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EULAR 2026最新数据显示,无论类风湿因子(RF)水平如何,CIMZIA(培塞利珠单抗)在类风湿关节炎中均展现出一致的疗效

New EULAR 2026 data show CIMZIA[®] (certolizumab pegol) delivered consistent effect in rheumatoid arthritis, regardless of rheumatoid factor (RF) levels

优时比 等信源发布 2026-06-05 13:07

可切换为仅中文


Brussels (Belgium), 5 June 2026 – 07:00 (CEST)

布鲁塞尔(比利时),2026年6月5日 – 07:00(中欧夏令时)

– UCB, a global biopharmaceutical company, today announced the presentation of new data at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress addressing the clinical relevance of rheumatoid factor (RF) in rheumatoid arthritis (RA) and its implications for TNF inhibitor treatment selection..

– 全球生物制药公司优时比(UCB)今日宣布,在2026年欧洲抗风湿病联盟(EULAR)大会上展示了新数据,探讨类风湿因子(RF)在类风湿关节炎(RA)中的临床意义及其对肿瘤坏死因子(TNF)抑制剂治疗选择的影响。

1

1

The

in vitro

体外

data demonstrated that inflammatory signals increase with other biologics but not Fc- free CIMZIA in patients with high RF, providing mechanistic support to previous clinical observations of CIMZIA efficacy regardless of RF level.

数据显示,在高类风湿因子(RF)患者中,其他生物制剂的炎症信号增加,而无Fc段的CIMZIA则未出现这一现象,这为先前关于CIMZIA疗效不受RF水平影响的临床观察提供了机制上的支持。

2,3,4

2,3,4

Elevated RF levels remain common in clinical practice,

在临床实践中,升高的类风湿因子水平仍然常见,

5

5

and high RF has been linked with lower exposure and reduced responses to Fc-containing TNF inhibitors (e.g., adalimumab).

并且高RF与较低的暴露量和对含Fc的TNF抑制剂(例如阿达木单抗)的反应减弱有关。

5,6

5,6

It is estimated that around one in four patients treated with biologic therapies have high RF levels,

据估计,在接受生物制剂治疗的患者中,约有四分之一具有高水平的类风湿因子(RF)。

7

7

which have historically been associated with poorer prognosis and reduced effectiveness of some Fc‑containing biologics.

这些情况在历史上与较差的预后以及某些含Fc片段生物制剂疗效降低相关。

4,8

4,8

The new EULAR data, together with a recent update to the EU Summary of Product Characteristics (SmPC) and Medicines and Healthcare products Regulatory Agency (MHRA), reinforce CIMZIA’s differentiated Fc‑free structure and its relevance when initiating TNF inhibitor (TNFi) therapy.

欧洲抗风湿病联盟(EULAR)的最新数据,连同欧盟产品特性概要(SmPC)和英国药品和保健品管理局(MHRA)的近期更新,进一步印证了CIMZIA独特的无Fc段结构及其在启动肿瘤坏死因子抑制剂(TNFi)治疗时的重要性。

8

8

“Rheumatoid factor is more than a diagnostic marker, it can meaningfully influence how patients respond to therapy,” said Dr. James Galloway, Professor of Rheumatology at King’s College London and Honorary Consultant Rheumatologist at King’s College Hospital, London. “These EULAR data help explain differences in treatment response seen in patients with high RF and highlight the value of RF informed decision making.'.

“类风湿因子不仅是一个诊断标志物,它还能显著影响患者对治疗的反应,”伦敦国王学院风湿病学教授、伦敦国王学院医院荣誉顾问风湿病学家詹姆斯·加洛韦博士表示。“这些欧洲抗风湿病联盟(EULAR)的数据有助于解释高类风湿因子患者在治疗反应上的差异,并凸显了基于类风湿因子信息进行临床决策的价值。”

New EULAR 2026 data clarify the clinical relevance of rheumatoid factor

EULAR 2026新数据阐明类风湿因子的临床意义

The new

新的

in vitro

体外

study, presented at EULAR, demonstrated that RF antibodies bind to Fc containing biologic DMARDs, forming immune complexes that stimulate pro inflammatory cytokine release from peripheral blood mononuclear cells (PBMCs). In contrast, RF did not bind to Fc free certolizumab pegol, and no immune complex formation or cytokine induction was observed..

在EULAR大会上发表的一项研究表明,RF抗体与含Fc段的生物制剂DMARDs结合,形成免疫复合物,刺激外周血单个核细胞(PBMCs)释放促炎细胞因子。相比之下,RF不与不含Fc段的赛妥珠单抗聚乙二醇结合,也未观察到免疫复合物形成或细胞因子诱导现象。

1

1

These findings provide mechanistic insight into previously reported observations that certolizumab pegol demonstrates consistent efficacy irrespective of RF levels.

这些发现为先前报道的观察结果提供了机制性见解,即无论类风湿因子(RF)水平如何,培戈利赛妥珠单抗均显示出一致的疗效。

3,4,5

3,4,5

“At UCB, we are committed to generating robust, meaningful evidence that helps support informed and personalized treatment decisions for people living with immune mediated diseases,” said Donatello Crocetta, Chief Medical Officer and Global Head of Medical Affairs, UCB. “The EULAR data, together with the recent EU and MHRA label updates, underscore our continued focus differentiating CIMZIA through science and addressing the diverse needs of people living with rheumatoid arthritis.'.

“在UCB,我们致力于生成有力且有意义的证据,以支持为免疫介导疾病患者提供明智且个性化的治疗决策,”UCB首席医疗官兼全球医学事务负责人Donatello Crocetta表示。“EULAR的数据,连同近期欧盟和英国药品和健康产品管理局(MHRA)的标签更新,突显了我们持续通过科学手段差异化CIMZIA,并满足类风湿关节炎患者多样化需求的专注。”

These data form part of UCB’s broader presence at the 2026 EULAR Annual Meeting, where a total of 27 abstracts will be presented across the UCB immunology portfolio assets in PsA, psoriasis, axial spondyloarthritis, rheumatoid arthritis, and systemic lupus erythematosus.

这些数据构成了优时比(UCB)在2026年欧洲抗风湿病联盟(EULAR)年度会议上的更广泛展示内容的一部分。届时,将在银屑病关节炎、银屑病、中轴型脊柱关节炎、类风湿性关节炎和系统性红斑狼疮等领域,围绕优时比免疫学产品组合资产,共计展示27篇摘要。

EU SmPC update reflects Fc-free mechanism

欧盟药品特性概要(SmPC)更新反映了无Fc机制

The EU Summary of Product Characteristics (SmPC) for CIMZIA has been updated in Section 5.1 to further describe its Fc free mechanism of action, reinforcing mechanistic differences from Fc containing biologics. This update is also reflected in UK product information8 maintained by the Medicines and Healthcare products Regulatory Agency (MHRA), which publishes the most up‑to‑date SmPCs as part of a medicine’s licensed information..

CIMZIA 的欧盟产品特性概要(SmPC)已在第 5.1 节中更新,以进一步描述其无 Fc 段的作用机制,从而强化其与含 Fc 段生物制品在机制上的差异。英国药品和保健品管理局(MHRA)维护的英国产品信息8 也反映了这一更新,该机构作为药品许可信息的一部分,发布最新的产品特性概要。

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Together with emerging

与新兴的

in vitro

体外

evidence, these data support differentiation of certolizumab pegol in patients with varying RF profiles.

证据表明,这些数据支持在具有不同类风湿因子(RF)谱的患者中区分培戈洛赛妥珠单抗的疗效。

Notes to editors

编者注

For further information, contact UCB:

如需更多信息,请联系 UCB:

Investor Relations

投资者关系

Yvonne Naughton

伊冯·诺顿

T: +44.175.344.7521

电话:+44.175.344.7521

Email: Yvonne.Naughton@ucb.com

邮箱:Yvonne.Naughton@ucb.com

Sahar Yazdian

萨哈尔·亚兹迪安

T +32.2.559.91.37

T +32.2.559.91.37

email sahar.yazdian@ucb.com

电子邮件 sahar.yazdian@ucb.com

Corporate Communications

企业传播

Laurent Schots

洛朗·肖茨

T: +32.2.559.92.6

电话:+32.2.559.92.6

Email: Laurent.schots@ucb.com

电子邮件:Laurent.schots@ucb.com

Global Communications

全球通信

Adriaan Snauwaert

阿德里安·斯瑙沃特

T: +32.497.70.23.46

电话:+32.497.70.23.46

Email: adriaan.snauwaert@ucb.com

电子邮件:adriaan.snauwaert@ucb.com

About CIMZIA

关于CIMZIA

®

注册商标

(certolizumab pegol) in the EU/EEA

(赛妥珠单抗聚乙二醇)在欧盟/欧洲经济区

8

8

In the EU, CIMZIA

在欧盟,CIMZIA

®

注册商标

(certolizumab pegol) in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs), including MTX, has been inadequate. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.

聚乙二醇化赛妥珠单抗联合甲氨蝶呤(MTX)适用于治疗对包括甲氨蝶呤在内的改善病情抗风湿药(DMARDs)反应不足的成人中重度活动性类风湿关节炎(RA)患者。在对甲氨蝶呤不耐受或继续甲氨蝶呤治疗不适宜的情况下,可单独使用聚乙二醇化赛妥珠单抗进行治疗。

Certolizumab pegol in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. Certolizumab pegol has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with MTX. .

培塞利珠单抗联合甲氨蝶呤(MTX)也适用于治疗此前未接受过甲氨蝶呤或其他改善病情抗风湿药(DMARDs)治疗的成人严重、活动性且进展性的类风湿关节炎(RA)。研究表明,培塞利珠单抗与甲氨蝶呤联用可降低X射线评估的关节损伤进展速率,并改善身体功能。

Certolizumab pegol, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. .

培塞利珠单抗联合甲氨蝶呤(MTX)也适用于既往改善病情抗风湿药(DMARD)治疗反应不足的成人活动性银屑病关节炎的治疗。在对甲氨蝶呤不耐受或继续接受甲氨蝶呤治疗不适宜的情况下,可单用培塞利珠单抗。

Certolizumab pegol is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:

塞妥珠单抗聚乙二醇在欧洲联盟也适用于治疗患有严重活动性中轴型脊柱关节炎(axSpA)的成年患者,包括:

Ankylosing spondylitis (AS) – adults with severe active AS who have had an inadequate response to, or are intolerant to, non-steroidal anti-inflammatory drugs (NSAIDs).

强直性脊柱炎(AS)– 适用于对非甾体抗炎药(NSAIDs)反应不足或不耐受的成人重度活动性强直性脊柱炎患者。

Axial spondyloarthritis (axSpA) without radiographic evidence of AS – adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have had an inadequate response to, or are intolerant to, NSAIDs. .

无强直性脊柱炎(AS)放射学证据的轴向脊柱关节炎(axSpA)——患有严重活动性axSpA、无AS放射学证据但具有C反应蛋白(CRP)升高和/或磁共振成像(MRI)显示的客观炎症征象,且对非甾体抗炎药(NSAIDs)反应不足或不耐受的成年患者。

Certolizumab pegol is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

培塞利珠单抗适用于治疗适合接受全身治疗的成人中度至重度斑块状银屑病。

CIMZIA

希敏佳

®

®

(certolizumab pegol) EU/EEA Important Safety Information

(赛妥珠单抗聚乙二醇)欧盟/欧洲经济区重要安全信息

Cimzia

西姆扎

®

®

was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with Cimzia® and post-marketing were viral infections (includes herpes zoster, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthenia, leukopenia (including lymphopenia, neutropenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea.

在对照试验和开放标签试验中,对4,049名类风湿关节炎(RA)患者进行了长达92个月的研究。在Cimzia®的临床试验及上市后监测中,常见报告的不良反应用于(发生率1-10%)包括:病毒感染(包括带状疱疹、乳头瘤病毒、流感)、细菌感染(包括脓肿)、皮疹、头痛(包括偏头痛)、乏力、白细胞减少(包括淋巴细胞减少、中性粒细胞减少)、嗜酸性粒细胞紊乱、疼痛(任何部位)、发热、感觉异常、高血压、瘙痒(任何部位)、肝炎(包括肝酶升高)、注射部位反应以及恶心。

Serious adverse reactions include sepsis, opportunistic infections, tuberculosis (including miliary, disseminated and extrapulmonary), herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis).

严重不良反应包括脓毒症、机会性感染、结核病(包括粟粒性、播散性和肺外结核)、带状疱疹、淋巴瘤、白血病、实体器官肿瘤、血管神经性水肿、心肌病(包括心力衰竭)、缺血性冠状动脉疾病、全血细胞减少、高凝状态(包括血栓性静脉炎、肺栓塞)、脑血管意外、血管炎、肝炎/肝病(包括肝硬化)以及肾损伤/肾病(包括肾炎)。

In RA controlled clinical trials, 4.4% of patients discontinued taking Cimzia® due to adverse events vs. 2.7% for placebo..

在类风湿关节炎(RA)的对照临床试验中,4.4%的患者因不良事件而停止服用Cimzia®,而安慰剂组为2.7%。

Cimzia was initially studied in 325 patients with active axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis) in the AS001 clinical study for up to 4 years, which includes a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 156-week open-label treatment period.

Cimzia 在 AS001 临床研究中最初对 325 名活动性中轴型脊柱关节炎(包括强直性脊柱炎和非放射学中轴型脊柱关节炎)患者进行了长达 4 年的研究,其中包括一个 24 周的安慰剂对照阶段,随后是一个 24 周的盲法剂量期和一个 156 周的开放标签治疗期。

Cimzia was subsequently studied in 317 patients with non-radiographic axial spondyloarthritis in a placebo-controlled study for 52 weeks (AS0006). Cimzia was also studied in patients with axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis) in a clinical study for up to 96 weeks, which included a 48-week open label run-in phase (N=736) followed by a 48-week placebo-controlled phase (N=313) for patients in sustained remission (C-OPTIMISE).

随后,在一项为期52周的安慰剂对照研究(AS0006)中,对317例非放射性中轴型脊柱关节炎患者进行了Cimzia的研究。此外,还在一项长达96周的临床研究中对中轴型脊柱关节炎患者(包括强直性脊柱炎和非放射性中轴型脊柱关节炎)进行了Cimzia的研究,该研究包括一个48周的开放标签导入期(N=736),随后是一个针对持续缓解患者的48周安慰剂对照期(N=313)(C-OPTIMISE)。

Cimzia was also studied in a 96-week open label study in 89 axSpA patients with a history of documented anterior uveitis flares. In all 4 studies, the safety profile for these patients was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia. Cimzia® was studied in 409 patients with psoriatic arthritis (PsA) in a clinical study for up to 4 years which included a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 168-week open-label treatment period.

Cimzia 还在一项为期 96 周的开放标签研究中进行了评估,该研究纳入了 89 名有记录在案的前葡萄膜炎发作病史的轴性脊柱关节炎(axSpA)患者。在所有 4 项研究中,这些患者的安全性特征与类风湿关节炎患者中的安全性特征以及既往使用 Cimzia 的经验一致。在一项长达 4 年的临床研究中,对 409 名银屑病关节炎(PsA)患者使用了 Cimzia®,该研究包括一个 24 周的安慰剂对照阶段,随后是一个 24 周的设盲剂量阶段和一个 168 周的开放标签治疗阶段。

The safety profile for axSpA and PsA patients treated with Cimzia® was consistent with the safety profile in RA and previous experience with Cimzia®. .

在轴性脊柱关节炎(axSpA)和银屑病关节炎(PsA)患者中,Cimzia®的安全性特征与类风湿关节炎(RA)中的安全性特征以及既往使用Cimzia®的经验一致。

Cimzia® was studied in 1112 patients with psoriasis in controlled and open-label studies for up to 3 years. In the Phase III program, the initial and maintenance periods were followed by a 96-week open-label treatment period. The long-term safety profile of Cimzia® 400 mg every 2 weeks and Cimzia® 200 mg every 2 weeks was generally similar and consistent with previous experience with Cimzia. .

在对照研究和开放标签研究中,对1112名银屑病患者使用Cimzia®进行了长达3年的研究。在III期临床试验项目中,初始治疗期和维持治疗期之后是一个为期96周的开放标签治疗期。每2周给予400 mg Cimzia®和每2周给予200 mg Cimzia®的长期安全性特征总体相似,并与以往使用Cimzia®的经验一致。

Cimzia® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections, and moderate to severe heart failure.

Cimzia® 禁用于对活性成分或任何辅料过敏、活动性结核病或其他严重感染(如败血症或机会性感染)以及中度至重度心力衰竭的患者。

Serious infections including sepsis, tuberculosis and opportunistic infections (e.g. histoplasmosis, nocardia, candidiasis) have been reported in patients receiving Cimzia®. Some of these events have been fatal. Before initiation of therapy with Cimzia®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection.

在接受Cimzia®治疗的患者中,已报告发生严重感染,包括败血症、结核病和机会性感染(例如组织胞浆菌病、诺卡氏菌病、念珠菌病)。其中一些事件曾导致死亡。在开始使用Cimzia®治疗之前,必须对所有患者进行活动性和非活动性(潜伏性)结核感染的评估。

If active tuberculosis is diagnosed prior to or during treatment, Cimzia® therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti- tuberculosis therapy must be started before initiating treatment with Cimzia®. .

如果在治疗前或治疗期间诊断为活动性结核病,则不得启动且必须停止Cimzia®治疗。如果诊断为潜伏性结核病,则在开始Cimzia®治疗之前必须先开始适当的抗结核治疗。

Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Cimzia®. Carriers of HBV who require treatment with Cimzia® should be closely monitored and in the case of HBV reactivation Cimzia® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated..

在包括使用Cimzia®在内的TNF拮抗剂治疗的慢性乙肝病毒携带者(即表面抗原阳性)中,曾发生乙型肝炎再激活的情况。部分病例导致死亡。在开始使用Cimzia®治疗前,应对患者进行乙型肝炎病毒(HBV)感染筛查。对于需要接受Cimzia®治疗的HBV携带者,应密切监测;若发生HBV再激活,应停用Cimzia®,并启动有效的抗病毒治疗及适当的辅助支持治疗。

TNF antagonists including Cimzia® may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease including multiple sclerosis; of formation of autoantibodies and uncommonly of the development of a lupus like syndrome; of severe hypersensitivity reactions.

包括Cimzia®在内的TNF拮抗剂可能会增加新发或加剧临床症状和/或多发性硬化症等脱髓鞘疾病的放射学证据的风险;增加自身抗体形成以及罕见情况下出现类似狼疮综合征的风险;还可能增加严重过敏反应的风险。

If a patient develops any of these adverse reactions, Cimzia® should be discontinued and appropriate therapy instituted. .

如果患者出现任何这些不良反应,应停用Cimzia®并采取适当的治疗措施。

With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia®.

根据现有知识,无法排除接受TNF拮抗剂治疗的患者发生淋巴瘤、白血病或其他恶性肿瘤的潜在风险。已有报道指出,在接受Cimzia®治疗的患者中,罕见神经系统疾病病例,包括癫痫发作、神经炎和周围神经病变。

Adverse reactions of the haematologic system, including medically significant cytopenia, have been reported with Cimzia®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia®.

已有报告指出,使用 Cimzia® 可能出现血液系统不良反应,包括具有临床意义的血细胞减少症。应告知所有患者,若在使用 Cimzia® 期间出现提示血液系统异常或感染的体征和症状(例如持续发热、瘀伤、出血、苍白),应立即就医。

Consider discontinuation of Cimzia® therapy in patients with confirmed significant haematological abnormalities..

对于确诊存在显著血液学异常的患者,应考虑停用Cimzia®治疗。

The use of Cimzia® in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, Cimzia® should not be administered concurrently with live vaccines. The 14-day half-life of Cimzia® should be taken into consideration if a surgical procedure is planned.

由于可能存在严重感染风险增加的情况,不建议将Cimzia®与anakinra或abatacept联合使用。由于缺乏相关数据,Cimzia®不应与活疫苗同时接种。如果计划进行手术,应考虑Cimzia®的14天半衰期。

A patient who requires surgery while on Cimzia® should be closely monitored for infections. .

正在使用Cimzia®的患者如需进行手术,应密切监测感染情况。

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information.

有关其他副作用、完整安全性信息及处方信息,请参阅完整的处方资料。

European SmPC date of revision April 2026.

欧洲产品特性概要(SmPC)修订日期:2026年4月。

https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-productinformation_en.pdf

https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-productinformation_en.pdf

* EU/EEA means European Union/European Economic Area

* 欧盟/欧洲经济区指欧洲联盟/欧洲经济区

Abbreviations: ACR: American College of Rheumatology; AS: ankylosing spondylitis; axSpA: axial spondyloarthritis; CD28: cluster of differentiation 28 (a protein expressed on T cells); CRP: C-reactive protein; DMARDs: disease-modifying antirheumatic drugs; EEA: European Economic Area; EU: European Union; HBV: hepatitis B virus; MRI: magnetic resonance imaging; MTX: methotrexate; NSAIDs: non-steroidal anti-inflammatory drugs; RA: rheumatoid arthritis; RF: rheumatoid factor; TNFis: tumor necrosis factor inhibitors.

缩写:ACR:美国风湿病学会;AS:强直性脊柱炎;axSpA:中轴型脊柱关节炎;CD28:分化簇28(一种表达于T细胞上的蛋白质);CRP:C反应蛋白;DMARDs:改善病情抗风湿药;EEA:欧洲经济区;EU:欧盟;HBV:乙型肝炎病毒;MRI:磁共振成像;MTX:甲氨蝶呤;NSAIDs:非甾体抗炎药;RA:类风湿关节炎;RF:类风湿因子;TNFis:肿瘤坏死因子抑制剂。

.

About UCB

关于 UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of € 7.7 billion in 2025.

优时比(UCB,www.ucb.com)是一家总部位于比利时布鲁塞尔的全球性生物制药公司,专注于发现和开发创新药物及解决方案,以改善患有严重免疫系统疾病或中枢神经系统疾病患者的生活。公司在约40个国家拥有约9,000名员工,2025年实现营业收入77亿欧元。

UCB is listed on Euronext Brussels (symbol: UCB).

UCB 在布鲁塞尔泛欧交易所上市(股票代码:UCB)。

Forward looking statements

前瞻性陈述

This document contains forward-looking statements, including, without limitation, statements containing the words “potential”, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management.

本文件包含前瞻性陈述,包括但不限于含有“潜在”、“相信”、“预期”、“预计”、“打算”、“计划”、“寻求”、“估计”、“可能”、“将”、“继续”等词语及类似表述的陈述。这些前瞻性陈述基于管理层当前的计划、估计和信念。

All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results.

除历史事实陈述外,所有陈述均可能被视为前瞻性陈述,包括对收入、营业利润率、资本支出、现金及其他财务信息的估计,以及对法律、仲裁、政治、监管或临床试验结果或实践的预期,以及其他此类估计和结果。

By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. .

就其性质而言,此类前瞻性陈述并不保证未来表现,且受已知和未知的风险、不确定性和假设的影响,这些因素可能导致优时比(UCB)的实际业绩、财务状况、表现或成就,或行业结果,与本文件中所含前瞻性陈述所明示或暗示的任何未来业绩、表现或成就存在重大差异。

Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB’s information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in laws and/or rules pertaining to tax and duties or the administration of such laws and/or rules, and hiring, retention and compliance of employees.

可能导致此类差异的重要因素包括但不限于:战争、流行病和恐怖主义的全球蔓延及其影响;总体地缘政治环境;气候变化;总体经济、商业和竞争状况的变化;无法获得必要的监管批准,或无法在可接受的条款下或预期的时间内获得此类批准;与研发相关的成本;优时比(UCB)管线中或正在开发的产品前景变化;未来司法判决或政府调查的影响;安全、质量、数据完整性或生产问题;供应链中断和业务连续性风险;潜在或实际的数据安全和数据隐私泄露,或优时比信息技术系统的中断;产品责任索赔;对产品或候选产品专利保护的挑战;来自其他产品(包括生物类似药)或颠覆性技术/商业模式竞争;法律或法规的变化;汇率波动;与税收和关税相关的法律和/或规则或其执行方面的变化或不确定性;以及员工的招聘、留任和合规问题。

There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans.

无法保证在研发管线中发现或识别出新的候选产品,也无法保证现有产品的新适应症会得到开发和批准。从概念到商业化产品的过程具有不确定性;临床前研究结果并不能保证候选产品在人体中的安全性和有效性。

So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has.

迄今为止,计算机模型、细胞培养系统或动物模型尚无法复现人体的复杂性。完成临床试验并获得产品上市监管审批所需的时间长度亦然。

Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise.

鉴于存在上述不确定性,提醒公众不要对此类前瞻性陈述过度依赖。这些前瞻性陈述仅反映截至本文件发布之日的情况,并未体现前述不断演变的事件或风险以及其他不利因素可能产生的任何影响,除非另有说明。

The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB..

本公司持续密切关注相关事态发展,以评估这些事件对UCB的财务影响(如适用)。

UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations..

UCB 明确声明,除非适用法律和法规要求,其不承担任何更新本文件中任何前瞻性陈述的义务,无论是为了确认实际结果,还是为了报告或反映其前瞻性陈述的任何变化,或反映任何此类陈述所依据的事件、条件或情况的变化。

References

参考文献

Bidgood SR, et al. RFs do not bind Fc free certolizumab pegol but bind Fc containing bDMARDs, inducing cytokine release in vitro [abstract]. Ann Rheum Dis. 2026; EULAR. #POS0903.

Bidgood SR 等。RFs 不与不含 Fc 段的培塞利珠单抗结合,但可与含 Fc 段的生物合成改善病情抗风湿药(bDMARDs)结合,并在体外诱导细胞因子释放 [摘要]。《风湿病年鉴》. 2026; EULAR. #POS0903.

Bidgood SR, et al. Fragment Crystallizable (Fc)-Free Certolizumab Pegol Is Not Bound by Rheumatoid Factors, While Fc Containing Biological DMARDs Are, Driving Immune Complex Formation and Cellular Clearance. 2024. ACR. #0059.

Bidgood SR 等. 不含结晶片段(Fc)的聚乙二醇化赛妥珠单抗不被类风湿因子结合,而含 Fc 的生物合成改善病情抗风湿药则会被结合,从而驱动免疫复合物形成和细胞清除。2024. ACR. #0059.

Smolen JS, et al.

Smolen JS 等

Rheumatology (Oxford)

风湿病学(牛津)

. 2024;63(11):3015–3024.

. 2024;63(11):3015–3024.

Martínez Feito A, et al.

马丁内斯·费托 A,等。

Clin Exp Rheumatol

临床与实验风湿病学

. 2024;42(5):999–1005.

. 2024;42(5):999–1005.

Oliveira VDRS, et al.

奥利维拉 VDRS 等

Rheumatol Ther

风湿病治疗

. 2025;12:123–36.

. 2025;12:123–36.

Nakayama Y, et al.

中山Y,等。

Rheumatol Int

风湿病学国际

. 2022;42:1227–34.

. 2022;42:1227–34.

Tanaka Y, et al.

田中Y等

Rheumatology (Oxford)

风湿病学(牛津)

. 2025;64(Suppl 2):ii9–ii14.

. 2025;64(增刊2):ii9–ii14。

CIMZIA

希姆扎

®

注册商标符号

EU SmPC.

欧盟药品特性概要(SmPC)。

https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-product-information_en.pdf

https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-product-information_en.pdf

. Last accessed: June 2026.

最后访问日期:2026年6月。

Products. Medicines & Healthcare Products Regulatory Agency. https://products.mhra.gov.uk/. Last accessed: June 2026.

产品。药品和保健品监管局。https://products.mhra.gov.uk/。最后访问日期:2026年6月。