Brussels (Belgium), September 17, 2025 – 07:05 (CEST)

布鲁塞尔（比利时），2025年9月17日 – 07:05（CEST）

– UCB, a global biopharmaceutical company, today announced three-year data from the BE HEARD trials^ for BIMZELX

优时比（UCB），一家全球生物制药公司，今天宣布了BIMZELX的BE HEARD试验的三年数据。

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(bimekizumab) in moderate to severe hidradenitis suppurativa (HS). Bimekizumab, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),

（比美珠单抗）用于中度至重度化脓性汗腺炎 (HS)。比美珠单抗是首个也是唯一获得批准的药物，能够选择性地抑制白细胞介素 17A（IL-17A）和白细胞介素 17F（IL-17F）。

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continues to be generally well tolerated, and demonstrated sustained disease control and durable resolution of key HS symptoms.

继续普遍耐受良好，并显示出持续的疾病控制和关键HS症状的持久缓解。

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“A crucial goal for treating people with hidradenitis suppurativa is achieving and maintaining long term disease control at the most stringent levels,” said John Ingram, Professor of Dermatology, Cardiff University. “These data for bimekizumab – including HiSCR100 and IHS4-100 – showed disease control can be maintained long-term.

“治疗化脓性汗腺炎患者的关键目标是以最严格的标准实现并维持长期的疾病控制，”卡迪夫大学皮肤病学教授约翰·英格拉姆表示。“这些关于bimekizumab的数据——包括HiSCR100和IHS4-100——显示疾病控制可以长期维持。”

Importantly, the resolution of inflammatory lesions highlights the potential to prevent long-term structural damage commonly associated with this disease.”.

重要的是，炎症病灶的消解决定了预防与该疾病通常相关的长期结构损伤的潜力。”

Among patients with HS, improvements in HiSCR50/75/90/100 seen at one year were sustained and further improved to three years in 90.2% (331/367), 81.2% (298/367), 64.3% (236/367) and 50.1% (184/367) of patients, respectively.

在HS患者中，一年时观察到的HiSCR50/75/90/100改善情况得以维持，并在三年内进一步改善，分别有90.2%（331/367）、81.2%（298/367）、64.3%（236/367）和50.1%（184/367）的患者达到相应指标。

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* Improvements in quality of life, as measured by DLQI 0/1, seen at year one in 27.4% (151/551) of patients were sustained to three years, with 38.1% (137/360) of patients reporting no effect of skin disease on their quality of life.

* 在第一年中有27.4%（151/551）的患者生活质量改善（通过DLQI 0/1衡量），这种改善持续了三年，其中38.1%（137/360）的患者报告皮肤疾病对他们的生活质量没有影响。

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* Patients who achieved IHS4-55/75/90/100 at Week 48 sustained this response to two years in 90.8% (315/347), 85.1% (235/276), 71.2% (136/191) and 64.3% (74/115) of cases, respectively.

在第48周达到IHS4-55/75/90/100的患者中，分别有90.8%（315/347）、85.1%（235/276）、71.2%（136/191）和64.3%（74/115）的病例持续保持这一反应达两年。

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* Patients with shorter disease duration since HS diagnosis had better outcomes than those with longer disease duration, particularly at higher efficacy thresholds, emphasizing the potential impact of earlier treatment with bimekizumab upon diagnosis.

* 自HS诊断以来病程较短的患者比病程较长的患者获得更好的治疗效果，尤其是在较高疗效阈值时，这强调了在诊断后尽早使用bimekizumab治疗的潜在影响。

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* At Week 96, proportions of patients in the lowest disease duration quartile (<2.38 years [n=115]) achieving IHS4-55/75/90/100 were 88.7% (n=102), 73.9% (n=85), 59.1% (n=68) and 46.1% (n=53), respectively.

在第96周时，处于最低疾病持续时间四分位数（<2.38年 [n=115]）的患者中，达到IHS4-55/75/90/100的比例分别为88.7%（n=102）、73.9%（n=85）、59.1%（n=68）和46.1%（n=53）。

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* Similarly, IHS4-55/75/90/100 responses in the highest disease duration quartile (≥10.74 years [n=101]) at Week 96 were 77.2% (n=78), 62.4% (n=63), 39.6% (n=40) and 22.8% (n=23), respectively.

同样，在第96周，疾病持续时间最长的四分位数（≥10.74年 [n=101]）中，IHS4-55/75/90/100反应率分别为77.2%（n=78）、62.4%（n=63）、39.6%（n=40）和22.8%（n=23）。

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* Over two years, at the patient level, bimekizumab treatment reduced the number of draining tunnels in the majority of individuals.

两年多的时间里，在患者层面，比美珠单抗治疗减少了大多数个体的引流隧道数量。

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* In addition, over two years of treatment with bimekizumab, a greater reduction in skin pain severity translated into an improvement in health-related quality of life for people living with HS.

* 此外，使用bimekizumab治疗两年以上，皮肤疼痛严重程度的更大减轻转化为HS患者健康相关生活质量的改善。

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“The three-year data on bimekizumab presented at EADV demonstrated deep and sustained responses across stringent efficacy endpoints, as well as long-term improvements in health-related quality of life – raising the treatment bar for people living with hidradenitis suppurativa,” said Donatello Crocetta, Head of Medical and Chief Medical Officer, UCB.

“在EADV上发布的关于bimekizumab的三年数据显示，在严格的疗效终点上表现出深度且持续的反应，同时在健康相关生活质量方面有长期改善——为患有化脓性汗腺炎的人群提高了治疗标准，”UCB医学主管兼首席医学官唐纳泰罗·克罗切塔表示。

“Long-term efficacy and safety data are vital for advancing understanding of chronic inflammatory conditions like hidradenitis suppurativa, and these findings underscore UCB’s commitment to advancing science-led insights and providing transformative treatment options to improve outcomes for patients.”.

“长期疗效和安全性数据对于增进对化脓性汗腺炎等慢性炎症状况的理解至关重要，这些发现强调了UCB致力于推进科学引领的见解，并提供变革性的治疗选择以改善患者的预后。”

Treatment with bimekizumab was generally well tolerated, with no new safety signals observed up to three years.

比美珠单抗治疗通常耐受性良好，最长三年内未观察到新的安全信号。

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* The safety profile up to three years was consistent with years one and two.

* 三年内的安全性与第一年和第二年一致。

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* The most common TEAEs were hidradenitis (19.6/100 patient years [PY]), coronavirus infection (14.1/100 PY) and oral candidiasis (9.3/100 PY).

最常见的TEAE是汗腺炎（19.6/100患者年[PY]）、冠状病毒感染（14.1/100 PY）和口腔念珠菌病（9.3/100 PY）。

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

优时比关于bimekizumab治疗化脓性汗腺炎的数据将在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银屑病、银屑病关节炎、轴向脊柱关节炎中关于bimekizumab的19项展示内容之一，同时也包括了在研疗法galvokimig用于特应性皮炎的摘要。

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*OC: Data are reported as observed case (OC). The data reported are from an observational, open-label study. Patients completing the 48-week BE HEARD I & II studies could enroll in BE HEARD EXT and receive open-label bimekizumab (BKZ) 320 mg every 2 weeks (Q2W) or Q4W based on HiSCR90 response averaged from Weeks 36, 40 and 44.

*OC：数据按观察病例（OC）报告。所报告的数据来自一项观察性、开放标签研究。完成为期48周的BE HEARD I和II研究的患者可以入组BE HEARD EXT，并接受开放标签的比美珠单抗（BKZ）320 mg，每2周一次（Q2W）或每4周一次（Q4W），具体取决于从第36周、第40周和第44周平均计算的HiSCR90反应。

Data are reported for patients randomized to BKZ from baseline in BE HEARD I & II who entered BE HEARD EXT (BKZ Total group, n=556) at Week 48. Only patients who entered the third year are included..

从BE HEARD I & II研究中基线随机分配到BKZ组并进入BE HEARD EXT（BKZ总组，n=556）的患者数据在第48周报告。仅包括进入第三年的患者。

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Receiving BKZ Q2W to Week 16, then Q4W thereafter is the approved dosing regimen (Q2W/Q4W). Results included patients receiving both Q2W and Q4W after Week 48. All patients who continued in the trial after Week 48 were subsequently switched to Q4W by the end of year three. For safety outcomes, data are reported for patients who received one or more dose of BKZ across BE HEARD I & II and BE HEARD EXT (total of three years)..

接受BKZ Q2W至第16周，之后改为Q4W是获批的给药方案（Q2W/Q4W）。结果包含第48周后接受Q2W和Q4W治疗的患者。所有在第48周后继续参与试验的患者均在第三年年底前逐步转为Q4W。对于安全性结果，数据涵盖了在BE HEARD I、BE HEARD II及BE HEARD EXT（总计三年）中接受过一剂或多剂BKZ治疗的患者。

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

Galvokimig目前正在进行临床研究，尚未获得全球任何监管机构的批准。

Notes to Editors:

编辑须知：

HiSCR50/HiSCR75/HiSCR90/HiSCR100: These are defined as at least a 50%/75%/90%/100% reduction in the total abscess and inflammatory nodule count from baseline with no increase from baseline in abscess or draining tunnel count

HiSCR50/HiSCR75/HiSCR90/HiSCR100：这些指标定义为从基线开始，脓肿和炎性结节数量总体减少至少50%/75%/90%/100%，同时脓肿或引流隧道数量没有从基线增加。

IHS4‑55/75/90/100: IHS4 is the clinician-rated International HS Severity Score System (IHS4), which evaluates the number of inflammatory nodules/abscesses/draining tunnels. IHS4‑55/75/90/100 is defined as at least a 55%/75%/90%/100% improvement from baseline in a patient’s IHS4 total score. IHS4-100 equates to complete resolution of inflammatory lesions.

IHS4‑55/75/90/100：IHS4是由临床医生评定的国际HS严重程度评分系统（International HS Severity Score System，简称IHS4），用于评估炎性结节/脓肿/引流隧道的数量。IHS4‑55/75/90/100定义为患者IHS4总分从基线至少改善55%/75%/90%/100%。IHS4-100等同于炎性病变的完全消退。

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Draining tunnels: These are painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarring

引流隧道：这些是由于长期炎症导致的皮肤下疼痛、流脓的隧道，经常导致疤痕形成。

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DLQI 0/1: Dermatology Life Quality Index (DLQI) is a patient-reported questionnaire consisting of 10 questions concerning symptoms and feelings, daily activities, leisure, work, and school, personal relationships and treatment.

DLQI 0/1：皮肤病生活质量指数（DLQI） 是一份患者报告的问卷，包含有关症状和感受、日常活动、休闲、工作和学校、个人关系及治疗的10个问题。

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Each question is scored from 0 to 3 and the scores summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment).

每个问题的评分范围为 0 到 3，将各题得分相加，总分范围为 0（生活质量无损害）到 30（最大程度的损害）。

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All questions relate “to the last week”. The DLQI was designed to be used in adults over the age of 18 years.

所有问题都与“上周”有关。DLQI 旨在用于 18 岁以上的成年人。

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DLQI 0/1 denotes the percentage of patients who achieved an overall score of 0 or 1 in the questionnaire, and denotes no effect at all on a patient's quality of life.

DLQI 0/1 表示在问卷中总体评分达到 0 或 1 的患者百分比，表示对患者生活质量完全没有影响。

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About hidradenitis suppurativa

关于化脓性汗腺炎

Hidradenitis suppurativa (HS) is a chronic, painful and potentially debilitating inflammatory skin disease that is associated with systemic manifestations.

化脓性汗腺炎（HS）是一种慢性、疼痛且可能致残的炎症性皮肤病，与全身性表现相关。

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The main symptoms are nodules, abscesses and pus discharging draining tunnels (or sinus tracts leading out of the skin) which typically occur in the armpits, groin and buttocks.

主要症状是结节、脓肿和脓液排出的引流隧道（或通向皮肤外的窦道），通常出现在腋窝、腹股沟和臀部。

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People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.

患有 HS 的人会经历疾病的发作以及剧烈的疼痛，这对生活质量可能产生重大影响。

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HS develops in early adulthood and affects approximately one percent of the population in most studied countries.

HS在成年早期发展，并影响大多数研究国家中约百分之一的人口。

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^About BE HEARD trials

关于BE HEARD试验

The efficacy and safety profile of bimekizumab were evaluated in adult patients with moderate to severe hidradenitis suppurativa (HS) in two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD I and BE HEARD II).

在两项多中心、随机、双盲、安慰剂对照的 III 期研究（BE HEARD I 和 BE HEARD II）中，评估了比美珠单抗在中度至重度化脓性汗腺炎（HS）成人患者中的疗效和安全性。

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The two studies had a combined enrollment of 1,014 participants.

这两项研究共有1014名参与者。

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In each study, patients were randomized 2:2:2:1 (initial [16 weeks]/maintenance [32 weeks]) to bimekizumab 320 mg every two weeks, four weeks or a combination (BKZ Q2W/Q2W, BKZQ2W/Q4W, BKZQ4W/Q4W or placebo/BKZQ2W).

在每项研究中，患者被随机分为2:2:2:1（初始[16周]/维持[32周]），分别接受每两周一次、每四周一次或组合方案的320 mg bimekizumab治疗（BKZ Q2W/Q2W、BKZQ2W/Q4W、BKZQ4W/Q4W 或安慰剂/BKZQ2W）。

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Patients who completed Week 48 could enroll in the open-label extension.

完成第48周的患者可以入组开放标签扩展期。

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Of 1,014 total patients, 556 patients randomized at baseline to bimekizumab in BE HEARD I and II completed Week 48 and entered the open-label extension study; 446 patients in the open-label extension study completed Week 96,

在总共1,014名患者中，BE HEARD I和II研究中基线时随机分配至bimekizumab组的556名患者完成了第48周并进入开放标签扩展研究；开放标签扩展研究中的446名患者完成了第96周。

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and 367 completed Week 148.

并且367人完成了第148周。

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For details about BE HEARD EXT:

有关 BE HEARD EXT 的详细信息：

www.clinicaltrials.gov/study/NCT04901195

www.clinicaltrials.gov/study/NCT04901195

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About BIMZELX

关于BIMZELX

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▼(bimekizumab)

▼（比美珠单抗）

BIMZELX

BIMZELX

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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

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▼(bimekizumab) EU/EEA

▼（bimekizumab）欧盟/欧洲经济区

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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活动性银屑病关节炎成年患者。

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 适用于治疗具有客观炎症迹象（如C反应蛋白（CRP）升高和/或磁共振成像（MRI）显示）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）反应不足或不耐受；亦适用于治疗对常规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 治疗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

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▼(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（在银屑病、银屑病关节炎、轴向脊柱关节炎和化脓性汗腺炎中分别为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、口咽部念珠菌病、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.

比美珠单抗可能会增加感染的风险。任何有临床重要活动性感染的患者都不应开始使用比美珠单抗治疗。接受比美珠单抗治疗的患者应被指导在出现提示感染的体征或症状时寻求医疗建议。如果患者发生感染，应对患者进行仔细监测。

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消退。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..

接受比美珠单抗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.

包括过敏反应在内的严重超敏反应已在IL-17抑制剂中被观察到。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.

欧洲药品说明书修订日期：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.

该药品受到额外的监控。这将有助于快速识别新的安全信息。医疗专业人士被要求报告任何疑似不良反应。

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

Adriaan Snauwaert

阿德里安·斯诺瓦特

T +32.4.977.02.346

电话：+32.4.977.02.346

email adriaan.snauwaert@ucb.com

电子邮件 adriaan.snauwaert@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及解决方案，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”、“打算”、“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的风险、不确定性和假设的影响，这些因素可能导致UCB的实际结果、财务状况、业绩或成就，或行业结果，与本文件中包含的此类前瞻性陈述所明示或暗示的任何未来结果、业绩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、疫情和恐怖主义的全球蔓延及影响，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款内或预期时间内获得批准，与研发相关的成本，UCB在研产品或开发中产品的前景变化，未来司法裁决或政府调查的影响，安全、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，对产品或候选产品的专利保护挑战，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，与税收和关税相关法律及规则或其执行的变更或不确定性，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确定新的产品候选者，也无法保证现有产品的新的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产品候选者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，公众被提醒不要对这些前瞻性陈述给予任何过度依赖。这些前瞻性陈述仅在本文档的日期作出，并且不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，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..

公司继续认真跟进事态发展，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..

除非适用法律法规要求，UCB明确表示不承担更新本文件中任何前瞻性声明的义务，无论该等声明是为了确认实际结果，还是为了报告或反映与之相关的前瞻性声明的任何变更，或任何该等声明所依据的事件、条件或情况的任何变更。

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

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