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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

PubMedBMC gastroenterology2026-09-19

Leucine-rich alpha-2 glycoprotein as a predictor of primary non-response to anti-TNF-α therapy in biologic-naïve Egyptian IBD patients.

Amer Ibrahiem I, El Batae Hassan H, Elshaer Yasmine A YA, Sherief Dalia Elsayed DE et al.

Anti-tumor necrosis factor-α (anti-TNF-α) agents are a cornerstone in inflammatory bowel disease (IBD) therapy, yet primary non-response remains a significant practical challenge. Leucine-rich alpha-2 glycoprotein (LRG) has been recognized as a promising marker for disease activity. This study aimed to evaluate the predictive significance of pre-treatment serum LRG for response to anti-TNF-α therapy in biologic-naïve Egyptian IBD patients. In this prospective cohort study, 100 biologic-naïve IBD adult patients (50 Crohn's disease [CD], 50 ulcerative colitis [UC]) and 100 healthy controls were enrolled. Patients received induction therapy with adalimumab or infliximab. Clinical, biochemical, and endoscopic evaluations were conducted at baseline and at week 24. Response was defined by clinical indices and endoscopic improvement, while biochemical normalization was evaluated as a secondary, supportive parameter. IBD patients had significantly elevated baseline LRG levels compared to the healthy controls (p < 0.001). Responders' baseline LRG was substantially lower than that of non-responders in both UC (26.53 vs. 34.88 µg/mL; p = 0.008) and CD (26.03 vs. 35.07 µg/mL; p = 0.006). Receiver operating characteristic analysis revealed a cut-off of > 29 µg/mL for predicting non-response, yielding sensitivities of 74.2% and 80.0% with specificities of 69.57% and 65.71% for UC and CD, respectively and negative predictive values of 85.7% for UC and 88.5% for CD. Multivariate regression confirmed baseline LRG as an independent predictor of non-response. Baseline serum LRG levels > 29 µg/mL demonstrated moderate discriminatory ability for predicting primary non-response to anti-TNF-α therapy in Egyptian IBD patients. LRG may serve as a useful adjunctive biomarker for pre-treatment risk estimation and recognizing patients who may require alternative therapeutic strategies.

PMID 42760552
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PubMedCrohn's & colitis 3602026-09-19

Advanced therapy options, choice, access, and treatment empowerment for inflammatory bowel disease (ADVOCATE-IBD): a UK-wide semi-structured interview study exploring patient preferences around advanced therapy decisions in inflammatory bowel disease.

Hardasani Ronit R, Radford Shellie Jean SJ, Peerally Mohammad Farhad MF

Advanced therapies, including biologics and small molecule drugs, are increasingly used in the management of inflammatory bowel disease (IBD), but their diverse characteristics can influence patient treatment choices and experiences. Understanding patient priorities and practicing shared decision-making can optimize treatment satisfaction and adherence. This qualitative study explored patient experiences on advanced therapies to identify factors influencing treatment decisions aiming to develop a practical tool supporting shared decision-making when initiating or switching treatments. Using purposive sampling, participants on advanced therapies for moderate-to-severe IBD were recruited through Crohn's & Colitis UK and social media until achieving data saturation. Semi-structured interviews were conducted using a topic guide developed from literature review and patient representative input. Audio recordings were transcribed and analyzed using reflexive thematic analysis. Of 26 participants, most were female (73.1%) and using Vedolizumab (30.7%) or Infliximab (26.9%). The age group 31-40 (34.6%) was most commonly represented, and 46.2% had ulcerative colitis. All participants were in self-reported clinical remission. Four overarching themes were identified: embedding treatment realities into daily routines; negotiating the tension between therapeutic benefits and potential risks; navigating formal and informal support structures; and asserting agency in treatment decisions. Patient decision-making around advanced therapies for the management of moderate-to-severe IBD is influenced by treatment practicality and life impact, balancing efficacy and risk management, access to healthcare support networks, and involvement in care decisions. The Advanced therapy options, choice, access, and treatment empowerment for IBD tool, developed from these findings, provides clinicians with a framework to understanding individual patient priorities and values, supporting meaningful shared decision-making.

PMID 42762039
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PubMedBMJ open2026-09-18

Randomised treatment of acute pancreatitis with infliximab: protocol for a double-blind, placebo-controlled, multi-centre, adaptive, phase 2 superiority trial (RAPID-I).

Lin Juan J, Smyth Matt M, Spowart Catherine C, Brown Michaela M et al.

Acute pancreatitis (AP) is an increasingly common cause of substantial morbidity and risk of mortality without licensed specific drug therapy. Because tumour necrosis factor α (TNF-α) contributes to AP, anti-TNF therapy may improve outcome from AP. This trial aims to test the efficacy, safety, cost-effectiveness and mechanism of action of the anti-TNF antibody infliximab in patients with AP. Randomised treatment of Acute Pancreatitis with Infliximab: Double-blind, placebo-controlled, multi-centre trial (RAPID-I) is a phase 2b trial designed to randomise 240 patients with AP to receive a single 5 mg/kg or 10 mg/kg infliximab or placebo infusion in a 1:1:1 ratio, initiated within 36 hours of hospital admission. The primary outcome is mean serum C-reactive protein (CRP) on trial days 2, 4 (±1 day) and 14 (±2 days) summated as area under the curve (AUC), with 25% reduction in either active arm compared with placebo considered clinically meaningful. Secondary outcomes include cumulative pain scores, opiate requirements, nutritional deficit (days without solid food), decline in serum albumin (negative AUC), rise in neutrophils (AUC), cumulative selective serial organ failure assessment (SOFA-2) scores, local pancreatic injury on contrast-enhanced CT scan (CECT day 14±7 days), infections, length of stay, mortality and patient reported outcome on days 4 (±1 day), 14 (±2 days) and 90 (±7 days). Cost-effectiveness will be based on costs and quality-adjusted life years over 90 (±7) days. Potential safety signals will be adverse events related to infliximab. Transcriptomic, cytokine and leucocyte profiles will be assessed at baseline and the same time points as CRP. Two adaptive interim analyses are planned. The protocol has received Research Ethics Committee approval (South Central - Oxford C Research Ethics Committee 18/SC/0262). The findings will be disseminated through peer reviewed publication, national and international conferences and meetings. NCT03684278.

PMID 42760074
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PubMedBritish journal of clinical pharmacology2026-09-18

Switching standard dosed intravenous to subcutaneous infliximab leads to similar drug exposure in inflammatory bowel disease patients independent of concomitant immunosuppressants (SHUFFLE study).

van de Ven-van Dinter Lieke M J LMJ, Romberg-Camps Mariëlle J L MJL, Wong Dennis R DR, van Bodegraven Adriaan A AA et al.

Subcutaneous (SC) flat-dose infliximab (IFX) biosimilar offers potential advantages over intravenous (IV) weight-based dosing. Prospective pharmacokinetic data and clinical outcomes in inflammatory bowel disease (IBD) are scarce, since drug approval was primarily based on a rheumatoid-arthritis study population concomitantly using methotrexate. We aim to compare IFX exposure during IV and SC therapy in IBD patients and address the effect of concomitant immunosuppressants. In this single-centre, prospective study, adult IBD patients in clinical remission on a 6-8 weekly IFX IV-dosing interval were switched to biweekly SC IFX and followed for 24 weeks. Primary endpoint was the area under the concentration-time curves (AUCs). Secondary endpoints included trough levels, time burden and quality-of-life (inflammatory bowel disease questionnaire [IBDQ-NL]). As an additional follow-up assessment, trough levels at ≥12 months were compared across IFX mono-, combination- and immunosuppressant discontinuation groups. Thirty-five patients were evaluated: 20 received IFX monotherapy and 15 IFX combination therapy. Mean AUCs6-8 weeks were comparable between IV and SC administration, independent of immune suppressive. IFX trough levels increased on SC IFX median 4.6 mg/L vs.16.1 mg/L (p < 0.05), independent of concomitant immunosuppressants. These results were consistent at ≥12 months, regardless of monotherapy, combination therapy or immunosuppressant discontinuation. Time burden decreased substantially (median -9.3 h/6 months, p < 0.05), and IBDQ-NL score increased (189-197, p < 0.05). There were no exacerbations during follow-up. After 24 weeks, 97% were still being treated with IFX SC. SC IFX in IBD patients maintained equivalent drug exposure with higher trough levels, reduced time burden and stable quality-of-life, independent of concomitant immunosuppressants.

PMID 42755407
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PubMedFrontiers in immunology2026-09-18

Mechanisms of therapeutic antibodies immunogenicity: infliximab oligomeric aggregates increase T-cell response and uptake by dendritic cells involving mannose-sensitive receptor CD206.

Lteif Maria M, Nabhan Myriam M, Tardif Cécile C, Smadja Claire C et al.

Aggregation of therapeutic antibodies (Ab)s is now recognized as a major product-related factor associated with increased potential of immunogenicity. Regulatory agencies have established limits for the presence of (sub)visible particles in commercialized products. These particles are considered a potential risk factor for the development of unwanted immune responses. However, little is known concerning the role of oligomeric Abs aggregates of nanometric size in Abs' immunogenicity. The objective of this work was to better understand the role and the mechanisms of T-cell response to nanometric Ab aggregates using infliximab (IFX) as a model. We produced nanosized IFX aggregates by exposing native IFX to ultraviolet light. These aggregates were characterized using size exclusion chromatography (SEC), dynamic light scattering (DLS) and field flow fractionation coupled with a multi-angle light scattering detector (FFF-MALS). We then investigated the impact of IFX aggregation on its uptake by dendritic cells and the subsequent activation of IFX-specific T-cell responses. Using a human in vitro autologous dendritic cell (DC)/T-cells coculture assay, we showed that aggregation increased the frequency of responsive T cells to IFX. Moreover, we observed exclusive T-cell responses to IFX aggregates and different TCR clonotypes responding to each form of IFX. Using fluorescent native or aggregated IFX, we found a significantly higher internalization rate of aggregated IFX by DCs in a mannose-dependent manner. Confocal microscopy experiments showed that aggregates were rapidly internalized and associated with markers of early endosomes and lysosomes as well as antigen presentation molecules, compared to the native form of IFX. Our results suggest that internalization of IFX oligomeric aggregates via the mannose receptor pathway significantly contributes to enhanced IFX uptake by DCs and increased routing into the degradative pathway for processing into peptides. Increased presentation of immunogenic peptides may contribute to the augmentation of T-cell recruitment with aggregates compared to the native form. .

PMID 42756419
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PubMedCancer reports (Hoboken, N.J.)2026-09-18

Cardiovascular Immune-Related Adverse Events of Immune Checkpoint Inhibitors: A Systematic Review and Meta-Summary of Case Reports.

Godin Shea-Lee SL, Kingma Tyler T, Pillai Ashwin A, Kholoki Obada O et al.

Reports of immune checkpoint inhibitor (ICI) therapy-associated immune-related adverse events (irAEs) exhibit considerable heterogeneity, particularly when comparing data from clinical trials and real-world observational studies. We conducted a systematic review of real-world observational studies (case reports and series) reporting cardiovascular irAEs in PubMed and Embase from inception to April 1, 2024. We analyzed 116 case reports from 115 studies and highlighted the commonest irAEs, treatments instituted, and ensuing outcomes. Myocarditis was the most common, accompanied frequently by pericarditis and heart failure. Treatment typically included corticosteroids and discontinuation of ICI therapy. Higher doses of corticosteroids appeared promising. Refractory cases benefited from plasmapheresis, intravenous immunoglobulin, mycophenolate, tacrolimus, or infliximab. Rechallenging ICI therapy after irAEs resulted in mixed outcomes. Given the heterogeneity of data, analysis of aggregated data from central repositories like Side Effect Registry Immuno-Oncology (SERIO) would be invaluable.

PMID 42754915
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