优时比公司旗下药物CIMZIA®（赛妥珠单抗）获美国FDA突破性疗法认定，用于患有抗磷脂综合征（APS）的孕妇-动脉网

UCB receives U.S. FDA Breakthrough Therapy Designation for CIMZIA®(certolizumab pegol) in pregnant women with antiphospholipid syndrome (APS)

CISION 等信源发布 2026-09-09 19:57



可切换为仅中文







Antiphospholipid syndrome (APS) is a serious autoimmune condition that mainly affects women of childbearing age (WoCBA) and can cause serious adverse pregnancy outcomes, with no therapies currently approved.

抗磷脂综合征（APS）是一种严重的自身免疫性疾病，主要影响育龄期女性（WoCBA），并可导致严重的不良妊娠结局，目前尚无获批的治疗方法。

The Breakthrough Therapy Designation (BTD) is supported by findings from the investigator-initiated IMPACT study, which demonstrated the potential of CIMZIA

突破性疗法认定（BTD）得到了研究者发起的IMPACT研究结果的支持，该研究证明了CIMZIA的潜力

to address a significant unmet need for women with APS.

以满足抗磷脂综合征（APS）女性患者尚未得到满足的重大需求。

The designation builds on the recent Orphan Drug Designation for CIMZIA

该认定建立在CIMZIA近期获得的孤儿药认定基础之上

in APS and reinforces UCB's long-standing commitment to advancing innovation for people living with rare diseases, including sustained investment in research that supports women throughout their reproductive journey.

在抗磷脂综合征（APS）领域，并强化优时比（UCB）长期以来致力于推动罕见病患者创新治疗的承诺，包括持续投资支持女性在整个生殖健康历程的研究。

ATLANTA

亚特兰大

，

Sept. 9, 2026

2026年9月9日

/PRNewswire/ --

/美通社/ --

08:00

(EST) –

（东部标准时间）–

UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to CIMZIA

全球生物制药公司优时比（UCB）今日宣布，美国食品药品监督管理局（FDA）已授予CIMZIA突破性疗法认定（BTD）。

注册商标符号

(certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women who have antiphospholipid syndrome (APS) and are positive for lupus anticoagulant (LA). These patients were considered at risk due to prior obstetric and blood clotting (thrombotic) events.

（赛妥珠单抗聚乙二醇）用于预防患有抗磷脂综合征（APS）且狼疮抗凝物（LA）阳性的孕妇出现胎盘介导的不良妊娠结局。由于既往有产科事件和血栓形成（血栓性）事件，这些患者被认为存在风险。

The designation is supported by preliminary clinical evidence from the IMPACT study,

该认定得到了IMPACT研究的初步临床证据的支持，

and recognizes the potential of CIMZIA to address a significant unmet medical need

并认识到CIMZIA在满足重大未竟医疗需求方面的潜力

3-4

in an area where there are currently no FDA-approved therapies for the prevention of adverse pregnancy outcomes in patients with APS.

在抗磷脂综合征（APS）患者预防不良妊娠结局方面，目前尚无美国食品药品监督管理局（FDA）批准的疗法。

2-6

A BTD is granted to medicines intended to treat a serious or life-threatening condition when preliminary clinical evidence indicates the therapy may demonstrate substantial improvement over available treatments on one or more clinically significant endpoints. The designation is designed to facilitate development and expedite the FDA review of promising new therapies..

当初步临床证据表明，某种疗法在一个或多个具有临床意义的终点指标上可能较现有治疗方案有显著改善时，用于治疗严重或危及生命疾病的药物可获得突破性疗法认定（BTD）。该认定旨在促进开发并加速美国食品药品监督管理局（FDA）对有前景的新疗法的审评。

APS is a rare autoimmune disorder associated with increased risk of blood clots and serious pregnancy complications,

抗磷脂综合征（APS）是一种罕见的自身免疫性疾病，与血栓形成风险增加及严重的妊娠并发症相关。

3,8-10

including recurrent pregnancy loss in the first trimester, pre-eclampsia, placental insufficiency, fetal growth restriction, preterm birth, and stillbirth.

包括妊娠早期复发性流产、子痫前期、胎盘功能不全、胎儿生长受限、早产和死胎。

Despite the significant burden of the condition, patients are typically managed with low-dose aspirin and heparin,

尽管该疾病负担沉重，但患者通常接受低剂量阿司匹林和肝素治疗。

highlighting a substantial unmet medical need.

凸显出巨大的未满足医疗需求。

3-4

'This designation is a testament to UCB's commitment to advancing innovation in areas of significant unmet need, including our long-standing focus on supporting women of childbearing age,' said Donatello Crocetta, Chief Medical Officer and Global Head of Medical Affairs at UCB. 'Building on our experience across immune-mediated conditions, we continue to explore new approaches for people living with rare diseases and other underserved conditions where treatment options remain limited.'.

UCB首席医疗官兼全球医学事务负责人多纳泰罗·克罗切塔表示：“这一认定彰显了UCB致力于在存在重大未满足需求的领域推动创新的承诺，包括我们长期以来对支持育龄女性的关注。凭借我们在免疫介导疾病领域的经验，我们继续探索针对罕见病患者及其他治疗选择仍然有限的需求不足疾病患者的新方法。”

Results from the IMPACT study demonstrated the potential of CIMZIA to prevent adverse pregnancy outcomes in women with APS considered high risk due to LA positivity and prior obstetric or thrombotic manifestations of the disease. The findings add to growing evidence implicating tumor necrosis factor (TNF)-mediated inflammation in APS-related pregnancy complications..

IMPACT研究的结果表明，CIMZIA在预防因狼疮抗凝物（LA）阳性及既往产科或血栓性疾病表现而被视为高风险的抗磷脂综合征（APS）女性患者出现不良妊娠结局方面具有潜力。这些发现进一步佐证了越来越多的证据，即肿瘤坏死因子（TNF）介导的炎症与APS相关的妊娠并发症有关。

'For women living with APS, pregnancy can be an especially challenging and uncertain experience,' said Dr. Jane E. Salmon, Collette Kean Research Chair, Hospital for Special Surgery, and Co-Lead Investigator of the IMPACT study. 'Despite current management approaches, many patients remain at risk of serious complications, including preeclampsia, intrauterine growth restriction, premature birth, and fetal death, highlighting the need for additional treatment options for this underserved population.

“对于患有抗磷脂综合征（APS）的女性而言，妊娠可能是一段尤为充满挑战和不确定性的经历，”特殊外科医院Collette Kean研究讲席教授、IMPACT研究共同主要研究者Jane E. Salmon博士表示。“尽管目前已有相应的管理策略，许多患者仍面临严重并发症的风险，包括子痫前期、宫内生长受限、早产和胎儿死亡，这凸显出为这一医疗资源不足的人群提供更多治疗选择的必要性。”

Today's designation represents an encouraging step forward in efforts to improve outcomes for women of childbearing age and their families.'.

“今天的指定代表了在改善育龄妇女及其家庭健康结果方面迈出的令人鼓舞的一步。”

The designation builds on the FDA's recent Orphan Drug Designation for CIMZIA for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant patients with APS.

该认定基于美国食品药品监督管理局（FDA）最近授予CIMZIA的孤儿药资格，用于预防患有抗磷脂综合征（APS）的孕妇出现胎盘介导的不良妊娠结局。

十一

CIMZIA is not currently approved in pregnant women with APS, and the safety and efficacy have not been established for this use.

CIMZIA 目前尚未获批用于患有抗磷脂综合征（APS）的孕妇，且该用途的安全性和有效性尚未确立。

Notes to editors

编者注

About antiphospholipid syndrome (APS)

关于抗磷脂综合征（APS）

Antiphospholipid syndrome (APS) is a rare and serious autoimmune condition that mainly affects women of childbearing age (WoCBA), characterized by the presence of antiphospholipid antibodies, which can cause repeated blood clots in arteries and veins.

抗磷脂综合征（APS）是一种罕见且严重的自身免疫性疾病，主要影响育龄期女性（WoCBA），其特征是存在抗磷脂抗体，可导致动脉和静脉反复形成血栓。

2-3,5

The condition is associated with serious pregnancy complications, including recurrent pregnancy loss in the first trimester, pre-eclampsia, placental insufficiency, fetal growth restriction, preterm birth, stillbirth, and a range of serious placenta-mediated adverse pregnancy outcomes.

该状况与严重的妊娠并发症相关，包括孕早期复发性流产、子痫前期、胎盘功能不全、胎儿生长受限、早产、死产以及一系列严重的胎盘介导的不良妊娠结局。

3-4,9

Current standard-of-care treatment typically includes low-dose aspirin and heparin during pregnancy

当前的标准治疗通常包括在怀孕期间使用低剂量阿司匹林和肝素。

4-5

; however, no therapies are currently approved specifically for the prevention of adverse pregnancy outcomes in this patient population.

然而，目前尚无专门批准用于预防该患者群体不良妊娠结局的疗法。

3-5

About the IMPACT Study

关于IMPACT研究

IMPACT (IMProve Pregnancy in APS with Certolizumab Therapy) was an investigator-sponsored study evaluating certolizumab pegol in pregnant women with APS at high risk of adverse pregnancy outcomes. Published results demonstrated the potential of certolizumab pegol to prevent adverse pregnancy outcomes in this high-risk population..

IMPACT（通过赛妥珠单抗治疗改善抗磷脂综合征患者的妊娠结局）是一项由研究者发起的研究，旨在评估赛妥珠单抗聚乙二醇在高危不良妊娠结局的抗磷脂综合征孕妇中的疗效。已发表的结果表明，赛妥珠单抗聚乙二醇在这一高危人群中具有预防不良妊娠结局的潜力。

About Breakthrough Therapy Designation (BTD)

关于突破性疗法认定（BTD）

Breakthrough Therapy Designation (BTD) is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. The designation is granted when preliminary clinical evidence indicates that a therapy may demonstrate substantial improvement over available treatment options on one or more clinically significant endpoints.

突破性疗法认定（BTD）是美国食品药品监督管理局（FDA）的一项计划，旨在加速针对严重或危及生命疾病的药物开发和审评。当初步临床证据表明，某种疗法在一个或多个具有临床意义的终点指标上可能比现有治疗方案有显著改善时，即可获得该认定。

BTD provides opportunities for more intensive FDA guidance and organizational commitment to support efficient development and review, and is not a label indication approval..

突破性疗法认定（BTD）提供了获得更密集的FDA指导以及组织承诺的机会，以支持高效的开发与审评，但这并不等同于标签适应症的批准。

About Orphan Drug Designation

关于孤儿药资格认定

十二

Orphan Drug Designation is granted by the FDA to medicines intended for the treatment, prevention, or diagnosis of rare diseases or conditions affecting fewer than 200,000 people in the United States. The designation is designed to encourage the development of therapies for rare diseases and may provide incentives to sponsors, including development support and certain regulatory and commercial benefits.

孤儿药资格认定由美国食品药品监督管理局（FDA）授予，适用于旨在治疗、预防或诊断在美国影响人数少于20万的罕见疾病或病症的药物。该资格认定旨在鼓励罕见病疗法的开发，并可为申办方提供激励措施，包括开发支持以及某些监管和商业方面的优惠。

The designation does not constitute marketing approval or determine a medicine's safety or efficacy..

该认定不构成上市许可，也不决定药品的安全性或有效性。

About CIMZIA

关于CIMZIA

(certolizumab pegol)

（赛妥珠单抗）

in the U.S.

在美国

CIMZIA is a tumor necrosis factor (TNF) blocker indicated for:

CIMZIA 是一种肿瘤坏死因子（TNF）阻滞剂，适用于：

Reducing signs and symptoms of Crohn's disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy

减轻克罗恩病（CD）的体征和症状，并在对传统疗法反应不足的中等至重度活动性疾病的成年患者中维持临床应答

Treatment of adults with moderately to severely active rheumatoid arthritis (RA)

治疗中度至重度活动性类风湿关节炎（RA）的成年患者

Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older

用于治疗2岁及以上患者的活动性多关节型幼年特发性关节炎（pJIA）

Treatment of adult patients with active psoriatic arthritis (PsA)

成人活动性银屑病关节炎（PsA）患者的治疗

Treatment of adults with active ankylosing spondylitis (AS)

活动性强直性脊柱炎（AS）成人患者的治疗

Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

伴有客观炎症征象的活动性非放射学中轴型脊柱关节炎（nr-axSpA）成人患者的治疗

Treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy

适用于适合接受系统治疗或光疗的中重度斑块状银屑病（PSO）成年患者的治疗

Important Safety Information

重要安全信息

Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA.

已有报告指出，使用CIMZIA（赛妥珠单抗）可能出现严重且有时致命的副作用，包括结核病（TB）、细菌性败血症、侵袭性真菌感染（如组织胞浆菌病）以及其他机会性病原体（如军团菌或李斯特菌）引起的感染。在使用CIMZIA治疗期间及治疗后，应密切监测患者是否出现感染的体征和症状。

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. .

在包括Cimzia在内的TNF抑制剂治疗的儿童和青少年患者中，已有淋巴瘤和其他恶性肿瘤（部分为致命性）的报告。

CONTRAINDICATIONS

禁忌症

CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.

对于有对赛妥珠单抗聚乙二醇或任何辅料过敏史的患者，禁用CIMZIA。过敏反应包括血管性水肿、过敏性休克、血清病和荨麻疹。

SERIOUS INFECTIONS

严重感染

Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

接受CIMZIA治疗的患者发生严重感染的风险增加，这些感染可能导致住院或死亡。大多数发生这些感染的患者同时使用了免疫抑制剂，如甲氨蝶呤或皮质类固醇。

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

如果患者发生严重感染或败血症，应停用CIMZIA。

Reported infections include:

报告的感染包括：

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use.

活动性结核病（TB），包括潜伏性结核病的再激活。结核病患者常表现为播散性或肺外疾病。在使用CIMZIA之前及治疗期间，应对患者进行潜伏性结核病检测。在使用CIMZIA之前，应启动潜伏性结核病的治疗。

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.

侵袭性真菌感染，包括组织胞浆菌病、球孢子菌病、念珠菌病、曲霉病、芽生菌病和肺孢子菌病。患有组织胞浆菌病或其他侵袭性真菌感染的患者可能表现为播散性疾病，而非局限性疾病。部分活动性感染患者的组织胞浆菌病抗原和抗体检测可能呈阴性。

Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. .

对于有侵袭性真菌感染风险且出现严重全身性疾病的患者，应考虑经验性抗真菌治疗。

Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

由机会性病原体（包括军团菌和李斯特菌）引起的细菌、病毒及其他感染。

Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection.

在开始使用CIMZIA治疗前，请仔细权衡以下患者的风险与获益：患有慢性或复发性感染的患者；曾暴露于结核病的患者；有 opportunistic 感染病史的患者；居住或曾前往真菌病流行地区的患者；以及存在可能使其易感感染的基础疾病的患者。

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. .

在CIMZIA治疗期间及治疗后，密切监测患者是否出现感染的体征和症状，包括在治疗前潜伏性结核感染检测为阴性的患者中可能出现结核病的情况。

Do not start CIMZIA during an active infection, including localized infections.

在存在活动性感染（包括局部感染）期间，请勿开始使用CIMZIA。

Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.

年龄大于65岁的患者、伴有合并症的患者和/或同时服用免疫抑制剂的患者，感染风险可能更高。

If an infection develops, monitor carefully and initiate appropriate therapy.

如果发生感染，应密切监测并启动适当的治疗。

MALIGNANCY

恶性肿瘤

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member.

在接受TNF阻滞剂（包括CIMZIA）治疗的儿童和青少年患者中，已有淋巴瘤和其他恶性肿瘤（部分为致命性）的报告。

Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.

在已知患有恶性肿瘤的患者中开始或继续CIMZIA治疗前，请考虑其风险与益处。

In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.

在临床试验中，与对照组患者相比，接受CIMZIA治疗的患者中观察到更多的恶性肿瘤病例。

In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.

在CIMZIA的临床试验中，淋巴瘤的发生率约为美国普通人群预期值的2倍。类风湿关节炎患者，尤其是病情高度活跃的患者，其淋巴瘤风险高于普通人群。

Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population..

在接受TNF阻滞剂治疗的儿童、青少年和年轻成人中，已报告出现恶性肿瘤病例，其中部分为致命性。约半数病例为淋巴瘤，其余为其他类型的恶性肿瘤，包括与免疫抑制相关的罕见类型以及在该患者人群中通常不常见的恶性肿瘤。

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis, and the majority were in adolescent and young adult males.

已有报道指出，在接受肿瘤坏死因子（TNF）阻滞剂（包括CIMZIA）治疗的患者中，出现了肝脾T细胞淋巴瘤（HSTCL，一种罕见的T细胞淋巴瘤）的上市后病例。这些病例病程进展极为迅猛，且已导致死亡。在报告的TNF阻滞剂相关病例中，大多数发生于克罗恩病或溃疡性结肠炎患者，且多数为青少年和年轻成年男性。

Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types..

几乎所有这些患者在确诊时或之前都曾接受过硫唑嘌呤或6-巯基嘌呤与TNF阻断剂联合治疗。在此类患者中使用CIMZIA治疗时，应仔细评估其风险与获益。

Cases of acute and chronic leukemia were reported with TNF blocker use.

有报道指出，在使用TNF阻滞剂期间出现了急性和慢性白血病病例。

HEART FAILURE

心力衰竭

Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.

已有报道指出，TNF阻滞剂可导致充血性心力衰竭（CHF）恶化及新发。请谨慎使用并密切监测。

HYPERSENSITIVITY REACTIONS

超敏反应

Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex that may cause an allergic reaction in individuals sensitive to latex..

已有报道在给予CIMZIA后出现血管性水肿、过敏反应、呼吸困难、低血压、皮疹、血清病和荨麻疹。如果发生严重过敏反应，应停用CIMZIA并采取适当的治疗措施。CIMZIA预充式注射器可拆卸帽内的针头护罩含有天然橡胶乳胶的衍生物，可能对乳胶敏感个体引起过敏反应。

HEPATITIS B VIRUS REACTIVATION

乙型肝炎病毒再激活

Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.

使用TNF抑制剂（包括CIMZIA）可能会增加慢性携带者乙型肝炎病毒（HBV）再激活的风险。部分病例已导致死亡。

Test patients for HBV infection before initiating treatment with CIMZIA.

在开始使用CIMZIA治疗前，对患者进行乙型肝炎病毒（HBV）感染检测。

Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.

对于乙型肝炎病毒（HBV）携带者患者，应谨慎使用CIMZIA治疗，并在治疗前和治疗期间进行监测。

Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.

对于出现乙型肝炎病毒（HBV）再激活的患者，应停用CIMZIA并开始抗病毒治疗。在HBV治疗后恢复使用CIMZIA时需谨慎。

NEUROLOGIC REACTIONS

神经反应

TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.

包括CIMZIA在内的TNF抑制剂，与中枢神经系统和周围神经脱髓鞘疾病的新发或加重罕见病例有关，这些疾病包括多发性硬化、癫痫发作障碍、视神经炎、周围神经病和吉兰-巴雷综合征。

HEMATOLOGIC REACTIONS

血液学反应

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.

已有使用TNF抑制剂导致全血细胞减少（包括再生障碍性贫血）的罕见报告。CIMZIA引起具有临床意义的血细胞减少的报道较为少见。

Consider stopping CIMZIA if significant hematologic abnormalities occur.

如果出现显著的血液学异常，应考虑停用CIMZIA。

DRUG INTERACTIONS

药物相互作用

Do not use CIMZIA in combination with other biological DMARDs.

请勿将CIMZIA与其他生物制剂DMARDs联合使用。

AUTOIMMUNITY

自身免疫

Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

使用CIMZIA治疗可能导致自身抗体的形成，极少数情况下可能引发类狼疮综合征。如果出现类狼疮综合征的症状，应停止治疗。

IMMUNIZATIONS

免疫接种

Avoid use of live vaccines during or immediately prior to initiating CIMZIA. Update immunizations in agreement with current immunization guidelines prior to initiating CIMZIA therapy.

在开始使用CIMZIA期间或紧邻开始前，避免使用活疫苗。在开始CIMZIA治疗前，根据当前的免疫接种指南更新疫苗接种。

ADVERSE REACTIONS

不良反应

The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).

在CIMZIA的临床试验中，最常见的不良反应（≥8%）为上呼吸道感染（18%）、皮疹（9%）和尿路感染（8%）。

Please see ucb-usa.com for full prescribing information

请参阅 ucb-usa.com 获取完整的处方信息

。

About UCB

关于 UCB

UCB, Brussels, Belgium (

比利时布鲁塞尔 UCB（

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 € 7.7 billion in 2025.

）是一家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9,000多名员工，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，包括但不限于使用“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和其他此类估计与结果。

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、不确定性及假设的影响，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，与本文件中所载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，或无法以可接受的条款或在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的前景变化；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；对产品或候选产品的专利保护提出的挑战；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的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，人体的复杂性尚无法在计算机模型、细胞培养系统或动物模型中重现。完成临床试验并获得产品上市监管批准所需的时间长度亦然。

Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition.

作为合作伙伴关系、合资企业或许可合作主题的现有产品或潜在产品，可能会引发合作方之间的争议，或者可能被证明不如优时比（UCB）在此类合作开始时所认为的那样安全、有效或具有商业成功性。优时比为收购其他产品或公司以及整合被收购公司的运营所付出的努力，可能无法达到其在收购时所预期的成功程度。

Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products.

此外，优时比（UCB）或其他方可能在产品上市后才发现其产品和/或器械存在安全性、副作用或生产方面的问题。若发现与优时比某款产品类似的产品存在重大问题，且该问题涉及整个产品类别，则可能对整个受影响产品类别的销售产生重大不利影响。

Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes.

此外，销售可能受到国际和国内推行管理式医疗及控制医疗保健成本趋势的影响，这些趋势包括价格压力、政治和公众审查、客户和处方医生的模式或做法、第三方付款人实施的报销政策，以及影响生物制药定价和报销活动及结果的立法。

Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems..

最后，系统故障、网络攻击或信息安全漏洞可能会损害优时比（UCB）数据和系统的机密性、完整性和可用性。

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.

鉴于上述不确定性，提醒公众不要对此类前瞻性陈述产生不当依赖。这些前瞻性陈述仅反映截至本文件发布之日的情况，并未体现上述不断演变的事件或风险以及其他不利因素可能带来的任何潜在影响，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..

公司继续密切关注事态发展，以评估这些事件对UCB的财务影响（视具体情况而定）。

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，否则其不承担任何义务更新本文档中的任何前瞻性陈述，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，或此类陈述所依据的事件、条件或情况的任何变化。

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:

电子邮件：

[email protected]

Sahar Yazdian

萨哈尔·亚兹迪安

T +32.2.559.91.37

电子邮件

[email protected]

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:

电子邮件：

[email protected]

U.S. Communications

美国通信

Nicole Herga

妮可·赫尔加

T: +773-960-5349

电话：+773-960-5349

Email:

电子邮件：

[email protected]

References

参考文献

U.S. Food and Drug Administration. Breakthrough Therapy Designation letter for CIMZIA

美国食品药品监督管理局。CIMZIA突破性疗法认定函

(certolizumab pegol) for the prevention of adverse pregnancy outcomes in patients with antiphospholipid syndrome (APS). Date issued: August 2026. On file with UCB.

（培塞利珠单抗）用于预防抗磷脂综合征（APS）患者的不良妊娠结局。发布日期：2026年8月。存档于优时比公司。

Branch DW, et al. Certolizumab pegol to prevent adverse pregnancy outcomes in patients with antiphospholipid syndrome and lupus anticoagulant (IMPACT): results of a prospective, single-arm, open-label, phase 2 trial.

Branch DW 等。聚乙二醇化赛妥珠单抗用于预防抗磷脂综合征合并狼疮抗凝物患者的不良妊娠结局（IMPACT）：一项前瞻性、单臂、开放标签的 II 期试验结果。

Ann Rheum Dis

《风湿病年鉴》

. 2025;84(7):1011-1022.

Branch DW, Lim MY. How I diagnose and treat antiphospholipid syndrome in pregnancy.

Branch DW, Lim MY. 我如何诊断和治疗妊娠期抗磷脂综合征。

Blood

血液

. 2024;143(9):757-768.

2024;143(9):757-768.

Lee EE, Jun JK, Lee EB. Management of Women with Antiphospholipid Antibodies or Antiphospholipid Syndrome during Pregnancy.

李 EE，Jun JK，李 EB。妊娠期抗磷脂抗体或抗磷脂综合征女性的管理。

J Korean Med Sci

韩国医学科学杂志

. 2021;36(4):e24.

U.S. Food and Drug Administration (FDA). Drugs@FDA Database. Available at:

美国食品药品监督管理局（FDA）。Drugs@FDA 数据库。网址：

https://www.accessdata.fda.gov/scripts/cder/daf/

. Last accessed: September 2026.

最后访问日期：2026年9月。

Adams CG, Rudnicki J, Petersen BF, et al. The urgent need for randomized controlled trials in pregnant women with antiphospholipid antibodies—protecting women through research.

Adams CG、Rudnicki J、Petersen BF 等。在患有抗磷脂抗体的孕妇中开展随机对照试验的迫切需求——通过研究保护女性健康。

Front. Lupus.

《狼疮前沿》

4:1747204.

U.S. Food and Drug Administration. Breakthrough Therapy. Available at:

美国食品药品监督管理局。突破性疗法。网址：

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

. Last accessed: September 2026.

最后访问日期：2026年9月。

Murvai VR, Galiș R, Panaitescu A, et al. Antiphospholipid syndrome in pregnancy: a comprehensive literature review

Murvai VR，Galiș R，Panaitescu A，等。妊娠期抗磷脂综合征：一项全面的文献综述

. BMC Pregnancy Childbirth

BMC 妊娠与分娩

. 2025;25:230.

Alijotas-Reig J, Esteve-Valverde E, Ferrer-Oliveras Ret al; EUROAPS Study Group. The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): A survey of 1000 consecutive cases.

Alijotas-Reig J, Esteve-Valverde E, Ferrer-Oliveras R 等；EUROAPS 研究组。欧洲产科抗磷脂综合征登记研究（EUROAPS）：1000 例连续病例的调查。

Autoimmun Rev

《自身免疫评论》

. 2019;18(4):406-414.

2019;18(4):406-414.

Berman J, Girardi G, Salmon JE. TNF-α Is a Critical Effector and a Target for Therapy in Antiphospholipid Antibody-Induced Pregnancy Loss.

Berman J, Girardi G, Salmon JE. TNF-α是抗磷脂抗体诱导妊娠丢失的关键效应分子及治疗靶点。

J Immunol.

《免疫学杂志》

2005;174(1):485-490.

2005；174(1):485-490。

U.S. Food and Drug Administration (FDA). Search Orphan Drug Designations and Approvals: certolizumab pegol for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant patients with antiphospholipid syndrome. Date designated: March 2, 2026. Available at:

美国食品药品监督管理局（FDA）。孤儿药指定和批准查询：培戈化赛妥珠单抗用于预防抗磷脂综合征孕妇患者由胎盘介导的不良妊娠结局。指定日期：2026年3月2日。网址：

https://www.accessdata.fda.gov/scripts/opdlisting/oopd/

. Last accessed: September 2026.

最后访问日期：2026年9月。

Science Insights. Orphan Drug Designation: What It Means and How It Works. Available at:

科学洞察。孤儿药资格认定：含义及运作机制。获取网址：

https://scienceinsights.org/orphan-drug-designation-what-it-means-and-how-it-works/

. Last accessed: September 2026.

最后访问：2026年9月。

SOURCE UCB

来源：加州大学伯克利分校

二十一