A Randomised, Double-blind, Parallel-group, Phase 3 Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis

This is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, and immunogenicity of FYB202 compared to Stelara® in patients with Moderate-to-Severe Plaque Psoriasis.

开始日期2020-11-09

申办/合作机构

bioeq GmbH

100 项与乌司奴单抗生物类似药 (Formycon) 相关的临床结果

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100 项与乌司奴单抗生物类似药 (Formycon) 相关的转化医学

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100 项与乌司奴单抗生物类似药 (Formycon) 相关的专利（医药）

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项与乌司奴单抗生物类似药 (Formycon) 相关的文献（医药）

2025-05-01·ADVANCES IN THERAPY

A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis

Article

作者: Freudensprung, Brigitte ; Nopora, Katrin ; Balser, Sigrid ; Trieb, Michael ; Papp, Kim ; Rewerski, Piotr

INTRODUCTION:

Biosimilars allow more patients access to affordable treatment options and help reduce the financial burden on healthcare systems. This multicentre trial compared the efficacy, safety, and immunogenicity of the approved biosimilar ustekinumab FYB202 with reference ustekinumab.

METHODS:

Eligible patients were ≥ 18 years old with stable moderate-to-severe plaque psoriasis for ≥ 6 months and inadequate treatment response to or intolerance of ≥ 1 previous systemic treatment. Patients were randomised (1:1) to double-blind treatment with FYB202 or reference ustekinumab; patients in the reference group who achieved Psoriasis Area and Severity Index (PASI) 75 percent improvement at week 28 were re-randomised to FYB202 or reference product. The primary efficacy endpoint was percent improvement in PASI score from baseline to week 12. Therapeutic equivalence was demonstrated if, depending on the regulatory requirement with respect to the significance level, the two-sided 95% and 90% confidence intervals (CIs) were within the pre-defined equivalence intervals of ± 11% and ± 10%, respectively.

RESULTS:

A total of 392 patients were randomised to FYB202 (n = 197) or reference ustekinumab (n = 195). Baseline characteristics were well balanced between groups. Mean percent improvement in PASI score at week 12 was equivalent between FYB202 and reference ustekinumab with an estimated least-squares mean treatment difference of 3.27% and the two-sided 95% (- 0.90%, 7.44%) and 90% (- 0.22%, 6.77%) CIs fully contained within the pre-defined equivalence margins. Safety and immunogenicity profiles were comparable between groups. Switching from reference product to FYB202 had no clinically relevant effect on efficacy, safety, or immunogenicity.

CONCLUSION:

FYB202 demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate-to-severe plaque psoriasis.

TRIAL REGISTRATION:

NCT04595409; EudraCT 2019-004364-21.

2024-12-01·Clinical Pharmacology in Drug Development

New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double‐Blind, Parallel‐Group, Single‐Dose Trial in Healthy Subjects

Article

作者: Wedemeyer, Ralph‐Steven ; Anschütz, Maria ; Nopora, Katrin ; Balser, Sigrid ; Schug, Barbara ; Körner, Juliane

Abstract:

In the RUSTIC trial, pharmacokinetic (PK) similarity between the proposed ustekinumab biosimilar FYB202 and EU‐approved (EU‐Ref) and US‐licensed ustekinumab (US‐Ref) as well as between both reference drugs was assessed after a single 45‐mg subcutaneous injection. Safety analyses comprised immunogenicity (antidrug antibodies, neutralizing antibodies), adverse events, and local tolerability. Overall, 491 healthy adults were randomized 1:1:1 and observed for up to 112 days; 486 completed the trial, and 478 were included in the PK analysis. All 3 comparisons showed PK similarity, since the 90% confidence intervals of the respective geometric mean ratios for area under the concentration‐time curve from time 0 to infinity and maximum serum concentration were contained within the acceptance interval of 80%‐125%. No clinically meaningful differences regarding overall safety, immunogenicity, and local tolerability were observed. Notably, after FYB202 administration, in fewer subjects at least 1 positive antidrug antibody result was observed compared to the reference groups (FYB202, 20%; EU‐Ref, 42%; US‐Ref, 51%). In conclusion, the RUSTIC trial demonstrated equivalent PK characteristics for FYB202 when compared to both EU‐Ref and US‐Ref ustekinumab and between both reference drugs. It provides the basis for the marketing authorization of FYB202, together with an extensive analytical characterization and the results of a confirmatory efficacy and safety trial in patients with moderate to severe plaque psoriasis.

2011-11-01·mAbs2区 · 医学

Discovery and mechanism of ustekinumab

2区 · 医学

Review

作者: Jill M. Giles-Komar ; David Peritt ; Jacqueline M. Benson ; Mary Ann Mascelli ; George A. Heavner ; David J. Shealy ; Bernard J. Scallon

Monoclonal antibody (mAb) therapy was first established upon the approval of a mouse antibody for treatment of human acute organ rejection. However, the high incidence of immune response against the mouse mAb restricted therapeutic utility. Development of chimeric, "humanized" and human mAbs broadened therapeutic application to immune-mediated diseases requiring long-term treatment. Indeed, mAb therapeutics targeting soluble cytokines are highly effective in numerous immune-mediated disorders. A recent example is ustekinumab, a first-in-class therapeutic human immunoglobulin G1 kappa mAb that binds to the interleukins (IL)-12 and IL-23, cytokines that modulate lymphocyte function, including T-helper (Th) 1 and Th17 cell subsets. Ustekinumab was generated via recombinant human IL-12 immunization of human immunoglobulin (hu-Ig) transgenic mice. Ustekinumab binds to the p40 subunit common to IL-12 and IL-23 and prevents their interaction with the IL-12 receptor β1 subunit of the IL-12 and IL-23 receptor complexes. Ustekinumab is approved for treatment of moderate-to-severe plaque psoriasis and has demonstrated efficacy in Crohn disease and psoriatic arthritis. The clinical characterization of ustekinumab continues to clarify our understanding of human immune pathologies and may offer a novel therapeutic option for certain immune-mediated diseases.

项与乌司奴单抗生物类似药 (Formycon) 相关的新闻（医药）

2026-05-07

·合理哥

靶向TNFα与IL-23双重通路在炎症性肠病中的机制、临床验证与商业前景深度剖析

▎Helixbro 在当今全球免疫与炎症（I&I）疾病的治疗格局中，炎症性肠病（Inflammatory Bowel Disease, IBD），特别是溃疡性结肠炎（UC）和克罗恩病（CD），正面临着严峻的临床挑战。尽管过去二十年来，生物制剂和小分子靶向药物的涌现极大地改变了IBD的治疗轨迹，但临床上单一靶点药物的有效性正在触及不可逾越的“天花板” 。随着对单一生物制剂原发性无应答（发生率高达30%）和继发性失应答（发生率约40%）现象的日益普遍，寻找能够打破这一僵局的下一代治疗策略成为了整个行业的焦点。在这一背景下，强生（Johnson & Johnson）基于Guselkumab（抗IL-23p19单抗）和Golimumab（抗TNFα单抗）的联合给药方案，以及随后开发的固定剂量复方制剂JNJ-78934804（又称JNJ-4804），为“双重先进靶向疗法”（Dual Targeted Therapy, DTT）确立了关键的临床与商业基准。一、双通路阻断的分子病理机制与生物学原理从免疫学和系统生物学的底层逻辑来看，炎症性肠病并非由单一的致病细胞因子所驱动，而是由多条相互交织、具有高度冗余性和代偿性的免疫级联反应网络共同介导。抗肿瘤坏死因子（Anti-TNFα）药物在诱导和维持IBD临床缓解方面曾取得巨大成功，但随之而来的免疫原性（如抗药抗体的产生）和靶向逃逸现象揭示了黏膜免疫网络的动态流动性。当TNFα通路被长期阻断时，肠道局部微环境倾向于上调其他促炎旁路以维持炎症状态，其中IL-23/Th17轴的作用尤为核心。1.1 TNFα与IL-23的协同放大效应与正反馈回路 IL-23是一种由活化的单核巨噬细胞和树突状细胞分泌的异二聚体细胞因子，由p19特异性亚基和p40共有亚基组成。在IBD及其他免疫介导的炎症性疾病（如银屑病）中，IL-23是驱动初始T细胞向致病性Th17细胞分化并维持其存活的关键上游信号。Th17细胞不仅分泌IL-17A、IL-17F和IL-22等效应因子，还在局部组织的免疫微环境中扮演着促炎与组织修复的复杂角色。基础生物学研究揭示，TNFα与IL-17A（由IL-23驱动产生）在靶细胞层面上存在深度的协同作用。在对人类原代细胞（如角质形成细胞）的研究中发现，TNFα和IL-17A的联合刺激能够显著诱导细胞自身产生大量的IL-23 。这一过程的分子机制被证明受到表观遗传控制（如H3K9二甲基化）以及EGFR信号传导通路的调控。由于IL-23对Th17细胞的激活至关重要，靶组织在TNFα和IL-17A刺激下分泌的IL-23又会反过来进一步激活Th17细胞，促使其分泌更多的IL-17A和TNFα 。这种细胞因子之间的串扰形成了一个极具破坏性的“正反馈回路”（Positive Feedback Loop），解释了为何慢性炎症能够在局部黏膜中持久维持并演变为难治性病理状态。1.2 协同阻断的免疫重塑学基础单独阻断IL-17A在IBD治疗中已被证明具有潜在的恶化病情风险，这主要是因为IL-17A在肠道中同时具有介导宿主保护性免疫防御（抵抗细胞外细菌）和维持上皮屏障完整性的功能。然而，靶向位于更为上游的IL-23p19亚基，不仅能够精准下调致病性Th17克隆的扩增，还能保留其他非致病性IL-17的生理功能。当同时使用Guselkumab阻断IL-23p19并使用Golimumab阻断TNFα时，治疗策略实现了对炎症级联反应的空间与时间双重拦截。TNF抑制剂通过下调内皮细胞黏附分子（如e-选择素、ICAM-1、VCAM-1）来阻断循环白细胞向肠道黏膜的浸润，并诱导表达跨膜TNF的炎症细胞发生凋亡。与此同时，IL-23抑制剂则从源头上切断了Th17细胞的维持信号，瓦解了局部的细胞因子正反馈网络。转录组学（RNAseq）数据表明，这种双重阻断能够在分子水平上引发更为深刻的重塑，不仅显著下调IL-23通路模块，还广泛抑制了干扰素应答模块以及炎症性上皮和髓系细胞的转录状态。二、药物开发形式的路径抉择：双抗与固定剂量复方的博弈在确立了TNFα与IL-23双重阻断的生物学合理性后，药物研发领域面临着一个重大的技术分水岭：是开发单一的双特异性抗体（Bispecific Antibody），还是采用两种单克隆抗体的固定剂量复方（Co-formulation）？顶尖药企在这两条路径上的探索揭示了现代抗体工程的技术局限与商业考量。2.1 双特异性抗体在炎症靶向中的物理化学及临床药理学挑战双特异性抗体虽然在肿瘤免疫治疗（如T细胞接合器，TCE）中取得了显著成功，但在系统性炎症疾病的细胞因子阻断中却面临着难以逾越的药代动力学（PK）、药效动力学（PD）以及化学、制造与控制（CMC）障碍。强生公司曾大力推进一款名为JNJ-61178104的靶向TNFα与IL-17A的人源化单价双特异性抗体。在体外细胞实验和鼠类肺部中性粒细胞浸润模型中，JNJ-61178104表现出了强效的靶点中和能力，甚至优于二价亲本抗体的联合使用。然而，当该药物进入食蟹猴和人类的体内靶标占有率（Target Engagement）定量评估环节时，研究人员惊讶地发现，双抗分子在体内的表观结合亲和力远低于预期，且显著弱于具有等摩尔剂量的二价亲本抗体。这一现象的底层原因是双抗分子结构中的空间位阻效应，以及体内循环系统中高浓度、大分子量靶抗原（特别是形成多聚体的TNFα）对单价结合位点的竞争性干扰。此外，免疫原性（ADA）是导致双特异性抗体在非肿瘤领域折戟的另一大元凶。同时结合两种不同的可溶性细胞因子极易形成巨大的、不可预测的高分子量免疫复合物。例如，另一款靶向TNF和TL1A的双抗AMG-966在I期临床中导致高达98%的受试者产生中和性抗药抗体，直接造成药物在体内暴露量的灾难性丧失。同时，双特异性抗体在CMC扩大生产阶段常常面临链错配、热稳定性下降和高聚集倾向等成药性（Developability）挑战，导致药物审批过程中的完整回应函（CRL）签发率居高不下。2.2 固定剂量复方与口服纳米抗体的创新突围基于上述严酷的科学现实，强生的研发战略发生了务实的转向。通过将已经历广泛临床验证的Guselkumab和Golimumab结合为固定剂量复方制剂JNJ-78934804，强生不仅彻底规避了新分子实体的CMC风险，保留了两种药物原有的二价高亲和力结合特性，还能够根据临床需求灵活调整两种抗体的剂量比例。与此同时，针对口服给药的创新双抗策略也在Biotech界引起了广泛关注。例如，Sorriso Pharmaceuticals开发的V56B2是一种新型的双特异性纳米抗体（Domain Antibody），融合了靶向IL-23p19的V900和靶向TNFα的V565 。其精妙之处在于，V56B2包含一个中央蛋白酶敏感的连接肽。当药物口服进入小肠后，肠道内的胰蛋白酶会切割连接肽，将双抗分解为两个完全独立的单体纳米抗体。这种设计既实现了口服给药的便利性与靶向递送，又完美避免了在黏膜局部产生由于双靶点同时结合而导致的空间干扰与高分子聚合物风险。小鼠模型和IBD患者结肠活检的体外培养研究证实，这种在肠道原位释放的单体组合能够深度抑制组织磷蛋白水平，并实现极高的粪便药物浓度，为未来改善患者依从性提供了颠覆性的技术选项。三、突破疗效天花板：VEGA与DUET临床数据的多维解构对双重靶向策略的临床信心，建立在强生开展的一系列设计严谨的随机、双盲、对照临床试验数据之上。VEGA（Phase 2a）和DUET（Phase 2b）研究的数据不仅确立了联合疗法在初治患者中的压倒性优势，也为其在多重耐药患者中的挽救性应用提供了坚实证据。3.1 VEGA试验：第12周诱导期的断层式临床响应 VEGA是一项具有里程碑意义的2a期概念验证研究，共招募了214名对常规免疫抑制剂或皮质类固醇反应不足、且未曾使用过生物制剂（Biologic-naïve）的中重度活动性UC成人患者。受试者被均等随机分配至三个研究臂：Guselkumab + Golimumab联合诱导组、Guselkumab单药组（TREMFYA）以及Golimumab单药组（SIMPONI）。在第12周的主要终点评估中，联合疗法打破了长期以来UC治疗中约20%-30%临床缓解率的统计学瓶颈。基于修正意向治疗人群的分析揭示了联合疗法跨越所有关键维度的优效性：第12周疗效评估核心指标 Guselkumab + Golimumab 联合治疗组 Guselkumab 单药组 Golimumab 单药组临床应答率 (Clinical Response, Mayo) 83.1% 74.6% 61.1% 临床缓解率 (Clinical Remission, mMayo) 47.0% 24.0% 25.0% 内镜改善率 (Endoscopic Improvement) 49.0% 30.0% 25.0% 组织学缓解率 (Histologic Remission) 56.0% 49.0% 32.0% 组织学-内镜复合缓解 41.0% 27.0% 15.0% 粪便钙卫蛋白中位数 (FCP, mg/kg) 117.5 397.5 505.0 (数据来源：VEGA Phase 2a 研究，Feagan等，2023 ) 这些数据表明，通过同时扑灭TNF驱动的急性炎症招募和IL-23驱动的Th17持续活化，联合治疗在短短12周内不仅将临床应答率推高至惊人的83.1%，其在客观炎症标志物（如粪便钙卫蛋白大幅下降至117.5 mg/kg）和黏膜愈合上的表现更是实现了对单药组的降维打击。3.2 VEGA试验：第38周维持期的深度组织学重塑 IBD治疗的终极目标不仅是短期症状的控制，更是实现长期的无皮质类固醇缓解和深度的黏膜组织学愈合，这直接关联到结直肠癌风险的降低和远期手术率的下降。在VEGA试验中，联合组在完成12周的联合诱导后，转换为Guselkumab单药维持治疗，并随访至第38周。在第38周的维持期数据中，联合诱导所建立的深度响应态势得到了完美延续：临床缓解持久性：基于改良Mayo评分，联合组的临床缓解率维持在47.9%，显著优于Guselkumab单药组的31.0%和Golimumab单药组的20.8% 。无皮质类固醇临床缓解：极为难得的是，在第38周达到临床缓解的联合组患者中，有100%（31/31）的患者在过去60天内完全摆脱了对皮质类固醇的依赖，这在改善患者长期生活质量和降低代谢毒性方面具有无可估量的价值。金标准：Geboes组织学评估：VEGA研究采用了极其严苛的Geboes评分系统来定义组织学缓解，要求黏膜固有层和上皮中完全无中性粒细胞浸润、无隐窝破坏、无糜烂或溃疡以及无肉芽组织形成。在这一严苛标准下，联合组在第38周实现了24%的组织学缓解与内镜正常化复合终点，是Guselkumab单药组（13%）的近两倍，是Golimumab单药组（6%）的四倍。伴随活检RNAseq揭示的炎症转录模块的长效下调，证实了双重诱导能够产生长期的“免疫学记忆”与疾病修饰（Disease Modification）效应。3.3 DUET试验：攻克多重耐药壁垒的2026年最新进展如果说VEGA试验确立了联合疗法在初治患者中的理论上限，那么正在进行的DUET-UC和DUET-CD（Phase 2b）研究则直指当前IBD治疗中最棘手的痛点——难治性与多重耐药群体。 DUET项目评估了三种不同剂量梯度（高、中、低）的JNJ-78934804复方制剂的效力。尤为关键的是，该研究中约有一半的参与者属于既往对两种或两种以上全身性治疗类别（例如抗TNF、抗整合素或JAK抑制剂）反应不足的高度难治性亚群。根据在2026年美国消化疾病周（DDW）会议上公布的最新突破性进展：在DUET-CD的第48周主要终点分析中，针对这一高度难治性克罗恩病亚组，JNJ-4804展示出了颠覆性的挽救疗效。其临床缓解率达到了表现最佳对照组的近两倍，而内镜应答率比对照组高出60%以上。这一数据不仅巩固了强生在IBD管线上的统治地位，更从实质上宣告了JNJ-78934804具备成为所有现有疗法失败后的终极“超级挽救疗法”的潜力。四、安全性监控与药政监管路径的前瞻性研判在临床疗效大幅跃升的背后，顶尖临床专家和药政监管机构（如FDA和EMA）对双重免疫抑制可能引发的严重感染和肿瘤风险抱有高度的警惕性。对于将两种强效细胞因子阻断剂合二为一的复方制剂，其安全窗和监管审评路径相较于单药有着本质的差异。4.1 安全性图谱：机会性感染的微弱信号与整体耐受性整体而言，VEGA试验跨越50周的安全性数据出人意料地呈现出高度的平稳性。联合治疗组发生任何不良事件（AEs）的比例为63%，不仅未出现预期的不良事件叠加效应，反而低于Golimumab单药组的76%和Guselkumab单药组的65% 。这种现象的潜在解释是，快速且深度的黏膜愈合本身减少了因疾病活动性引起的系统性炎症和继发性并发症。此外，各组间严重不良事件（SAEs，均为6%）和严重感染（均为3%）的发生率均保持一致且处于较低水平。然而，针对特定机制的机会性感染不容忽视。在VEGA联合治疗组中，临床医生报告了1例在第18周确诊的结核病（TB）以及1例在第14周确诊的巨细胞病毒（CMV）结肠炎。TNFα在人体内是维持结核分枝杆菌肉芽肿稳定、防止潜伏感染激活的关键细胞因子；而IL-23在宿主抵抗细胞外病原体（包括真菌和特定细菌）中发挥着屏障防卫作用。双通路的联合压制削弱了机体的双重防线。对强生多项大规模临床试验（如GALAXI、GRAVITI、QUASAR以及VEGA）的汇总分析也强调了以100人年（Patient-years）为单位严密监测活性结核发生率的必要性。未来在真实世界临床实践中，更为严格的潜伏结核和慢性病毒基线筛查，以及在治疗周期内的高频病原学监测，将是使用此类双重疗法的先决条件。4.2 药政监管框架：FDA指南与复方制剂的批准门槛从药政监管的视角来看，联合疗法在不同地区的审批面临着截然不同的法规挑战。FDA在关于双特异性抗体及多特异性产品开发的工业指南（FDA-2019-D-0621）中虽然主要聚焦双抗，但也对化学、制造与控制（CMC）以及多靶点干预的脱靶效应提出了严格要求。更为重要的是，FDA和EMA对固定剂量复方制剂（Fixed-Dose Combinations, FDCs）有一项核心的监管原则：必须提供确凿的证据证明复方中的每一个活性成分（Contribution of Components）都对最终的疗效或安全性做出了实质性的独立贡献。这也是为何DUET试验必须设计复杂的6个研究臂（包含安慰剂、单药对照以及三种不同剂量的复方）的根本原因。强生需要通过庞大且昂贵的剂量探索研究矩阵，向FDA证明Guselkumab和Golimumab的联合绝不是简单的叠加，且无法通过提高任何一种单药的剂量来达到同等的疗效水平。此外，在全球化开发战略中，EMA对共同包装（Copackaging）的严厉限制也迫使药企必须推进真正的固定剂量复方研发，而非简单地将两支单抗打包销售。FDA肿瘤学卓越中心负责人理查德·帕兹杜尔（Richard Pazdur）博士等人在讨论组合疗法审批时也曾强调，组合策略不仅是新药审批的重点，更是伴随诊断和精准医疗（防止无反应患者暴露于高风险组合）不可或缺的组成部分。五、商业估值、卫生经济学与竞争性市场格局 JNJ-78934804不仅仅是一个临床突破，更是捍卫企业在免疫与炎症领域核心商业版图的战略性武器。面对日益拥挤的单药市场和来势汹汹的生物类似药，双靶点疗法的商业逻辑正在被重塑。5.1 全球IBD市场的宏大增量与生物类似药冲击随着工业化进程、饮食结构改变以及人口老龄化，全球溃疡性结肠炎和克罗恩病的患病基数正处于爆发式增长期。权威市场研究机构的预测数据显示，全球UC市场规模将从2024年的约73亿美元稳步攀升，预计到2030至2035年间将突破108亿美元至153亿美元，其复合年增长率（CAGR）将强劲维持在5.7%至8.5%的区间。如果将体量相仿的CD市场计算在内，这是一个总体量超过300亿美元的巨型蓝海市场。然而，这个庞大的市场正遭遇生物类似药（Biosimilars）的剧烈洗牌。目前，抗TNF类药物（英夫利西单抗、阿达木单抗）早已面临大量低成本竞争；更为严峻的是，针对强生自身重磅炸弹Stelara（乌司奴单抗，靶向IL-12/23）的多款生物类似药（如Wezlana、Otulfi、Selarsdi、Yesintek）已经获批，正以极具破坏性的共同保险（Co-insurance）价格折扣（预估共同保险费用低至840-1696美元）疯狂蚕食市场份额。在此背景下，Tremfya（Guselkumab）的单药迭代和JNJ-78934804的复方升维，构成了强生构筑新专利护城河、维持高价值产品线生命周期的唯一防线。5.2 卫生经济学与结果研究（HEOR）：支撑高昂定价的底层逻辑双重靶向疗法的商业化面临的最尖锐矛盾在于“定价上限”。现有的单一先进生物制剂年治疗费用普遍高达5万至10万美元，如果按单药价格的简单叠加来为联合疗法定价，必将彻底击穿全球绝大多数医保支付系统（如美国Medicare、欧洲HTA及中国国家医保目录）的承受底线。因此，双靶点复方制剂的定价必须高度依赖于具有说服力的卫生经济学（HEOR）证据链。通过马尔可夫模型（Markov Model）等高级统计工具进行的系统性评价显示，虽然组合疗法大幅推高了初始用药成本，但在针对重度难治性CD患者的长期经济学评估中，这种投资是具有高度成本效益的。例如，在一项基于中国医疗体系视角的成本效益分析中，以人均GDP的1倍（2024年约为13444.68美元）作为意愿支付阈值，包含阿达木单抗和乌司奴单抗序贯或联合使用的治疗策略（ADA-UST）产生了最高的绝对净货币效益（NMB），达到35850.93美元，并展现出极佳的增量成本效益比（ICER），即每增加一个质量调整生命年（QALY）的成本为2285.38美元。这一经济学优势的核心在于“手术规避”（Surgery Avoidance）。对于多线生物制剂失败的难治性患者而言，如果缺乏有效挽救手段，只能被迫接受全结肠切除术、小肠切除术及永久性造口手术。这些侵入性干预带来的高昂外科及住院费用、持续的术后护理成本、短肠综合征的静脉营养开销，以及患者终身劳动力丧失所引发的社会经济损失，其综合成本极其惊人。JNJ-78934804凭借其将临床缓解率翻倍和实现深层黏膜愈合的能力，能够有效阻断疾病向不可逆的外科终点演进。强生完全可以通过收集长期的无激素缓解和手术规避数据，与全球支付方谈判签订“基于价值的定价（Value-Based Pricing）”和“按疗效付费（Outcomes-based）”协议，从而理直气壮地获取双重靶向带来的商业溢价。六、投资人的资本配置逻辑与战略重构 JNJ-78934804的数据发布以及各大MNC在2026年摩根大通（JPM）医疗健康大会上的战略表态，正在驱动资本向免疫与炎症领域的特定赛道重新集结。

2026-02-14

·护卫通医事服务

大国名医｜中山大学附属第一医院陈旻湖：消化内科首席专家的炎症性肠病“治疗经”

大国名医陈旻湖教授主任医师消化内科首席专家学科带头人国务院特殊津贴专家中华医学会消化病学分会主任委员中国医师协会消化医师分会副会长第九届亚洲炎症性肠病协会主席中华消化杂志副总编辑中华炎性肠病杂志副总编辑 Journal of Digestive Disease共同主编 1 炎症性肠病陈旻湖教授介绍，炎症性肠病虽然病变在胃肠道，但会累及全身，包括皮肤、关节、眼睛和肝脏都可能有损伤，临床上称为肠外表现。炎症性肠病的并发症很多，可以引起肠梗阻、肠穿孔、肠瘘，病史较长的患者可能癌变。炎症性肠病需要和其它疾病做鉴别，临床上易被误诊。　　炎症性肠病的发病与自身免疫功能紊乱有关，目前临床上多针对免疫紊乱进行治疗，其他的治疗方法如粪菌移植、干细胞移植等疗法还都处于研究阶段。　对于在国内已经开始较大范围应用的粪菌移植疗法，陈旻湖教授认为走的太快了一点，他不主张现在就大规模的开展临床应用，因为还有很多问题没有搞清楚。　　陈旻湖教授解释，研究发现，炎症性肠病患者的肠道会发生菌群紊乱，或者叫微生态失衡。研究显示，接受健康人的粪菌移植后，部分溃疡性结肠炎患者症状可以得到不同程度的缓解，部分患者内镜下黏膜炎症也有改善。　　但问题在于一是移植不方便，二是效果不能持久，停止粪菌移植后病人很快复发。人体肠道微生态十分复杂，我们不知道该移植什么菌种、移植多少菌量、多久移植一次，也许每个患者都不一样，需要进行个体化研究。现在不清楚的问题还太多，粪菌移植应该限于临床研究。　　在国际上，公认的粪菌移植临床应用仅限于难辨梭状芽孢杆菌感染。“国际公认粪菌移植可用于难治性的难辨梭状芽孢杆菌感染的治疗，而且是一线治疗后复发的病人才需要使用粪菌移植来治疗，在其它疾病领域，欧美国家都没有批准用于临床治疗。”　　得了炎症性肠病的患者，意味着要长期与药物相伴。陈旻湖教授表示，炎症性肠病患者没有统一的固定疗程。目前认为，当病人治疗后症状得到完全缓解，内镜下看到黏膜愈合，炎症生物指标正常后，最好再维持用药1-2年，化验检查依然正常，方可考虑逐渐停药并随访。炎症性肠病（IBD），包括克罗恩病（CD）和溃疡性结肠炎（UC），是一组慢性、复发性肠道疾病，近年来在全球范围内发病率呈上升趋势。数据显示，中国的IBD患者数量不断增加，给患者的生活质量及医疗系统带来了巨大的挑战。 2 治疗炎症性肠病克罗恩病，是一种典型的炎症性肠病（IBD），发病高峰年龄是15- 35岁，病因及发病机制尚未完全明确、易反复发作，目前没有治疗手段可以完全根治。一旦确诊，就意味着患者需终生与该疾病为伴，虽不致命，但严重影响生活质量，所以克罗恩病也被称为“绿色癌症”、“不死的癌症”。 “克罗恩病影响着整个消化道，主要症状为胃肠道溃疡，可以导致肠道狭窄和穿孔，非常容易复发且致残率高，超过一半的患者需要进行多次手术治疗。”陈旻湖道。 2023年由中山大学附属第一医院消化内科学科带头人陈旻湖牵头完成的研究，验证了全球首个白细胞介素-6（IL-6）反式信号通路抑制剂-Olamkicept（奥拉奇西普或TJ301）可有效治疗中重度溃疡性结肠炎，显著提高IBD患者的临床应答、临床缓解和黏膜愈合等疗效指标，且安全性良好。陈旻湖表示，该研究将为中国炎症性肠病患者带来更有效、更安全的治疗方案，奥拉奇西普总体安全性、耐受性良好，更适合于早期及长期使用，可有效减少炎症性肠病疾病并发症和死亡率。 2024年是IBD治疗领域的关键之年，多种靶向机制的生物制剂获得全球范围的批准，彰显出治疗策略的多样性与精细化。紧随米利珠单抗（Mirikizumab）的上市，其他生物制剂，包括古塞奇尤单抗（Guselkumab）、利生奇珠单抗（Risankizumab）也在2024年相继获美国食品与药物管理局（Food and Drug Administration，FDA）批准用于中重度UC患者的治疗。这些药物通过阻断IL-23的信号通路，调控过度活跃的免疫反应，为患者提供了一种高效、可控的新选择。而作为选择性 S1P1受体调节剂（sphingosine-1-phosphate receptor modulator）的伊曲莫德（etrasimod）也在欧洲药品管理局（European Medicines Agency ，EMA)批准下用于中重度UC患者的治疗。此外，多款生物类似药（biosimilars）兴起，如Otulfi、Fymskina等（Ustekinumab生物类似药）在美国和欧洲地区获批中重度UC和CD的适应证。这些药物在疗效、安全性与原研药相当的同时，大幅降低了治疗成本，为患者提供了更多选择。 3 推动中国炎症性肠病诊疗水平陈旻湖为进一步推动我国IBD诊疗水平的全面提升，成立了中国炎症性肠病诊治质控评估中心（Inflammatory Bowel Disease Quality of Care Center，IBDQCC）。自2018年成立以来，在中华医学会消化病学分会和IBD学组的指导下，致力于构建符合我国国情的IBD规范化诊疗体系。其核心任务包括制定内镜、病理及影像学检查的质量控制标准，规范化IBD药物治疗流程，推进IBD中心建设，培养IBD专科医生，以及建立分级诊疗制度，以满足全国各级医疗机构服务IBD患者的需求。 2024年，IBDQCC进一步深化其工作内容，通过加强区域协作，推动多级质控体系建设，并积极促进IBD诊疗的精准化和高质量发展。具体举措包括组织区域内的互动交流与学术会议，发起和支持IBD科研基金项目，提升基层和专科医生的科研能力，以及系统化开展专科医师培训。 2024年，IBDQCC专家组正式发布了《乌帕替尼治疗IBD患者临床规范化使用流程（SOP）》。这是我国首个针对小分子药物治疗IBD的规范性指导意见，为未来更多新型药物在中国的推广和应用奠定了基础。此外，IBDQCC成功将全国29家医疗单位纳入2024年度IBD区域中心名单。这一举措不仅进一步完善了IBD区域诊疗中心的覆盖范围，也为构建全国IBD专病医联体提供了有力支持。通过持续优化标准、加强合作和推动科研创新，IBDQCC正在逐步引领中国IBD诊疗迈向高质量、国际化的道路，为患者提供更加精准和个体化的诊疗方案，也标志着中国IBD规范化管理水平正在稳步提升至国际前沿。 “一名优秀的医生，不能只考虑治疗某个患者，还要考虑如何通过个人能力影响到广大同行，继而为更多患者带来健康。”正是基于这样的医者担当与社会责任，陈旻湖推动我国在IBD领域直追西方甚至赶超西方。【护卫通医事服务公司介绍】

微生物疗法临床研究

2026-01-06

·BioSpace

Fresenius Kabi Introduces New Presentation of Otulfi® (ustekinumab-aauz), a Biosimilar to Stelara®

45 mg/0.5 mL single dose vial provides dosing flexibility for pediatric patients LAKE ZURICH, Ill.--(BUSINESS WIRE)-- #CommittedToLife --Fresenius Kabi, an Operating Company of Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced a new presentation of Otulfi ® (ustekinumab-aauz) in a 45 mg/0.5 mL single-dose vial for subcutaneous injection. Otulfi ® is a prescription medicine and the brand name for Fresenius Kabi’s FDA-approved biosimilar of the reference product, Stelara ® (ustekinumab). With this addition, Fresenius Kabi now offers all dosage forms and strengths of the reference product, giving physicians flexibility and supporting patient treatment continuity. Fresenius Kabi’s Otulfi ® has also received interchangeability designation from the FDA. Otulfi ® was approved by the U.S. Food and Drug Administration in September 2024 for the treatment of adults with moderately to severely active Crohn’s disease and ulcerative colitis, and adults and pediatric patents ages 6 and older with moderate to severe plaque psoriasis (who are candidates for phototherapy or systemic therapy) and active psoriatic arthritis. The new dosage form provides dosing flexibility for pediatric patients under 60kg (132 lbs) who have plaque psoriasis and psoriatic arthritis. In March, Fresenius Kabi introduced Otulfi ® in 45 mg/0.5mL and 90mg/mL single-dose prefilled syringes for subcutaneous injection and a 130mg/26mL single-dose vial for intravenous infusion. “With this new presentation of Otulfi, we’re expanding treatment options for pediatric patients and reinforcing our commitment to improving access to biosimilars. Fresenius Kabi continues to grow its biosimilar portfolio to ensure patients of all ages benefit from therapies that meet the FDA’s rigorous standards for safety and efficacy," said Dr. Sang-Jin Pak, President Biopharma, Fresenius Kabi. In May 2025, the FDA designated Otulfi ® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara ® (ustekinumab). Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider 1 . This can lead to a reduced administrative burden. Not all biosimilars receive interchangeability status. About Otulfi ® (ustekinumab-aauz) Otulfi ® (ustekinumab-aauz) is indicated for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients; moderate to severe plaque psoriasis for adult patients and pediatric patients six years or older, who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis in adults and pediatric patients six years or older. Otulfi ® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Otulfi ® . The drug received FDA approval in September 2024 and has been available in the U.S. since March 2025. Otulfi ® is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, which play an important role in inflammatory and immune responses. The FDA approval of Otulfi ® was based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical, and manufacturing data. Otulfi ® demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara ® in patients with moderate to severe plaque psoriasis. Otulfi ® was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S. Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in early and late-stage development. Indications Otulfi ® (ustekinumab-aauz) is an IL-12/23 antagonist indicated for treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis. Otulfi ® is also indicated for pediatric patients ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis. IMPORTANT SAFETY INFORMATION Otulfi ® (ustekinumab-aauz) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Otulfi ® (ustekinumab-aauz). Infections Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, urinary tract infections; Psoriatic arthritis: cholecystitis; Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, Listeria meningitis and Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, listeriosis. Avoid initiating treatment with Otulfi ® (ustekinumab-aauz) in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of Otulfi ® (ustekinumab-aauz) in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with Otulfi ® (ustekinumab-aauz). Discontinue Otulfi ® (ustekinumab-aauz) for serious or clinically significant infections until the infection resolves or is adequately treated. Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), Salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances). Pre-Treatment Evaluation of Tuberculosis (TB) Evaluate patients for TB prior to initiating treatment with Otulfi ® (ustekinumab-aauz). Avoid administering Otulfi ® (ustekinumab-aauz) to patients with active TB infection. Initiate treatment of latent TB before administering Otulfi ® (ustekinumab-aauz). Consider anti-TB therapy prior to initiation of Otulfi (ustekinumab-aauz) in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving Otulfi ® (ustekinumab-aauz) for signs and symptoms of active TB during and after treatment. Malignancies Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer (NMSC). Monitor all patients receiving Otulfi ® (ustekinumab-aauz) for the appearance of NMSC. Closely follow patients >60 years of age, those with a medical history of prolonged immunosuppressant therapy, and those with a history PUVA treatment. Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Otulfi ® (ustekinumab-aauz). Posterior Reversible Encephalopathy Syndrome (PRES) Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after initiating ustekinumab products. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab. Monitor all patients treated with Otulfi ® (ustekinumab-aauz) for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue Otulfi ® (ustekinumab-aauz). Immunizations Prior to initiating therapy with Otulfi ® (ustekinumab-aauz), patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with Otulfi ® (ustekinumab-aauz) should not receive live vaccines. Avoid administering BCG vaccines during treatment with Otulfi ® (ustekinumab-aauz), or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving Otulfi ® (ustekinumab-aauz) because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of Otulfi ® (ustekinumab-aauz) may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue Otulfi ® (ustekinumab-aauz) and institute appropriate treatment. Most Common Adverse Reactions The most common adverse reactions (≥3%) seen in patients treated with Otulfi ® (ustekinumab-aauz) are: Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, fatigue; Crohn’s disease, induction: vomiting; Crohn’s disease, maintenance: nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis; Ulcerative colitis, induction: nasopharyngitis and Ulcerative colitis, maintenance: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, nausea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or to report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or . Please click to see the full Prescribing Information and Medication Guide for Otulfi ® (ustekinumab-aauz) here . About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to essential medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit . To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn and Facebook . Reference: U.S. Food and Drug Administration. (2024, June 20). 9 Things to Know About Biosimilars and Interchangeable Biosimilars . This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release. Otulfi ® (ustekinumab-aauz) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stelara ® is a registered trademark of Johnson & Johnson. Contacts Media contact Joanie Clougherty (614) 717-5741 Joan.Clougherty@fresenius-kabi.com

上市批准突破性疗法

100 项与乌司奴单抗生物类似药 (Formycon) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AC05	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
银屑病	加拿大	Fresenius Kabi Canada Ltd.	2024-12-01
银屑病关节炎	欧盟	Fresenius Kabi Deutschland GmbH	2024-09-25
银屑病关节炎	欧盟	Formycon AG	2024-09-25
银屑病关节炎	冰岛	Fresenius Kabi Deutschland GmbH	2024-09-25
银屑病关节炎	冰岛	Formycon AG	2024-09-25
银屑病关节炎	列支敦士登	Fresenius Kabi Deutschland GmbH	2024-09-25
银屑病关节炎	列支敦士登	Formycon AG	2024-09-25
银屑病关节炎	挪威	Fresenius Kabi Deutschland GmbH	2024-09-25
银屑病关节炎	挪威	Formycon AG	2024-09-25
活动性中度克罗恩病	欧盟	Fresenius Kabi Deutschland GmbH	2024-09-25
活动性中度克罗恩病	欧盟	Formycon AG	2024-09-25
活动性中度克罗恩病	冰岛	Fresenius Kabi Deutschland GmbH	2024-09-25
活动性中度克罗恩病	冰岛	Formycon AG	2024-09-25
活动性中度克罗恩病	列支敦士登	Fresenius Kabi Deutschland GmbH	2024-09-25
活动性中度克罗恩病	列支敦士登	Formycon AG	2024-09-25
活动性中度克罗恩病	挪威	Fresenius Kabi Deutschland GmbH	2024-09-25
活动性中度克罗恩病	挪威	Formycon AG	2024-09-25
活动性重度克罗恩病	欧盟	Formycon AG	2024-09-25
活动性重度克罗恩病	欧盟	Fresenius Kabi Deutschland GmbH	2024-09-25
活动性重度克罗恩病	冰岛	Formycon AG	2024-09-25

未上市

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适应症	最高研发状态	国家/地区	公司	日期
克罗恩病	临床1期	波兰	Fresenius Kabi SwissBioSim GmbH	2025-11-15
免疫系统疾病	临床1期	-	Aristo Pharma GmbH	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed 人工标引	N/A	-	491	FYB202	鹽鬱糧簾繭繭繭遞蓋糧(願範蓋製願繭鬱網鬱觸) = All 3 comparisons showed PK similarity, since the 90% confidence intervals of the respective geometric mean ratios for area under the concentration-time curve from time 0 to infinity and maximum serum concentration were contained within the acceptance interval of 80%-125%. 蓋顧廠窪構餘願築構憲 (遞構獵夢遞願選齋遞製 ) 更多	相似	2024-10-19
				EU-Ref
FDA_CDER 人工标引	N/A	克罗恩病	1,368	Placebo (CD-1)	蓋淵繭醖淵夢鑰艱鬱膚(餘餘簾襯選獵積廠觸顧) = 醖齋鏇簾鹹簾顧憲顧鹽願網築衊鹹製築積鑰齋 (網觸願衊壓夢遞積鹹選 ) 更多	积极	2024-09-27
				Ustekinumab (CD-1)	蓋淵繭醖淵夢鑰艱鬱膚(餘餘簾襯選獵積廠觸顧) = 鬱衊窪齋獵鹽獵範鏇願願網築衊鹹製築積鑰齋 (網觸願衊壓夢遞積鹹選 ) 更多
FDA_CDER 人工标引	N/A	银屑病关节炎	927	Placebo (PsA STUDY 1)	鬱夢壓鹹鹹鏇積簾鹽壓(壓觸網鹹餘窪艱遞構壓) = 窪觸憲鏇鏇窪築膚獵餘襯壓廠壓膚壓獵顧顧膚 (簾鏇廠構繭願選鏇遞衊 ) 更多	积极	2024-09-27
				Ustekinumab 45 mg (PsA STUDY 1)	鬱夢壓鹹鹹鏇積簾鹽壓(壓觸網鹹餘窪艱遞構壓) = 製齋襯觸壓壓鹽壓簾觸襯壓廠壓膚壓獵顧顧膚 (簾鏇廠構繭願選鏇遞衊 ) 更多
FDA_CDER 人工标引	N/A	斑块状银屑病	1,996	Placebo (Ps STUDY 1)	襯齋憲鬱繭積壓憲壓顧(齋醖淵艱淵鏇廠鹽衊糧) = 鏇糧艱齋淵觸襯鏇窪築鏇齋淵膚鬱構糧顧觸衊 (獵齋襯繭憲齋製艱鹽製 ) 更多	积极	2024-09-27
				UstekinumabUstekinumab 45 mg (Ps STUDY 1)	襯齋憲鬱繭積壓憲壓顧(齋醖淵艱淵鏇廠鹽衊糧) = 餘範襯積構繭鹽廠選製鏇齋淵膚鬱構糧顧觸衊 (獵齋襯繭憲齋製艱鹽製 ) 更多
FDA_CDER 人工标引	N/A	溃疡性结肠炎	961	Placebo (Prior biologic failure)	夢鏇窪糧淵鏇範醖鹹鹹(鹽鹽鬱繭糧鏇鑰夢遞構) = 壓蓋夢鹽鏇醖鑰糧構夢壓鑰獵範襯積鬱壓鬱艱 (艱顧製築憲繭鏇淵窪鑰 ) 更多	积极	2024-09-27
				Ustekinumab	夢鏇窪糧淵鏇範醖鹹鹹(鹽鹽鬱繭糧鏇鑰夢遞構) = 簾淵襯積網醖構鹹網網壓鑰獵範襯積鬱壓鬱艱 (艱顧製築憲繭鏇淵窪鑰 ) 更多
FDA_CDER 人工标引	N/A	克罗恩病	388	Placebo (CD-3)	範齋鏇範糧選窪範醖遞(鬱簾壓襯網壓築鏇衊製) = 壓構遞製蓋選繭鹽積艱鑰膚糧繭夢觸選觸鏇顧 (餘鑰壓鬱餘衊鹽鹹醖構 ) 更多	积极	2024-09-27
				Ustekinumab (CD-3)	範齋鏇範糧選窪範醖遞(鬱簾壓襯網壓築鏇衊製) = 積簾齋壓遞構築憲製餘鑰膚糧繭夢觸選觸鏇顧 (餘鑰壓鬱餘衊鹽鹹醖構 ) 更多
FDA_CDER 人工标引	N/A	斑块状银屑病	73	Placebo	鏇繭願膚觸積選鹽簾憲(廠鏇壓顧壓憲網鹽觸醖) = 鹽艱鏇齋選醖鏇艱窪糧艱鏇艱顧衊鏇憲鏇襯網 (簾憲構觸壓壓齋鹹網憲 ) 更多	积极	2024-09-27
				Ustekinumab	鏇繭願膚觸積選鹽簾憲(廠鏇壓顧壓憲網鹽觸醖) = 願顧鏇餘遞鹹積蓋鏇廠艱鏇艱顧衊鏇憲鏇襯網 (簾憲構觸壓壓齋鹹網憲 ) 更多