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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

PubMedComputer methods in biomechanics and biomedical engineering2026-09-10

UCResponNet-X: cross-platform multi-dataset gene expression for predictive modeling of drug response in ulcerative colitis.

Topkaraoğlu Mehmet Kutalmış MK, Cantürk İsmail İ

Predictive modeling of biologic drug response using transcriptomic data is challenged by strong platform-specific effects between microarray and RNA-sequencing technologies. In this study, we propose UCResponNet-X, a computational framework designed to evaluate and improve cross-platform generalizability of machine-learning models for predicting infliximab response in ulcerative colitis. The framework integrates three independent microarray cohorts for training and validation and assesses model transferability on an external RNA-seq dataset. We systematically compare log2 transformation, quantile normalization, and z-score standardization in combination with batch-effect correction and biologically informed feature selection. Multiple classification algorithms are evaluated under a unified cross-validation protocol. Our results demonstrate that z-score and log2 normalization substantially outperform quantile normalization in preserving predictive signal across platforms, achieving mean cross-validation AUC values up to 0.824 and an external RNA-seq test AUC of 0.821. The findings highlight the normalization strategy as a decisive computational factor in cross-platform transcriptomic modeling and support the reuse of legacy microarray data for predictive biomedical engineering applications.

PMID 42717746
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PubMedFrontiers in pharmacology2026-09-10

Biologic and targeted synthetic therapies in ankylosing spondylitis: a pharmacological review.

Ameer Omar Z OZ, Temsah Reem R, Alsouss Yara O YO, Al-Amoudi Raghad R et al.

Ankylosing spondylitis (AS) is a prototypical axial spondyloarthritis (axSpA) defined by chronic inflammatory back pain, progressive spinal stiffness, and frequent extra-articular manifestations such as acute anterior uveitis (21%-33%), inflammatory bowel disease (5%-10%), and psoriasis (4%-13%). Management has shifted from non-steroidal anti-inflammatory drugs (NSAIDs) to highly targeted biologic and synthetic disease-modifying antirheumatic drugs (DMARDs). This comprehensive review focuses on the current evidence for biologic and targeted synthetic therapeutics in the management of AS, emphasizing mechanisms of action, regulatory approvals, dosing regimens, and clinical efficacy. Three major therapeutic classes are identified: two biologic DMARD classes, comprising tumor necrosis factor-alpha (TNF-α) inhibitors and interleukin-17 (IL-17) inhibitors, and the targeted synthetic DMARDs, namely, the Janus kinase-signal transducer and activator of transcription (JAK-STAT) inhibitors. TNF inhibitors (adalimumab, infliximab, etanercept, golimumab, certolizumab pegol) typically achieve Assessment of Spondyloarthritis International Society 40% improvement (ASAS40) rates of 40%-58% at 12-24 weeks versus 13%-24% with placebo, and maintain clinical benefit in many patients over 5-8 years. IL-17 inhibitors (secukinumab, ixekizumab, bimekizumab, brodalumab, netakimab) yield broadly similar ASAS40 responses (30%-50% versus 10%-20% placebo) and are particularly useful in patients with concomitant psoriasis with substantially reduced risk of tuberculosis reactivation. JAK inhibitors (tofacitinib, upadacitinib) represent the newest class, offering oral administration with ASAS40 responses of 40%-52% versus 13%-26% for placebo in both biologic-naïve and biologic-experienced AS, though cardiovascular safety considerations necessitate careful patient selection. Therapeutic selection should consider comorbidities (uveitis favors TNF monoclonal antibodies; psoriasis favors IL-17 inhibitors), safety profile, route of administration, and sequencing after non-steroidal anti-inflammatory drug failure. Understanding these pharmacological distinctions enables personalized therapeutic decisions based on the specific molecular pathology and risk profile of the individual patient.

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PubMedThe lancet. Gastroenterology & hepatology2026-09-10

Long-term outcomes of top-down therapy versus a conventional step-up strategy in adults newly diagnosed with Crohn's disease: 5-year follow-up of the PROFILE trial.

Noor Nurulamin M NM, Sharip Mohmmed Tauseef MT, Zheng Haiyan H, Widmer Barry B et al.

The PROFILE trial previously reported better 48-week outcomes for patients with Crohn's disease who received top-down anti-TNF treatment from diagnosis, compared with a conventional step-up strategy. Through subsequent follow-up of PROFILE participants, we aimed to assess whether the benefit of top-down treatment from diagnosis results in modification of the long-term disease course. PROFILE was a multicentre, open-label, randomised controlled trial completed in 40 hospitals in the UK, which included patients aged 16-80 years with newly diagnosed Crohn's disease. Eligible patients were randomly assigned via a secure online platform to a top-down (infliximab plus immunomodulator) or a step-up protocolised treatment strategy for 48 weeks, after which participants reverted to local standards of care. Objective outcome data were extracted for up to 5 years after the week 48 visit, including need for Crohn's-related abdominal surgery as the primary outcome. Data were analysed based on the original PROFILE randomisation and intention-to-treat population. Participants without long-term follow-up data were censored at the week 48 visit. Time-to-event analyses were performed using the Kaplan-Meier method and Cox proportional hazards model. The trial was registered with the ISRCTN registry, number 11808228 and is complete. Between Dec 29, 2017, and Jan 5, 2022, 483 patients were assessed for inclusion. 389 patients were enrolled and randomly assigned (three patients were excluded due to ineligibility), 193 to top-down treatment and 193 to step-up treatment. Of the 386 participants in the PROFILE primary trial, 358 (93%) had post-week 48 records available for review (182 [51%] top-down and 176 [49%] step-up). Median follow-up was approximately 5 years from randomisation (1809 days [IQR 1300-2101]), by which point 172 (89%) of 193 patients in the step-up group and 191 (99%) of 193 patients in the top-down group had received biological or immunomodulator therapy. Relating to the primary outcome, during follow-up there were 28 Crohn's disease-related abdominal surgeries in 26 patients treated with a step-up approach versus six surgeries in six patients treated with a top-down approach. Time to surgery was shorter in the step-up group than the top-down group (adjusted hazard ratio [aHR] 5·23 [95% CI 1·99-13·76]; p=0·0008). For the secondary outcomes, incidence of Crohn's disease-related hospital admissions was higher in patients originally managed with step-up treatment versus top-down treatment (41 [21%] of 193 patients vs 22 [11%] of 193 patients); and time to first hospital admission was shorter with step-up treatment than with top-down treatment (aHR 2·01 [95% CI 1·18-3·41], p=0·017). Progression to B2 or B3 complications was also more frequent in those originally managed with step-up treatment compared with top-down treatment (32 [17%] of 192 patients vs 13 [7%] of 193 patients); with time to disease progression being shorter in the step-up group than in the top-down group (aHR 2·46 [95% CI 1·25-4·86]; p=0·010). There was no difference in safety outcomes between groups for either serious infections (12 [6%] of 193 step-up patients and 14 [7%] of 193 top-down patients) or malignancies (five patients [3%] and three patients [2%] respectively). Early top-down anti-TNF treatment from diagnosis was associated with improved long-term outcomes at 5 years compared with step-up treatment and is suggestive of a disease-modifying effect in Crohn's disease. Wellcome and Celltrion.

PMID 42721994
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PubMedFederal practitioner : for the health care professionals of the VA, DoD, and PHS2026-09-09

Cross-Sectional Analysis of Biologic Use in the Treatment of Veterans With Hidradenitis Suppurativa.

Wendland Zachary Z, Rypka Katelyn K, Greenlund Lindsey L, Herzog Claire C et al.

Biologic medications, such as adalimumab, secukinumab, and bimekizumab, are currently the only medications approved by the US Food and Drug Administration for the treatment of hidradenitis suppurativa (HS). Low rates of biologic use in HS have been reported, with significant differences in prescription patterns by sex, race, and age. However, no studies have analyzed these metrics in the Veterans Health Administration (VHA). This study evaluated HS therapy in the VHA and potential disparities in biologic prescription patterns for patients. This retrospective cross-sectional analysis used VHA data from January 1, 2011, to December 31, 2021. Biologic prescriptions, including adalimumab and infliximab, were analyzed across varying patient demographics and characteristics. In VHA, 29,483 individuals had ≥ 1 diagnosis of HS, of whom 5.2% were prescribed ≥ 1 biologic (adalimumab or infliximab). Most patients diagnosed with HS were White (60.6%), men (75.3%), and obese (59.3%) and had prior or current tobacco use (73.5%). An age-dependent reduction in the odds of being prescribed a biologic in patients with HS (P < .001) was observed. Obesity (body mass index ≥ 30) significantly increased the odds of biologic prescription (P < .001). Biologic use in patients with HS was relatively low but higher or within the same range as previous studies. Understanding biologic prescription patterns offers potential to identify and improve access to underserved HS populations.

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PubMedRevista espanola de enfermedades digestivas2026-09-09

Time trends of pediatric inflammatory bowel disease in Catalonia from 2011 to 2023. Population-based cohort study.

Brunet-Mas Eduard E, Garcia Diana D, Vela Emili E, Comalrena Clara C et al.

Data on temporal trends in treatment use in pediatric inflammatory bowel disease (PIBD) are limited. This study aimed to evaluate treatment trends in PIBD in Catalonia and to explore their association with outcomes, including surgery and hospitalization. We conducted a population-based cohort study including all pediatric patients (<18 years) with IBD included in the Catalan Health Surveillance System, covering a population of more than 7.5 million individuals, between 2011 and 2023 were identified. Exposure to IBD treatments was obtained from electronic dispensation records. Temporal trends in treatment use, surgical procedures, and hospitalization rates were analyzed. Correlation analyses between treatments and outcomes were performed at the population level. The use of salicylates and corticosteroids increased from 18.6% to 24.8% and from 5.2% to 12.3%, respectively. Immunosuppressive treatment increased during the early study period and subsequently declined, with similar rates at baseline and study end (28.3% vs 29.5%). Advanced therapies increased markedly from 27.0% to 41.8%, with infliximab remaining the most frequently prescribed advanced therapy. Surgical rates (ostomies and resections per 1,000 patient-years) fluctuated over time without a consistent trend (p=0.21). Rates of PIBD-related hospitalization decreased from 205.2 to 150.3 per 1,000 patient-years. Advanced therapies use in PIBD increased substantially over the study period in Catalonia. This trend coincided with a reduction in PIBD-related hospitalization rates, whereas surgical outcomes remained unchanged. This increase occurred concurrently with a reduction in hospitalization rates, whereas no statistically significant linear trend was observed for surgical outcomes.

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PubMedAdvances in therapy2026-09-08

Comparative Cost-Effectiveness of Advanced Treatment Sequences for Moderately to Severely Active Ulcerative Colitis in Japan.

Kamei Kazumasa K, Enami Miwa M, Matsuda Hiroyuki H, Yamagami Katsuya K et al.

Ulcerative colitis (UC) is a chronic immune-mediated inflammatory disease characterized by a relapsing course, substantial symptom burden, and long-term healthcare utilization. Although multiple advanced therapies (ATs) are available for patients with moderately to severely active UC, evidence to guide optimal treatment sequencing remains limited, particularly in Japan. This study evaluated the cost-effectiveness of clinically relevant AT sequences for moderately to severely active UC in Japan. A hybrid decision-tree and Markov model was developed to compare AT sequences over a lifetime horizon from the payer perspective. The model captured both induction and maintenance phases for each therapy. Efficacy and safety inputs were derived from a previously published Bayesian network meta-analysis and supplemented with Japan-specific clinical and economic data. Costs and quality-adjusted life years (QALYs) were discounted at an annual rate of 2.0%. Incremental cost-effectiveness ratios (ICERs) were calculated, and cost-effectiveness was assessed against a Japanese cost-effectiveness threshold of JPY 7,500,000 per QALY (USD 49,547 per QALY). A total of 79 treatment sequences were evaluated. First-line etrasimod followed by second-line upadacitinib yielded the greatest health benefit (17.801 QALYs). Four treatment sequences-infliximab followed by ustekinumab, infliximab followed by etrasimod, infliximab followed by upadacitinib, and etrasimod followed by upadacitinib-were located on the efficiency frontier. Compared with infliximab-ustekinumab, infliximab-etrasimod resulted in an ICER of JPY 1,095,181 (USD 7235) per QALY. In turn, infliximab-upadacitinib had an ICER of JPY 1,218,896 (USD 8052) per QALY compared with infliximab-etrasimod. Etrasimod-upadacitinib had an ICER of JPY 6,684,442 (USD 44,160) per QALY compared with infliximab-upadacitinib. All ICERs were below the Japanese cost-effectiveness threshold. Under the assumptions of this model, a treatment sequence with first-line etrasimod followed by second-line upadacitinib was identified as the most cost-effective strategy for advanced therapy-naïve patients with moderately to severely active UC in Japan.

PMID 42709323
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