率为 43%（3/7）和 56%（5/9）。相比之下，安慰剂组分别仅为 17%（1/6）、33%（2/6）和 0%。此外，每日两次组中有 2 名患者（2/9）实现临床缓解并伴内镜改善。初步的临床证明了该口服双抗不仅展现了初步的疗效，也具有良好的安全性。Sorriso Pharmaceuticals表示，今年晚些时候将会启动Ⅱ期临床，期待后续的疗效。除 Sorriso 外，TNF-α/TNFR 通路的研发在全球也呈多技术路线并行推进。和铂医药、Novartis 等布局了用于干眼症的融合蛋白与 scFv（III/II 期）；Sanofi 推进 TNFR1 小分子于 RA、银屑病等领域（II 期）；Alvotech 亦在开展 TNFR1 单抗的 I 期研究。总结在更精准、更便捷治疗策略的推动下，TNF-α/TNFR 通路的创新潜力正不断释放，逐渐成为重塑自免治疗格局的关键枢纽。吉满生物吉满生物可提供 TNF-α/TNFR 细胞系、抗体和蛋白系列产品，为研究相关疾病的药物筛选和机制研究提供了重要支持。 1 靶点相关细胞系：适用于药物功能筛选、活性评价、药效学研究及信号通路验证 2 高活性重组蛋白：满足结合分析、筛选及免疫研究需求 3 高特异性抗体：提供经严格验证的抗体产品，支持流式细胞术、免疫组化、Western Blot、ELISA 等多种检测应用，确保实验结果准确可靠产品列表及数据展示 1 数据展示1 GM-C25776 H_TNFR2 Reporter V2 Cell Line（GM-C25776）是一株敲除了H_TNFR1的Luciferase报告基因细胞系。当mTNF-α或者TNFR2激动剂与TNFR2结合时，导致下游通路激活；加入拮抗剂后，阻断下游信号通路，进而导致荧光素酶（Luciferase）的表达变化。 Luciferase读值即代表信号通路的激活效果，可用于TNFR2激动剂或者拮抗剂的体外效果评价。 TNFR2在V2细胞中表达 TNFR1在V2细胞中不表达 GM-C25776拮抗剂相关验证该细胞能有效验证拮抗剂的抑制效果 GM-C25776激动剂验证该细胞能有效验证激动剂的激活效果，且具有高传代稳定性。 2 数据展示2 GM-C27615 H_TNFR2 Null Reporter Cell Line细胞，是基于 TNF 信号通路构建的一种 Luciferase 报告基因细胞系。其只表达TNFR1受体，不表达TNFR2受体。因此可用于TNFR1靶向药物的研发。 TNFR2在Null细胞中不表达 TNFR1在Null细胞中表达 GM-C27615拮抗剂相关验证该细胞能有效验证拮抗剂的抑制效果 GM-C27615蛋白验证该细胞能有效评价相关激动剂或者融合蛋白药物的药效，同时具备高传代稳定性 3 数据展示3 GM-C33297 Membrane Bound H_TNFα(cleavage-resistant) CHO-K1 Cell Line 该细胞已经过功能验证，表达稳定可靠，可有效帮助用户进行药物筛选和活性评价，助力抗体药物研发与临床申报。联系我们吉满生物(Genomeditech)成立于2011年，是专业从事生物科技服务和前沿技术研发的高新技术企业。吉满生物专注为生物药开发赋能，自主创立了国内知名的细胞系品牌-DDXCELL，目前已布局近400个热门靶向药靶点，超1500株现货单克隆细胞系，涵盖GPCR、细胞因子、免疫检查点、TAA等多领域，做到进口细胞的国产替代。此外，吉满生物还可在药物研发进程中提供一系列抗体、蛋白产品，旨在为客户提供高效的研发工具和解决方案! 扫码咨询扫码找现货参考资料 1.https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.42415 2.https://doi.org/10.1016/S2468-1253(25)00296-1 3.https://sorrisopharma.com/science/sor101-oral-anti-tnfa-vorabody/ 4.https://mp.weixin.qq.com/s/C2G-pnwwL3r8D58bSVtP2g

临床1期免疫疗法引进/卖出临床结果

100 项与 SOR-102 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
溃疡性结肠炎	临床2期	-	Sorriso Pharmaceuticals, Inc.	-
克罗恩病	临床2期	-	Sorriso Pharmaceuticals, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06080048 (Pubmed \| Lancet Gastroenterol Hepatol 1 \| Lancet Gastroenterol Hepatol 2) 人工标引	临床1期	溃疡性结肠炎	64	SOR102 135 mg to 3645 mg, single dose (Part 1)	憲糧糧襯觸憲鹽艱鹽顧(憲窪鹽襯觸選積顧觸夢) = 廠蓋選糧網積願夢選壓膚簾齋觸壓鑰遞鏇淵憲 (鹹艱餘憲壓蓋獵鹽範衊 ) 更多	积极	2026-01-01
				Placebo (Part 1)	憲糧糧襯觸憲鹽艱鹽顧(憲窪鹽襯觸選積顧觸夢) = 齋鬱艱積艱齋鏇憲鬱鑰膚簾齋觸壓鑰遞鏇淵憲 (鹹艱餘憲壓蓋獵鹽範衊 ) 更多
NCT06080048 (SOR102-101, NEWS) 人工标引	临床1期	溃疡性结肠炎	22	High-dose SOR102SOR102 (ITT)	選簾廠遞夢襯觸鏇簾憲(艱襯範範選鏇壓積網網) = 衊憲築積構鏇鑰願範觸鏇淵顧範築顧鏇餘醖製 (衊艱廠遞繭憲壓齋範衊 ) 更多	积极	2025-02-27
				Placebo (ITT)	選簾廠遞夢襯觸鏇簾憲(艱襯範範選鏇壓積網網) = 遞簾鹹觸鏇衊顧鬱簾顧鏇淵顧範築顧鏇餘醖製 (衊艱廠遞繭憲壓齋範衊 ) 更多