Brussels (Belgium), April 11, 2025 – 14:00 (CET)

布鲁塞尔（比利时），2025年4月11日 – 14:00（欧洲中部时间）

– UCB, a global biopharmaceutical company, today announced findings from a collection of real-world evidence studies to reaffirm the effectiveness and clinical impact of romosozumab, the only dual-acting osteoporosis treatment that increases bone formation and decreases bone resorption, around the world..

优时比（UCB），一家全球生物制药公司，今天宣布了一组真实世界证据研究的结果，以重新确认罗莫珠单抗（romosozumab）在世界范围内的有效性和临床影响。罗莫珠单抗是唯一一种具有双重作用的骨质疏松症治疗药物，可促进骨形成并减少骨吸收。

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The data were presented as a poster at the 25th World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) 2025 in Rome, Italy, 10-13 April.

该数据以海报形式呈现在2025年4月10日至13日于意大利罗马举行的第25届世界骨质疏松、骨关节炎和肌肉骨骼疾病大会（WCO-IOF-ESCEO）上。

A systematic literature review identified 362 records from 67 studies across 10 countries and found that romosozumab was associated with significant improvements in bone mineral density (BMD) at 12 months versus baseline in lumbar spine, total hip and femoral neck studies. BMD gains in treatment-naïve patients were significantly larger compared with previously treated patients, emphasizing the importance of treatment sequencing..

系统文献综述从涉及10个国家的67项研究中筛选出362条记录，发现与基线相比，罗莫苏单抗在12个月时可显著改善腰椎、全髋关节和股骨颈研究中的骨矿物质密度（BMD）。未接受过治疗的患者其BMD增长显著高于既往接受过治疗的患者，突显了治疗顺序的重要性。

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“This collection of evidence across multiple countries further confirms that treating patients at high fracture risk with romosozumab at the right time plays a crucial role in strengthening bones and significantly reducing fracture risk,” said lead study investigator Prof Bente Langdahl (Clinical Professor, Aarhus University Hospital, Denmark).

“这项跨越多国的证据收集进一步证实，在合适的时间使用罗莫珠单抗治疗高骨折风险患者，对增强骨骼和显著降低骨折风险起着至关重要的作用，”首席研究调查员本特·朗达尔教授（临床教授，丹麦奥胡斯大学医院）表示。

“By following the established guidelines that advise optimal treatment sequencing, healthcare professionals have the potential to change the trajectory of a patient’s fracture risk.”.

“通过遵循建议的最佳治疗顺序的既定指南，医疗专业人员有可能改变患者骨折风险的轨迹。”

At WCO-IOF-ESCEO 2025, UCB is further expanding the real-world evidence base for romosozumab with multiple data readouts:

在 WCO-IOF-ESCEO 2025 上，UCB 正在通过多项数据读数进一步扩展罗莫珠单抗的真实世界证据基础：

A retrospective analysis of healthcare resource utilization in Germany found that total patient costs the year before (11,109 EUR [SD 13,314; median 8,033]) and the year after starting romosozumab (18,630 EUR [SD 24,470; median 12,215] were similar despite the additional cost of the medication. Costs decreased below pre-treatment levels in the second year (5,604 EUR [SD 7,778], indicating potential long-term cost-effectiveness and reduced healthcare burden..

德国对医疗资源利用的回顾性分析发现，尽管增加了药物费用，但在开始使用罗莫单抗前一年（11,109欧元 [标准差 13,314；中位数 8,033]）和之后一年（18,630欧元 [标准差 24,470；中位数 12,215]）的总患者费用相似。第二年的费用下降到低于治疗前水平（5,604欧元 [标准差 7,778]），表明其可能具有长期的成本效益并减轻了医疗负担。

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In a Swedish registry study on osteoporosis, over three-quarters of patients (76.9%) treated with romosozumab were treatment-naïve, indicating broad adoption of osteoanabolic therapy as a first-line approach.

在一项关于骨质疏松症的瑞典注册研究中，超过四分之三（76.9%）的接受罗莫单抗治疗的患者是初治患者，这表明骨合成代谢疗法作为一线治疗方法得到了广泛采用。

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A claims data analysis on women aged 55+ in Germany found gaps in osteoporosis guideline-adherent treatment, with many women with high-risk fractures remaining untreated, leading to more secondary fractures. This highlights the urgent need for adherence to the 2023 Guideline of the Dachverband Osteologie for the Prevention, Diagnosis and Therapy of Osteoporosis in Adults (DVO) guideline, which includes a 3-year fracture risk threshold for timely treatment..

德国一项针对55岁以上女性的索赔数据分析发现，遵循骨质疏松症指南的治疗存在差距，许多高风险骨折的女性未接受治疗，导致更多继发性骨折。这突显了迫切需要遵守2023年德国骨科协会（DVO）发布的《成人骨质疏松症预防、诊断和治疗指南》，该指南包括一个用于及时治疗的3年骨折风险阈值。

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“We have the opportunity to make this a defining era in osteoporosis management, where no woman at high risk of fracture is overlooked or untreated,” said Emmanuel Caeymaex, Chief Commercial Officer and Head of Patient Impact, UCB. 'The growing body of real-world evidence behind romosozumab reinforces our continued commitment of bringing meaningful benefits to patients and provides healthcare professionals with the confidence that romosozumab will deliver significant improvements in the clinical setting.”.

“我们有机会使这成为骨质疏松症管理的一个决定性时代，让每一位高骨折风险的女性都不被忽视或未经治疗，”优时比（UCB）首席商务官兼患者影响主管伊曼纽尔·凯马克斯表示。“支持罗莫珠单抗的现实世界证据不断增加，这坚定了我们为患者带来显著益处的承诺，并让医疗保健专业人员相信罗莫珠单抗将在临床环境中带来重要的改善。”

Romosozumab was approved in the European Union in December 2019 for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

2019年12月，罗莫苏单抗在欧盟获得批准，用于治疗骨折高风险的绝经后严重骨质疏松症女性。

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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 9414

电话：+32 2 559 9414

Antje.witte@ucb.com

安特耶·维特@ucb.com

Global Communications

全球通讯

Adriaan Snauwaert

阿德里安·斯瑙瓦特

T+32 497 70 23 46

电话：+32 497 70 23 46

Adriaan.snauwaert@ucb.com

Adriaan.snauwaert@ucb.com

Notes to editors:

编辑须知：

About the real-world effectiveness of romosozumab: a systematic literature review

关于罗莫珠单抗的真实世界有效性：系统文献综述

A systematic literature review (SLR) was conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE, Embase and relevant conference proceedings were searched to 2nd December 2024 for observational studies of patients receiving romosozumab reporting effectiveness outcomes..

根据系统综述和荟萃分析的首选报告项目（PRISMA）指南进行了系统的文献回顾（SLR）。截至2024年12月2日，检索了MEDLINE、Embase及相关的会议记录，寻找接受罗莫单抗治疗并报告有效性结果的患者的观察性研究。

The SLR identified 362 records, of which 67 unique studies across 10 countries were included. The majority were retrospective cohort studies (n=39) and 29/67 were comparative. Numbers of patients ranged from six to 29,512 for romosozumab and 21 to 537,927 for comparators, with denosumab most commonly reported.

系统文献回顾（SLR）筛选出362条记录，其中包含来自10个国家的67项独特研究。大多数为回顾性队列研究（n=39），且67项中有29项为对比研究。罗莫单抗涉及的患者人数范围为6至29,512人，对照组为21至537,927人，其中最常报告的是地诺单抗。

Mean patient age ranged from 52.3 to 84.4 years. .

患者的平均年龄范围为52.3至84.4岁。

Across both romosozumab and comparator arms, mean bone mineral density (BMD; T-score) at baseline ranged from –3.80 to –1.79 at the lumbar spine, –3.00 to –2.15 at the total hip, and –3.30 to –2.20 at the femoral neck. Mean percentage change in lumbar spine BMD at 12 months ranged from 0.97% to 20.0% and 1.07% to 8.10% for patients treated with romosozumab and comparators, respectively.

在罗莫珠单抗和对照组中，基线时腰椎的平均骨密度（BMD；T值）范围为-3.80至-1.79，全髋关节为-3.00至-2.15，股骨颈为-3.30至-2.20。接受罗莫珠单抗和对照药物治疗的患者，12个月时腰椎骨密度的平均百分比变化分别从0.97%到20.0%和1.07%到8.10%。

Mean percentage change in total hip BMD ranged from –0.40% to 9.10% (romosozumab) and –2.80% to 3.60% (comparators) with similar changes in femoral neck BMD..

总髋部BMD的平均百分比变化范围为-0.40%至9.10%（罗莫珠单抗）和-2.80%至3.60%（对照组），股骨颈BMD的变化相似。

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About the claims data analysis on women aged 55+ in Germany

关于德国55岁以上女性的索赔数据分析

This retrospective analysis of a German claims database (4.1 million insured) included statutorily health insured (SHI) women aged 55+ years with proximal femoral or vertebral fractures in 2017–2021. In untreated femoral fracture patients (n=282,026; period 2017–2021), 28.1% had another femoral fracture and 5.0% a vertebral fracture within one year.

这项对德国索赔数据库（410万参保人）的回顾性分析，纳入了2017-2021年间55岁及以上发生股骨近端或椎体骨折的法定健康保险（SHI）女性。在未经治疗的股骨骨折患者中（n=282,026；时间段为2017-2021年），28.1%在一年内发生了另一次股骨骨折，5.0%发生了椎体骨折。

Untreated patients with vertebral fracture (n=630,102) had a risk of 27.8% for a second vertebral and 2.0% for a femoral fracture within one year after index..

未治疗的椎体骨折患者（n=630,102）在指数事件后一年内，发生第二次椎体骨折的风险为27.8%，股骨骨折的风险为2.0%。

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About romosozumab

关于罗莫索珠单抗

Romosozumab is a bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation and, to a lesser extent, decreased bone resorption. The romosozumab development program includes 19 clinical studies that enrolled approximately 14,000 patients.

Romosozumab 是一种促进骨形成的单克隆抗体。它通过抑制硬化素的活性来发挥作用，同时导致骨形成增加，并在一定程度上减少骨吸收。Romosozumab 的开发计划包括 19 项临床研究，共招募了大约 14,000 名患者。

Romosozumab has been studied for its potential to reduce the risk of fractures in an extensive global phase 3 program that included two large fracture trials comparing romosozumab to either placebo or active comparator in over 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab..

罗莫索珠单抗在一项广泛的全球三期项目中进行了研究，该项目包括两项大型骨折试验，比较了罗莫索珠单抗与安慰剂或活性对照药物在超过11,000名绝经后骨质疏松症女性中的效果，以评估其降低骨折风险的潜力。安进和UCB正在共同开发罗莫索珠单抗。

Important Safety Information about romosozumab in the EU/EEA

关于罗莫苏单抗在欧盟/欧洲经济区的重要安全信息

In the EU, romosozumab is indicated for treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

在欧盟，罗莫索珠单抗用于治疗骨折高风险的绝经后女性严重骨质疏松症。

Contraindications: Romosozumab is contraindicated in patients who are allergic to romosozumab or any of the excipients, who have low levels of calcium in the blood (hypocalcaemia), or who have a history of myocardial infarction (heart attack) or stroke. Myocardial infarction or stroke: Heart attack and stroke have been reported in patients receiving romosozumab in randomised controlled trials (uncommon).

禁忌症：对罗莫珠单抗或任何辅料过敏的患者、血液中钙水平低（低钙血症）的患者，或有心肌梗死（心脏病发作）或中风病史的患者禁用罗莫珠单抗。心肌梗死或中风：在随机对照试验中，接受罗莫珠单抗治疗的患者报告了心脏病发作和中风（不常见）。

Treatment with romosozumab should not be initiated in patients with a history of heart attack or stroke. When determining whether to use romosozumab for an individual patient, the presence of risk factors for cardiovascular problems, including established cardiovascular disease, high blood pressure, high blood fat levels, diabetes, smoking or kidney problems, should be evaluated.

有心脏病发作或中风病史的患者不应开始使用罗莫苏单抗治疗。在确定是否对某个患者使用罗莫苏单抗时，应评估心血管问题的风险因素，包括已确诊的心血管疾病、高血压、高血脂、糖尿病、吸烟或肾脏问题。

romosozumab should only be used if the prescriber and patient agree that the benefit outweighs the risk. If a patient experiences a myocardial infarction or stroke during therapy, treatment with romosozumab should be discontinued. Hypocalcaemia: Transient hypocalcaemia has been observed in patients receiving romosozumab.

仅当处方医生和患者均认为利大于弊时，才应使用罗莫单抗。若患者在治疗期间出现心肌梗死或中风，应停止使用罗莫单抗。低钙血症：在接受罗莫单抗治疗的患者中已观察到短暂性低钙血症。

Hypocalcaemia should be corrected prior to initiating therapy with romosozumab and patients should be monitored for signs and symptoms of hypocalcaemia. If any patient presents with suspected symptoms of hypocalcaemia during treatment, calcium levels should be measured. Patients should be adequately supplemented with calcium and vitamin D.

在开始使用罗莫单抗治疗之前，应先纠正低钙血症，并监测患者是否有低钙血症的迹象和症状。如果任何患者在治疗期间出现疑似低钙血症的症状，应测量钙水平。患者应充分补充钙和维生素D。

Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29ml/min/1.73m2) or receiving dialysis are at greater risk of developing hypocalcaemia and the safety data for these patients are limited. Calcium levels should be monitored in these patients. Hypersensitivity: Clinically significant hypersensitivity reac.

严重肾功能损害（估算肾小球滤过率[eGFR]为15至29ml/min/1.73m2）或接受透析的患者发生低钙血症的风险更高，且针对这些患者的安全性数据有限。应对这些患者的钙水平进行监测。超敏反应：具有临床意义的超敏反应。

Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Available at https://www.ema.europa.eu/en/documents/product-information/evenity-epar-product-information_en.pdf.

有关其他不良反应和完整的处方信息，请参阅欧洲产品特性总结。可访问 https://www.ema.europa.eu/en/documents/product-information/evenity-epar-product-information_en.pdf 获取。

EVENITY

偶然性

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®

is a registered trademark of the UCB Group of Companies.

是UCB集团公司群的注册商标。

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 more than 9 000 people in approximately 40 countries, the company generated revenue of € 6.1 billion in 2024.

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和解决方案，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9000多名员工，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）。

About the Amgen and UCB Collaboration

关于安进和UCB的合作

Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for the treatment of osteoporosis.

自 2004 年以来，安进和优时比一直在合作和许可协议下共同研究、开发和销售针对硬化蛋白的抗体产品。根据该协议，两家公司继续合作开发罗莫索单抗，用于治疗骨质疏松症。

UCB has rights to lead commercialization for EVENITY in most countries in Europe. Amgen, as the principal, leads commercialization for EVENITY and recognizes product sales in all other territories, including the United States. This gene-to-drug project demonstrates how Amgen and UCB are joining forces to translate a genetic discovery into a new medicine, turning conceptual science into a reality..

UCB在欧洲大多数国家拥有EVENITY商业化的主导权。安进作为主导方，负责EVENITY在包括美国在内的所有其他地区的商业化，并确认产品销售。这个从基因到药物的项目展示了安进和UCB如何携手将基因发现转化为新药，将概念科学变为现实。

Forward looking statements

前瞻性声明

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results.

本新闻稿包含基于管理层当前计划、估计和信念的前瞻性陈述。所有陈述，除历史事实陈述外，均为可能被视为前瞻性陈述的陈述，包括收入、营业利润率、资本支出、现金、其他财务信息、预期的法律、政治、监管或临床结果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 risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. 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, 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, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. .

此类前瞻性陈述因其性质并非未来业绩的保证，并且受制于可能导致实际结果与本新闻稿中包含的此类前瞻性陈述所暗示的结果存在重大差异的风险、不确定性和假设。导致此类差异的重要因素包括：宏观经济、商业和竞争环境的总体变化，无法获得必要的监管批准或以可接受的条件获得这些批准，与研发相关的成本，UCB产品线或开发中的产品前景的变化，未来司法裁决或政府调查的影响，产品责任索赔，针对产品或候选产品的专利保护挑战，法律法规的变化，汇率波动，税法及其管理的变化或不确定性，以及员工的招聘和留任。

UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations. There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved.

UCB提供截至本新闻稿发布日期的信息，并明确声明不承担更新本新闻稿中任何信息的责任，无论是确认实际结果还是报告其预期的变化。不能保证研发管线中的新候选产品会进展到产品获批，也不能保证现有产品的新增适应症能够开发并获得批准。

Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement..

合作伙伴关系、合资企业或授权合作涉及的产品或潜在产品可能会受到合作伙伴之间差异的影响。此外，UCB 或其他公司可能在产品上市后发现其产品的安全性、副作用或生产问题。而且，销售可能会受到国际和国内对管理式医疗和医疗成本控制趋势的影响，以及第三方支付方实施的报销政策和影响生物制药定价与报销的立法的影响。

References

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EVENITY

偶然性

®

®

EU SmPC. Available at https://www.ema.europa.eu/en/documents/product-information/evenity-epar-product-information_en.pdf. Accessed March 2025.

欧盟药品特性摘要。可访问 https://www.ema.europa.eu/en/documents/product-information/evenity-epar-product-information_en.pdf。引用日期：2025年3月。

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洛伦茨 B.2025. 世界海关组织-国际骨质疏松基金会-欧洲骨质疏松和骨关节疾病临床经济学会 2025. #631.

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