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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

PubMedImmunity, inflammation and disease2026-07-27

The Diagnostic Challenge of Crohn's Disease With Initial Duodenal Involvement: Two Cases and Literature Review.

Chen Chaochao C, Li Yongrong Y, Chen Yiyao Y, He Zhoutao Z et al.

Upper gastrointestinal Crohn's disease (UGI-CD) is rare, with an adult prevalence of 0.5%-4.0%. Its nonspecific symptomatology and the absence of clear diagnostic guidelines pose significant diagnostic challenges. We present two patients with UGI-CD treated at Hainan General Hospital. In the first case, a 47-month diagnostic delay led to disease progression and surgical intervention. In the second case, prompt diagnosis of a duodenal ulcer enabled medical management, avoiding surgery. Both patients received infliximab and achieved remission. These cases highlight diagnostic challenges in UGI-CD and offer three key lessons: (i) UGI-CD should be suspected in refractory, Helicobacter pylori-negative duodenal ulcers; (ii) an endoscopic-radiologic mismatch may occur; and (iii) we propose a diagnostic algorithm to assist early recognition, though it has not been prospectively validated. Given the descriptive nature of this two-case series, these findings are hypothesis-generating and require further validation.

PMID 42504643
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PubMedThe new microbiologica2026-07-27

Clinical characteristics and risk factor analysis of EBV and CMV infection in the patients with inflammatory bowel disease.

He Yuting Y, Wu Zhongwen Z

Epstein-Barr virus (EBV) and cytomegalovirus (CMV) are common opportunistic viruses in inflammatory bowel disease (IBD). Clinical features and risk factors of EBV and CMV infection in IBD patients have been explored. Clinical information of IBD patients was collected. Viral loads were detected by quantitative polymerase chain reaction (qPCR) and Clostridioides difficile (C. difficile) toxin genes were detected using GeneXpert. Univariate and multivariate logistic regression analyses were performed. Both positive groups showed higher ulcerative colitis (UC) to Crohn's disease (CD) ratio and more severe disease activity (P < 0.05). The EBV infection group had higher proportions of males, older patients, severe diarrhea, and C. difficile infection (P < 0.05). Glucocorticoid therapy was associated with increased EBV and CMV prevalence and infliximab (IFX)/lizumab was associated with increased EBV prevalence (P < 0.05). Age > 60 years, UC, severe disease activity and IFX/lizumab use were identified as risk factors for EBV infection. UC was an independent risk factor for CMV infection. UC patients are more susceptible to CMV and EBV infection. Higher-risk patients for EBV infection include those aged >60 years, those with severe disease activity, or those on IFX/lizumab therapy, especially males and those with C. difficile infection.

PMID 42507125
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PubMedClinical pharmacokinetics2026-07-26

Pharmacometric Targets During Anti-TNF Induction and Their Association with Deep Remission in Pediatric Crohn's Disease.

Nasr Alexander A, Mizuno Tomoyuki T, Irie Kei K, Dillman Jonathan R JR et al.

Personalizing anti-tumor necrosis factor (TNF) therapy in pediatric Crohn's disease (CD) remains challenging due to variable drug clearance and response. Identifying pharmacokinetic (PK) and pharmacodynamic (PD) predictors of deep remission could enable precision dosing strategies. The primary aim was to define PK metrics and PD biomarkers associated with deep remission. Patients initiating infliximab or adalimumab were prospectively enrolled from four pediatric centers with longitudinal blood and stool biospecimens collected for one year. Deep remission was defined as a combination of weighted pediatric CD activity index (wPCDAI) < 12.5 and Simple Endoscopic Score-CD < 3. Trough concentrations (cTrough) were measured throughout the study. Drug exposure (area under the curve, AUC) and clearance were estimated using drug-specific population PK models and Bayesian estimation using nonlinear mixed-effects modeling (NONMEM). Deep remission was achieved in 34/70 (48.6%) with no difference in outcomes between biologics. Infliximab cTrough thresholds associated with deep remission were 33 µg/mL (Week 2), 15 µg/mL (Week 6), and 4.7 µg/mL (Month 3) with Week 6 cTrough targets ranging 15-26 µg/mL depending on the outcome of interest. Higher AUC during induction for both infliximab and adalimumab was associated with deep remission, whereas rapid infliximab clearance at various timepoints was inversely associated with deep remission. Baseline predictors of rapid infliximab clearance included older age, low albumin, and elevations in body mass index, C-reactive protein, soluble CD64, and wPCDAI. We identified PK/PD cut-points associated with deep remission and rapid infliximab clearance, providing actionable metrics to individualize induction dosing and optimize maintenance therapy for children starting anti-TNF therapy.

PMID 42503050
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PubMedRevista de gastroenterologia del Peru : organo oficial de la Sociedad de Gastroenterologia del Peru2026-07-26

[PANCCO Clinical Practice Guideline Update for the treatment of ulcerative colitis in adults].

Núñez Figueroa Paulina P, Sánchez Orozco Abel A, Alfaro Pérez Ignacio I, Andara Ramírez María Teresa MT et al.

To update the recommendations of the Pan American Crohn's and Colitis Organisation (PANCCO) for the treatment of moderate-to-severe ulcerative colitis (UC) in adults, incorporating recent evidence on new biologics, small molecules, subcutaneous formulations and appendectomy. The PAHO rapid GRADE methods were applied. PANCCO adapted the Colombian guideline 2025 for upadacitinib, tofacitinib, ozanimod and the switch to subcutaneous formulations, and developed de novo recommendations for etrasimod, guselkumab, risankizumab, ustekinumab, mirikizumab, filgotinib and appendectomy. The search was carried out in MEDLINE, Embase, Cochrane and Epistemonikos through February 2026, with quality appraised with ROBIS, AMSTAR-2, RoB 2.0 and ICEMAN; strength of recommendations was established using GRADE. Recommendations were issued for nine clinical questions. In moderate-to-severe UC, upadacitinib, tofacitinib, filgotinib, ustekinumab, mirikizumab, risankizumab and guselkumab are recommended; ozanimod and etrasimod are conditionally suggested, considering the cardiovascular profile. In patients with response to intravenous induction, switching to subcutaneous vedolizumab or subcutaneous infliximab is suggested. In UC refractory to advanced therapies, laparoscopic appendectomy is conditionally suggested as an adjuvant strategy. This third update expands the therapeutic armamentarium for moderate-to-severe UC in Latin America. Treatment choice should be individualized according to prior therapy, comorbidities, cardiovascular and thrombotic risk, availability and patient preferences.

PMID 42502002
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PubMedZhonghua yi xue za zhi2026-07-26

[Efficacy and safety analysis of adalimumab in the treatment of pediatric patients with inflammatory bowel disease].

He X X, Luo X T XT, Wang M J MJ, Gong Y Z YZ et al.

To evaluate the efficacy and safety of adalimumab (ADA) in pediatric patients with inflammatory bowel disease (IBD). Clinical data of IBD children who initially received ADA treatment at the Capital Center for Children' s Health, Capital Medical University from January 2020 to August 2025 were retrospectively collected. At week 12 of ADA therapy, according to whether the children achieved clinical remission or endoscopic remission, they were divided into clinical remission group [pediatric Crohn's disease activity index (PCDAI)<10.0 points or pediatric ulcerative colitis activity index (PUCAI)<10 points] and clinical non-remission group, endoscopic remission group [Crohn's disease endoscopic index of severity (CDEIS)<3 points or ulcerative colitis endoscopic index of severity (UCEIS)=0 points] and endoscopic non-remission group. At weeks 12, 24 and 48, the clinical remission rate and endoscopic remission rate of the children were assessed, respectively. The baseline data of the remission group and the non-remission group at week 12 were compared, and the safety and antibody production status of ADA treatment were also evaluated. A total of 39 pediatric IBD patients were included, with 20 males and 19 females. The age at onset [M(Q1, Q3)] was 11 (6, 14) years, and the median follow-up time was 70 (19, 130) weeks. For ADA treatment at weeks 12, 24, and 48, the clinical remission rates of the children were 69.2% (27/39), 75.0% (18/24), and 73.7% (14/19), respectively; the endoscopic remission rates were 31.8% (7/22), 33.3% (1/3), and 42.9% (6/14), respectively. At week 12, the clinical remission group had a shorter baseline disease duration[12 (5, 24) vs 41 (34, 52) months, P<0.001] and lower baseline fecal calprotectin levels [560 (389, 1 800) vs 1 380 (813, 1 800) μg/g, P=0.015] compared to the clinical non-remission group; At week 4, ADA trough concentration was higher [22 (18, 32) vs 13 (9, 19) mg/L, P=0.017] than that in the non-remission group. Compared to the endoscopic non-remission group, at week 12 the endoscopic remission group had lower baseline fecal calprotectin levels [504 (369, 567) vs 1 200 (659, 1 800) μg/g, P=0.019] and fewer prior infliximab (IFX) users [28.6% (2/7) vs 80.0% (12/15), P=0.020]; while at week 4, ADA trough concentration was higher [35 (23, 35) vs 13 (10, 20) mg/L, P<0.001] than that in the endoscopic non-remission group. The incidence of adverse reactions was 13% (5/39), including alopecia, allergic reactions, and cytomegalovirus infection; only 3 cases produced relatively high antibodies (>30 ng/ml). ADA demonstrates good efficacy and safety in pediatric IBD patients.

PMID 42502070
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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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