Brussels (Belgium) 14 May 2024 – 07:00 AM (CET) – UCB, a global biopharmaceutical company, today announced that the Journal of Neurology has published data from a post hoc analysis of the pivotal Phase 3 RAISE study and the ongoing Phase 3 RAISE-XT open-label extension (OLE) study evaluating the long-term effect of zilucoplan on fatigue in adult patients with mild to severe anti-acetylcholine receptor antibody positive (AChR-Ab+) gMG.5,6  .

布鲁塞尔（比利时）2024年5月14日上午7:00（CET）-全球生物制药公司UCB今天宣布，《神经病学杂志》发表了关键的3期RAISE研究和正在进行的3期RAISE-XT开放标签延伸（OLE）研究的事后分析数据，该研究评估了齐鲁计划对轻度至重度抗乙酰胆碱受体抗体阳性（AChR-Ab+）gMG成年患者疲劳的长期影响[5,6]。

The results showed that patients with gMG treated with once daily subcutaneous injections of the complement C5 inhibitor zilucoplan experienced clinically meaningful improvements in fatigue sustained for more than a year.5 Clinically meaningful improvement from baseline was defined as a change of − 3.5..

结果显示，每天一次皮下注射补体C5抑制剂齐鲁计划治疗的gMG患者在持续一年多的疲劳中经历了临床上有意义的改善。5临床上有意义的基线改善定义为-3.5的变化。。

“For people living with gMG, fatigue can be debilitating and have a huge impact across daily life, reducing their ability to engage in physical, functional, social and mental activities. The unpredictable nature of these gMG symptoms can lead to feelings of vulnerability and lack of control,” explained Donatello Crocetta, MD, Head of Global Rare Disease and Rare Medical at UCB.

“对于患有gMG的人来说，疲劳会使人衰弱，并对日常生活产生巨大影响，降低他们参与身体，功能，社交和心理活动的能力。这些gMG症状的不可预测性会导致脆弱感和缺乏控制感，”加州大学伯克利分校全球罕见病和罕见医学负责人DonatelloCrocetta医学博士解释道。

“This post hoc analysis reveals ZILBRYSQ’s role in helping manage an important yet understudied symptom of gMG. It follows the publication of the primary data in The Lancet Neurology last year which described clinically meaningful and statistically significant improvements in different MG-specific efficacy outcomes.

“这项事后分析揭示了ZILBRYSQ在帮助管理gMG的一个重要但尚未得到充分研究的症状方面的作用。去年，《柳叶刀神经病学》发表了主要数据，描述了不同MG特异性疗效结果的临床意义和统计学显着改善。

UCB is committed to providing targeted treatment options that can help reduce the ongoing burden of gMG, giving patients flexible treatment options that work alongside their daily life.”.

UCB致力于提供有针对性的治疗选择，以帮助减轻gMG的持续负担，为患者提供灵活的治疗选择，与他们的日常生活一起工作。”。

The post hoc analysis showed that mean Neuro-QoL Short Form Fatigue T-scores improved from double-blind baseline to Week 12 in the zilucoplan group (n=86) with a clinically meaningful difference versus placebo (n=88; least squares mean difference: −3.61 [nominal p-value=0.0060]), and these improvements were sustained up to Week 60 mean [SE] CFB −9.15 [1.80].

事后分析显示，齐鲁计划组（n=86）的平均神经生活质量短期疲劳T评分从双盲基线改善到第12周，与安慰剂组相比有临床意义的差异（n=88；最小二乘平均差：-3.61[标称p值=0.0060]），这些改善持续到第60周平均值[SE]CFB-9.15[1.80]。

At Week 12, more patients on zilucoplan (n=34, 47.2%) experienced improvements in ≥1 fatigue severity level from baseline versus placebo (n=23, 28.4%; p=0.017).5 .

在第12周，更多服用齐鲁计划的患者（n=34，47.2%）与安慰剂相比，基线时≥1疲劳严重程度有所改善（n=23，28.4%；p=0.017）。

The improvements in fatigue observed in the zilucoplan group during the double-blind period of RAISE continued further into RAISE-XT, the ongoing OLE study, and were sustained up to Week 60 (mean [SE] CFB −10.71 [1.81]), indicating that zilucoplan improved fatigue in patients with MG up to 60 weeks.

在RAISE的双盲期内，齐鲁计划组观察到的疲劳改善持续到正在进行的OLE研究RAISE-XT，并持续到第60周（平均[SE]CFB-10.71[1.81]），表明齐鲁计划改善了MG患者长达60周的疲劳。

Among patients who transitioned from placebo to zilucoplan in the OLE (placebo-switch group), improvements were observed at the first week after switching to zilucoplan 0.3mg/kg (Week 13).5 .

在OLE（安慰剂转换组）中从安慰剂转换为齐鲁计划的患者中，在转换为齐鲁计划0.3mg/kg（第13周）后的第一周观察到改善。

Looking at fatigue severity scores, at double-blind baseline, the majority of patients had “severe” or “moderate” fatigue (n=66, 78.6%; N=84). Overall, by Week 60, most patients had seen an improvement to “mild” or no fatigue (n=55, 65.5%). These findings were consistent across the zilucoplan group and in the placebo-switch group (data not shown). .

从疲劳严重程度评分来看，在双盲基线时，大多数患者患有“严重”或“中度”疲劳（n=66，78.6%；n=84）。总体而言，到第60周，大多数患者的“轻度”或无疲劳有所改善（n=55，65.5%）。这些发现在齐鲁计划组和安慰剂转换组中是一致的（数据未显示）。。

“The results showing improvements in fatigue scores and severity with zilucoplan treatment seen in the RAISE and RAISE-XT post hoc analysis are important as this is the first analysis of T-score transformation of Neuro-QoL Short Form Fatigue scores in patients with MG in a Phase 3 study, allowing us to assess the clinical meaningfulness of these data,” said Michael Weiss, Professor of Neurology at University of Washington and lead author on the paper.

华盛顿大学神经病学教授、论文主要作者迈克尔·韦斯（MichaelWeiss）说：“RAISE和RAISE-XT事后分析结果显示，齐鲁计划治疗后疲劳评分和严重程度有所改善，这一结果很重要，因为这是对MG患者神经生活质量简式疲劳评分T评分转换的首次分析。这项研究在3期研究中，使我们能够评估这些数据的临床意义。”。

“Fatigue is one of the more debilitating symptoms in gMG and a major contributor to reductions in patients’ health-related QoL. In addition to MG-specific outcome measures, it is important for clinicians to routinely measure fatigue as part of the overall assessment of MG symptoms in their patients.”.

“疲劳是gMG中更令人衰弱的症状之一，也是患者健康相关生活质量下降的主要原因。除了MG特定的结局指标外，临床医生常规测量疲劳作为患者MG症状总体评估的一部分也很重要。”。

Overall, zilucoplan was well tolerated and had a favorable long-term safety profile. Out of 200 enrolled patients, 188 (94.0%) patients experienced a TEAE, and 64 (32.0%) patients experienced serious TEAEs. The most common TEAEs were (worsening of) MG (26.0%), COVID-19 (24.5%), headache (17.5%), diarrhoea (15.0%) and nasopharyngitis (15.0%).

总体而言，齐鲁计划耐受性良好，具有良好的长期安全性。在200名入选患者中，188名（94.0%）患者经历了TEAE，64名（32.0%）患者经历了严重的TEAE。最常见的TEAE是（恶化）MG（26.0%），COVID-19（24.5%），头痛（17.5%），腹泻（15.0%）和鼻咽炎（15.0%）。

Seventeen (8.5%) patients had a TEAE resulting in permanent withdrawal from treatment.5 .

17名（8.5%）患者出现TEAE，导致永久退出治疗。

gMG is a rare, chronic, heterogeneous, unpredictable autoimmune disease characterized by dysfunction and damage at the neuromuscular junction (NMJ).7,8,9 Several factors are understood to be drivers of gMG disease pathology, including the complement cascade, immune cells and pathogenic immunoglobulin G (IgG) autoantibodies.7,8,9 .

gMG是一种罕见的，慢性的，异质性的，不可预测的自身免疫性疾病，其特征在于神经肌肉接头（NMJ）的功能障碍和损伤[7,8,9]。一些因素被认为是gMG疾病病理学的驱动因素，包括补体级联，免疫细胞和致病性免疫球蛋白G（IgG）自身抗体[7,8,9]。

In AChR antibody positive gMG, pathogenic AChR autoantibodies (IgG1 and IgG3) initiate the classical complement pathway, which, together with the alternative and lectin complement pathways, converge at C5, leading to MAC (membrane attack complex) deposition, damage to the NMJ, loss of AChRs and subsequent impaired synaptic transmission.9,10 Preventing MAC formation reduces damage to the post-synaptic membrane, reduces disruption of ionic channel conductance and helps to preserve neuromuscular transmission. .

在AChR抗体阳性的gMG中，致病性AChR自身抗体（IgG1和IgG3）启动经典补体途径，其与替代和凝集素补体途径一起聚集在C5，导致MAC（膜攻击复合物）沉积，NMJ损伤，AChR丢失和随后的突触传递受损[9,10]。预防MAC形成可减少突触后膜的损伤，减少离子通道电导的破坏，并有助于保持神经肌肉传递。。

MG has a global prevalence of 100–350 cases per every 1 million people.8

MG的全球患病率为每100万人中有100-350例。8

Zilucoplan has been approved by the European Commission (EC), the US FDA, the Japanese Ministry of Health, Labour and Welfare (MHLW), and the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA), for the treatment of gMG.1,2,3,4

Zilucoplan已获得欧盟委员会（EC），美国FDA，日本厚生劳动省（MHLW）和英国（英国）药品和保健品管理局（MHRA）的批准，用于治疗gMG。1,2,3,4

▼ 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。

About zilucoplan

关于zilucoplan

Zilucoplan is a once-daily SC, self-administered peptide inhibitor of complement component 5 (C5 inhibitor). As a C5 inhibitor, zilucoplan inhibits complement-mediated damage to the neuromuscular junction through its targeted dual mechanism of action.6

齐鲁计划是一种每日一次的补体成分5（C5抑制剂）的自我给药肽抑制剂。作为C5抑制剂，齐鲁计划通过其靶向的双重作用机制抑制补体介导的神经肌肉接头损伤

In September 2023, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved zilucoplan for the treatment of gMG in adult patients (only for patients who inadequately respond to steroids or other immunosuppressants).1 In October 2023, the U.S. Food and Drug Administration (FDA) approved zilucoplan for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.3 In December 2023, the European Commission granted zilucoplan approval as an add-on to standard therapy for the treatment of generalized Myasthenia Gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.2 In January 2024, the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Zilbrysq as an add-on to standard therapy for adult patients who are anti-acetylcholine receptor (AChR) antibody positive.4.

2023年9月，日本厚生劳动省（MHLW）批准了齐鲁计划用于治疗成年患者的gMG（仅适用于对类固醇或其他免疫抑制剂反应不足的患者）。1 2023年10月，美国食品和药物管理局（FDA）批准了齐鲁计划用于治疗抗乙酰胆碱受体（AChR）抗体阳性的成年患者的全身性重症肌无力（gMG）。3 2023年12月，欧盟委员会批准齐鲁计划作为标准疗法的补充，用于治疗抗乙酰胆碱受体（AChR）的成年患者的全身性重症肌无力（gMG）R）抗体阳性。2 2024年1月，英国（UK）药品和保健品管理局（MHRA）批准了Zilbrysq的上市许可，作为抗乙酰胆碱受体（AChR）抗体阳性成年患者标准治疗的附加品。

Zilucoplan is currently under review by the Australian Therapeutic Goods Administration (TGA) and Health Canada for the treatment of adults with gMG. Responses from these regulatory bodies are expected during 2024.

澳大利亚治疗用品管理局（TGA）和加拿大卫生部目前正在审查Zilucoplan治疗成人gMG。预计这些监管机构将在2024年作出回应。

About generalized myasthenia gravis (gMG)

关于全身性重症肌无力（gMG）

gMG is a rare autoimmune disease with a global prevalence of 100–350 cases per every 1 million people.5,8 People living with gMG can experience a variety of symptoms, including severe muscular weakness that can result in double vision, drooping eyelids, difficulty with swallowing, chewing and talking, as well as life-threatening weakness of the muscles of respiration.7,11.

gMG是一种罕见的自身免疫性疾病，全球患病率为每100万人100-350例。5,8患有gMG的人会出现多种症状，包括严重的肌肉无力，可导致双眼失明，眼睑下垂，吞咽困难，咀嚼困难和说话困难，以及危及生命的呼吸肌无力[7,11]。

In MG, pathogenic autoantibodies can impair synaptic transmission at the neuromuscular junction (NMJ) by targeting specific proteins on the post-synaptic membrane.12 This disrupts the ability of the nerves to stimulate the muscle and results in a weaker contraction.9 gMG can occur in any race, gender or age.7,11.

在MG中，致病性自身抗体可通过靶向突触后膜上的特定蛋白质来损害神经肌肉接头（NMJ）的突触传递[12]。这会破坏神经刺激肌肉的能力并导致收缩减弱[9]。gMG可能发生在任何种族，性别或年龄[7,11]。

About the RAISE/RAISE-XT studies5,6

关于RAISE/RAISE-XT研究5,6

RAISE (NCT04115293) was a multi-centre, Phase 3, randomized, double-blind, placebo-controlled study to confirm the efficacy, safety profile, and tolerability of zilucoplan in adult patients with anti-acetylcholine receptor (AChR) antibody positive gMG. Patients were randomized in a 1:1 ratio to receive daily subcutaneous (SC) injections of 0.3 mg/kg zilucoplan or placebo for 12 weeks.6.

RAISE（NCT04115293）是一项多中心，3期，随机，双盲，安慰剂对照研究，旨在证实齐鲁计划在抗乙酰胆碱受体（AChR）抗体阳性gMG成年患者中的疗效，安全性和耐受性。患者以1:1的比例随机接受每日皮下（SC）注射0.3 mg/kg齐鲁计划或安慰剂12周。

The primary endpoint for the RAISE study was change from baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score. Secondary endpoints included change from baseline in the Quantitative Myasthenia Gravis (QMG) score, the Myasthenia Gravis Composite (MGC) and the Myasthenia Gravis Quality of Life 15 revised (MG-QoL15r) score to Week 12, time to first rescue therapy, the proportion of patients with minimal symptom expression (MSE) (defined as MG-ADL of 0 or 1 without rescue therapy), the proportion with a ≥3-point reduction in MG-ADL without rescue therapy and the proportion with a ≥5-point reduction in QMG without rescue therapy, all measured at Week 12.

RAISE研究的主要终点是重症肌无力日常生活活动（MG-ADL）评分从基线到第12周的变化。次要终点包括定量重症肌无力（QMG）评分，重症肌无力综合评分（MGC）和重症肌无力生活质量15修订（MG-QoL15r）评分从基线到第12周的变化，首次抢救治疗的时间，最小症状表达（MSE）患者的比例（定义为无抢救治疗的MG-ADL为0或1），无抢救治疗的MG-ADL降低≥3分的比例以及无抢救治疗的QMG降低≥5分的比例，所有这些都是在第12周测量的。

Change from baseline to week 12 in Neuro-QoL short form fatigue scale was assessed as exploratory endpoint. The secondary safety endpoint was incidence of TEAEs.6 A clinically meaningful improvement from baseline was defined as a change of – 3.5, and clinically meaningful worsening was defined as a change of + 3.2, in Neuro-OoL Short Form Fatigue T-score from double-blind baseline.6.

神经生活质量简式疲劳量表从基线到第12周的变化被评估为探索性终点。次要安全性终点是TEAE的发生率[6]。临床上有意义的基线改善定义为-3.5的变化，临床上有意义的恶化定义为双盲基线的Neuro-OoL短期疲劳T评分变化为+3.2。

Patients who completed the RAISE trial had the possibility to enter the open-label extension study, RAISE-XT (NCT04225871).5,6 RAISE-XT is an ongoing, multicentre, open-label extension (OLE) study of zilucoplan where participants who completed the 12-week treatment period in either the Phase 2 double-blind study of zilucoplan or RAISE could opt to receive daily subcutaneous doses of 0.3mg/kg zilucoplan.5,6.

完成RAISE试验的患者有可能进入开放标签扩展研究RAISE-XT（NCT04225871）[5,6]。RAISE-XT是一项正在进行的，多中心，开放标签扩展（OLE）的齐鲁计划研究，参与者在齐鲁计划或RAISE的2期双盲研究中完成了12周的治疗期，可以选择接受每日皮下剂量为0.3mg/kg的齐鲁计划[5,6]。

For more information about the trials visit https://clinicaltrials.gov/ct2/show/NCT04115293  and https://clinicaltrials.gov/study/NCT04225871.

有关试验的更多信息，请访问https://clinicaltrials.gov/ct2/show/NCT04115293和https://clinicaltrials.gov/study/NCT04225871.

About UCB

关于UCB

UCB, Brussels, Belgium 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是一家全球性生物制药公司，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。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). .

UCB在布鲁塞尔泛欧交易所上市（符号：UCB）。[UNK]。

▼ZILBRYSQ® (zilucoplan) EU/EEA* Important Safety Information

◇ZILBRYSQ® （zilucoplan）欧盟/欧洲经济区*重要安全信息

▼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. The most frequently reported adverse reactions were injection site reactions (injection site bruising (13.9%) and injection site pain (7.0%)) and upper respiratory tract infections (nasopharyngitis (5.2%), upper respiratory tract infection (3.5%) and sinusitis (3.5%)).

▼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。最常报告的不良反应是注射部位反应（注射部位瘀伤（13.9%）和注射部位疼痛（7.0%））和上呼吸道感染（鼻咽炎（5.2%），上呼吸道感染（3.5%）和鼻窦炎（3.5%））。

The adverse reactions from the pooled placebo controlled (n=115) and open-label extension (n=213) studies in gMG are as follows: Very common adverse reactions: (≥ 1/10): Upper respiratory tract infections and Injection site reactions; Common adverse reactions (≥ 1/100 to < 1/10) Diarrhoea, Lipase increased, Amylase increased and Morphoea; Uncommon adverse reaction ((≥ 1/1000 to < 1/100) blood eosinophils increased.

gMG合并安慰剂对照（n=115）和开放标签扩展（n=213）研究的不良反应如下：非常常见的不良反应：（≥1/10）：上呼吸道感染和注射部位反应；常见不良反应（≥1/100至<1/10）腹泻，脂肪酶升高，淀粉酶升高和形态；罕见的不良反应（≥1/1000至<1/100）血液嗜酸性粒细胞增加。

Zilucoplan is contra-indicated in patients with hypersensitivity to the active substance or to any of the excipients, in patients who are not currently vaccinated against Neisseria meningitidis and in patients with unresolved Neisseria meningitidis infection. Due to its mechanism of action, the use of zilucoplan may increase the patient’s susceptibility to infections with Neisseria meningitidis.

对于对活性物质或任何赋形剂过敏的患者，目前尚未接种脑膜炎奈瑟菌疫苗的患者以及未解决脑膜炎奈瑟菌感染的患者，禁用齐鲁计划。由于其作用机制，使用齐鲁计划可能会增加患者对脑膜炎奈瑟菌感染的易感性。

As a precautionary measure, all patients must be vaccinated against meningococcal infections, at least 2 weeks prior to the start of treatment. If treatment needs to start less than 2 weeks after vaccination against meningococcal infections, the patient must receive appropriate prophylactic antibiotic treatment until 2 weeks after the first vaccination dose.

作为预防措施，所有患者必须在开始治疗前至少2周接种脑膜炎球菌感染疫苗。如果在接种脑膜炎球菌感染疫苗后不到2周就需要开始治疗，患者必须接受适当的预防性抗生素治疗，直到第一次接种疫苗后2周。

Meningococcal vaccines reduce but do not completely eliminate the risk of meningococcal infections. Vaccines against serogroups A, C, Y, W, and wher.

脑膜炎球菌疫苗可以减少但不能完全消除脑膜炎球菌感染的风险。针对血清群A，C，Y，W和wher的疫苗。

For further information, contact UCB:

有关更多信息，请联系UCB：

Global Rare Disease Communications

全球罕见病传播

Jim Baxter

吉姆·巴克斯特

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jim.baxter@ucb.com

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Corporate Communications, Media Relations

企业传播、媒体关系

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Laurent.schots@ucb.com

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Investor Relations

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Antje Witte

Antje Witte

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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、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的估计。

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: the global spread and impact of COVID-19, 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 .

可能导致这种差异的重要因素包括：新型冠状病毒在全球的传播和影响，一般经济、商业和竞争条件的变化，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，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。

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 and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB.

UCB仅在本新闻稿发布之日提供了这些信息，包括前瞻性声明，除非另有说明，否则它不反映不断演变的新型冠状病毒大流行的任何潜在影响。加州大学银行正在努力跟踪全球事态发展，以评估这场大流行对加州大学银行的财务意义。

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登记或取得资格之前，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：

Data on file: Japan MHLW, 25 September 2023.

存档数据：日本MHLW，2023年9月25日。

Zilucoplan EU SmPC https://www.ema.europa.eu/en/documents/product-information/zilbrysq-epar-product-information_en.pdf. Accessed April 2024.

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Data on file: MHRA approval. UCB January 2024.

存档数据：MHRA批准。UCB 2024年1月。

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