IMAAVY™（尼波卡利单抗-aahu）在新发布的间接治疗比较（ITC）中，于24周内的多个时间点上，对广义重症肌无力（gMG）显示出比已批准的FcRn阻断剂更持久的疾病控制效果-动脉网

IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)

强生等信源发布 2025-06-23 05:35

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可切换为仅中文







The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control in managing a chronic autoantibody disease like gMG

ITC比较了这些治疗的所有已发表的第三阶段数据，利用纵向结果，研究结果强调了在管理像gMG这样的慢性自身抗体疾病时，持续、稳定的疾病控制的重要性。

IMAAVY, an FcRn blocker, received U.S. FDA approval earlier this year for the broadest population of individuals living with gMG, including anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older

IMAAVY是一种FcRn阻断剂，今年早些时候获得了美国FDA的批准，适用于最广泛的gMG患者群体，包括抗AChR和抗MuSK抗体阳性的成人以及12岁及以上的儿童gMG患者。

SPRING HOUSE, Pa.

宾夕法尼亚州斯普林豪斯

，

June 23, 2025

2025年6月23日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from an indirect treatment comparison (ITC) that showed consistent and sustained disease control with IMAAVY™ (nipocalimab-aahu) versus other approved FcRn blockers in adults with generalized myasthenia gravis (gMG). These data, featured at the European Academy of Neurology (EAN) 2025 Congress in Helsinki, Finland, are among the 11 abstracts Johnson & Johnson is presenting..

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布了一项间接治疗比较（ITC）的新数据，显示在患有全身性重症肌无力（gMG）的成人中，IMAAVY™（nipocalimab-aahu）相较于其他已批准的FcRn阻断剂表现出一致且持续的疾病控制效果。这些数据在芬兰赫尔辛基举行的2025年欧洲神经病学学会（EAN）大会上展示，是强生公司正在呈现的11篇摘要之一。

Based on the ITC, which included the pivotal Phase 3 Vivacity-MG3 study data, IMAAVY showed comparable onset of symptom relief at Week 1 and showed consistent and sustained disease control with greater or statistically significant improvement of MG-ADL

基于包括关键的三期Vivacity-MG3研究数据在内的ITC，IMAAVY在第一周显示出相似的症状缓解起效时间，并显示出持续且一致的疾病控制，MG-ADL有更大或统计学显著改善。

scores versus the published Phase 3 data of other marketed FcRn blockers at several timepoints up to 24 weeks

与其他已上市的FcRn阻断剂在多个时间点（最长至24周）的第三阶段临床数据对比评分

of treatment.

治疗。

Results were consistent across multiple ITC methods

结果在多种ITC方法中保持一致

。

Population-adjusted ITCs without a common control

按人口调整的无共同对照的ITCs

exhibited significantly greater mean improvements in MG-ADL scores favoring IMAAVY over other FcRn blockers, at Weeks 8-24

在第8-24周，MG-ADL评分的平均改善显著更高，IMAAY优于其他FcRn阻断剂。

versus one comparator and at Weeks 10-14

与一个对照组对比，并在第10-14周。

versus another comparator.

与另一个比较器相对比。

In placebo-adjusted ITCs

在安慰剂调整的间接比较（ITCs）中

, IMAAVY was associated with numerically greater efficacy versus one treatment comparator at Weeks 8

，IMAAVY在第8周时相较于一个治疗对照组表现出更大的疗效

and 18-24

以及18-24

and versus another at Weeks 10-14

和另一个在第10到14周之间的对比

, with statistical significance at Weeks 10

`, 在第10周具有统计学意义`

and 12

和 12

。

'These analyses provide useful population-adjusted comparative data and add to the body of evidence supporting the use of IMAAVY for the treatment of gMG for certain patients,' said Saiju Jacob, M.D., Professor, Department of Immunology and Immunotherapy at University of Birmingham, UK

“这些分析提供了有用的人群调整后的比较数据，并增加了支持在某些患者中使用IMAAVY治疗gMG的证据，”英国伯明翰大学免疫学与免疫治疗系教授Saiju Jacob说道。

, 'The significantly greater mean improvements on MG-ADL scores with IMAAVY reflect important new evidence of the ongoing need for sustained disease control in a chronic condition like gMG.'

“IMAIVY在MG-ADL评分上的显著更高的平均改善反映了在像gMG这样的慢性病中持续疾病控制的持续需求的重要新证据。”

Unlike cyclic therapies that require clinical evaluation and symptom relapse prior to initiating subsequent treatment cycles, IMAAVY has a biweekly dosing regimen that may allow for a schedule that patients and healthcare providers can plan around.

与需要临床评估和症状复发才能开始后续治疗周期的周期性疗法不同，IMAAVY 每两周一次的给药方案可能允许患者和医疗保健提供者制定可规划的时间表。

These data provide insights about the predictability that IMAAVY may offer and potentially help clinical decision making when treating patients with gMG.

这些数据提供了关于 IMAAVY 可能提供的可预测性见解，并可能在治疗 gMG 患者时帮助临床决策。

'At Johnson & Johnson, we recognize that for people living with gMG, the goal isn't just temporary relief, but rather sustained disease control. This analysis provides additional insights into the profile of IMAAVY and highlights its potential as a reliable treatment option for appropriate patients aged 12 and older living with gMG,' said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine.

“在强生公司，我们认识到对于患有gMG的人来说，目标不仅是暂时的缓解，而是持续的疾病控制。这项分析提供了对IMAAVY特点的更多见解，并突显了其作为12岁及以上适当患者治疗选择的潜力，”强生创新医药副总裁、自身抗体产品组合及母胎免疫疾病领域负责人凯蒂·阿布扎赫尔医学博士表示。

'As we continue to research the potential impact of IMAAVY and work with regulators worldwide, we are committed to helping patients with chronic, debilitating autoantibody conditions, like gMG.'.

“当我们继续研究 IMAAVY 的潜在影响并与全球监管机构合作时，我们致力于帮助患有慢性、致残性自身抗体疾病的患者，如 gMG。”

ITCs are utilized by regulatory agencies, health technology assessment agencies and medical guideline committees to comparatively evaluate treatment options when there is no or limited availability of evidence from head-to-head clinical trials.

当没有或仅有有限的头对头临床试验证据可用时，监管机构、卫生技术评估机构和医疗指南委员会会利用ITC来比较评估治疗选项。

ITCs, however, cannot replace and should not be considered the same as head-to-head clinical trials.

然而，ITCs不能替代头对头临床试验，也不应被视为等同于头对头临床试验。

Unanchored population-adjusted and placebo-anchored Bucher ITC methods were used in this analysis.

此分析中使用了非锚定的人群调整和安慰剂锚定的Bucher ITC方法。

Unanchored population-adjusted indirect comparisons allow for adjustment of population differences using individual patient-level data from IMAAVY and aggregate data from other approved FcRn blockers.

非锚定的经人群调整的间接比较允许使用来自IMAAVY的个体患者水平数据和来自其他已批准的FcRn阻断剂的汇总数据来调整人群差异。

Placebo-anchored Bucher ITCs evaluate a small number of treatments through a common comparator such as the trial placebo and use aggregate data from different trials.

通过共同的对照（如试验安慰剂）评估少数治疗的安慰剂锚定Bucher间接比较，并使用来自不同试验的汇总数据。

IMAAVY

is approved

已批准

in the U.S. for adult and pediatric patients (12 years of age and older) with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive gMG. Johnson & Johnson also submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) .

在美国，适用于12岁及以上抗乙酰胆碱受体（AChR）或抗肌肉特异性酪氨酸激酶（MuSK）抗体阳性的成人和儿童患者。强生公司还向欧洲药品管理局（EMA）提交了上市授权申请（MAA）。

seeking approval

寻求批准

of nipocalimab in gMG in September 2024.

2024年9月，nipocalimab用于gMG。

Editor's notes:

编辑注释：

MG-ADL (Myasthenia Gravis-Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.

MG-ADL（重症肌无力-日常生活活动）提供了一个快速的临床评估，评估患者对影响日常活动的症状的回忆，总分范围为0到24；分数越高表示症状越严重。

There are no head-to-head data available for any FcRn blockers, and no claim of superiority can be made about any FcRn blockers in the absence of such head-to-head trial data.

任何FcRn阻滞剂之间都没有头对头的数据，没有这样的头对头试验数据，就不能声称任何FcRn阻滞剂具有优越性。

The ITC did not evaluate safety among the FcRn blocker agents.

ITC并未评估FcRn阻断剂之间的安全性。

In unanchored population-adjusted indirect comparison, IMAAVY versus one treatment at Week 8 had a mean difference of -2.36 [(95% confidence interval [CI]: -3.56, -1.16);

在未锚定的人群调整间接比较中，IMAAVY 与另一种治疗在第 8 周的平均差异为 -2.36 [（95% 置信区间 [CI]：-3.56，-1.16）；

=0.001]; this trend continued up to Week 24 (

=0.001]；这一趋势持续到第24周（

<0.05). For another comparator, at Week 10 IMAAVY had a mean difference of –2.38 at one comparator dose [(95% CI: -3.57, -1.18);

<0.05）。对于另一个对照组，在第10周时，IMAAVY在一个对照剂量下的平均差异为-2.38 [(95% CI: -3.57, -1.18);

<0.001] and a mean difference of -3.14 with a different comparator dose [(95% CI: -4.15, -2.14);

<0.001]，与不同的比较剂量的平均差异为-3.14 [(95% CI: -4.15, -2.14);

<0.001]; this trend continued up to Week 14 (

<0.001]；这一趋势持续到第14周（

<0.001).

<0.001)。

In placebo-anchored indirect comparison, MG-ADL change from baseline (CFB) was greater at Week 8 by -1.24 versus one treatment comparator (95% CI: -2.78, 0.30), at Week 18 by -1.13 (95% CI: -2.77, 0.50), at Week 20 by -1.44 (95% CI: -3.21, -0.33), at Week 22 by -1.79 (95% CI: -4.16, 0.59), and at Week 24 by -2.89 (95% CI: -5.67, -0.12)..

在安慰剂为基准的间接比较中，MG-ADL 从基线的变化（CFB）在第8周时比一个治疗对照组高出-1.24（95% CI: -2.78, 0.30），第18周时高出-1.13（95% CI: -2.77, 0.50），第20周时高出-1.44（95% CI: -3.21, -0.33），第22周时高出-1.79（95% CI: -4.16, 0.59），第24周时高出-2.89（95% CI: -5.67, -0.12）。

函数。

In placebo-anchored indirect comparison, treatment with IMAAVY demonstrated a greater MG-ADL CFB versus a comparator dose at Week 10 (mean CFB=-1.19, 95% CI: -2.75, 0.37), Week 12 (mean CFB= -1.41, 95% CI: -2.94, 0.12) and Week 14 (mean CFB= -1.01, 95% CI: -2.51, 0.49).

在以安慰剂为对照的间接比较中，IMAAVY治疗在第10周（平均CFB=-1.19，95% CI：-2.75，0.37）、第12周（平均CFB=-1.41，95% CI：-2.94，0.12）和第14周（平均CFB=-1.01，95% CI：-2.51，0.49）时，相对于比较剂量显示出更大的MG-ADL CFB。

•

Similar trends were observed for IMAAVY versus a different comparator dose at Week 10 (mean CFB= -2.16, 95% CI: -3.58, -0.73), Week 12 (mean CFB= -1.99, 95% CI: -3.53, -0.45) and Week 14 (mean CFB= -1.12, 95% CI: -2.55, 0.31).

类似的趋势也在第10周（平均CFB= -2.16，95% CI: -3.58, -0.73）、第12周（平均CFB= -1.99，95% CI: -3.53, -0.45）和第14周（平均CFB= -1.12，95% CI: -2.55, 0.31）观察到，IMAAVY与不同的对照剂量相比。

Saiju Jacob, M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work.

赛朱·雅各布博士曾为强生公司提供咨询、顾问和演讲服务。他未因任何媒体工作获得报酬。

ABOUT GENERALIZED MYASTHENIA GRAVIS (

关于全身型重症肌无力 (

gMG)

Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK]), which target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction..

重症肌无力（MG）是一种自身抗体疾病，免疫系统错误地产生抗体（例如，抗乙酰胆碱受体[AChR]、抗肌肉特异性酪氨酸激酶[MuSK]），这些抗体会靶向神经肌肉接头处的蛋白质，可能阻断或干扰神经到肌肉的正常信号传递，从而损害或阻止肌肉收缩。

5,6,7

The disease impacts an estimated 700,000 people worldwide.

该疾病影响全球约 70 万人。

The disease affects both men and women and occurs across all ages, racial and ethnic groups, but most frequently starts in young women and older men.

这种疾病影响男性和女性，发生在所有年龄、种族和民族群体中，但最常见于年轻女性和老年男性。

Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.

大约50%的重症肌无力（MG）患者为女性，其中约五分之一的女性具有生育能力。

9,10,11

9，10，11

Approximately 10 to 15% of new cases of MG are diagnosed in pediatric patients 12-17 years of age.

大约10%到15%的新诊断重症肌无力（MG）病例是在12至17岁的儿科患者中确诊的。

12,13,14

12，13，14

Among juvenile MG patients, girls are affected more often than boys with over 65% of pediatric MG cases in the U.S. diagnosed in girls.

在美国，青少年MG患者中，女孩的患病率高于男孩，超过65%的儿童MG病例被诊断为女孩。

15,16,17

15、16、17

Initial disease manifestations are usually eye-related but approximately 85% of MG patients experience additional advancements to the disease manifestations, referred to as generalized myasthenia gravis (gMG). This is characterized by severe muscle weakness and difficulties in speech and swallowing..

初始疾病表现通常与眼部相关，但大约85%的重症肌无力（MG）患者会经历疾病表现的进一步发展，称为全身型重症肌无力（gMG）。其特征为严重的肌肉无力以及言语和吞咽困难。

18,19,20,21,22

18，19，20，21，22

Approximately 100,000 individuals in the U.S. are living with gMG.

美国大约有 10 万人患有 gMG。

二十三

Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.

脆弱的gMG人群，例如儿科患者，其治疗选择更为有限。

ABOUT THE INDIRECT TREATMENT COMPARISON

关于间接治疗比较

Indirect treatment comparisons (ITCs) were conducted to compare efficacy onset using 1-week timepoint, and for consistency and sustained disease control, comparisons were conducted for multiple timepoints up to 24 weeks for one treatment comparator (up to 3-cycle duration) and up to 14 weeks for another treatment comparator (final visit data reported)..

间接治疗比较（ITCs）进行了1周时间点的疗效起效比较，为了评估一致性和持续疾病控制，对多个时间点进行了比较，一个治疗对照组最长至24周（最长3个周期），另一个治疗对照组最长至14周（报告最终访视数据）。

The data used in the analysis came from published registrational trials of IMAAVY and comparator FcRn blockers approved to treat gMG (efgartigimod and rozanolixizumab).

分析中使用的数据来自 IMAAVY 和已批准用于治疗 gMG 的比较药物 FcRn 阻断剂（efgartigimod 和 rozanolixizumab）的注册试验。

The differences in clinical trial design across FcRn blockers coupled with differences in background standard of care (SOC) required multiple indirect treatment comparison methods to be utilized.

FcRn阻断剂在临床试验设计上的差异，加上背景标准护理（SOC）的差异，需要使用多种间接治疗比较方法。

Therefore, ITCs were conducted using unanchored population-adjusted indirect comparisons (with active treatment arm only and adjusting for cross-trial patient differences) and placebo-anchored (includes both active treatment and placebo arms) Bucher method. Differences <0 favored nipocalimab for all comparisons..

因此，使用了非锚定的人群调整间接比较（仅包括活性治疗组并调整试验间的患者差异）和安慰剂锚定（包括活性治疗组和安慰剂组）的Bucher方法进行ITCs。所有比较中，差异<0时，nipocalimab均占优势。

This ITC adheres to all governing standards and requirements as demanded by global health technology assessment agencies, journal review committees and regulatory authorities. The ITC was funded by Janssen Research & Development, LLC.

本ITC遵循全球卫生技术评估机构、期刊审查委员会和监管机构所要求的所有管理标准和要求。ITC由Janssen Research & Development, LLC提供资金支持。

THE PHASE 3 VIVACITY-MG3 STUDY

第三阶段 VIVACITY-MG3 研究

The Phase 3 Vivacity-MG3 study (

第三阶段 Vivacity-MG3 研究 (

NCT04951622

) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high. Antibody positive or negative adult gMG patients with insufficient response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199 patients, 153 of whom were antibody positive, enrolled in the 24-week double-blind placebo-controlled trial..

）该试验专门设计用于在这一不可预测的慢性疾病中通过持续给药来评估持续的疗效和安全性，目前这种疾病仍存在高度未满足的需求。筛选对现有标准治疗（SOC）反应不足（MG-ADL ≥6）的抗体阳性或阴性的成年gMG患者，并纳入了199名患者进入这项为期24周的双盲安慰剂对照试验，其中153名为抗体阳性患者。

25,26

25，26

Randomization was 1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC.

随机分组为1:1，接受尼波卡利单抗加当前标准治疗（30 mg/kg静脉负荷剂量，随后每两周15 mg/kg）或安慰剂加当前标准治疗。

Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).

基线人口统计学在各组间是均衡的（77例尼泊卡利单抗，76例安慰剂）。

The primary efficacy endpoint was the comparison of the mean change from baseline to Weeks 22, 23, and 24 between treatment groups in the MG-ADL total score.

主要疗效终点是比较治疗组之间从基线到第22、23和24周的MG-ADL总分的平均变化。

A key secondary endpoint included change in Quantitative Myasthenia Gravis (QMG) score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.

一个关键的次要终点包括定量重症肌无力 (QMG) 评分的变化。长期安全性和有效性在正在进行的开放标签扩展 (OLE) 阶段中得到了进一步评估。

ABOUT IMAAVY™ (nipocalimab-aahu)

关于IMAAVY™（尼泊卡利单抗-aahu）

IMAAVY is a monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies that underlie generalized myasthenia gravis (gMG) without additional detectable effects on other adaptive and innate immune functions. IMAAVY is currently approved in the U.S.

IMAAVY是一种单克隆抗体，旨在高亲和力结合以阻断FcRn，并降低导致全身性重症肌无力（gMG）的循环免疫球蛋白G（IgG）抗体水平，而不会对其他适应性免疫和先天免疫功能产生额外可检测的影响。IMAAVY目前已在美国获批。

for the treatment of gMG in adults and pediatric patients 12 years of age and older who are AChR or MuSK antibody positive..

用于治疗12岁及以上AChR或MuSK抗体阳性的成人和儿童gMG患者。

Nipocalimab is continuing to be investigated across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases.

Nipocalimab正在自身抗体领域的三个关键细分领域继续研究，包括罕见自身抗体疾病、由母体同种抗体介导的母胎疾病以及风湿病。

28,29,30,31,32,32,33,34,35,36

The investigational monoclonal antibody is designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) auto and alloantibodies potentially without additional detectable effects on other adaptive and innate immune functions.

该研究性单克隆抗体旨在以高亲和力结合以阻断FcRn，并降低循环免疫球蛋白G（IgG）自身抗体和同种抗体的水平，同时可能不会对其他适应性免疫和先天免疫功能产生额外可检测的影响。

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:

美国食品药品监督管理局 (FDA) 和欧洲药品管理局 (EMA) 已授予尼波卡利单抗多项关键指定，包括：

U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, fetal and neonatal alloimmune thrombocytopenia) FNAIT in March 2024 and Sjögren's disease (SjD) in March 2025

2019年7月，获得美国FDA快速通道资格，用于治疗胎儿和新生儿溶血病（HDFN）及温抗体型自身免疫性溶血性贫血（wAIHA），2021年12月用于重症肌无力（gMG），2024年3月用于胎儿和新生儿同种免疫性血小板减少症（FNAIT），2025年3月用于干燥综合征（SjD）。

U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023

2019年12月获得美国FDA授予的wAIHA孤儿药资格，2020年6月HDFN，2021年2月gMG，2021年10月慢性炎性脱髓鞘性多发性神经病（CIDP），2023年12月FNAIT。

U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for Sjögren's disease in November 2024

美国FDA于2024年2月授予HDFN突破性疗法称号，并于2024年11月授予Sjögren病突破性疗法称号。

U.S. FDA granted Priority Review in gMG in Q4 2024

美国食品药品监督管理局（FDA）在2024年第四季度授予gMG优先审查。

EU EMA Orphan medicinal product designation for HDFN in October 2019 and FNAIT in April 2025

2019年10月获得欧盟EMA授予的HDFN孤儿药资格，2025年4月获得FNAIT孤儿药资格。

WHAT IS IMAAVY™ (nipocalimab-aahu)?

什么是IMAAVY™（尼波卡利单抗-aahu）？

IMAAVY™ is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

IMAAVY™ 是一种处方药，用于治疗 12 岁及以上患有全身性重症肌无力 (gMG) 的成人和儿童，这些患者抗乙酰胆碱受体 (AChR) 或抗肌肉特异性酪氨酸激酶 (MuSK) 抗体呈阳性。

It is not known if IMAAVY™ is safe and effective in children under 12 years of age.

不知道IMAAVY™在12岁以下儿童中是否安全有效。

IMPORTANT SAFETY INFORMATION

重要安全信息

What is the most important information I should know about IMAAVY™?

我应该了解哪些关于IMAAVY™的最重要信息？

IMAAVY™ is a prescription medicine that may cause serious side effects, including:

IMAAVY™ 是一种处方药，可能会导致严重的副作用，包括：

Infections

感染

are a common side effect of IMAAVY™ that can be serious. Receiving IMAAVY™ may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms:

是 IMAAVY™ 的常见副作用，可能会很严重。接受 IMAAVY™ 治疗可能会增加感染风险。如果出现以下任何感染症状，请立即告知您的医疗保健提供者：

o fever

o 发热

o chills

o 寒冷

o shivering

o 发抖

o cough

咳嗽

o sore throat

o 喉咙痛

o fever blisters

o 发热性水泡

o burning when you urinate

尿尿时灼烧感

Allergic (hypersensitivity) reactions

过敏（超敏）反应

may happen during or up to a few weeks after your IMAAVY™ infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY™ infusion:

可能在输注IMAAY™期间或之后的几周内发生。如果在输注IMAAY™期间或之后出现以下任何症状，请立即寻求紧急医疗帮助：

o a swollen face, lips, mouth, tongue, or throat

o 脸部、嘴唇、口腔、舌头或喉咙肿胀

o difficulty swallowing or breathing

吞咽或呼吸困难

o itchy rash (hives)

o 瘙痒性皮疹（荨麻疹）

o chest pain or tightness

胸部疼痛或紧绷感

Infusion-related reactions

与输注相关的反应

are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY™ infusion:

是可能的。如果您在IMAavy™输注期间或几天后出现任何这些症状，请立即告知您的医疗保健提供者：

o headache

头痛

o rash

o 皮疹

o nausea

恶心

o fatigue

疲劳

o dizziness

头晕

o chills

o 寒冷

o flu-like symptoms

流感样症状

o redness of skin

皮肤发红

Do not receive IMAAVY™

请勿接收 IMAAVY™

if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY™. Reactions have included angioedema and anaphylaxis.

如果您对尼波卡利单抗-aahu或IMAAVY™中的任何成分有严重过敏反应。这些反应包括血管性水肿和过敏性休克。

Before using IMAAVY™, tell your healthcare provider about all of your medical conditions, including if you:

在使用IMAAVY™之前，请告诉您的医疗保健提供者您的所有医疗状况，包括如果您：

ever had an allergic reaction to IMAAVY™.

对IMAAVY™产生过过敏反应。

have or had any recent infections or symptoms of infection.

有或曾经有任何近期的感染或感染症状。

have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY™ should not receive live vaccines.

最近已接种或计划接种疫苗的人。服用IMAAVY™的人不应接种活疫苗。

are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY™ will harm your baby.

怀孕、计划怀孕或正在哺乳。目前尚不清楚IMAAVY™是否会对您的宝宝造成伤害。

Pregnancy Safety Study.

怀孕安全研究。

There is a pregnancy safety study for IMAAVY™ if IMAAVY™ is given during pregnancy or you become pregnant while receiving IMAAVY™. Your healthcare provider should report IMAAVY™ exposure by contacting Janssen at 1-800-526-7736 or

如果在怀孕期间使用了IMAAVY™或在接受IMAAVY™期间怀孕，将有一项关于IMAAVY™的妊娠安全研究。您的医疗保健提供者应通过拨打1-800-526-7736联系Janssen报告IMAAVY™的暴露情况，或者

www.IMAAVY.com

。

Tell your healthcare provider about all the medicines you take,

告诉您的医疗保健提供者您所服用的所有药物，

including prescription and over-the-counter medicines, vitamins, and herbal supplements.

包括处方药和非处方药、维生素以及草本补充剂。

What are the possible side effects of

可能的副作用有哪些

IMAAVY™

？

IMAAVY™

may cause serious side effects. See 'What is the most important information I should know about

可能引起严重的副作用。参见“关于该药物我应该了解的最重要的信息是什么”

IMAAVY™

？'

The most common side effects of

最常见的副作用

IMAAVY™

include:

包含：

respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.

呼吸道感染、外周水肿（手、脚踝或足部肿胀）以及肌肉痉挛。

These are not all the possible side effects of IMAAVY™. Call your doctor for medical advice about side effects.

这些并非 IMAAVY™ 的所有可能副作用。如需了解有关副作用的医疗建议，请咨询您的医生。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit

我们鼓励您向 FDA 报告处方药的负面副作用。访问

www.fda.gov/medwatch

, or call

，或者拨打

1-800-FDA-1088

。

Please see the full

请参阅完整内容

Prescribing Information

处方信息

and

和

Medication Guide

药物指南

for IMAAVY™ and discuss any questions you have with your doctor.

适用于IMAAVY™，并就您遇到的任何问题与您的医生讨论。

Dosage Form and Strengths:

剂型和强度：

IMAAVY™ is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.

IMAAVY™ 每盒提供一支300毫克/1.62毫升和一支1,200毫克/6.5毫升（185毫克/毫升）的单剂量小瓶，用于静脉注射。

ABOUT JOHNSON & JOHNSON

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. .

在强生，我们相信健康就是一切。我们在医疗保健创新方面的实力使我们能够构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且侵入性更小，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们具备独特的优势，能够在当今整个医疗保健解决方案领域进行创新，以提供明日的突破性成果，并对人类健康产生深远影响。

Learn more at

了解更多内容请访问

https://www.jnj.com/

or at

或在

https://innovativemedicine.jnj.com/

关注我们

@JNJInnovMed.

@JNJInnovMed

Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.

扬森研究与发展有限责任公司和扬森生物科技公司是强生公司的子公司。

CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的关于产品开发以及IMAAVY潜在益处和治疗影响的“前瞻性声明”。

™

. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson.

读者被提醒不要依赖这些前瞻性陈述。这些陈述基于对未来事件的当前预期。如果基本假设被证明不准确，或已知或未知的风险或不确定性成为现实，实际结果可能与强生公司的预期和预测大相径庭。

Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

风险和不确定性包括但不限于：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性和获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手获得的新产品和专利；专利挑战；因产品功效或安全问题导致的产品召回或监管行动；医疗保健产品和服务购买者的行为和支出模式的变化；适用法律法规的变更，包括全球医疗改革；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

这些风险、不确定性及其他因素的进一步列表和描述，请参见强生公司最近的Form 10-K年度报告，包括标题为“关于前瞻性陈述的警示声明”和“项目1A. 风险因素”的部分，以及强生公司随后的Form 10-Q季度报告和其他提交给证券交易委员会的文件。

Copies of these filings are available online at .

这些文件的副本可在线获取，网址为。

www.sec.gov

，

www.jnj.com

or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

或应Johnson & Johnson的要求。Johnson & Johnson不承担因新信息或未来事件或发展而更新任何前瞻性声明的义务。

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IMAAVY™ U.S. Prescribing Information

IMAAVY™ 美国处方信息

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强生公司。数据存档。

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Media contact:

媒体联系人：

Bridget Kimmel

布里吉特·金梅尔

bkimmel@its.jnj.com

Investor contact:

投资者联系方式：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com

投资者关系@its.jnj.com

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/imaavy-nipocalimab-aahu-showed-greater-sustained-disease-control-versus-approved-fcrn-blockers-for-generalized-myasthenia-gravis-gmg-at-multiple-timepoints-over-24-weeks-in-newly-published-indirect-treatment-comparison-itc-302487317.html

https://www.prnewswire.com/news-releases/imaavy-nipocalimab-aahu-在新发布的间接治疗比较（ITC）中，与已批准的FCRN阻断剂相比，在24周内的多个时间点显示出对全身性重症肌无力（GMG）更大的持续疾病控制效果-302487317.html

SOURCE Johnson & Johnson

来源：强生公司

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