An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet in Patients With Advanced Hepatocellular Carcinoma.

An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).

开始日期2025-07-25

申办/合作机构

中山康方生物医药有限公司

[+1]

NCT06457919

/ Recruiting临床1/2期IIT

A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT-00420) in Combination With Androgen Receptor Signaling Inhibitors (ARSIs) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).

开始日期2024-06-04

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+1]

100 项与替恩戈替尼相关的临床结果

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100 项与替恩戈替尼相关的转化医学

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100 项与替恩戈替尼相关的专利（医药）

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项与替恩戈替尼相关的文献（医药）

2026-02-01·Lancet Gastroenterology & Hepatology

Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial

Article

作者: Sahai, Vaibhav ; Richards, Donald ; Peng, Peng ; Cohn, Allen ; Javle, Milind ; Ni, Shumao ; Sun, Caixia ; Fountzilas, Christos ; Fonkoua, Lionel Kankeu ; Pelster, Meredith ; Wang, Hui ; Li, Daneng ; Kingsley, Edwin ; Fan, Jean ; Liao, Chih-Yi ; Mahipal, Amit ; Deming, Dustin ; Hennessy, Katie ; Wu, Frank ; Mantry, Parvez

BACKGROUND:

Cholangiocarcinoma is a rare, aggressive cancer often driven by FGFR2 fusions, which are targetable with inhibitors such as pemigatinib and futibatinib. However, resistance frequently develops due to acquired FGFR2 mutations. In this study, we aimed to evaluate the efficacy and safety of tinengotinib in previously treated patients with advanced cholangiocarcinoma.

METHODS:

This open-label, multicentre, phase 2 trial was done at 32 medical centres in the USA. Eligible patients were aged 18 years or older with advanced or metastatic cholangiocarcinoma, who had previous systemic chemotherapy, and an Eastern Cooperative Oncology Group score of 0-1. Patients were assigned to one of four cohorts on the basis of FGFR status: cohort A1, FGFR2 fusions with primary FGFR inhibitor resistance; cohort A2, FGFR2 fusions with acquired FGFR inhibitor resistance; cohort B, other FGFR alterations; or cohort C, FGFR wild-type. Patints orally self-administered tinengotinib 10 mg daily in 28-day cycles in 28-day treatment cycles until documented disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was objective response rate as per investigator assessment, defined as the proportion of patients with confirmed tumour response (complete response or partial response) that was redocumented 4 weeks or after initial assessment based on RECIST (version 1.1), as assessed by the investigator. The primary endpoint was assessed in the in the efficacy evaluable population, which included all patients who received at least one dose of tinengotinib, had measurable disease at baseline, and had at least one post-baseline tumour assessment. Safety assessed in all patients who received at least one dose of tinengotinib. This trial is registered with ClinicalTrials.gov, NCT04919642, and enrolment is complete.

FINDINGS:

Between Nov 19, 2021, and March 5, 2024, 55 patients were enrolled and assigned to one of four cohorts (cohort A1 [n=18], cohort A2 [n=11], cohort B [n=13], and cohort C [n=13]); all received tinengotinib. Patients had a median age of 61 years (IQR 56-68); 31 (56%) patients were female. All patients had received at least one previous systemic therapy. Median follow-up was 11·3 months (IQR 6·5-17·3). Among 51 patients included in the efficacy evaluable set, the objective response rate was 6·3% (95% CI 0·2-30·2; one confirmed partial response) in cohort A1, 30·0% (6·7-65·3; three confirmed partial responses) in cohort A2, 23·1% (5·0-53·8; three confirmed partial responses) in cohort B, and 0% in cohort C. Grade 3 treatment-related adverse events included hypertension in 17 (31%) of 55 patients, palmar-plantar erythrodysesthesia syndrome in seven (13%) patients, and stomatitis in six (11%) patients. Grade 4 treatment-related adverse events occurred in two (4%) of 55 patients (increased lipase [n=1] and posterior reversible encephalopathy syndrome [n=1]); no grade 5 treatment-related adverse events were reported.

INTERPRETATION:

These findings suggest that tinengotinib might have activity in patients with cholangiocarcinoma with FGFR2 fusions that progressed following FGFR inhibitor therapy. Anti-tumour activity was also observed in patients with other FGFR alterations. The data from this phase 2 study supported the initiation of a phase 3 registration trial.

FUNDING:

TransThera Sciences.

2025-04-01·CANCER SCIENCE

Multiple Kinase Small Molecule Inhibitor Tinengotinib (TT‐00420) Alone or With Chemotherapy Inhibit the Growth of SCLC

Article

作者: Qiang, Xiaoyan ; Tang, Chenchen ; Zhao, Peiyan ; Li, Hui ; Cheng, Ying ; Li, Rixin ; Lan, Shaowei ; Peng, Peng ; Lu, Yuanhua ; Wu, Chunjiao ; Zhong, Rui ; Liu, Ying ; Wu, Frank ; Liu, Yan

ABSTRACT:

There is an urgent need to develop new targeted treatment agents for small cell lung cancer (SCLC). Tinengotinib (TT‐00420) is a novel, multi‐targeted, and spectrally selective small‐molecule kinase inhibitor that has shown significant inhibitory effects on certain solid tumors in preclinical studies. However, its role and mechanism of action in SCLC remain unclear. In this study, we demonstrated that tinengotinib effectively inhibited SCLC cell proliferation, especially highly expressing NeuroD1 (SCLC‐N), in the SCLC cell line‐derived xenograft (CDX) model and the malignant pleural effusion cell model of patients with SCLC. When combined with etoposide/cisplatin, it synergistically inhibited SCLC growth. Tinengotinib regulates proliferation, apoptosis, migration, cell cycle and angiogenesis in SCLC cells. Mechanistic studies revealed that c‐Myc expression may be a key factor influencing the effect of tinengotinib in SCLC‐N. This study provides reliable preclinical data and a new direction for tinengotinib as a promising therapy for SCLC, either alone or in combination with chemotherapy.

2025-04-01·ANNALS OF ONCOLOGY

A model for decoding resistance in precision oncology: acquired resistance to FGFR inhibitors in cholangiocarcinoma

Article

作者: Qiang, X ; Borad, M ; Kambadakone, A R ; Shroff, R T ; Danysh, B P ; Flaherty, K T ; Leshchiner, I ; Martin, E E ; DiToro, D ; Lennerz, J K ; Saha, S K ; Lin, B ; Javle, M ; Chen, C T ; Iyer, R ; Sun, C ; Friboulet, L ; Harris, T ; Wang, H ; Li, L ; Reyes, S ; Cleary, J M ; Stone, J R ; Fan, J ; Gordan, J D ; Karasic, T ; Bensen, D C ; Iyer, S ; Kelley, R K ; Hoffman, I D ; Berchuck, J E ; Sootome, H ; Maurer, J ; Damjanov, N ; Baiev, I ; Goyal, L ; Peng, P ; Uboha, N V ; Wehrenberg-Klee, E ; Mody, K ; Parida, L ; Getz, G ; Walmsley, C ; Hollebecque, A ; Juric, D ; Nelson, K J ; Harris, W ; Majeed, U ; Zhang, K ; Zhu, A X ; Facchinetti, F ; Wu, F ; Vasseur, D ; Hirai, H ; Pinto, C

BACKGROUND:

Fibroblast growth factor receptor (FGFR) inhibitors have significantly improved outcomes for patients with FGFR-altered cholangiocarcinoma, leading to their regulatory approval in multiple countries. As with many targeted therapies, however, acquired resistance limits their efficacy. A comprehensive, multimodal approach is crucial to characterizing resistance patterns to FGFR inhibitors.

PATIENTS AND METHODS:

This study integrated data from six investigative strategies: cell-free DNA, tissue biopsy, rapid autopsy, statistical genomics, in vitro and in vivo studies, and pharmacology. We characterized the diversity, clonality, frequency, and mechanisms of acquired resistance to FGFR inhibitors in patients with FGFR-altered cholangiocarcinoma. Clinical samples were analyzed longitudinally as part of routine care across 10 institutions.

RESULTS:

Among 138 patients evaluated, 77 met eligibility, yielding a total of 486 clinical samples. Patients with clinical benefit exhibited a significantly higher rate of FGFR2 kinase domain mutations compared with those without clinical benefit (65% versus 10%, P < 0.0001). We identified 26 distinct FGFR2 kinase domain mutations, with 63% of patients harboring multiple. While IC50 assessments indicated strong potency of pan-FGFR inhibitors against common resistance mutations, pharmacokinetic studies revealed that low clinically achievable drug concentrations may underly polyclonal resistance. Molecular brake and gatekeeper mutations predominated, with 94% of patients with FGFR2 mutations exhibiting one or both, whereas mutations at the cysteine residue targeted by covalent inhibitors were rare. Statistical genomics and functional studies demonstrated that mutation frequencies were driven by their combined effects on drug binding and kinase activity rather than intrinsic mutational processes.

CONCLUSION:

Our multimodal analysis led to a model characterizing the biology of acquired resistance, informing the rational design of next-generation FGFR inhibitors. FGFR inhibitors should be small, high-affinity, and selective for specific FGFR family members. Tinengotinib, a novel small molecule inhibitor with these characteristics, exhibited preclinical and clinical activity against key resistance mutations. This integrated approach offers a blueprint for advancing drug resistance research across cancer types.

137

项与替恩戈替尼相关的新闻（医药）

2026-01-08

·北京医学感染与传染研究

柳叶刀胃肠病学与肝病学 11卷 1-2期（2026年1月8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

2026-01-07

·有驾

终于来了！药监连放大招按下新药上市快进键，12款重磅抗肿瘤新药今年扎堆获批覆盖多癌种，百万癌友迎来救命新希望

2026年国内抗肿瘤新药市场将迎来历史性爆发：12款纳入优先审评的重磅创新药即将首次获批上市，把套细胞淋巴瘤、非小细胞肺癌、肝细胞癌等10大癌种的治疗版图快速更新。这不是普通的药企新品扎堆，是中国精准肿瘤治疗真正从“跟跑”转向“并跑、领跑”的高光时刻——从突破BTK耐药壁垒的淋巴瘤特效药，到填补实体瘤细胞疗法空白的肝癌术后防复发方案，从全球首创双抗ADC鼻咽癌疗法，到国产首报HER2双抗胃癌药，每一款药的获批节点，都是数万身处治疗绝境的患者重新看到希望的时刻。接下来，我们拆解这份即将兑现的新药名单，看这些药物如何击穿难治癌种的治疗天花板。 1. 淋巴瘤与骨髓瘤：精准配方补上耐药短板，末线患者生存再扩容套细胞淋巴瘤的最大窘境是BTK抑制剂耐药无药可医，一款在2025年5月获受理并纳入优先审评的特效药，正好击中了这一临床空白——专为接受过BTK抑制剂治疗的复发患者定制，批准后BTK耐药不再意味着终点。而百济神州的新一代BCL2抑制剂索托克拉同样是淋巴瘤与骨髓瘤领域的双赛道选手：针对慢性淋巴细胞白血病/小淋巴细胞淋巴瘤的申报等待兑现，同时其与硼替佐米、地塞米松联合方案，已经提交复发难治多发性骨髓瘤的上市申请并纳入优先审评，能为骨髓瘤患者再新增一套核心治疗组合。这些药物的精准性在于跳出“广谱杀癌”旧思路，直奔最核心的耐药靶点和复发环节，用靶向武器把淋巴瘤、骨髓瘤的“不可治”范围连续缩小。 2. HER2胃癌战场：国产双抗+ADC双拳出击，末线绝境的突破口 HER2阳性胃癌曾被进口药长期占据市场，但2026年国产力量将彻底改写格局。安尼妥单抗作为首个报上市的国产HER2双抗，上市申请于2025年9月纳入优先审评，针对至少接受过一种系统性治疗失败的HER2阳性局部晚期或转移性胃/胃食管结合部腺癌患者，填补了国产HER2双抗治疗该适应症的空白。此外，另一款针对HER2 2.2表达阳性的胃癌候选药，上市申请于2025年6月获受理并纳入优先审评，攻克了HER2异常表达中被长期忽视的低表达/突变亚型，让末线胃癌患者的可用靶点再次扩充。从靶向阳性到覆盖异常变异亚型，这两款药不仅补全了HER2胃癌的治疗序列，更通过国产身份重构了药物可及性的想象空间。 3. 实体瘤细胞疗法破冰：首款国产CIK先敲碎肝癌复发壁垒原发性肝细胞癌根治术后的高复发率，是长期悬在患者心头的达摩克利斯之剑——手术治愈比例低，复发后通常进入快速进展阶段。永泰生物的爱可仑赛，这份填补双重空白的答卷将于2026年交出：作为国内首款报上市的实体瘤细胞疗法，在国内尚无CIK细胞治疗产品获批的背景下，其附条件上市申请瞄准“肝癌根治术后高复发风险人群预防复发”这一临床刚需。这是目前国内仅有人触及的实体瘤细胞治疗领域：不再聚焦晚期治疗，而是把防线推到术前术后的预防环节，用细胞疗法的特异性靶向清扫残余癌细胞，相当于为肝癌患者加装了一层“术后防火墙”，如果获批，将彻底刷新国内实体瘤细胞治疗的认知边界。 4. 胆管癌：多靶点药企联手撞线，末线患者的生存新延伸肝内胆管癌与胆道癌因靶点不明、治疗选择少长期被归为难治癌种，2026年两款精准特效药将打破这一困境。和黄医药的凡瑞格拉替尼聚焦肝内胆管癌二线治疗，上市申请已于2025年12月获受理并纳入优先审评，精准靶向致癌驱动基因；药捷安康的替恩戈替尼则更注重末线患者——针对至少接受过一种系统性治疗和FGFR抑制剂治疗失败的晚期胆管癌患者，后者恰好补上了FGFR靶向药耐药后的治疗空缺。现阶段国内胆管癌患者至一线治疗失败后有效方案不足20%，这两款药的获批，会让这部分患者的生存时间明显拉长，把胆管癌的“预后极差”标签再次淡化。 5. 罕见癌与鼻咽癌：全球首创与适应症突破同步百利天恒的BL-B01D1是全球目前唯此申报上市的双抗ADC药物，这款打破技术边界的创新药上市申请于2025年11月拿入优先审评。这类兼具精准靶向性和ADC细胞毒能力的组合型新药，对以往无针对性治疗方案的患者而言是降维打击。同时，拜耳的首款获批腱鞘巨细胞瘤小分子酪氨酸激酶抑制剂也将登陆国内——在国内该罕见病无标准化药物的背景下，这款2020年已在美国获批、2025年国内申请纳入优先审评的药物，为手足功能逐步丧失的腱鞘巨细胞瘤患者带来告别残疾风险可能。站在2026年开局看向这批即将落地的肿瘤新药，我们能看到清晰的迭代路径：从过去聚焦晚期癌种的“救火式治”，转向把治疗前端到“术后防复发”的“防御式治”；从紧紧跟随外企靶点的“同质化研发”，到打出全球首创双抗ADC、国产首报实体瘤细胞疗法的“差异化突破”。对医生而言，这是新增一套套经过临床验证的治疗工具箱；对患者家庭而言，是可及性不断提升的新选择；对中国生物医药产业而言，更是自身在全球精准治疗赛场站稳脚跟的重要论据。相信到2026年年底，这批新药的临床数据续贯和落地实践，还将为后续更多实体瘤、遗传性癌种的精准药开发带来启发——因为最好的药物永远是：把“没有希望”变成“下一个希望”。

优先审批抗体药物偶联物申请上市上市批准引进/卖出

2026-01-06

·赛柏蓝

2026年，20款重磅新药有望中国获批上市

编者按：本文来自新康界；赛柏蓝转载，编辑青黛根据公开信息整理，预计在2026年，将有约20款重磅新药有望获得上市批准，这些药物均已被CDE纳入优先审评程序，旨在加速其上市，以满足迫切的临床需求。这些药物不仅数量可观，更在治疗领域上呈现出多元化格局，涵盖肿瘤、感染性疾病、罕见病、自身免疫性疾病、神经系统疾病等多个治疗领域，展现了显著的临床价值和创新性。 01 肿瘤领域：靶向与细胞治疗并进肿瘤领域是本次有望获批新药最为集中的部分，涉及的癌种广泛，从血液肿瘤到实体瘤均有突破。在机制上，靶向疗法、抗体药物偶联物（ADC）及细胞治疗等前沿技术交相辉映，预示着肿瘤治疗将进入更精准、更个性化的新阶段。实体瘤 BAY 2927088（Sevabertinib，拜耳）：2025 年 7 月，该药上市申请获得受理。这是一款口服可逆酪氨酸激酶抑制剂（TKI），用于治疗携带HER2（ERBB2）激活突变且既往接受过一种全身性治疗的晚期非小细胞肺癌（NSCLC）成人患者。2025 年 11 月已在美国获批上市，用于 HER2 突变非鳞状 NSCLC 的二线治疗。舒瑞基奥仑赛（CT041，科济药业）：这是一款靶向Claudin18.2（CLDN18.2）的自体CAR-T细胞疗法，用于治疗CLDN18.2阳性、至少二线治疗失败的晚期胃/食管胃结合部腺癌患者。也是全球首款申报上市的实体瘤CAR-T产品。2025 年 6 月，科济药业舒瑞基奥仑赛注射液的上市申请获得受理。安尼妥单抗（石药集团/康宁杰瑞）：2025 年 9 月，石药集团和康宁杰瑞合作开发的安尼妥单抗上市申请获得受理。该药为HER2双特异性抗体，联合化疗用于治疗至少接受过一种系统性治疗失败的HER2阳性局部晚期、复发或转移性胃/胃食管结合部腺癌。这也是首个申报上市的国产HER2双抗。 BL-B01D1（iza-bren，百利天恒）：2025 年 11 月，百利天恒 BL-B01D1 上市申请获得受理。一款全球首创的EGFRxHER3双特异性抗体偶联药物（ADC），用于治疗既往经PD-1/PD-L1单抗治疗且经至少两线化疗失败的复发性或转移性鼻咽癌。这也是全球首个申报上市的双抗ADC。凡瑞格拉替尼（和黄医药）：2025 年 12 月，该药上市申请获得受理，凡瑞格拉替尼是一款高选择性成纤维细胞生长因子受体（FGFR）1/2/3抑制剂，用于治疗既往接受过系统性治疗且存在FGFR2融合或重排的晚期肝内胆管癌成人患者。安瑞替尼（威凯尔医药）：该药为新一代原肌球蛋白受体激酶（TRK）抑制剂，用于治疗携带NTRK融合基因的局部晚期或转移性实体瘤成人和青少年患者，有潜力解决第一代TRK抑制剂的耐药问题。2025 年 7月，威凯尔医药的安瑞替尼胶囊上市申请获得 CDE 受理。替恩戈替尼（药捷安康）：2025 年 12 月，替恩戈替尼上市申请获得受理。该药是多靶点小分子激酶抑制剂，用于既往至少接受过一种系统性治疗和FGFR抑制剂治疗的晚期胆管癌成人患者。目前，药捷安康正在全球范围内开展替恩戈替尼的多项临床试验，适应症涵盖胆管癌、前列腺癌、乳腺癌、肝癌等多种实体瘤。爱可仑赛（永泰生物）：2025 年 3 月，该药上市申请获受理。这是一款个性化自体细胞治疗产品（非基因修饰），用于原发性肝细胞癌根治术后高复发风险人群的术后预防复发治疗。这是国内首款申报上市的实体瘤细胞疗法。吡昔替尼（第一三共）：2025 年 1 月，吡昔替尼上市申请获受理。这是一款抑制集落刺激因子1受体（CSF1R）等靶点的小分子酪氨酸激酶抑制剂，用于治疗伴有重度病变或功能受限且无法通过手术改善的症状性腱鞘巨细胞瘤（TGCT）成年患者。有望成为全球首个获批治疗TGCT的药物。血液肿瘤玛贝兰妥单抗（GSK）：2024 年 12 月，GSK 的玛贝兰妥单抗上市申请获得 CDE 受理。该药是一款靶向B细胞成熟抗原（BCMA）的抗体药物偶联物（ADC），联合方案用于治疗既往接受过至少一种治疗的多发性骨髓瘤成年患者。值得一提的是，这也是全球首个获批上市的BCMA ADC。索托克拉（百济神州）：2025 年 4 月，百济神州索托克拉片的上市申请获得 CDE 受理。这是一款新一代BCL2抑制剂，拟用于治疗既往接受过治疗的慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）以及套细胞淋巴瘤（MCL）。与此同时，2025 年 11 月，美国 FDA 正式受理索托克拉的上市申请，并授予其优先审评资格，这也是首个在美国申报上市的国产BCL2抑制剂。洛布替尼（麓鹏制药）：2025 年 5 月，麓鹏制药的洛布替尼片上市申请获得受理，用于治疗既往接受过布鲁顿酪氨酸激酶（BTK）抑制剂治疗的成人套细胞淋巴瘤患者。这是一款第四代共价兼非共价BTK抑制剂，旨在克服既往BTK抑制剂的耐药问题。此外，在非肿瘤适应症方面，洛布替尼正在开展针对慢性自发性荨麻疹、多发性硬化、视神经脊髓炎等的临床研究。同时，2024 年 8 月，翰森与麓鹏制药达成战略合作，获得了洛布替尼所有非肿瘤适应症在中国的研发、注册、生产及商业化的权益。 02 罕见病与代谢性疾病：从RNA干扰到基因治疗针对一些长期缺乏有效治疗手段的罕见病，新兴技术正在带来根治或显著改善病情的机会。普乐司兰钠（赛诺菲）：2025年1月，普乐司兰钠上市申请获受理，用于治疗家族性乳糜微粒血症综合征（FCS）。这是一种RNA干扰（RNAi）疗法，FDA 已批准普乐司兰钠上市，作为饮食疗法的辅助手段以降低甘油三酯水平，患者仅需每三个月进行一次皮下注射。据悉，Arrowhead子公司维亚臻拥有该药大中华区权益，2025年8月，赛诺菲与其签署协议，获得普乐司兰钠相关权益。 Onasemnogene abeparvovec（OAV101，诺华）：2025 年 8 月2日，OAV101上市申请获得受理，是一款基于腺相关病毒（AAV）载体的基因治疗药物，通过单次静脉注射用于治疗6月龄及以上5q型脊髓性肌萎缩症（SMA）患者。此前，该药已在美国、欧盟、日本获批上市。 03 自身免疫性与炎症性疾病：靶点日益精准自身免疫性疾病领域的新药研发正朝着更精准的免疫调控方向发展。 MIL62（天广实）：2025 年 5 月，天广实 MIL62 注射液上市申请获得CDE受理。该药为第三代抗CD20重组人源化单克隆抗体，用于治疗视神经脊髓炎谱系疾病（NMOSD）。该药有望成为首个获批治疗NMOSD的国产药物。瑞西奇拜单抗（华海药业）：2025 年 10 月，华海药业的瑞西奇拜单抗注射液上市申请获得 CDE 受理，用于治疗泛发性脓疱型银屑病（GPP）。该药是一款创新抗白细胞介素-36受体（IL-36R）单克隆抗体，是首个申报上市的国产IL-36R单抗。尼卡利单抗（强生）：2025 年 4 月，强生尼卡利单抗注射液上市申请获得受理。该药是一款新生儿Fc受体（FcRn）抗体，通过降低致病性免疫球蛋白G（IgG）抗体水平，用于治疗自身抗体阳性的全身型重症肌无力（gMG）成人和青少年患者。同年4月，该药已获得 FDA 批准上市，用于治疗 gMG 患者。 MY008211A（朗来科技）：2025 年 10 月，朗来科技的 MY008211A片上市申请获得受理，用于治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人患者。这是一款补体B因子（CFB）抑制剂，目前国内外均只有一款 CFB 抑制剂获批上市，为诺华的伊普可泮。该药是首个申报上市的国产CFB抑制剂。 04 感染性疾病：破解“丁肝”治疗困境在病毒性肝炎领域，长期以来缺乏有效药物的丁型肝炎迎来了突破。立贝韦塔单抗（华辉安健）：2024年年底，华辉安健的立贝韦塔单抗上市申请获得CDE 受理。该药是一款靶向乙肝病毒表面大包膜蛋白前S1区的中和抗体，用于治疗慢性丁型肝炎病毒感染。这是全球首个靶向该位点的中和抗体，也是首个在中国递交上市申请的丁肝治疗药物。 05 神经系统疾病：关注多动症治疗需求丝右哌甲酯右哌甲酯复方胶囊（爱科百发）：2025 年 6 月，爱科百发递交的丝右哌甲酯右哌甲酯复方胶囊上市申请获得 CDE 受理。据了解，这是一款含有速释右哌甲酯和前药丝右哌甲酯的复方制剂，用于治疗6岁及6岁以上注意缺陷多动障碍（ADHD，多动症）。2021 年 3 月，该药已在美国获批上市；同年，爱科百发与Commave Therapeutics 达成一项总金额为 1.055 亿美元的授权合作，获得了 AK0901 在大中华区的开发、生产及商业化权利。参考资料来自Insight 数据库、网络公开信息，包括新闻资讯、企业官网、政府文件等。 END 内容沟通：Xinmeitizhongxin- 商务合作：13810647732

细胞疗法抗体药物偶联物免疫疗法优先审批上市批准

100 项与替恩戈替尼相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
晚期胆管癌	申请上市	中国	无锡合全药业有限公司	2025-12-19
晚期胆管癌	申请上市	中国	药捷安康（南京）科技股份有限公司	2025-12-19
不能切除的胆管癌	申请上市	中国	药捷安康（南京）科技股份有限公司	2025-12-19
不能切除的胆管癌	申请上市	中国	无锡合全药业有限公司	2025-12-19
转移性胆管癌	申请上市	中国	药捷安康（南京）科技股份有限公司	2025-12-19
转移性胆管癌	申请上市	中国	无锡合全药业有限公司	2025-12-19
FGFR2阳性肝内胆管癌	临床3期	中国	药捷安康（南京）科技股份有限公司	2026-01-08
FGFR阳性胆管癌	临床3期	美国	药捷安康（南京）科技股份有限公司	2023-12-20
FGFR阳性胆管癌	临床3期	奥地利	药捷安康（南京）科技股份有限公司	2023-12-20
FGFR阳性胆管癌	临床3期	比利时	药捷安康（南京）科技股份有限公司	2023-12-20

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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


NCT04919642 (Pubmed \| Lancet Gastroenterol Hepatol)	临床2期	转移性胆管癌	55	Tinengotinib (FGFR2 fusions with acquired FGFR inhibitor resistance)	選築獵廠觸積願選鬱壓(遞醖鏇淵襯廠餘衊鬱築) = Grade 3 treatment-related adverse events included hypertension in 17 (31%) of 55 patients, palmar-plantar erythrodysesthesia syndrome in seven (13%) patients, and stomatitis in six (11%) patients. 鏇簾鹹齋憲膚選鹹鹹鑰 (夢蓋膚餘壓膚選選網鏇 ) 更多	积极	2025-12-01
NCT03654547 (ESMO2025)	临床1/2期	晚期胆管癌 FGFR2-altered	109	Tinengotinib	壓繭夢鬱蓋顧餘顧淵鬱(選鹹積積遞鹹壓壓齋蓋) = 製積衊糧範膚艱簾醖窪構鬱餘糧壓餘獵襯艱鑰 (鬱膚淵製艱餘獵網積鏇 ) 更多	积极	2025-10-17
				Tinengotinib (FGFR2-altered)	醖鏇餘積選遞鏇衊淵餘(壓網繭窪鹹衊選選蓋顧) = 簾網鬱鏇鹹觸繭鹹網鹹範築醖餘製鏇願餘網壓 (構糧蓋艱艱範構鑰遞鑰, 9.43 ~ 19.48) 更多
NEWS 人工标引	N/A	胆管癌	43	Tinengotinib	淵膚遞選遞鏇壓齋夢製(築繭製願壓夢觸壓鬱夢) = 夢選鹹壓繭獵餘膚築夢選範壓製餘簾醖鬱網淵 (積繭製膚壓鏇壓觸襯鑰 ) 更多	积极	2025-07-13
NCT04919642 (TransThera's phase 2, ASCO2025)	临床2期	胆管癌 FGFR2 fusion \| FGFR alterations \| FGFR wild type	37	Tinengotinib	觸鬱積餘製艱壓顧壓簾(範鬱醖夢艱顧獵憲遞齋) = 襯鬱窪願鏇鹹蓋鏇餘膚遞積鹽夢艱簾壓餘願餘 (壓遞鹽選餘願願壓鏇醖 ) 更多	积极	2025-05-30
NCT04742959 (AACR2025)	临床1/2期	晚期恶性实体瘤 Aurora kinases A/B \| Janus kinases (JAK) \| receptor tyrosine kinases (FGFRs and VEGFRs)	197	Tinengotinib 4mg BID	鏇範顧衊獵鹹選遞淵夢(簾壓鹹積簾鹽壓鏇鹽壓) = No notable difference in AUC was observed in QD vs. BID schedules 淵鹽顧鑰簾鹹壓鏇網繭 (鏇淵獵簾糧顧範壓構蓋 ) 更多	-	2025-04-29
				Tinengotinib 6mg BID
NCT04742959 (AACR2025)	临床1/2期	转移性胆管癌 FGFR fusions \| FGFR2 KD mutations	2	Tinengotinib 12mg once daily	鹽壓夢衊範襯糧膚觸餘(構衊齋糧窪淵繭廠餘製) = suspected grade 3 TSH increase 簾鹹鹽網艱遞製齋範願 (積淵夢網艱淵衊製膚鹹 ) 更多	积极	2025-04-27
				Chemotherapy
NCT04919642 (ASCO_GI2025) 人工标引	临床2期	转移性胆管癌 MED12 mutation \| ARID1A mutation	55	Tinengotinib 10 mg QD (A1: FGFR2 fusion(s) with primary progression on previous FGFR inhibitor (FGFRi))	壓鏇網衊選積範窪鏇夢(壓積獵衊積廠淵廠遞築) = 選憲鹹憲範壓夢網鏇製網簾夢夢顧窪憲鏇鹹願 (範獵鹹獵鑰範膚選鹽鹹, 7.5 ~ 19.5)	积极	2025-01-23
				Tinengotinib 10 mg QDTinengotinib 10 mg QD (A2: FGFR2 fusion(s) with progression after prior response to FGFRi)	壓鏇網衊選積範窪鏇夢(壓積獵衊積廠淵廠遞築) = 憲鏇顧襯糧範顧鹹網壓網簾夢夢顧窪憲鏇鹹願 (範獵鹹獵鑰範膚選鹽鹹, 9.6 ~ NR)
NCT05253053 (TT-00420, ESMO_ASIA2024) 人工标引	临床1/2期	胆道癌	31	Tinengotinib + Atezolizumab	鏇齋築窪窪窪願遞範遞(鏇觸願衊獵鏇齋膚選壓) = 淵鬱憲憲選遞廠衊淵餘淵壓製願積蓋衊膚鏇糧 (膚鏇範遞製築簾遞鏇顧 ) 更多	积极	2024-12-07
				Tinengotinib + Atezolizumab (cholangiocarcinoma)	鏇齋築窪窪窪願遞範遞(鏇觸願衊獵鏇齋膚選壓) = 醖遞構憲積夢憲窪築窪淵壓製願積蓋衊膚鏇糧 (膚鏇範遞製築簾遞鏇顧 ) 更多
NCT05253053 \| NCT04742959 \| NCT03654547 \| NCT04919642 (AACR2024) 人工标引	临床1/2期	实体瘤 FGFR1 Mutation \| FGFR2 Mutation \| FGFR3 Mutation	53	Tinengotinib 5-12mg	願醖獵製選遞鑰觸簾積(鑰繭憲獵遞蓋衊顧製鹹) = 鑰憲鹹觸淵選繭鹹醖顧願夢積築範衊窪築憲簾 (壓鏇窪鹽壓艱鏇齋餘積 ) 更多	积极	2024-04-05
				Tinengotinib 5-12mg (prior FGFR inhibitor)	願醖獵製選遞鑰觸簾積(鑰繭憲獵遞蓋衊顧製鹹) = 願憲窪齋齋築糧鹹觸願願夢積築範衊窪築憲簾 (壓鏇窪鹽壓艱鏇齋餘積 ) 更多
NCT05253053 \| NCT04742959 \| NCT03654547 (ASCO_GU2024) 人工标引	临床1/2期	转移性去势抵抗性前列腺癌	30	Tinengotinib	簾淵願餘憲網繭鹽鏇築(蓋夢築範選構鬱積顧網) = 積遞衊鏇鹽鏇齋願獵齋窪選範繭壓壓襯鬱顧範 (鏇醖鑰憲壓願選構製鏇 ) 更多	-	2024-01-25