ADHERE data show VYVGART®Hytrulo has potential to be first advancement for CIDP patients in 30 years

ADHERE数据显示，VYVGART®Hytrulo有潜力成为30年来CIDP患者的首次进步

Real-world data demonstrate gMG patients able to significantly reduce steroid use over first six months of initiating VYVGART® treatment

现实世界的数据表明，在开始VYVGART®治疗的前六个月内，gMG患者能够显着减少类固醇的使用

April 16, 2024 – 7:00am CET

2024年4月16日——欧洲中部时间早上7:00

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that data from its Phase 3 ADHERE trial evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) were presented for the first time to the medical community during the Clinical Trials Plenary Session at the American Academy of Neurology (AAN) Annual Meeting in Denver, CO..

荷兰阿姆斯特丹–致力于改善患有严重自身免疫性疾病的人的生活的全球免疫学公司argenx SE（Euronext＆Nasdaq:ARGX）今天宣布，在科罗拉多州丹佛举行的美国神经病学学会（AAN）年会的临床试验全体会议上，首次向医学界提交了评估VYVGART Hytrulo（efgartigmod alfa和透明质酸酶qvfc）慢性炎症性脱髓鞘性多发性神经病（CIDP）患者的3期ADHERE试验数据。。

argenx also highlighted clinical trial and real-world data across seven posters and presentations that continue to reinforce VYVGART and VYVGART Hytrulo as a transformative treatment option for gMG patients.

argenx还强调了七张海报和演示文稿中的临床试验和现实世界数据，这些海报和演示文稿继续加强VYVGART和VYVGART Hytrulo作为gMG患者的变革性治疗选择。

“Our innovative approach to autoimmunity research is changing expectations for the global immunology community,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “The gMG and CIDP data presented at AAN reinforce that our pioneering approach to transforming autoimmunity is redefining what is possible for patients and their communities.”.

“我们对自身免疫研究的创新方法正在改变全球免疫学界的期望，”argenx首席医学官Luc Truyen医学博士说。“AAN上提供的gMG和CIDP数据进一步表明，我们开创性的自身免疫转化方法正在重新定义患者及其社区的可能性。”。

“Patients with CIDP face a number of diagnostic and treatment challenges” said Jeffrey Allen, M.D., Professor, Department of Neurology, University of Minnesota and Principal Investigator in the ADHERE trial. “The results of the ADHERE trial show that VYVGART Hytrulo reduces the risk of clinical deterioration in patients with CIDP while minimizing side effects and reducing the treatment burden.

明尼苏达大学神经病学系教授、ADHERE试验首席研究员杰弗里·艾伦（JeffreyAllen）医学博士说：“CIDP患者面临着许多诊断和治疗挑战。”。ADHERE试验的结果表明，VYVGART-Hytrulo降低了CIDP患者临床恶化的风险，同时最大程度地减少了副作用并减轻了治疗负担。

These findings enhance our understanding of the role that IgG autoantibodies are likely to play in the disease, and open the door to new safe, effective and well-tolerated treatments that eliminate pathogenic IgGs.”.

这些发现增强了我们对IgG自身抗体可能在疾病中发挥的作用的理解，并为消除致病性IgG的新的安全，有效和耐受性良好的治疗打开了大门。”。

ADHERE Plenary Session (PL5) Highlights Rapid, Deep and Clinically Meaningful, and Durable Functional Improvementsin CIDP

ADHERE全体会议（PL5）强调了CIDP中快速，深入且具有临床意义且持久的功能改善

In the ADHERE study, a majority of patients treated with VYVGART Hytrulo, regardless of prior treatment, demonstrated evidence of rapid clinical improvement, and a reduced risk of relapse compared to those treated with placebo. As previously reported, ADHERE met its primary endpoint (p=0.000039) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo.

在ADHERE研究中，大多数接受VYVGART-Hytrulo治疗的患者，无论之前是否接受过治疗，都表现出临床快速改善的证据，并且与安慰剂治疗的患者相比，复发风险降低。如先前报道，ADHERE达到了其主要终点（p=0.000039），表明与安慰剂相比，复发风险降低了61%（HR:0.39 95%CI:0.25；0.61）。

VYVGART Hytrulo was well-tolerated, and the observed safety and tolerability profile was consistent with previous clinical trials..

VYVGART-Hytrulo耐受性良好，观察到的安全性和耐受性与之前的临床试验一致。。

Evidence of rapid onset and maintenance of clinical response: In the open-label Stage A of the ADHERE study, 67% of patients treated with VYVGART Hytrulo demonstrated evidence of clinical improvement (ECI), including 40% who had achieved ECI by the earliest possible measure at week 4. In Stage B, VYVGART Hytrulo-treated patients maintained a clinical response to treatment longer than those on placebo as evidenced by a statistically significant and clinically relevant reduction in risk of relapse.

临床反应快速发作和维持的证据：在ADHERE研究的开放标签阶段A中，67%接受VYVGART-Hytrulo治疗的患者表现出临床改善（ECI）的证据，其中40%的患者在第4周通过最早的可能措施达到了ECI。在B期，VYVGART-Hytrulo治疗的患者对治疗的临床反应持续时间长于安慰剂组，这可以通过统计学上显着且临床相关的复发风险降低来证明。

Results across both Stage A and B indicate IgG autoantibodies play a significant role in mediating the underlying biology of CIDP..

A期和B期的结果表明，IgG自身抗体在介导CIDP的潜在生物学中起着重要作用。。

Deep and clinically meaningful functional improvements: 81% of VYVGART Hytrulo-treated patients demonstrated ≥1 point improvement on the aINCAT as compared to baseline Stage A scores in ADHERE, which includes 42% of patients with ≥2 point improvement, 28% with ≥3 point improvement, and 12% with ≥4 point improvement..

深度和临床意义上的功能改善：与ADHERE的基线A期评分相比，81%的VYVGART-Hytrulo治疗患者在aINCAT上表现出≥1分的改善，其中42%的患者改善≥2分，28%的患者改善≥3分，12%的患者改善≥4分。。

Clinical benefit demonstrated regardless of prior CIDP treatment: Clinical benefit was seen across all patient subtypes, including those who had previously received corticosteroids, intravenous or subcutaneous immunoglobulin, or were on no treatment prior to study entry.

无论先前的CIDP治疗如何，临床获益均得到证实：所有患者亚型均获得临床获益，包括先前接受皮质类固醇，静脉或皮下免疫球蛋白治疗或在研究进入前未接受治疗的患者。

High rate of treatment continuation: 99% of eligible patients continued to the ADHERE-Plus open-label extension study.

继续治疗率高：99%的合格患者继续进行ADHERE Plus开放标签扩展研究。

FDA decision on CIDP sBLA expected by June 21, 2024: Data from the ADHERE trial were submitted to the U.S. Food and Drug Administration (FDA) as part of a supplemental Biologics License Application (sBLA) for VYVGART Hytrulo for the treatment of CIDP. The application was accepted for Priority Review in February 2024 and has been granted a PDUFA target action date of June 21, 2024..

FDA预计在2024年6月21日前对CIDP sBLA做出决定：ADHERE试验的数据已提交给美国食品和药物管理局（FDA），作为VYVGART Hytrulo治疗CIDP的补充生物制剂许可证申请（sBLA）的一部分。该申请于2024年2月被接受优先审查，并被授予2024年6月21日的PDUFA目标行动日期。。

AAN presentations highlight rapid, deep, and sustained improvements in gMG with ability to reduce steroid burden

AAN的演讲强调了gMG的快速，深入和持续的改善，并能够减轻类固醇负担

Clinical trial data and real-world evidence presented during AAN continue to highlight the differentiated efficacy and safety profile of VYVGART and VYVGART Hytrulo, driving rapid, deep, and sustained improvement across disease scales and with different dosing schedules, including the ability for patients to achieve minimal symptom expression (MSE)..

AAN期间提供的临床试验数据和现实世界证据继续突出了VYVGART和VYVGART-Hytrulo的不同疗效和安全性，推动了疾病规模和不同给药方案的快速，深入和持续改善，包括患者实现最小症状表达（MSE）的能力。。

MSE results in ADAPT/ADAPT+: Poster Session 10

MSE导致适应/适应+：海报课程10

ADAPT-SC+ interim results: Poster Session 10

ADAPT-SC+中期结果：海报课程10

ADAPT-NXT interim results: Poster Session 10

ADAPT-NXT中期结果：海报课程10

Cost-benefit analysis of efgartigimod to IVIG in Canada: Poster Session 4

efgartigimod对加拿大IVIG的成本效益分析：海报第4期

Side effects from long-term steroid use continue to be a significant burden associated with autoimmune disease, reinforcing the importance of the favorable safety profile of VYVGART. New data presented in an oral presentation (Scientific Platform Session 38) during AAN characterize how VVYGART treatment can significantly reduce concomitant steroid use..

长期使用类固醇的副作用仍然是与自身免疫性疾病相关的重大负担，加强了VYVGART良好安全性的重要性。AAN期间口头报告（科学平台会议38）中提供的新数据描述了VVYGART治疗如何显着减少伴随的类固醇使用。。

A substantial proportion of gMG patients (46%) were able to reduce steroid use over the first six months of initiating VYVGART treatment, including 34% of patients who tapered to <5mg/day and 18% who reduced completely to zero.

在开始VYVGART治疗的前六个月，相当大比例的gMG患者（46%）能够减少类固醇的使用，其中34%的患者逐渐减少到每天5mg以下，18%的患者完全减少到零。

Overview of efgartigimod safety profile across indications: Poster Session 4

efgartigimod跨适应症安全概况概述：海报课程4

Analysis of serious infections and malignancies in MG: Poster Session 10

MG中严重感染和恶性肿瘤的分析：海报会议10

About ADHERE Trial Design

关于ADHERE试验设计

The ADHERE trial was a multicenter, randomized, double-blind, placebo-controlled trial evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). ADHERE enrolled 322 adult patients with CIDP who were treatment naïve (not on active treatment within the past six months or newly diagnosed) or being treated with immunoglobulin therapy or corticosteroids.

ADHERE试验是一项多中心，随机，双盲，安慰剂对照试验，评估VYVGART®Hytrulo（efgartigimod alfa和透明质酸酶qvfc）治疗慢性炎症性脱髓鞘性多发性神经病（CIDP）。ADHERE招募了322名未接受治疗（过去六个月内未接受积极治疗或新诊断）或接受免疫球蛋白治疗或皮质类固醇治疗的成年CIDP患者。

The trial consisted of an open-label Stage A followed by a randomized, placebo-controlled Stage B. In order to be eligible for the trial, the diagnosis of CIDP was confirmed by an independent panel of experts. Patients entered a run-in stage, where any ongoing CIDP treatment was stopped and in order to be eligible for Stage A had to demonstrate active disease, with clinically meaningful worsening on at least one CIDP clinical assessment tool, including INCAT, I-RODS, or mean grip strength.

该试验包括一个开放标签的A期，然后是一个随机的安慰剂对照的B期。为了有资格参加该试验，CIDP的诊断得到了一个独立专家组的确认。患者进入磨合阶段，停止任何正在进行的CIDP治疗，为了有资格进入a期，必须表现出活动性疾病，至少有一种CIDP临床评估工具（包括INCAT，I-RODS）的临床意义恶化，或平均握力。

Treatment naïve patients were able to skip the run-in period with proof of recent worsening. To advance to Stage B, patients needed to demonstrate evidence of clinical improvement (ECI) with VYVGART Hytrulo. ECI was achieved through improvement of the INCAT score, or improvement on I-RODS or mean grip strength if those scales had demonstrated worsening during the run-in period.

未接受治疗的患者能够跳过磨合期，并证明最近病情恶化。为了进入B期，患者需要证明VYVGART-Hytrulo的临床改善（ECI）证据。ECI是通过改善INCAT评分或改善I型杆或平均握力（如果这些量表在磨合期间表现出恶化）来实现的。

In Stage B, patients were randomized to either VYVGART Hytrulo or placebo for up to 48 weeks. The primary endpoint was measured once 88 total relapses or events were achieved in Stage B and was based on the hazard ratio for the time to first adjusted INCAT deterioration (i.e. relapse). After Stage B, all patients had the option to roll-over to an open-label extension study to receive VYVGART Hytrulo..

在B期，患者被随机分配到VYVGART Hytrulo或安慰剂长达48周。在B期达到88次总复发或事件后，测量主要终点，并基于首次调整INCAT恶化（即复发）时间的风险比。B期后，所有患者都可以选择转入开放标签扩展研究以接受VYVGART-Hytrulo。。

See Important Safety Information below, full United States Prescribing Information for VYVGART and full Prescribing Information for VYVGART Hytrulo for additional information.

有关更多信息，请参阅下面的重要安全信息、VYVGART的完整美国处方信息和VYVGART Hytrulo的完整处方信息。

What is VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?

什么是用于静脉（IV）输注的VYVGART®（efgartigmod alfa fcab），什么是用于皮下注射的VYVGART®HYTRULO（efgartigmod alfa和透明质酸酶qvfc）？

VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive)..

VYVGART和VYVGART-HYTRULO都是处方药，每种药物都用于治疗一种称为全身性重症肌无力的疾病，这种疾病会导致全身肌肉疲劳并容易衰弱，成年人的乙酰胆碱受体抗体阳性（抗AChR抗体阳性）。。

IMPORTANT SAFETY INFORMATION

重要安全信息

Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting..

如果您对efgartigmod alfa或VYVGART中的任何其他成分严重过敏，请不要使用VYVGART。如果您对efgartigmod alfa、透明质酸酶或VYVGART HYTRULO中的任何其他成分有严重过敏，请不要使用VYVGART HYTRULO。VYVGART和VYVGART-HYTRULO会引起严重的过敏反应和血压下降，导致晕厥。。

VYVGART and VYVGART HYTRULO may cause serious side effects, including:

VYVGART和VYVGART-HYTRULO可能会引起严重的副作用，包括：

Infection

感染

VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain..

VYVGART和VYVGART-HYTRULO可能会增加感染风险。efgartigimod alfa fcab治疗患者最常见的感染是尿路和呼吸道感染。感染的体征或症状可能包括发烧、发冷、尿频和/或疼痛、咳嗽、疼痛和鼻腔/鼻窦阻塞、喘息、呼吸急促、疲劳、喉咙痛、痰过多、鼻涕、背痛和/或胸痛。。

Allergic Reactions (hypersensitivity reactions)

过敏反应（超敏反应）

VYVGART and VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab..

VYVGART和VYVGART-HYTRULO会引起过敏反应，如皮疹、皮下肿胀和呼吸急促。在用VYVGART HYTRULO治疗的患者中也观察到荨麻疹。据报道，efgartigimod alfa fcab有严重的过敏反应，如呼吸困难和血压下降导致晕厥。。

Infusion-Related Reactions

输液相关反应

VYVGART and VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.

VYVGART和VYVGART-HYTRULO可引起输液相关反应。efgartigimod alfa fcab报告的最常见症状和体征是高血压，寒战，寒战，胸痛，腹痛和背痛。

Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction..

如果你有感染、过敏反应或输液相关反应的体征或症状，请告诉你的医生。这些可能发生在您接受VYVGART或VYVGART-HYTRULO治疗时或之后。您的医生可能需要暂停或停止您的治疗。如果您有严重过敏反应的体征或症状，请立即联系您的医生。。

Before taking VYVGART or VYVGART HYTRULO, tell your doctor if you:

服用VYVGART或VYVGART-HYTRULO之前，如果您：

take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,

服用任何药物，包括处方药和非处方药、补充剂或草药，

have received or are scheduled to receive a vaccine (immunization), or

已接种或计划接种疫苗（免疫），或

have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.

有任何过敏或医疗状况，包括怀孕或计划怀孕，或正在母乳喂养。

What are the common side effects of VYVGART and VYVGART HYTRULO?

VYVGART和VYVGART-HYTRULO的常见副作用是什么？

The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives..

efgartigimod alfa fcab治疗患者最常见的副作用是呼吸道感染，头痛和尿路感染。VYVGART-HYTRULO的其他常见副作用是注射部位反应，包括皮疹，皮肤发红，瘙痒感，瘀伤，疼痛和荨麻疹。。

These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.

这些并不是VYVGART和VYVGART-HYTRULO所有可能的副作用。打电话给你的医生，询问有关副作用的医疗建议。您可以通过1-800-FDA-1088向美国食品和药物管理局报告副作用。

Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO.

请参阅VYVGART的完整处方信息和VYVGART HYTRULO的完整处方信息。

About Generalized Myasthenia Gravis

关于全身性重症肌无力

Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months,1 where muscles throughout the body may be affected.

全身性重症肌无力（gMG）是一种罕见的慢性自身免疫性疾病，其中IgG自身抗体破坏神经和肌肉之间的通讯，导致衰弱并可能危及生命的肌肉无力。大约85%的MG患者在24个月内发展为gMG，1全身肌肉可能受到影响。

Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population..

确诊AChR抗体的患者约占总gMG人群的85%。。

About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

关于慢性炎症性脱髓鞘性多发性神经病（CIDP）

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves.

慢性炎性脱髓鞘性多发性神经病（CIDP）是一种罕见且严重的周围神经系统自身免疫性疾病。尽管疾病病理生理学的确认仍在出现，但越来越多的证据表明IgG抗体在周围神经损伤中起关键作用。

People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair..

患有CIDP的人会经历疲劳，肌肉无力以及手臂和腿部的感觉丧失，随着时间的推移可能会变得更糟，或者可能会来来去去。这些症状会严重损害一个人在日常生活中的功能。如果不进行治疗，三分之一的CIDP患者将需要轮椅。。

About VYVGART®

关于VYVGART®

VYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker in the United States, EU, China and Canada for the treatment of adults with generalized myasthenia gravis (gMG) who are anti- acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs)..

VYVGART是与新生儿Fc受体（FcRn）结合的人IgG1抗体片段，导致循环IgG自身抗体的减少。它是美国、欧盟、中国和加拿大首次批准的FcRn阻滞剂，用于治疗抗乙酰胆碱受体（AChR）抗体阳性的全身性重症肌无力（gMG）成人，在日本用于治疗对类固醇或非类固醇免疫抑制疗法（IST）反应不足的gMG成人。。

About VYVGART® Hytrulo

关于VYVGART® Hytrula

VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG.

VYVGART Hytrulo是Efgartigmod alfa（一种作为VYVGART®静脉注射使用的人IgG1抗体片段）和重组人透明质酸酶PH20（rHuPH20）（Halozyme的ENHANZE®药物递送技术）的皮下组合，用于促进生物制剂的皮下注射递送。在与新生儿Fc受体（FcRn）结合时，VYVGART-Hytrulo导致循环IgG的减少。

It is the first-and-only approved FcRn blocker administered by subcutaneous injection..

它是第一个也是唯一一个通过皮下注射给药的批准的FcRn阻滞剂。。

VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following approval in other regions.

VYVGART Hytrulo是皮下efgartigmod alfa和重组人透明质酸酶PH20在美国的专有名称。在其他地区获得批准后，它可能会以不同的专有名称销售。

About argenx

关于argenx

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.

argenx是一家全球免疫学公司，致力于改善患有严重自身免疫性疾病的人的生活。argenx通过其免疫学创新计划（IIP）与领先的学术研究人员合作，旨在将免疫学突破转化为世界一流的新型抗体药物组合。

argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises.

argenx在美国、日本、以色列、欧盟、英国、加拿大和中国开发并正在商业化第一种经批准的新生儿Fc受体（FcRn）阻滞剂。该公司正在评估efgartigmod在多种严重自身免疫性疾病中的作用，并在其治疗特许经营范围内推进了几种早期实验药物。

For more information, visit www.argenx.com and follow us on LinkedIn, Twitter, and Instagram..

有关更多信息，请访问www.argenx.com，并在LinkedIn、Twitter和Instagram上关注我们。。

Contacts

联系人

Media:

媒体：

Ben Petok

本·佩托克

bpetok@argenx.com

bpetok@argenx.com

Investors:

投资者：

Alexandra Roy (US)

亚历山德拉·罗伊（美国）

aroy@argenx.com

aroy@argenx.com

Lynn Elton (EU)

Lynn Elton（欧盟）

lelton@argenx.com

lelton@argenx.com

Forward-Looking Statements

前瞻性声明

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aims,” “committed,” “expects,” “may,” “will,” “potential,” 'likely,' or and include statements argenx makes concerning the potential impact of VYVGART and VYVGART Hytrulo for CIDP patients; its pioneering approach to transforming autoimmunity redefining what is possible for patients and their communities; the role IgG autoantibodies are likely to play in the disease, and new safe, effective and well-tolerated treatments that eliminate pathogenic IgGs; and the expected FDA's decision of CIDP sBLA.

本公告的内容包括属于或可能被视为“前瞻性声明”的声明。这些前瞻性声明可以通过使用前瞻性术语来识别，包括术语“目标”，“承诺”，“预期”，“可能”，“将”，“潜在”，“可能”，或包括argenx就VYVGART和VYVGART Hytrulo对CIDP患者的潜在影响所作的声明；它开创性地改变了自身免疫，重新定义了患者及其社区的可能性；IgG自身抗体可能在疾病中发挥作用，以及消除致病性IgG的新的安全，有效和耐受性良好的治疗方法；以及预期的FDA对CIDP sBLA的决定。

By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx’s clinical trials, expectations regarding the inherent uncertainties associated with development of novel drug therapies, preclinical and clinical trial and product development activities and regulatory approval requirements, the acceptance of argenx's products and product candidates by its patients as safe, effective and cost-effective, the impact of governmental laws and regulations on its business, and the results of its PDUFA review.

就其性质而言，前瞻性陈述涉及风险和不确定性，读者应注意，任何此类前瞻性陈述都不能保证未来的表现。由于各种重要因素的影响，argenx的实际结果可能与前瞻性声明预测的结果存在重大差异，包括但不限于argenx的临床试验结果，对与新药开发相关的固有不确定性的期望疗法，临床前和临床试验和产品开发活动以及监管批准要求，患者对argenx产品和候选产品的安全，有效和成本效益的接受程度，政府法律法规对其业务的影响以及PDUFA审查的结果。

A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the.

有关这些风险、不确定性和其他风险的更多列表和描述，请参阅阿根克斯美国证券交易委员会（SEC）的文件和报告，包括阿根克斯最近提交给美国证券交易委员会（SEC）的20-F表格年度报告。