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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

PubMedCrohn's & colitis 3602026-08-04

Comparative effectiveness of adalimumab versus infliximab in children with Crohn's disease: real-world data from the prospective PIBD-SETQuality inception cohort study.

Vuijk Stephanie A SA, Klomberg Renz C W RCW, Katgert Eva E, Wessels Margreet M S MMS et al.

Infliximab and adalimumab are effective anti-tumor necrosis factor (anti-TNF) therapies for the treatment of pediatric Crohn's disease (CD). The aim of this study was to compare the effectiveness of infliximab and adalimumab in a real-world cohort of children with CD. Data from biological-naïve children with luminal CD (age 3-18 years) who commenced anti-TNF and completed at least 1 year of follow-up were collected from the prospective multicenter observational PIBD-SETQuality study. The primary outcome was steroid-free clinical remission (SFCR), defined as clinical remission (weighted pediatric Crohn's disease activity index [wPCDAI] <12.5) without systemic steroids or luminal surgery at 1 year. The relative risk (RR) of SFCR was calculated using standardization, correcting for the following baseline covariates: age, upfront anti-TNF, C-reactive protein, erythrocyte sedimentation rate, albumin, leukocytes, disease behavior, wPCDAI, perianal disease, and concomitant immunomodulator use. Secondary outcomes included the durability of anti-TNF treatment without luminal surgery. Between January 1, 2017, and June 14, 2024, 178 patients with anti-TNF were included (infliximab: n = 121 [68%], adalimumab: n = 57 [32%]). At 12 months, 34/56 (61%) patients treated with adalimumab and 66/120 (55%) patients treated with infliximab had reached SFCR. The RR of SFCR at 1 year with adalimumab compared to infliximab was 1.25 (95% confidence interval [CI] 0.94-1.66], P = .13. Adalimumab was associated with a significant lower adjusted hazard ratio (aHR) of treatment discontinuation than infliximab in patients with a concomitant immunomodulator (aHR 0.17 [95% CI 0.04-0.75], P = .020), adjusted for upfront anti-TNF. In this prospective cohort of children with CD, adalimumab and infliximab showed comparable clinical effectiveness 1 year after the start of anti-TNF treatment. The ClincalTrials.gov ID of this study is NCT03571373.

PMID 42549261
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PubMedClinical case reports2026-08-04

A Challenging Case of Advanced Cardiac Sarcoidosis Refractory to Infliximab Therapy.

Ibrahim Manal M, Dulay Mansimran Singh MS, Wechalekar Kshama K, Kouranos Vasileios V et al.

Cardiac sarcoidosis can be life-threatening, and lack of response to immunosuppressive therapy remains a significant challenge in active disease. We present a case of refractory cardiac sarcoidosis despite third-line immunosuppression (infliximab). Ongoing multimodality assessment is essential for managing refractory cardiac sarcoidosis.

PMID 42548916
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PubMedSkin health and disease2026-08-02

Drug survival of biologic treatments for psoriasis and psoriatic arthritis in Denmark, 2018-23: a nationwide register-based cohort study.

Kim Sejun S, Jensen Andreas A, Egeberg Alexander A, Stensballe Lone Graff LG

Psoriasis is a chronic inflammatory skin condition. It is being increasingly treated with biologic agents targeting specific immune pathways. These treatments target specific immune system pathways involved in the disease. Drug survival (how long patients remain on a given treatment) is a key measure of long-term effectiveness and safety. To analyse the drug survival rates of approved biologics for psoriasis using Danish nationwide register-based data from 2018 to 2023. This study used a nationwide register-based cohort of patients diagnosed with psoriasis in Denmark who were treated with biologics between 2018 and 2023. Patients were stratified by the presence or absence of psoriatic arthritis (PsA). Drug survival was assessed using Kaplan-Meier curves, and the rate of discontinuation was analysed using Cox proportional hazards regression models. Of the biologics studied, infliximab had the highest 1-year drug survival (49%), followed by ustekinumab (42%). Bimekizumab, the most recently introduced biologic in Denmark, had a 19% drug survival rate after 349 days. Ustekinumab had longer persistence in patients who only had psoriasis, but the drug survival rate was reduced in patients with PsA. In contrast, infliximab maintained robust performance across both patient groups, with a significantly lower risk of discontinuation compared with ustekinumab (hazard ratio 0.59, 95% confidence intervals 0.53-0.67), particularly in patients with PsA. Drug survival differed across biologic treatments and according to PsA status. Infliximab had higher overall drug survival, particularly in patients with PsA. Ustekinumab had greater treatment persistence in patients without PsA but lower drug survival in those with PsA.

PMID 42540015
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PubMedRadiology case reports2026-08-02

Tumefactive parenchymal lesion of neurosarcoidosis responsive to infliximab.

Dhillon Karn K, Roy Shuvro S

Neurosarcoidosis is an uncommon manifestation of systemic sarcoidosis and can involve any part of the nervous system. Intraparenchymal tumefactive lesions are particularly rare and pose a diagnostic challenge due to their radiographic resemblance to high-grade gliomas or metastatic disease. Optimal management remains complex, especially in cases refractory to or dependent on glucocorticoids.

PMID 42540650
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PubMedCrohn's & colitis 3602026-08-02

Induction-phase infliximab monitoring accelerates time to remission in pediatric IBD: a retrospective cohort study.

Iovino Nicholas N, Paglinco Samantha R SR, Abdel-Rasoul Mahmoud M, McNicol Megan M et al.

In pediatric inflammatory bowel disease (IBD), the optimal timing to begin therapeutic drug monitoring (TDM) of infliximab (IFX) is unclear. We hypothesized that TDM during induction of IFX improves clinical outcomes in children with IBD. This retrospective cohort study utilized data from an internal database at Nationwide Children's Hospital between January 1, 2020, and December 31, 2023. Pediatric IBD patients receiving IFX with induction-phase TDM (I-TDM) at Week 6 were compared to those with maintenance-phase TDM (M-TDM) at Week 14. Propensity score matching (PSM) was used for sex, disease, and age at IFX start. The primary outcome was time to clinical remission. In total, 68 patients were matched from each group. The I-TDM group experienced a shorter median time to clinical remission (140 days [95% CI: 108, 167]) compared to the M-TDM group (203 days [95% CI: 167, 232]; P = .006). When adjusting for baseline variations, I-TDM remained independently associated with accelerated clinical remission (aHR = 1.68, 95% CI: 1.10, 2.55; P = .016). While time to therapeutic maintenance IFX levels was similar, post hoc analysis showed that 75% of patients in the I-TDM group achieved target levels in 134 days (95% CI: 114, 182) versus 183 days (95% CI: 153, 224) in the M-TDM group. There were no significant differences in long-term complications between the groups. Induction-phase TDM before the third infusion shortens the time to clinical remission, allowing for more prompt dose adjustments and improving patient outcomes. This approach warrants consideration in clinical practice for children with IBD.

PMID 42540636
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PubMedEULAR rheumatology open2026-08-02

Management of major organ involvement in Behçet syndrome: a systematic literature review informing the 2025 update of the EULAR recommendations.

Ozguler Yesim Y, Esatoglu Sinem Nihal SN, Tomasson Gunnar G, Falzon Louise L et al.

The objective of this study was to evaluate and update the evidence on pharmacologic and interventional treatments for major organ involvement in Behçet syndrome (BS), in order to inform the 2025 update of the European Alliance of Associations for Rheumatology recommendations. A systematic literature review was conducted using 2 distinct search strategies for pharmacologic and surgical/interventional therapies, covering major databases from October 2015 to November 2024. Controlled studies comparing active interventions with placebo or another active treatment were included. If no controlled trials were available for a specific research question, uncontrolled studies or case series with at least 10 patients with BS were included. Of 7128 citations, 69 studies on major organ involvement and tapering/withdrawal of immunosuppressives were included. Only 5 were randomised controlled trials (RCTs), 4 of them included patients with eye involvement, and 1 included patients with vascular or nervous system involvement. RCTs and comparative observational studies for eye involvement supported the use of monoclonal tumour necrosis factor alfa inhibitors and interferon alfa. The RCT that included patients with vascular or nervous system involvement favoured infliximab over cyclophosphamide based on complete response rates and safety. Observational data additionally supported the use of interferon alfa for venous thrombosis, whereas the role of adjunctive anticoagulation remains unclear. Noncomparative observational studies showed benefit with monoclonal tumour necrosis factor alfa inhibitors in patients with gastrointestinal involvement. This systematic literature review provided evidence on the management of major organ involvement to inform the task force for developing the 2025 update of the European Alliance of Associations for Rheumatology recommendations for the management of BS.

PMID 42540035
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