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在EADV上发布的BIMZELX(bimekizumab)在中度至重度斑块型银屑病中的数据显示,四年持续缓解,并有潜力降低银屑病关节炎进展风险

BIMZELX[®][▼] (bimekizumab) data in moderate-to-severe plaque psoriasis at EADV showed four-year sustained remission, and potential to reduce psoriatic arthritis progression risk

优时比 等信源发布 2025-09-17 15:20

可切换为仅中文


Brussels (Belgium), September 17, 2025 – 07:00 (CEST)

布鲁塞尔(比利时),2025年9月17日 – 07:00(欧洲中部夏令时间)

– UCB, a global biopharmaceutical company, today announced three- and four-year data from across their Phase 3 trials for BIMZELX

优时比(UCB),一家全球生物制药公司,今天公布了其 BIMZELX 三期临床试验的三至四年数据。

®

®

(bimekizumab) in moderate-to-severe plaque psoriasis. These new data build on established evidence that bimekizumab, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),

(bimekizumab)用于中度至重度斑块型银屑病。这些新数据建立在已确立的证据基础上,即bimekizumab是首个也是唯一获批可选择性抑制白细胞介素17A(IL-17A)和白细胞介素17F(IL-17F)的药物,

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not only provides long-term disease control but may also prevent disease progression in psoriasis.

不仅提供长期的疾病控制,还可能预防牛皮癣的疾病进展。

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“Achieving high disease control is a key treatment target for all patients with plaque psoriasis, as it prevents the cumulative burden of disease and potentially progression to PsA,” said Richard B. Warren, Professor of Dermatology, University of Manchester and Northern Care Alliance NHS Foundation Trust.

“实现高度的疾病控制是对所有斑块型银屑病患者的关键治疗目标,因为这可以防止疾病负担的累积,并可能阻止病情进展为银屑病关节炎(PsA),”曼彻斯特大学皮肤病学教授、北方护理联盟NHS基金会信托的理查德·B·沃伦表示。

“It is therefore highly relevant to observe complete skin clearance sustained over four years in nearly half of patients who received bimekizumab, demonstrating long-term control of inflammation and the potential to improve patient outcomes.”.

“因此,观察到近一半接受bimekizumab治疗的患者在四年期间持续出现完全的皮肤清除,这具有高度相关性,展示了对炎症的长期控制以及改善患者预后的潜力。”

Among Week 16 PASI 0 responders who entered the open-label extension (OLE) (bimekizumab [BKZ] Total group; N=503), 48.9% maintained PASI 0 at every visit from Week 16 to year four; 72.0% sustained PASI 0 at every visit except up to four visits with PASI >0–≤2, defined in this abstract as remission.2* In the same study, among Week 16 PASI 0 responders, 69.4% maintained body surface area (BSA) ≤1% at every visit to year four,2* and 81.7% maintained BSA ≤1% at every visit except up to four visits with BSA >1%–≤3%, defined in this abstract as high disease control.2* Separately, 81.8% (383/468) and 82.7% (386/467) of BKZ Total patients achieved nail matrix or nail bed mNAPSI 0 respectively at year three, which may contribute to reducing the risk of progression to PsA..

在第16周PASI 0应答者中,进入开放标签扩展(OLE)阶段的患者(bimekizumab [BKZ] 总体组;N=503),有48.9%从第16周到第四年每次随访均维持PASI 0;72.0%在除至多四次PASI >0–≤2的随访外的所有随访中持续保持PASI 0,在本摘要中定义为缓解。在同一研究中,在第16周PASI 0应答者中,69.4%在每次随访直至第四年均保持体表面积(BSA)≤1%,并且81.7%在除至多四次BSA >1%–≤3%的随访外的所有随访中维持BSA ≤1%,在本摘要中定义为高度疾病控制。另外,分别有81.8%(383/468)和82.7%(386/467)的BKZ总体组患者在第三年达到指甲基质或甲床mNAPSI 0,这可能有助于降低进展为PsA的风险。

3,5,6^

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Of BKZ Total patients with ≥4 baseline PsA risk factors (n=68), PASE <47 (no PsA symptoms) was maintained by 98.1% of patients to three years.

在BKZ总患者中,具有≥4个基线PsA风险因素的患者(n=68),98.1%的患者在三年内保持PASE <47(无PsA症状)。

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Similarly, in those with ≥4 baseline PsA risk factors (n=417), only 2.6% (0.9/100 PY) reported incidence of PsA TEAEs over four years.

同样,在那些具有≥4个基线PsA风险因素的患者中(n=417),四年内仅报告了2.6%(0.9/100 PY)的PsA TEAE发生率。

These data support long-term bimekizumab treatment to achieve high disease control, including remission, in psoriasis and reduce risk of progression to PsA.

这些数据支持长期使用 bimekizumab 治疗以实现对银屑病的高度疾病控制,包括缓解,并降低进展为银屑病关节炎 (PsA) 的风险。

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“The presentation of this three- and four-year data is further evidence of the depth and durability of response achieved with bimekizumab treatment in psoriasis, even at highly stringent measures of disease control,” said Donatello Crocetta, Head of Medical & Chief Medical Officer, UCB. “These results reinforce UCB’s commitment to developing evidence-driven solutions that aim to improve care for people living with chronic inflammatory diseases and reduce the risk of disease progression.”.

“这份三年和四年的数据展示进一步证明了使用bimekizumab治疗银屑病所能达到的深度和持久的疗效反应,即使是在极为严格的疾病控制标准下,”优时比(UCB)医学主管兼首席医学官唐纳泰罗·克罗切塔表示。“这些结果进一步强化了优时比致力于开发以证据为导向的解决方案,旨在改善慢性炎症性疾病患者的护理,并降低疾病进展的风险。”

UCB’s data on bimekizumab in psoriasis will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France, 17–20 September. These abstracts are part of the 19 presentations from UCB across bimekizumab in PSO, hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis, as well as the abstract for the investigational therapy galvokimig in atopic dermatitis..

优时比关于bimekizumab在银屑病中的数据将在2025年9月17日至20日在法国巴黎举行的欧洲皮肤病与性病学会(EADV)大会上展示。这些摘要属于优时比在bimekizumab涉及银屑病、化脓性汗腺炎、银屑病关节炎、轴向脊柱关节炎的19项报告的一部分,同时还有关于研究性治疗药物galvokimig在特应性皮炎中的摘要。

*mNRI-LOCF: Modified non-responder imputation last responder carried forward – patients who discontinued treatment due to lack of efficacy/treatment-related adverse events were considered non-responders at subsequent timepoints; the last observation carried forward was used for other missing data. Data were pooled from the 52-week BE VIVID, 56-week BE SURE and BE READY Phase 3 trials, and their 144 week open-label extension (OLE) BE BRIGHT.

*mNRI-LOCF:改良的无应答者填补法,最后一次观察值结转——因缺乏疗效/治疗相关不良事件而停止治疗的患者在后续时间点被视为无应答者;其他缺失数据采用最后一次观察值结转。数据汇总自52周BE VIVID、56周BE SURE和BE READY III期试验,以及它们的144周开放标签扩展(OLE)BE BRIGHT研究。

Data reported here are only for patients who received continuous bimekizumab (BKZ) and entered the OLE, regardless of dosing regimen (BKZ Total).  .

此处报告的数据仅针对接受持续使用比美珠单抗(BKZ)并进入OLE的患者,不论剂量方案如何(BKZ总计)。

^OC: Analyses were conducted post hoc for patients with baseline nail involvement (mNAPSI >0) using observed cases. Data are also reported for patients with psoriasis only at baseline (Psoriatic Arthritis Screening and Evaluation [PASE] <47 and no medical history of PsA). Data were pooled from the 52-week BE VIVID, 56-week BE SURE and BE READY Phase 3 trials, 96 weeks of their open-label extension (OLE), BE BRIGHT, and the BE RADIANT Phase 3b trial.

OC:对基线时有指甲受累(mNAPSI >0)的患者进行了事后分析,使用了观察到的病例。还报告了仅在基线时患有银屑病的患者的数据(银屑病关节炎筛查与评估 [PASE] <47 且无 PsA 病史)。数据汇总自为期 52 周的 BE VIVID、56 周的 BE SURE 和 BE READY III 期试验、它们的开放标签扩展 (OLE) 96 周的 BE BRIGHT,以及 BE RADIANT IIIb 期试验。

Data reported here are only for patients who received continuous BKZ and entered the OLE, regardless of dosing regimen (BKZ Total). .

此处报告的数据仅针对接受连续BKZ治疗并进入OLE的患者,不论剂量方案如何(BKZ总计)。

≠mNRI: Patients discontinuing due to lack of efficacy or treatment-related AEs were considered non-responders; multiple imputation was used for other missing data. Proportion of patients reported from the BE RADIANT Phase 3b trial (data only available from BE RADIANT). Included patients who received BKZ 320 mg every 4 weeks (Q4W) to Week 16, then Q4W or Q8W into the open-label extension.

≠mNRI:因缺乏疗效或治疗相关不良事件而停止治疗的患者被视为无反应者;其他缺失数据使用多重插补法处理。报告的比例来自BE RADIANT 3b期试验(数据仅来自BE RADIANT)。包括在第16周之前每4周接受BKZ 320 mg治疗,然后进入开放标签扩展阶段,按每4周(Q4W)或每8周(Q8W)给药的患者。

Data are reported for patients who received continuous BKZ and entered the OLE, regardless of dosing regimen (BKZ Total)..

报告了接受连续BKZ治疗并进入OLE的患者数据,不论剂量方案如何(BKZ总计)。

Galvokimig is currently under clinical investigation, and is not approved by any regulatory authority worldwide.

Galvokimig目前正在临床研究中,尚未获得全球任何监管机构的批准。

Notes to Editors:

编辑须知:

PASI 0: Psoriasis Area and Severity Index (PASI) is a tool used to measure the severity and extent of psoriasis. PASI 0 is the same measure as PASI 100 and is considered complete skin clearance. PASI 0 at every visit except up to 2/3/4 visits with PASI >0–≤2 was defined as remission of psoriasis in the abstract.

PASI 0:银屑病面积和严重程度指数(PASI)是用于衡量银屑病严重程度和范围的工具。PASI 0 与 PASI 100 相同,被认为实现了完全的皮肤清除。在每次随访中,PASI 0 被定义为银屑病的缓解,但允许在2/3/4次随访中 PASI >0–≤2。

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BSA: Body surface area. BSA ≤1% entails one percent or less of the body surface area is affected. BSA ≤1% at every visit except up to 2/3/4 visits with BSA >1%–≤3% was defined as high disease control in the abstract

BSA:体表面积。BSA ≤1% 意味着受影响的体表面积为百分之一或更少。在每次就诊时 BSA ≤1%,除了在 2/3/4 次就诊时 BSA >1%–≤3%,在摘要中被定义为高度疾病控制。

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mNAPSI 0: Patients achieving complete nail clearance in the nail matrix using the modified Nail Psoriasis Severity Index (mNAPSI)

mNAPSI 0:通过改良的指甲银屑病严重程度指数(mNAPSI)评估,指甲基质达到完全清除的患者。

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PASE <47: The Psoriatic Arthritis Screening and Evaluation (PASE) is a questionnaire that aids the early detection of PsA and intervention,

PASE <47: 银屑病关节炎筛查与评估 (PASE) 是一种有助于早期发现 PsA 并进行干预的问卷,

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helping to delay/halt progression and prevent long-term complications; PASE <47 indicates no PsA symptoms

帮助延缓/阻止病情进展,预防长期并发症;PASE <47 表示无 PsA 症状

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About plaque psoriasis

关于斑块状银屑病

Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.

银屑病是一种常见的、慢性炎症性疾病,主要累及皮肤。

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This skin condition affects men and women of all ages and ethnicities.

这种皮肤状况影响所有年龄和种族的男性和女性。

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Psoriasis signs and symptoms can vary, but may include patches of thick, red skin covered with silvery-white scales that itch or burn; dry, cracked skin that may bleed; and thickened, pitted or ridged nails.

牛皮癣的体征和症状可能有所不同,但可能包括:覆盖着银白色鳞屑的红色厚斑块,伴有瘙痒或灼热感;干燥、开裂并可能出血的皮肤;以及增厚、凹陷或有脊纹的指甲。

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Psoriasis affects two to three percent of the total population, or about 125 million people worldwide.

牛皮癣影响总人口的百分之二到三,也就是全世界约一千两百五十万人。

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About psoriatic arthritis

关于银屑病关节炎

Psoriatic arthritis is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a global prevalence of 0.02 percent to 0.25 percent of the population.

银屑病关节炎是一种严重的、高度异质性的、慢性的、全身性炎症性疾病,影响关节和皮肤,全球患病率在人口中的比例为0.02%至0.25%。

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Psoriatic arthritis affects approximately 30 percent of people living with psoriasis.

银屑病关节炎影响大约30%的银屑病患者。

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It manifests as joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis) and inflammation of the sites where tendons or ligaments insert into the bone (enthesitis).

它表现为关节疼痛和僵硬、皮肤斑块、脚趾和手指肿胀(指炎)以及肌腱或韧带附着于骨骼的部位发炎(附着点炎)。

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The burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with comorbidities including hypertension, cardiovascular disease, anxiety and depression.

银屑病关节炎 (PsA) 患者除了身体不适外,其生活质量也受到影响,同时伴有的合并症包括高血压、心血管疾病、焦虑和抑郁。

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About BIMZELX

关于BIMZELX

®

®

▼(bimekizumab)

▼(比美珠单抗)

BIMZELX

BIMZELX

®

®

is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.

是一种人源化的单克隆IgG1抗体,旨在选择性抑制白细胞介素17A(IL-17A)和白细胞介素17F(IL-17F),这两种关键的细胞因子会驱动炎症过程。

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About BIMZELX

关于BIMZELX

®

®

▼(bimekizumab) EU/EEA*

▼(比美珠单抗)欧盟/欧洲经济区*

The approved indications for bimekizumab▼ in the European Union are:

比美珠单抗▼在欧盟的获批适应症为:

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Plaque psoriasis

银屑病斑块

: Bimekizumab is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy

比美珠单抗适用于系统治疗的中度至重度斑块型银屑病成人患者。

Psoriatic arthritis

银屑病关节炎

: Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs)

Bimekizumab,单独使用或与甲氨蝶呤联合使用,适用于治疗对一种或多种疾病修饰抗风湿药物(DMARDs)反应不足或不耐受的成人活动性银屑病关节炎。

Axial spondyloarthritis

轴向脊柱关节炎

: Bimekizumab is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP), and/or magnetic resonance imaging (MRI), who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Bimekizumab 适用于治疗具有炎症客观体征(如C反应蛋白(CRP)升高和/或磁共振成像(MRI)所示)的活动性非放射学中轴型脊柱关节炎成人患者,这些患者对非甾体抗炎药(NSAIDs)反应不佳或不耐受;同时也适用于治疗对传统疗法反应不足或不耐受的活动性强直性脊柱炎成人患者。

Hidradenitis suppurativa

化脓性汗腺炎

: Bimekizumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy

Bimekizumab 适用于治疗对传统全身性 HS 疗法反应不佳的成人中重度活动性化脓性汗腺炎(HS;反向痤疮)。

The label information may differ in other countries where approved. Please check local Prescribing Information.

标签信息在其他已批准的国家可能会有所不同。请查阅当地的处方信息。

BIMZELX

BIMZELX

®

®

▼(bimekizumab) EU/EEA* Important Safety Information

▼(bimekizumab) 欧盟/欧洲经济区* 重要安全信息

The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively).

比美珠单抗最常见的不良反应是上呼吸道感染(在斑块型银屑病、银屑病关节炎、轴向脊柱关节炎(axSpA)和化脓性汗腺炎中分别为14.5%、14.6%、16.3%、8.8%)以及口腔念珠菌病(在PSO、PsA、axSpA和HS中分别为7.3%、2.3%、3.7%、5.6%)。

Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis), headache, rash, dermatitis and eczema, acne, injection site reactions (injection site erythema, reaction, edema, pain, swelling, hematoma), fatigue.

常见的不良反应(≥1/100至<1/10)包括口腔念珠菌病、癣感染、耳部感染、单纯疱疹感染、口咽念珠菌病、胃肠炎、毛囊炎、外阴阴道真菌感染(包括外阴阴道念珠菌病)、头痛、皮疹、皮炎和湿疹、痤疮、注射部位反应(注射部位红斑、反应、水肿、疼痛、肿胀、血肿)、疲劳。

Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab..

老年人使用bimekizumab时可能更容易出现某些不良反应,如口腔念珠菌病、皮炎和湿疹。

Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis).

比美珠单抗禁用于对活性物质或任何辅料过敏的患者,以及患有临床重要活动性感染(如活动性结核病)的患者。

Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored.

Bimekizumab可能会增加感染的风险。对于任何具有临床重要性的活动性感染患者,不得开始使用bimekizumab治疗。接受bimekizumab治疗的患者应被告知,如果出现提示感染的体征或症状,需寻求医疗建议。如果患者发生感染,应密切监测患者。

If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB.

如果感染变得严重或对标准治疗无反应,应停止治疗直到感染得到解决。在开始使用比美珠单抗治疗之前,应对患者进行结核病(TB)感染评估。比美珠单抗不应给予活动性结核病患者。

Patients receiving bimekizumab should be monitored for signs and symptoms of active TB..

接受 bimekizumab 治疗的患者应监测活动性结核病的体征和症状。

Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated..

使用bimekizumab已报告出现新的或炎症性肠病加重的病例。不建议炎症性肠病患者使用bimekizumab。如果患者出现炎症性肠病的症状和体征,或原有的炎症性肠病加重,应停止使用bimekizumab,并启动适当的医疗管理。

Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.

已观察到包括过敏反应在内的严重超敏反应与IL-17抑制剂有关。如果发生严重的超敏反应,应立即停止使用bimekizumab,并启动适当的治疗。

Live vaccines should not be given in patients treated with bimekizumab.

接受比美珠单抗治疗的患者不应接种活疫苗。

Please consult the Summary of Product Characteristics in relation to other side effects, full safety and Prescribing Information.

请参阅产品特性摘要以了解其他副作用、完整安全性和处方信息。

European SmPC date of revision: April 2025.

欧洲SmPC修订日期:2025年4月。

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

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

*EU/EEA means European Union/European Economic Area.

*欧盟/欧洲经济区是指欧洲联盟/欧洲经济区。

Last accessed: September 2025.

最后访问时间:2025年9月。

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

该药品受到额外监控。这将有助于快速识别新的安全信息。医疗专业人员被要求报告任何可疑的不良反应。

For further information, contact UCB:

如需更多信息,请联系UCB:

Investor Relations

投资者关系

Antje Witte

安特耶·维特

T +32.2.559.94.14

电话:+32.2.559.94.14

email antje.witte@ucb.com

电子邮件:antje.witte@ucb.com

Corporate Communications

企业传播

Laurent Schots

劳伦特·肖茨

T +32.2.559.92.64

电话:+32.2.559.92.64

email laurent.schots@ucb.com

电子邮件:laurent.schots@ucb.com

Brand Communications

品牌传播

Amy Cheshire

艾米·奇舍姆

T +44 7786 743 577

电话:+44 7786 743 577

email amy.cheshire@ucb.com

电子邮件:amy.cheshire@ucb.com

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 €6.1 billion in 2024.

优时比(UCB),比利时布鲁塞尔(www.ucb.com),是一家全球生物制药公司,专注于发现和开发创新药物与解决方案,以改变免疫系统或中枢神经系统严重疾病患者的生活。公司在约40个国家拥有约9,000名员工,并在2024年实现了61亿欧元的收入。

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

前瞻性声明

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,包括但不限于包含“潜在”、“相信”、“预期”、“预计”、“意图”、“计划”、“寻求”、“估计”、“可能”、“将”、“继续”等词语及类似表达的陈述。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.

所有声明,除历史事实声明外,均可能被视为前瞻性声明,包括收入、营业利润率、资本支出、现金、其他财务信息、预期法律、仲裁、政治、监管或临床结果或实践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. .

由于此类前瞻性陈述的性质,其并不能保证未来的表现,并且受到已知和未知风险、不确定性以及可能导致实际结果、财务状况、表现或UCB成就、或行业结果与本文件中包含的此类前瞻性陈述明示或暗示的任何未来结果、表现或成就存在重大差异的因素的影响。

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、疫情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在可接受的条件或预期时间内获得批准、与研发相关的成本、UCB正在开发或处于管线中的产品前景变化、未来司法裁决或政府调查的影响、安全性、质量、数据完整性或制造问题、供应链中断和业务连续性风险;潜在或实际的数据安全和隐私泄露,或UCB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)的竞争、法律法规的变化、汇率波动、税收及关税相关法律和/或规则及其管理方面的变化或不确定性,以及员工的招聘、留用和合规问题。

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会发现或识别新的候选产品,也无法保证现有产品的新增适应症能够被开发并获得批准。从概念到商业产品的推进过程充满不确定性;临床前结果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.

到目前为止,人体的复杂性无法在计算机模型、细胞培养系统或动物模型中重现。完成临床试验和获得产品上市监管批准的时间长度已经。

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.

鉴于这些不确定性,公众应注意不要对这些前瞻性陈述给予任何过度依赖。这些前瞻性陈述仅自本文档日期起作出,且除非另有说明,否则并未反映上述不断演变的事件或风险以及任何其他不利因素的潜在影响。

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

公司继续勤勉地跟进事态发展,以评估这些事件对UCB的财务重要性(如有)。

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明确表示,除非适用法律法规要求,否则不承担更新本文件中任何前瞻性陈述的义务,无论该等更新是为了确认实际结果,还是为了报告或反映与其前瞻性陈述相关的任何变化,或任何该等陈述所基于的事件、条件或情况的变化。

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BIMZELX

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