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infliximab (Anbaite / HS626 / HS 626)

✓ Approved

Zhejiang Hisun Pharmaceutical Co., Ltd. · TNF · 单克隆抗体

什么是 infliximab？

infliximab 是一种单克隆抗体，由Zhejiang Hisun Pharmaceutical Co., Ltd.研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

商品名Anbaite, HS626, HS 626
公司Zhejiang Hisun Pharmaceutical Co., Ltd.
药物类别单克隆抗体, 抗体
分子靶点TNF
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Zhejiang Hisun Pharmaceutical Co., Ltd.

作用机制

分子靶点

infliximab 作用于 1 个分子靶点：

TNFtumor necrosis factor (TNFA, TNF-alpha)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

infliximab 针对 5 个适应症，涉及 3 个治疗领域。

治疗领域疾病/病症分期
Musculoskeletal and connective tissue disordersAnkylosing spondylitis✓ Approved
Gastrointestinal disordersColitis ulcerative✓ Approved
Gastrointestinal disordersCrohn's disease✓ Approved
Skin and subcutaneous tissue disordersPsoriasis✓ Approved
Musculoskeletal and connective tissue disordersRheumatoid arthritis✓ Approved

相关研究文献

PubMedInternational journal of molecular sciences2026-10-27

Changes in Serum MMP-9 and TIMP-1 Concentrations in Children with Inflammatory Bowel Disease over a Six-Month Observation Period.

Zdanowicz Katarzyna K, Lebensztejn Dariusz Marek DM, Daniluk Urszula U

Inflammatory bowel disease (IBD) is a chronic condition with a long-term and often unpredictable course. The aim of our study was to evaluate serum levels of matrix metalloproteinase-9 (MMP-9) and tissue inhibitor of metalloproteinase-1 (TIMP-1) in children with IBD at diagnosis or disease exacerbation and during follow-up to assess their changes during the course of the disease. Patients were assessed at the time of inclusion (T0), after 3 months (T1), and after 6 months of follow-up (T2). At each time point, clinical disease activity was evaluated, along with routine laboratory tests and measurement of fecal calprotectin (fCal). Serum concentrations of MMP-9 and TIMP-1 were determined using the enzyme-linked immunosorbent assay method. Fifty-nine children with IBD were included in the study (19 with Crohn's disease and 40 with ulcerative colitis; 39 with newly diagnosed disease and 20 with disease exacerbation). During the six-month follow-up, patients received anti-TNF-α therapy with infliximab or adalimumab; at T1, 8 patients received infliximab and 5 received adalimumab, whereas at T2, 17 patients received infliximab and 7 received adalimumab. At T0, significant differences in MMP-9 and TIMP-1 were observed between IBD patients and controls. In the IBD group, a significant decrease in MMP-9 (p < 0.001), TIMP-1 (p < 0.001), and the MMP-9/TIMP-1 ratio (p = 0.006) was observed over the six-month follow-up. At T1, only TIMP-1 levels differed between groups, while at T2 no significant differences were observed. Patients who achieved clinical remission showed a significant decrease in MMP-9 (p = 0.001) and TIMP-1 (p < 0.001) levels, whereas no significant changes were observed in patients who did not achieve remission. However, the percentage change in MMP-9 did not differ significantly according to clinical remission status (p = 0.50). Similarly, patients who achieved fCal-defined biochemical remission showed significant reductions in MMP-9 (p = 0.005), TIMP-1 (p = 0.003), and the MMP-9/TIMP-1 ratio (p = 0.01) over time. In patients without fCal-defined biochemical remission, MMP-9 (p = 0.04) and TIMP-1 (p = 0.01) also decreased significantly over time, whereas the MMP-9/TIMP-1 ratio did not change significantly. However, direct comparisons showed no significant differences in the percentage changes in MMP-9 (p = 0.28) or TIMP-1 (p = 0.37) according to fCal-defined biochemical remission status. In conclusion, serum MMP-9 and TIMP-1 levels change over six months in children with IBD, reflecting changes in disease activity. Changes in these biomarkers were not significantly associated with fCal-defined biochemical remission. A significant difference in TIMP-1 percentage change was observed according to clinical remission status. However, this finding should be considered exploratory and interpreted with caution.

PMID 42941932
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PubMedBiomedicines2026-10-27

Prior Ustekinumab Exposure and Ulcerative Colitis Are Associated with Suboptimal Trough Levels in Patients Receiving Advanced-Line Vedolizumab or Ustekinumab for Inflammatory Bowel Disease: A Cross-Sectional Cohort Study.

Nagypál Petra P, Kovács Krisztián K, Vásárhelyi Barna B, Dezsőfi-Gottl Antal A et al.

Background: Ustekinumab (UST) and vedolizumab (VDZ) are established therapies for Crohn's disease (CD) and ulcerative colitis (UC), including in patients with prior tumour necrosis factor-alpha inhibitor (anti-TNF) failure. Trough levels (TRLs) and antidrug antibodies (ADAs) are among several factors associated with therapeutic response. The aim of this study was to retrospectively identify factors associated with suboptimal TRL and ADA presence in a large, multicentre, cross-sectional cohort. Methods: TRLs and ADAs for VDZ and UST were measured routinely during therapy. A Cox proportional hazards model was used to identify clinical and treatment-related factors associated with suboptimal TRLs. Results: A total of 184 patients (78 children and 106 adults) with inflammatory bowel disease (IBD) were included; 104 and 80 were treated with UST and VDZ, respectively. TRLs were measured as part of routine clinical care between 2022 and 2025. Of the 184 patients, 80 (43.48%) had previously received both infliximab and adalimumab. Overall, 103 patients (55.98%) had received at least two advanced therapies (infliximab, adalimumab, VDZ, UST or a small-molecule inhibitor (SMI)) before the current biologic therapy. In exploratory Cox analyses, prior UST exposure (HR = 4.13, 95% CI = 1.58-10.81, p = 0.004) and UC subtype (HR = 2.83, 95% CI = 1.39-5.76, p = 0.004) were associated with a higher hazard of suboptimal TRL, whereas longer duration of prior biologic therapy (HR = 0.89, 95% CI = 0.82-0.96, p = 0.003) and current VDZ treatment (HR = 0.36, 95% CI = 0.16-0.82, p = 0.014) were associated with a lower hazard. In a cross-sectional logistic model accounting for time on therapy, only longer duration of prior biologic therapy remained significantly associated with suboptimal TRL. Prior UST exposure was associated with ADA presence in the cross-sectional model, although the estimate was imprecise and sensitive to model specification. Conclusions: Prior UST exposure, UC subtype and current VDZ therapy were associated with suboptimal TRLs in exploratory Cox analyses; however, these associations were not reproduced in the cross-sectional logistic model and were sensitive to adjustment for inflammatory burden. Longer duration of prior biologic therapy remained associated with lower odds of suboptimal TRL in the cross-sectional analysis. The observed association between prior UST exposure and ADA presence was imprecise and model-dependent. Given the study's retrospective design and limited sample size, these findings should be considered preliminary and require validation in larger prospective cohorts.

PMID 42940137
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PubMedCrohn's & colitis 3602026-10-27

International practice patterns in the management of pouchitis: results from a global survey.

Fanizzi Fabrizio F, D'Amico Ferdinando F, Galbiati Maria M, Jairath Vipul V et al.

Pouchitis is the most frequent long-term complication after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis. This study aimed to describe current international practices, definitions, and treatment strategies among experienced clinicians. An international web-based survey was conducted in 2025, following CROSS guidelines, exploring diagnostic, monitoring, and therapeutic practices. Responses were anonymized and analyzed descriptively. A total of 412 physicians from 49 countries completed the survey, mostly gastroenterologists involved in IBD care (362/412, 87.8%). Most clinicians (156/412, 37.9%) estimated a pouchitis prevalence of 26%-50% among patients with IPAA, typically occurring within the first postoperative year. Follow-up was scheduled every 3-6 months by 164/412 (39.8%) physicians, with nearly half (47.6%) reporting the use of the pouch disease activity index (PDAI). Fecal calprotectin was the preferred non-invasive monitoring tool (326/412, 79.1%), whereas intestinal ultrasound was selected by 130/412 respondents (31.69%). Endoscopy was the primary diagnostic and follow-up modality (398/412, 96.6%), with biopsies routinely taken (364/412, 88%), although 46.7% of respondents reported not using a standardized histological scoring system. Prophylactic therapy was prescribed by 222/412 (53.9%), mainly probiotics (27.7%) and rectal mesalazine (18.2%). In acute pouchitis, ciprofloxacin plus metronidazole was the preferred first-line regimen (218/412, 52.9%). For chronic antibiotic-dependent or refractory pouchitis, advanced therapies were the predominant first-line option (254/412, 61.7%), with vedolizumab (198/412, 48.1%), and infliximab (170/412, 41.3%) most frequently selected. Ustekinumab, selective IL-23 inhibitors, JAK inhibitors and S1P receptor modulators were increasingly used in refractory cases. Treatment targets were primarily clinical (156/412, 37.9%) and endoscopic (124/412, 30.1%) remission, and most respondents (246/396, 62.1%) reported performing endoscopic assessment within 3-6 months after advanced treatment initiation. This international survey demonstrates substantial heterogeneity in pouchitis diagnosis, monitoring, and treatment, highlighting important gaps in standardized disease assessment and treatment strategies. The findings support the need for consensus-based approaches and prospective, pouch-specific studies to improve the standardization of pouchitis care.

PMID 42936095
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PubMedMedicina (Kaunas, Lithuania)2026-10-27

Impact of Smoking on the Effectiveness of Advanced Therapies in Inflammatory Bowel Disease: Active Smoking Is Associated with Reduced Effectiveness of Anti-TNF Treatment.

Cinque Sofia S, Annunziata Maria Laura ML, Bianchi Antonella A, Bertoli Peter P et al.

Background and Objectives: Smoking is a well-established risk factor for Crohn's disease (CD), whereas patients with ulcerative colitis (UC) who smoke may exhibit a milder disease course. The impact of smoking on the efficacy of advanced therapies (AT) in patients with inflammatory bowel disease (IBD) remains largely unknown. Materials and Methods: Patients with IBD receiving AT and with a detailed smoking history were retrospectively identified from our electronic database. The primary outcome was the rate of clinical response and remission. Secondary outcomes included endoscopic improvement, the need for AT sequencing, and surgery. Results: A total of 346 patients (136 UC and 210 CD) were analyzed, with a mean age of 47.3 years and a mean disease duration of 14.1 years (range, 0.5-48 years). Overall, 614 treatment courses were evaluated: 382 anti-TNF, 92 vedolizumab, 84 ustekinumab, 36 JAK inhibitor, 16 IL-23 inhibitor, and 4 etrasimod treatment courses. The anti-TNF effectiveness analysis included 371 infliximab/adalimumab courses after exclusion of 11 golimumab courses. A total of 107 patients (30.9%) were active smokers and 76 (21.9%) were former smokers. Anti-TNF therapy was significantly more effective in never smokers than in active smokers in the adjusted analysis (OR 1.44, 95% CI 1.04-2.00; p = 0.03), and this association remained significant in the mixed-effects model accounting for repeated treatment courses within patients (OR 1.35, 95% CI 1.01-1.80; p = 0.04). The association for advanced therapies overall was significant in the adjusted model (OR 1.25, 95% CI 1.01-1.55; p = 0.04) but was attenuated after accounting for repeated courses (OR 1.10, 95% CI 0.99-1.22; p = 0.07). No statistically significant differences were demonstrated for vedolizumab or ustekinumab, although the smaller sample sizes preclude exclusion of a clinically relevant effect. Former smokers had outcomes comparable to never smokers. Active smokers also required significantly more treatment courses than never smokers in both UC and CD (p = 0.03). Conclusions: Smoking is associated with a negative impact on the effectiveness of anti-TNF therapy in both UC and CD, highlighting the need for systematic smoking cessation counseling and patient education as an integral component of IBD management.

PMID 42942364
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PubMedAlimentary pharmacology & therapeutics2026-10-26

Baseline Clearance and Early Troughs Identify Candidates for Early Therapeutic Drug Monitoring During Infliximab Induction in Inflammatory Bowel Disease.

Mohamedi Juma A JA, Hoffert Yannick Y, Geukens Nick N, Rahier Jean-François JF et al.

The value of therapeutic drug monitoring during infliximab induction remains uncertain. We evaluated whether baseline infliximab clearance and early exposure metrics identify candidates for potential early proactive therapeutic drug monitoring during induction in inflammatory bowel disease. We analysed a multicenter Phase 4 study in which adults with Crohn's disease and ulcerative colitis initiated standard infliximab therapy (5 mg/kg at Weeks 0, 2, 6, 14, 22 and 30) with predefined peak, intermediate and trough sampling. A population pharmacokinetic model characterized disposition and covariates. Logistic regression assessed exposure-response relationships. The primary outcome was week-30 combined remission (Crohn's disease: Harvey-Bradshaw Index ≤ 4; ulcerative colitis: Partial Mayo score ≤ 2; with faecal calprotectin < 100 μg/g and C-reactive protein ≤ 5 mg/L). Seventy-five participants (33 female; median age 39 years, interquartile range 28-52) contributed pharmacokinetic data. Sixty-three were evaluable for exposure-response analyses. Twelve participants (19%) achieved combined remission (7/35 Crohn's disease; 5/28 ulcerative colitis). Lower serum albumin, higher body weight, and antibodies to infliximab increased clearance. In ulcerative colitis, baseline clearance and model-predicted week-6 trough concentration showed strong discrimination for combined remission (area under the receiver operating characteristic curve 0.88, 95% confidence interval 0.75-1.00; and 0.86, 0.69-1.00, respectively). Baseline clearance > 0.28 L/day and week-6 trough ≤ 21.6 mg/L identified high-risk subgroups with few remissions (0/18 and 1/20, respectively, p < 0.05). No robust predictors were identified in Crohn's disease. A pragmatic, risk-stratified, model-informed approach centered on baseline clearance and early troughs may guide personalized infliximab induction in ulcerative colitis. External validation is warranted. EudraCT number: 2015-004618-10.

PMID 42928429
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PubMedRevista espanola de enfermedades digestivas2026-10-26

Biosimilars in inflammatory bowel disease: from initial uncertainty to clinical normalization.

Argüelles-Arias Federico F, Zabana Yamile Y

Biosimilars have become an integral part of the treatment of inflammatory bowel disease (IBD), evolving from initial uncertainty regarding indication extrapolation and non-medical switching to widespread clinical acceptance. Early concerns focused mainly on the absence of disease-specific evidence and the potential impact of switching on effectiveness, safety, and immunogenicity. Over the past decade, however, extensive real-world evidence and randomized data have consistently supported the use of infliximab and adalimumab biosimilars in both biologic-naïve patients and patients switched from originator products. Recent systematic reviews and meta-analyses further reinforce these findings, showing preserved clinical remission, treatment persistence, inflammatory biomarkers, and immunogenicity after switching. The biosimilar landscape is now expanding to newer therapeutic targets, including ustekinumab, while biosimilar-to-biosimilar and multiple switching is becoming increasingly relevant in routine practice. Nevertheless, scientific interchangeability should not be equated to automatic substitution. Switching decisions should remain clinically supervised and involve gastroenterologists within a multidisciplinary framework, taking into account disease activity, previous response, safety, immunogenicity, and patient preferences. Appropriate communication is also essential to minimize a potential nocebo effect and to avoid unnecessary discontinuation. Biosimilars should therefore be considered fully established biological therapies rather than lower-tier alternatives to originator drugs. Future research should focus less on re-confirming single-switch equivalence and more on unresolved questions, including long-term outcomes after multiple switching, biosimilars of newer therapeutic targets, patient-reported outcomes, treatment persistence, and comparative pharmacoeconomic impact across healthcare systems.

PMID 42929266
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