Brussels (Belgium), April 4, 2024 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for BIMZELX® (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).

布鲁塞尔（比利时），2024年4月4日–07:00（CET）-全球生物制药公司UCB今天宣布，美国食品和药物管理局（FDA）已接受BIMZELX®（bimekizumab bkzx）（一种IL-17A和IL-17F抑制剂）的补充生物制剂许可证申请（sBLA）的审查，用于治疗成人中度至重度化脓性汗腺炎（HS）。

In addition, a second sBLA for the bimekizumab-bkzx 2mL device presentations has also been accepted..

此外，bimekizumab bkzx 2mL设备演示的第二个sBLA也已被接受。。

“We are excited to share the progress on our FDA applications. The most recent sBLA seeks approval for bimekizumab-bkzx in moderate to severe hidradenitis suppurativa, and is aligned to our goal of expanding the reach of bimekizumab to more patients living with IL-17 mediated diseases,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions, and Head of U.S., UCB.

“我们很高兴分享FDA申请的进展。最近的sBLA寻求批准bimekizumab bkzx治疗中度至重度化脓性汗腺炎，这与我们将bimekizumab的范围扩大到更多患有IL-17介导的疾病的患者的目标相一致，”免疫解决方案执行副总裁兼美国加州大学银行负责人Emmanuel Caeymaex说。

“In addition, the sBLA for the 2mL device presentations aims to offer increased convenience for patients. Today, one dose of bimekizumab in moderate to severe plaque psoriasis, is administered as two 1mL injections. Approval of the 2mL device presentations would mean that patients would have an alternative one injection regimen option.” .

“此外，用于2mL设备演示的sBLA旨在为患者提供更多便利。今天，中重度斑块状银屑病的一剂bimekizumab以两次1mL注射的形式给药。2mL设备演示的批准意味着患者将有另一种注射方案选择。”。

These new regulatory milestones represent two of five sBLAs accepted by the FDA for bimekizumab-bkzx in 2024, following the previously announced applications in psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). BIMZELX® was first approved in the U.S.

这些新的监管里程碑代表了FDA在2024年接受bimekizumab bkzx的五个SBLA中的两个，此前宣布了银屑病关节炎（PsA），非放射性轴性脊柱关节炎（nr-axSpA）和强直性脊柱炎（AS）的应用。BIMZELX®首次在美国获得批准。

in October 2023 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1 Bimekizumab-bkzx is not approved in the U.S. for the treatment of moderate to severe HS, PsA, nr-axSpA and AS, or for the 2mL device presentation. In the U.S., the efficacy and safety of bimekizumab-bkzx in the treatment of moderate to severe HS, PsA, nr-axSpA and AS have not been established and these are investigational indications only. .

2023年10月，用于治疗全身治疗或光疗候选者的成人中度至重度斑块状牛皮癣。美国未批准Bimekizumab bkzx用于治疗中度至重度HS，PsA，nr-axSpA和AS，或用于2mL设备介绍。在美国，bimekizumab bkzx治疗中重度HS，PsA，nr-axSpA和AS的疗效和安全性尚未确定，这些只是研究适应症。。

The sBLA in moderate to severe HS is supported by data from the Phase 3 BE HEARD I and BE HEARD II studies where bimekizumab-bkzx demonstrated clinically meaningful improvements in HiSCR50 vs. placebo at Week 16, the primary endpoint.2 A greater proportion of patients treated with bimekizumab vs. placebo also achieved HiSCR75 at Week 16, a key secondary endpoint.2 In addition, over 48 weeks, improvements increased for patients in these studies.2 The safety profile of bimekizumab-bkzx was consistent with previous studies with no new safety signals observed.2  .

中度至重度HS的sBLA得到了第3阶段BE HEARD I和BE HEARD II研究数据的支持，其中bimekizumab bkzx在第16周（主要终点）表现出HiSCR50与安慰剂相比具有临床意义的改善[2]。接受bimekizumab与安慰剂治疗的患者在第16周也达到了HiSCR75，这是一个关键的次要终点[2]。此外，在48周内，这些研究中患者的改善增加[2]。bimekizumab bkzx的安全性与之前的研究一致，没有观察到新的安全性信号。

The sBLA for the additional device presentations seeks approval of bimekizumab-bkzx 2mL safety syringe and 2mL autoinjector with the aim of providing a second option to the currently approved 1mL presentations.

sBLA为额外的设备演示寻求bimekizumab bkzx 2mL安全注射器和2mL自动注射器的批准，目的是为目前批准的1mL演示提供第二种选择。

Notes to editors:

编辑须知：

About hidradenitis suppurativa (HS)

关于化脓性汗腺炎（HS）

Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease that is associated with systemic manifestations.3,4  The main symptoms are nodules, abscesses, and pus-discharging tunnels (channels leading out of the skin) which typically occur in the armpits, groin, and buttocks.3,4 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.

化脓性汗腺炎（HS）是一种慢性，复发，疼痛和衰弱的炎症性皮肤病，与全身表现有关[3,4]。主要症状是结节，脓肿和脓液排出通道（通向皮肤的通道），通常发生在腋窝，腹股沟和臀部[3,4]。HS患者会出现疾病发作和严重疼痛，这可能对生活质量产生重大影响。

HS develops in early adulthood and affects approximately one percent of the population in most studied countries.3,4 .

HS在成年早期发展，影响大多数研究国家约1%的人口。3,4。

About BE HEARD I and BE HEARD II

关于被倾听我和被倾听II

The efficacy and safety of bimekizumab-bkzx were evaluated in adult patients with moderate to severe hidradenitis suppurativa (HS) in two multicentre, randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD I and BE HEARD II). The two studies had a combined enrolment of 1,014 participants with a diagnosis of moderate to severe HS.5,6  The primary endpoint in both trials was HiSCR50 at Week 16.5,6 A key secondary endpoint was HiSCR75 at Week 16.

在两项多中心，随机，双盲，安慰剂对照的3期研究（BE HEARD I和BE HEARD II）中，对成人中度至重度化脓性汗腺炎（HS）患者评估了bimekizumab bkzx的疗效和安全性。这两项研究共纳入1014名诊断为中度至重度HS的参与者[5,6]。两项试验的主要终点是第16周的HiSCR50.5,6一个关键的次要终点是第16周的HiSCR75。

HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.5,6 .

HiSCR50和HiSCR75被定义为总脓肿和炎性结节计数比基线至少减少50%或75%，脓肿或引流管计数与基线无增加[5,6]。

About BIMZELX®

关于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.7

BIMZELX®是一种人源化单克隆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），这是驱动炎症过程的两种关键细胞因子

In the U.S., bimekizumab-bkzx is approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1  Bimekizumab-bkzx is not approved in the U.S. for the treatment of moderate to severe HS, PsA, nr-axSpA and AS, or for the 2mL device presentation.

在美国，bimekizumab bkzx被批准用于治疗作为全身治疗或光疗候选者的成人中重度斑块状银屑病 Bimekizumab bkzx在美国未被批准用于治疗中度至重度HS，PsA，nr-axSpA和AS，或用于2mL设备展示。

In the U.S., the efficacy and safety of bimekizumab-bkzx in the treatment of moderate to severe HS, PsA, r-axSpA and AS have not been established and these are investigational indications only. .

在美国，bimekizumab bkzx治疗中重度HS，PsA，r-axSpA和AS的疗效和安全性尚未确定，这些只是研究适应症。。

Bimekizumab is not approved in HS by any regulatory authority worldwide.

Bimekizumab在HS中未获得全球任何监管机构的批准。

The approved indications for bimekizumab ▼ in the European Union are8:

bimekizumab的批准适应症▼在欧盟8：

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

斑块状银屑病：Bimekizumab适用于治疗全身治疗候选人的成人中度至重度斑块状银屑病。

Psoriatic arthritis: 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).

银屑病关节炎：Bimekizumab单独或与甲氨蝶呤联合用于治疗反应不足或对一种或多种缓解疾病的抗风湿药物（DMARDs）不耐受的成年人的活动性银屑病关节炎。

Axial Spondyloarthritis: 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. .

轴性脊柱关节炎：Bimekizumab适用于治疗活动性非放射性轴性脊柱关节炎的成人，其具有客观的炎症迹象，如C反应蛋白（CRP）升高和/或磁共振成像（MRI）所示，这些患者对非甾体抗炎药（NSAIDs）反应不足或不耐受，以及治疗对常规治疗反应不足或不耐受的活动性强直性脊柱炎成人。。

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

标签信息在其他批准的国家可能有所不同。请查看当地处方信息。

BIMZELX® U.S. IMPORTANT SAFETY INFORMATION1

BIMZELX®美国重要安全信息1

Please see Important Safety Information below and full U.S. prescribing information at www.ucb-usa.com/Innovation/Products/Bimzelx

请参阅下面的重要安全信息和完整的美国处方信息，网址为www.ucb-usa.com/Innovation/Products/Bimzelx

Suicidal Ideation and Behavior

自杀意念和行为

BIMZELX® (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B).  A causal association between treatment with BIMZELX and increased risk of SI/B has not been established.  Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B.

BIMZELX®（bimekizumab bkzx）可能会增加自杀念头和行为的风险（SI/B）。BIMZELX治疗与SI/B风险增加之间的因果关系尚未确定。在有严重抑郁症或SI/B病史的患者中使用BIMZELX之前，处方者应该权衡潜在的风险和益处。

Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, advise to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment. .

建议监测抑郁症、自杀念头或其他情绪变化的出现或恶化。如果发生这种变化，建议立即就医，酌情咨询心理健康专业人员，并重新评估继续治疗的风险和益处。。

Infections

感染

BIMZELX may increase the risk of infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated.  In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX.

BIMZELX可能会增加感染风险。在感染消退或得到充分治疗之前，不要对任何临床上重要的活动性感染患者开始使用BIMZELX治疗。对于有慢性感染或反复感染史的患者，在开具BIMZELX之前，请考虑其风险和益处。

Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves..

如果出现提示临床上重要感染的体征或症状，指导患者寻求医疗建议。如果患者发生这种感染或对标准治疗没有反应，请密切监测患者，在感染消退之前不要服用BIMZELX。。

Tuberculosis

结核病

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

在开始使用BIMZELX治疗之前，评估患者的结核病（TB）感染情况。避免在活动性结核病感染患者中使用BIMZELX。在服用BIMZELX之前开始治疗潜伏性结核病。对于既往有潜伏性或活动性结核病病史且无法确定适当疗程的患者，应考虑在开始使用BIMZELX之前进行抗结核治疗。

Closely monitor patients for signs and symptoms of active TB during and after treatment..

在治疗期间和治疗后密切监测患者活动性结核病的体征和症状。。

Liver Biochemical Abnormalities

肝脏生化异常

Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management.  If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded.

BIMZELX的临床试验报告血清转氨酶升高。在用BIMZELX治疗期间并根据常规患者管理，定期在基线测试肝酶，碱性磷酸酶和胆红素。如果发生与治疗相关的肝酶升高，并且怀疑是药物引起的肝损伤，则中断BIMZELX，直到排除肝损伤的诊断。

Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin.  Avoid use of BIMZELX in patients with acute liver disease or cirrhosis..

转氨酶和胆红素升高有因果关系的患者应永久停止使用BIMZELX。急性肝病或肝硬化患者应避免使用BIMZELX。。

Inflammatory Bowel Disease

炎症性肠病

Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX.  Avoid use of BIMZELX in patients with active IBD.  During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs..

据报道，用IL-17抑制剂（包括BIMZELX）治疗的患者出现炎症性肠病（IBD）病例。避免在活动性IBD患者中使用BIMZELX。在BIMZELX治疗期间，监测患者IBD的体征和症状，如果出现新发或体征和症状恶化，则停止治疗。。

Immunizations

疫苗接种

Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.

在开始使用BIMZELX治疗之前，根据当前的免疫指南完成所有适合年龄的疫苗接种。避免在接受BIMZELX治疗的患者中使用活疫苗。

Most Common Adverse Reactions

最常见的不良反应

Most common adverse reactions (≥ 1%) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.

最常见的不良反应（≥1%）是上呼吸道感染，口腔念珠菌病，头痛，注射部位反应，癣感染，胃肠炎，单纯疱疹感染，痤疮，毛囊炎，其他念珠菌感染和疲劳。

BIMZELX® ▼ (bimekizumab) EU/EEA* Important Safety Information8

BIMZELX® （bimekizumab）欧盟/欧洲经济区*重要安全信息8

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

bimekizumab最常报告的不良反应是上呼吸道感染（斑块型银屑病（PSO），银屑病关节炎（PsA）和轴性脊柱关节炎（axSpA）分别为14.5%，14.6%，16.3%）和口腔念珠菌病（PSO，PsA和axSpA分别为7.3%，2.3%，3.7%）。

Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headache, rash, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab..

常见不良反应（≥1/100至<1/10）为口腔念珠菌病、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、头痛、皮疹、皮炎和湿疹、痤疮、注射部位反应、疲劳。使用bimekizumab时，老年人可能更容易出现某些不良反应，例如口腔念珠菌病，皮炎和湿疹。。

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

Bimekizumab禁用于对活性物质或任何赋形剂过敏的患者以及具有临床重要活动性感染（例如活动性结核病）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可能会增加感染风险。对于任何临床上重要的活动性感染患者，不得开始使用bimekizumab治疗。如果出现提示感染的体征或症状，应指示接受bimekizumab治疗的患者寻求医疗建议。如果患者发生感染，应仔细监测患者。

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效，应停止治疗，直到感染消退。在开始使用bimekizumab治疗之前，应评估患者的结核病（TB）感染。活动性结核病患者不应服用Bimekizumab。

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..

bimekizumab报道了炎症性肠病新发或恶化的病例。Bimekizumab不推荐用于炎症性肠病患者。如果患者出现炎症性肠病的体征和症状或经历先前存在的炎症性肠病的恶化，则应停止使用bimekizumab，并应开始适当的医疗管理。。

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.

用IL-17抑制剂观察到严重的超敏反应，包括过敏反应。如果发生严重的超敏反应，应立即停止服用bimekizumab并开始适当的治疗。

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

接受bimekizumab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.

请参阅与其他副作用有关的产品特性摘要，完整的安全性和处方信息。

European SmPC date of revision: November 2023.

欧洲SmPC修订日期：2023年11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

Last accessed: April 2024.

上次访问时间：2024年4月。

*EU/EEA means European Union/European Economic Area

*EU/EEA是指欧盟/欧洲经济区

▼ 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

▼这种药品需要进行额外的监测。这样可以快速识别新的安全信息。要求医疗保健专业人员报告任何疑似不良反应

For further information, contact UCB:

有关更多信息，请联系UCB：

Investor Relations

投资者关系

Antje Witte

Antje Witte

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

公司通信

Laurent Schots

Laurent Schots

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

Eimear O’Brien

Eimear O'Brien

T +32.2.559.92.71

电话+32.2.559.92.71

email eimear.obrien@ucb.com

电子邮件eimear.obrien@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 €5.3 billion in 2023.

比利时布鲁塞尔UCB（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和解决方案，以改变患有严重免疫系统或中枢神经系统疾病的人的生活。该公司在大约40个国家拥有约9000名员工，2023年实现收入53亿欧元。

UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news..

UCB在布鲁塞尔泛欧交易所上市（符号：UCB）。在推特上关注我们：@UCB_news。。

Forward looking statements

前瞻性声明

This press release may contain forward-looking statements including, without limitation, statements containing the words “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.

本新闻稿可能包含前瞻性声明，包括但不限于包含“相信”、“预期”、“期望”、“打算”、“计划”、“寻求”、“估计”、“可能”、“将”、“继续”等字样的声明以及类似表述。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.

除历史事实报表外，所有报表均为可被视为前瞻性报表的报表，包括收入估计、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 guarantees of 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 differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release.

就其性质而言，此类前瞻性声明并非对未来业绩的保证，并受到已知和未知风险、不确定性和假设的影响，这些风险、不确定性和假设可能导致UCB的实际业绩、财务状况、业绩或成就或行业业绩与本新闻稿中此类前瞻性声明可能明示或暗示的结果存在重大差异。

Important factors that could result in such differences include: 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; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection fo.

可能导致这种差异的重要因素包括：一般经济、业务和竞争条件的变化，无法获得必要的监管批准，或无法在可接受的条款或预期的时间内获得批准，与研发相关的成本，UCB正在开发或正在开发的产品前景的变化，未来司法判决或政府调查的影响，安全、质量、数据完整性或制造问题；潜在或实际的数据安全和数据隐私违规，或我们的信息技术系统中断，产品责任索赔，对专利保护的挑战。

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future..

鉴于这些不确定性，您不应过度依赖任何此类前瞻性陈述。不能保证本新闻稿中描述的研究或批准产品将在任何市场或任何特定时间提交或批准销售或用于任何其他适应症或标签，也不能保证此类产品将来会或将继续取得商业成功。。

UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, 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仅在本新闻稿发布之日提供此信息，包括前瞻性声明。UCB明确拒绝更新本新闻稿中包含的任何信息，以确认实际结果，或报告或反映其前瞻性声明的任何变化，或任何此类声明所依据的事件、条件或情况的任何变化，除非适用法律法规要求此类声明。。

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. .

此外，本文件中包含的信息不构成出售要约或招揽购买任何证券的要约，也不构成在根据该司法管辖区的证券法进行注册或取得资格之前，在任何司法管辖区内的任何证券要约、招揽或出售都是非法的。。

References

参考文献

BIMZELX® (bimekizumab-bkzx) U.S. PI. Available at: https://www.ucb-usa.com/Innovation/Products/BIMZELX. Last accessed: April 2024.

BIMZELX®（bimekizumab bkzx）美国PI。网址：https://www.ucb-usa.com/Innovation/Products/BIMZELX.上次访问时间：2024年4月。

Zouboulis C. 2023, EADV 2023, Oral Presentation # 3262

Zouboulis C.2023，EADV 2023，口头陈述#3262

Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-64.

杰梅克GBE。临床实践。化脓性汗腺炎。英格兰医学杂志2012；366（2）：158-64。

Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(18):1-20.

Sabat R，Jemec GBE，Matusiak L等。化脓性手足口炎。Nat Rev Dis Primers。2020;6(18):1-20.

ClinicalTrials.gov. NCT04242446. Available at: https://clinicaltrials.gov/ct2/show/NCT04242446?term=be+heard&draw=2&rank=1. Last accessed date: April 2024.

ClinicalTrials.gov。NCT04242446。网址：https://clinicaltrials.gov/ct2/show/NCT04242446?term=be+heard&draw=2&rank=1。上次访问日期：2024年4月。

ClinicalTrials.gov. NCT04242498. Available at: https://clinicaltrials.gov/ct2/show/NCT04242498. Last accessed date: April 2024.

ClinicalTrials.gov。NCT04242498。网址：https://clinicaltrials.gov/ct2/show/NCT04242498.上次访问日期：2024年4月。

Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991–1001.

Glatt S，Helmer E，Haier B等。bimekizumab（一种人源化单克隆抗体和IL-17A和IL-17F的选择性双重抑制剂）在轻度银屑病中的首次人体随机研究。Br J临床药理学。2017年；83（5）：991-1001。

BIMZELX® (bimekizumab) EU SmPC. Available at https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf Last accessed: April 2024.

BIMZELX®（bimekizumab）欧盟SmPC。可在https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf上次访问时间：2024年4月。