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infliximab (Anbaite / HS626 / HS 626)

✓ Approved

Zhejiang Hisun Pharmaceutical Co., Ltd. · TNF · Monoclonal Antibodies

What is infliximab?

infliximab is a monoclonal antibodies developed by Zhejiang Hisun Pharmaceutical Co., Ltd.. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesAnbaite, HS626, HS 626
CompanyZhejiang Hisun Pharmaceutical Co., Ltd.
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetTNF
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Zhejiang Hisun Pharmaceutical Co., Ltd.

Mechanism of Action

Molecular Targets

infliximab acts on 1 molecular target:

TNFtumor necrosis factor (TNFA, TNF-alpha)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

infliximab is developed for 5 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
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

Related Research Articles

PubMedFrontiers in pharmacology2026-07-25

Infliximab-linked gut microbiome signatures as candidate treatment response biomarkers in pediatric inflammatory bowel disease: a systematic review.

Altaher Hala H, Al-Mashhadani Mustafa M, Usman Rameen R, Ghelani Hardik H et al.

Infliximab (IFX) is a chimeric monoclonal antibody against tumor necrosis factor-alpha (TNF-α) that is widely used for induction and maintenance therapy in pediatric inflammatory bowel disease (IBD), yet its effects on the developing intestinal microbiome and treatment response remain unclear. To systematically synthesize evidence on IFX-associated microbiome changes in pediatric IBD and evaluate microbiome features linked to treatment response. A systematic review was conducted following the PRISMA 2020 guidelines. PubMed, Scopus, Embase, and CENTRAL were searched from database inception until March 2026, and our results were synthesized narratively. Of the 945 records identified, 13 studies met the inclusion criteria, comprising 242 pediatric patients. Findings for alpha diversity were variable across studies. In contrast, beta-diversity patterns, taxonomic profiles, and functional analyses more consistently showed positive IFX-associated microbial changes. Responders to treatment more frequently showed enrichment of beneficial taxa, including Faecalibacterium, Subdoligranulum, and Bifidobacterium, while non-responders exhibited a tendency towards dysbiotic microbial signatures, evidenced by increased levels of Gammaproteobacteria and Candida. Functional and metabolomic studies suggested beneficial shifts in bile-acid metabolism, short-chain fatty acid-related pathways, and inflammatory signaling post IFX treatment. Clinical and biochemical improvements with IFX were consistently reported; however, these improvements were not always accompanied by uniform recovery of overall microbial diversity. In pediatric IBD, IFX is more consistently associated with shifts in microbial composition and function than with broad increases in overall microbial diversity. Further large, standardized studies are warranted to refine the role of microbiome features in biologic treatment stratification. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251133625, identifier CRD420251133625.

PMID 42499495
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PubMedJPGN reports2026-07-24

Proactive therapeutic drug monitoring of infliximab leads to treatment durability in paediatric Crohn's disease: A single-centre Australian experience.

Chuah Cher Wei CW, Eldredge Jessica J, Magoffin Annabel A, O'Loughlin Edward Vincent EV et al.

To evaluate the durability and predictors of loss of response of infliximab (IFX) over 2 years in paediatric Crohn's disease (CD) utilizing a proactive therapeutic drug monitoring (TDM) strategy. A retrospective, single-centre cohort study was conducted at The Children's Hospital at Westmead (CHW), Australia, from January 2019 to December 2021. Proactive TDM was performed at induction, end of induction and 6-monthly thereafter. The primary outcome was switching to a different biologic as a marker of treatment failure. Secondary outcomes of a physician global assessment (PGA) scale, calprotectin, albumin and C-reactive protein (CRP) levels were collected at induction, end of induction, 1-year and 2-year timepoints. Seventy-nine patients were included (62% male, median age 13 years). Durability was 96% at 1 year and 88% at 2 years. Nine patients switched biologics with a median time of 57 weeks. Predictors of therapy failure included the need for escalated induction (odds ratio [OR] 8.5, p = 0.01) colonic phenotype (OR 9.7, p < 0.01), and post-induction calprotectin level above 305 μg/g (positive predictive value 36%) were identified. Utilizing a proactive TDM results in excellent durability of IFX at 2 years in paediatric CD. Colonic phenotype is an independent predictor for IFX failure, highlighting the need for directed therapy.

PMID 42494426
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PubMedPloS one2026-07-24

Pharmacokinetic model selection for infliximab based on inflammatory bowel disease phenotype and severity: Toward model-informed precision dosing.

Homšek Ilić Ana A, Jovanović Marija M, Marković Srđan S, Vezmar Kovačević Sandra S et al.

Ulcerative colitis (UC) and Crohn's disease (CD) differ in intestinal location and depth of involvement. Patients with UC who have or experienced a flare-up according to Truelove-Witts criteria (ACUS), as well as those with fistulizing Crohn's disease (FIST), may represent difficult-to-treat populations. This study investigates the phenotype- and severity-driven selection of infliximab (IFX) population pharmacokinetic models to optimize predictive performance and support precision dosing in inflammatory bowel disease (IBD) care. A retrospective analysis was conducted at University Hospital Medical Centre "Zvezdara". Twenty published IFX models were evaluated across five datasets (overall, ASUC, CD, FIST, UC), primarily using trough concentrations obtained via routine therapeutic drug monitoring. Predictive accuracy was assessed using median prediction error (MDPE) and median absolute prediction error (MAPE). Bayesian forecasts were evaluated using median individual prediction error (MDIPE) and its absolute value (MAIPE). Normalized prediction distribution errors (NPDE) and visual predictive check (VPC) were used for simulation-based diagnostics. Moreover, probability of probability of target-attainment (PTA%) per model and subgroup was calculated. No model met all predefined prediction-based performance criteria. In a priori analysis, the Matsuoka model showed the satisfactory overall performance, while the Xu model was most suitable for CD patients. In a posteriori analysis, the Ternant 2008 model had the well overall accuracy, with other models (Dreesen 2021 for ASUC, Matsuoka for CD, Brandse 2016 for UC) performing satisfactory in respective subgroups. Simulation NPDE diagnostics identified the Aubourg model as suitable for the overall dataset, while VPC results mainly supported the a priori analysis conclusions. These findings highlight the relevance of disease phenotype and severity in selecting IFX pharmacokinetic models. Rather than relying on a one-size-fits-all approach, tailoring model choice to patient subgroups enhances predictive performance. This supports a more individualized, model-informed precision dosing (MIPD) strategy for optimizing IFX dosing in IBD.

PMID 42497217
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PubMedCureus2026-07-24

Tofacitinib as Rescue Therapy in Steroid-Refractory Acute Severe Ulcerative Colitis: A Retrospective Cohort Study with Observations on Cytomegalovirus Coinfection.

Banerjee Subhadeep S, Yadav Dawesh D, Gupta Anand A, Kumar Ujjwal U et al.

Acute severe ulcerative colitis (ASUC) is a severe and potentially life-threatening condition in which one-third of patients are refractory to intravenous corticosteroids. Established rescue therapies--infliximab and cyclosporine--are limited by cost, administration constraints, and toxicity. Tofacitinib, an oral Janus kinase (JAK) inhibitor, possesses pharmacokinetic and mechanistic properties that may be advantageous in the inpatient setting. This study was conducted to assess the short-term efficacy and safety of tofacitinib as rescue therapy in steroid-refractory ASUC and to identify clinical predictors of treatment failure. We conducted a retrospective cohort analysis of all patients with ASUC admitted to our tertiary gastroenterology unit between March 2023 and August 2025. ASUC was defined per Truelove and Witts' criteria. Patients who failed to respond to intravenous hydrocortisone by Day 3 and who could not receive infliximab (due to cost or contraindication) were initiated on tofacitinib (10 mg thrice daily for 3 days, followed by 10 mg twice daily). The primary outcome was clinical response by Day 5-7, defined as a reduction in Mayo score of ≥3 points (≥30% from baseline) with an absolute rectal bleeding sub-score of 0-1. Secondary outcomes included non-response rate, adverse events, and the impact of colonic cytomegalovirus (CMV) DNA burden on treatment response. Ten consecutive patients with steroid-refractory ASUC received tofacitinib rescue therapy. The mean age was 29.6 ± 9.1 years; 60% were male. Seven patients (70%) achieved clinical response within 5-7 days. Three patients (30%) failed to respond and required alternative rescue therapy or surgical consultation. CMV DNA was detected in the colonic tissue of four patients; both patients with high viral loads (>50,000 copies/mL) failed to respond to tofacitinib despite concurrent antiviral therapy. Adverse events were minimal; one patient developed bicytopenia of uncertain attribution. Tofacitinib demonstrated a 70% short-term clinical response rate in steroid-refractory ASUC, with an acceptable safety profile. Higher colonic CMV DNA appeared to be associated with a lower likelihood of clinical response; however, this observation requires validation with further research. Tofacitinib represents a viable, cost-effective rescue option, particularly in resource-limited settings or when conventional biologics are contraindicated. Prospective comparative studies are needed to define its optimal positioning within ASUC treatment algorithms.

PMID 42495474
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PubMedEuropean burn journal2026-07-24

IgM- and IgA-Enriched Intravenous Immunoglobulin Combined with Cryopreserved Human Amniotic Membrane for Pediatric Toxic Epidermal Necrolysis: A Case Report.

Costa Alfio Luca AL, Bastin Alessandro A, Patelli Alessandro Jad AJ, Carnio Aurora A et al.

Introduction: Toxic epidermal necrolysis in children is a life-threatening emergency requiring prompt withdrawal of the culprit drug, transfer to an experienced center, and intensive supportive care. Case Report: An 11-year-old girl developed toxic epidermal necrolysis involving 90 percent of total body surface area after exposure to a nonsteroidal anti-inflammatory drug, with concomitant viral positivity. At the referring pediatric hospital, on day 2 the patient received high-dose intravenous immunoglobulin 2 g/kg and a single infusion of infliximab 5 mg/kg. She was transferred on day 6 to our Burn Unit. Histopathology confirmed complete epidermal loss. Treatment included IgM- and IgA-enriched intravenous immunoglobulin over 72 h and methylprednisolone 0.74 mg/kg/day for 30 days. Cryopreserved amniotic membrane was applied to trunk and limbs, and fluorescent light energy to the face. Complete re-epithelialization occurred within 14 days without complications. Pain resolved rapidly, with a Visual Analog Scale score of 0 on day 2. At 6 months, skin and mucosae were intact with only transient dyschromia. Conclusions: In this child with extensive toxic epidermal necrolysis and high predicted mortality, IgM/IgA-enriched immunoglobulin, low-dose corticosteroid and early staged cryopreserved amnion were associated with infection-free, complete re-epithelialization and full functional recovery.

PMID 42496478
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PubMedCancer research2026-07-23

Crosstalk Between Schwann Cells and CD4+ T Cells Promotes Perineural Invasion in Colorectal Cancer.

Liu Huayuan H, Deng Yiqiao Y, Yang Yi Y, Xue Junshuai J et al.

Perineural invasion (PNI) is a common pathological feature associated with poor prognosis of colorectal cancer (CRC). A better understanding of the mechanisms underlying PNI formation could help identify potential strategies to inhibit tumor progression. Here, we revealed an integral role of CD4+ T cells in the development and progression of PNI in CRC. Single-cell RNA sequencing, spatial transcriptomics, and multiplex immunohistochemistry profiling uncovered a distinct HSPA6+CD4+ T cell subset expressing T stress (Tstr) cell markers in CRC PNI tissues. Schwann cells (SCs) colocalized with the HSPA6+CD4+ Tstr cells in PNI, and functional studies showed that SCs promoted Tstr cell differentiation while Tstr cells enhanced SC migration. Interaction between SCs and CD4+ T cells activated the MAPK pathway in SCs and the JAK-STAT pathway in Tstr cells, and inhibition of MAPK and STAT signaling suppressed nerve invasion of CRC cells in vivo. Moreover, SCs in contact with tumor cells possessed the ability to recruit CD4+ T cells; tumor-derived TNF-α stimulated SCs to secrete CCL4, thereby recruiting CD4+ T cells toward SCs. The anti-TNF-α monoclonal antibody infliximab reversed the pro-invasive and pro-migratory effects of SCs on CRC cells and reduced intratumoral CD4+ Tstr cells, and the combination of infliximab with anti-PD-1 treatment produced a combinatorial tumor suppressive effect. Together, this study suggests that SCs near CRC tissues recruit CD4+ T cells and promote their conversion to CD4+ Tstr cells to establish an immunosuppressive microenvironment and simultaneously enhance the migration and tumor-promoting capabilities of SCs, thereby accelerating PNI development.

PMID 42489533
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