New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open-label extension phase

新的有力结果显示，在关键的Vivacity-MG3研究及其开放标签扩展阶段中，免疫球蛋白G抗体持续减少18个月，且gMG症状持续改善。

Up to 128 weeks and 180 patient years of follow-up in the open-label extension

在开放标签扩展中，最长随访时间为128周和180个患者年

a

a

confirm a safety profile consistent with the Phase 3 Vivacity-MG3 study

确认与第三阶段Vivacity-MG3研究一致的安全性概况

45% of the patients receiving steroids at open-label extension baseline were able to decrease or discontinue their steroid use

在开放标签扩展基线时，45%的接受类固醇治疗的患者能够减少或停止类固醇的使用。

Additionally, the nipocalimab plus standard of care (SOC) group demonstrated four times greater odds of improving and maintaining the strength and function of different muscle groups as measured by QMG

此外，尼波卡利单抗加标准治疗（SOC）组在QMG测量的不同肌群的力量和功能的改善和维持方面，显示出四倍于对照组的优势。

b

b

response versus placebo plus SOC in the 24-week double blind phase of the study

研究的24周双盲阶段中，反应对比安慰剂加标准治疗（SOC）

SPRING HOUSE, Pa.

宾夕法尼亚州斯普林豪斯

,

，

April 8, 2025

2025年4月8日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced results from additional analyses of the Phase 3 Vivacity-MG3 double-blind study and the ongoing open-label extension

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天公布了Vivacity-MG3第三阶段双盲研究的更多分析结果以及正在进行的开放标签扩展研究的结果。

a

a

(OLE), evaluating the long-term efficacy and safety of investigational nipocalimab in a broad population of antibody-positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalized myasthenia gravis (gMG).

(OLE)，评估研究性药物nipocalimab在广泛的抗体阳性（抗AChR+、抗MuSK+、抗LRP4+）的全身性重症肌无力（gMG）成人患者中的长期疗效和安全性。

1

1

,2

，2

Patients treated with nipocalimab plus standard of care (SOC) maintained improvements in their MG-ADL

接受尼泊卡利单抗联合标准治疗（SOC）的患者在MG-ADL方面保持了改善。

c

c

and QMG

和 QMG

b

b

scores over 84 weeks with sustained reductions in total immunoglobulin G (IgG).

在84周内持续降低总免疫球蛋白G（IgG）的情况下得分。

1

1

These data are included in a presentation (Session 7 #022) and are among

这些数据包含在一份报告（第七场 #022）中，并且属于

12 abstracts

12篇摘要

that Johnson & Johnson will present at the American Academy of Neurology (AAN) 2025 Meeting in San Diego, California, which includes an oral presentation on QMG score improvements from the double-blind phase of the Phase 3 Vivacity-MG3 study.

强生公司将在加利福尼亚州圣地亚哥举行的2025年美国神经病学学会（AAN）会议上进行展示，其中包括关于Vivacity-MG3研究第三阶段双盲阶段QMG评分改善的口头报告。

'The sustained disease control seen over 84 weeks for nipocalimab is a key result given the chronic course of generalized MG and the significant burden on people living with this condition,' said Constantine Farmakidis M.D., Associate Professor of Neurology at University of Kansas Medical Center

“鉴于全身型重症肌无力的慢性病程以及对患者造成的显著负担，nipocalimab在84周内持续的疾病控制是一个关键结果，”堪萨斯大学医学中心神经学副教授Constantine Farmakidis博士说道。

d

d

. 'Overall, I am encouraged by these results that show improvement in disease control as measured by the MG-ADL and QMG scores across a broad population seropositive for AChR, MuSK, or LRP4 autoantibodies.'

“总体而言，这些结果显示了在MG-ADL和QMG评分中对疾病控制的改善，涵盖了一个广泛的、血清学检测呈阳性的AChR、MuSK或LRP4自身抗体人群，这让我感到鼓舞。”

Nipocalimab demonstrated a mean change in MG-ADL of -5.64 (p<0.001) from the double-blind baseline after 60 weeks in the OLE for study participants receiving nipocalimab and SOC, and -6.01 (p<0.001) mean change for study participants who transitioned from placebo and SOC to nipocalimab and SOC.

尼波卡利单抗在开放标签延长（OLE）阶段60周后，对于接受尼波卡利单抗和标准治疗（SOC）的研究参与者，其MG-ADL平均变化为-5.64（p<0.001），而对于从安慰剂和SOC转为尼波卡利单抗和SOC的参与者，MG-ADL平均变化为-6.01（p<0.001）。

1

1

In the antibody-positive population, 45% of patients receiving steroids at the OLE baseline were able to decrease or discontinue steroids at the time of this data cut by more than half of the baseline dose.

在抗体阳性人群中，接受类固醇治疗的患者中有45%在本次数据截止时能够减少或停止使用类固醇，其剂量较基线剂量减少了超过一半。

1

1

Among these patients, the mean dose of prednisone decreased from 23 to 10 mg per day.

在这些患者中，泼尼松的平均剂量从每天23毫克减少到10毫克。

1

1

Nipocalimab had a consistent and tolerable safety profile throughout the OLE phase.

Nipocalimab 在整个开放标签扩展（OLE）阶段表现出一致且可耐受的安全性特征。

1

1

Additional findings from the Phase 3 Vivacity-MG3 double-blind study indicate that patients treated with nipocalimab plus SOC achieved statistically significant improvements in their QMG score by -4.9 versus placebo plus SOC (p<0.001) over weeks 22 and 24.

三期Vivacity-MG3双盲研究的更多结果表明，接受尼泊卡利单抗联合标准治疗（SOC）的患者在第22周和第24周时，其QMG评分较安慰剂联合SOC组显著改善了-4.9分（p<0.001）。

2

2

Patients in the nipocalimab plus SOC treatment group were four times more likely to sustain symptom improvement at 20 weeks compared to the placebo plus SOC group, as measured by a three or greater point improvement on the QMG score.

与安慰剂加标准治疗组相比，接受尼波卡利单抗加标准治疗的患者在20周时症状改善持续的可能性是前者的四倍，这是根据QMG评分提高3分或更多来衡量的。

2

2

Results show significantly more patients treated with nipocalimab (36.4%,) versus placebo (10.5%, p<0.001) spent greater than 75% of study duration demonstrating improvements in the QMG score.

结果显示，与安慰剂组（10.5%，p<0.001）相比，接受尼泊珠单抗治疗的患者（36.4%）在研究期间超过75%的时间内QMG评分有所改善。

2

2

A reduction of more than three points in the QMG score indicates a decrease in the severity of the patient's symptoms as a result of improvements in muscle strength, allowing patients to carry out important daily activities such as swallowing and chewing.

QMG 评分减少超过三分意味着患者的症状严重程度有所减轻，这是由于肌肉力量的改善，使患者能够进行吞咽和咀嚼等重要的日常活动。

3

3

,4

，4

'People living with generalized MG around the world endure daily challenges, such as difficulties swallowing, impaired speech and muscle weakness. They deserve additional, effective treatment options that help address these challenges and provide sustained disease control and stability over time,' said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine.

“世界各地患有全身性重症肌无力的人每天都面临着诸如吞咽困难、语言障碍和肌肉无力等挑战。他们需要更多有效的治疗选择，以帮助应对这些挑战，并随着时间的推移提供持续的疾病控制和稳定性，”约翰逊创新医药公司的自身抗体产品组合副总裁兼母胎免疫疾病领域负责人凯蒂·阿布扎赫尔博士说道。

'These positive data underscore our commitment to helping develop potential innovative therapeutic options for patients living with autoantibody diseases, including gMG.' .

“这些积极的数据彰显了我们致力于帮助开发潜在的创新治疗方案，以造福包括gMG在内的自身抗体疾病患者。”

Editor's notes:

编者注：

a.

a.

The open-label extension (OLE) interim analysis includes 60 weeks of open-label data, totalling 84 weeks for nipocalimab-treated participants, including 24 weeks from the treatment group of the double-blind phase. Some patients have follow-up data extending to 128 weeks.

开放标签扩展（OLE）中期分析包括60周的开放标签数据，接受尼泊利单抗治疗的参与者总计84周的数据，其中包含双盲阶段治疗组的24周数据。部分患者的随访数据延长至128周。

1

1

b.

b.

QMG (Quantitative Myasthenia Gravis) is a 13-item assessment by a clinician that quantifies MG disease severity. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity.

QMG（定量重症肌无力）是由临床医生进行的13项评估，用于量化MG疾病的严重程度。QMG总分范围为0到39，分数越高表示疾病越严重。

3

3

c.

c.

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）提供了对患者回忆影响日常生活的症状的快速临床评估，总分范围为0到24；分数越高表示症状越严重。

3

3

d.

d.

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

康斯坦丁·法玛基迪斯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 (gMG)

关于全身性重症肌无力 (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] or anti-low density lipoprotein-related protein 4 [LRP4]), 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] 或抗低密度脂蛋白相关蛋白 4 [LRP4]），这些抗体会靶向神经肌肉接头处的蛋白质，可能阻断或破坏神经到肌肉的正常信号传递，从而损害或阻止肌肉收缩。

5

5

,

，

6

6

,7

，7

The disease impacts an estimated 700,000 people worldwide.

该疾病影响全球约 70 万人。

5

5

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.

该病影响男性和女性，所有年龄、种族和民族都会发病，但最常见于年轻女性和老年男性。

8

8

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MG患者为女性，其中约五分之一的女性具有生育能力。

9

9

,

，

10

10

,

，

11

11

Approximately 10 to 15% of new cases of MG are diagnosed in adolescents (12 – 17 years of age).

大约10%到15%的新发重症肌无力病例是在青少年（12-17岁）中诊断出来的。

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%的儿科MG病例被诊断为女孩。

15

15

,16,17

，16，17

Initial disease manifestations are usually ocular, but 85 percent of MG patients experience additional advancements to the disease manifestations – referred to as generalized myasthenia gravis (gMG). This is characterized by severe muscle weakness of the skeletal muscles and difficulties in speech and  swallowing..

初始疾病表现通常为眼部症状，但 85% 的 MG 患者会经历疾病表现的进一步发展，即所谓的全身型重症肌无力 (gMG)。其特征为骨骼肌严重无力以及言语和吞咽困难。

18,19

18,19

,

，

20

20

,

，

21

21

,

，

22

22

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

美国大约有 10 万人患有 gMG。

23

23

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。

24

24

Currently, SOC treatments for adolescents with gMG are extrapolated from adult trials.

目前，青少年 gMG 的 SOC 治疗方案是从成人试验中推断出来的。

14

14

Other than symptomatic treatments, there are no approved FcRn blockers for adolescents with gMG in the United States.

除对症治疗外，美国尚无批准用于青少年gMG的FcRn阻滞剂。

14

14

ABOUT THE PHASE 3 VIVACITY-MG3 STUDY

关于第三阶段VIVACITY-MG3研究

The Phase 3 Vivacity-MG3 study (

第三阶段 Vivacity-MG3 研究 (

NCT04951622

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..

）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有效性和安全性，目前这种疾病仍存在高度未满足的需求。筛选出对现有标准治疗（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，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。

25

25

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

基线人口统计学在各组之间是平衡的（77例尼波卡利单抗，76例安慰剂）。

25

25

The primary endpoint of the study was mean change in MG-ADL

该研究的主要终点是 MG-ADL 的平均变化

b

b

score from baseline over Weeks 22, 23 and 24 in antibody positive patients. A key secondary endpoint included change in QMG score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.

第22、23和24周抗体阳性患者的基线评分。一个关键的次要终点包括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。

26

26

ABOUT NIPOCALIMAB

关于尼泊卡利单抗

Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases..

Nipocalimab是一种研究性单克隆抗体，旨在高亲和力结合以阻断FcRn，并降低循环免疫球蛋白G（IgG）抗体的水平，可能不会对其他免疫功能产生影响。这包括在自身抗体领域中三个关键部分的多种病症相关的自身抗体和同种抗体，这些病症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。

26,27,28,29,30,31,32,33,34

26,27,28,29,30,31,32,33,34

Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.

阻断IgG与胎盘中FcRn的结合也被认为可限制母体同种抗体向胎儿的跨胎盘转移。

35

35

,36

`,36`

The U.S. FDA and 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 and fetal 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性疾病（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

2024年2月，HDFN获得美国FDA突破性疗法认定，2024年11月，Sjögren病获得认定。

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

2019年10月获得欧盟EMA授予的HDFN孤儿药资格认定

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优势使我们能够构建一个世界，在这个世界里，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且更少侵入性，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，我们有能力在当今整个医疗保健解决方案领域进行创新，以提供明天的突破性成果，并对人类健康产生深远影响。

Learn more at

了解更多信息，请访问

https://www.jnj.com/

https://www.jnj.com/

or at

或在

www.innovativemedicine.jnj.com

www.innovativemedicine.jnj.com

Follow us at

关注我们

@JNJInnovMed

@JNJInnovMed

.

。

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

杨森研发有限责任公司和杨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 nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.

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nipocalimab潜在益处和治疗影响的“前瞻性声明”。读者被提醒不要依赖这些前瞻性声明。这些声明是基于对未来事件的当前预期。

If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. 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.

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，实际结果可能与杨森研发有限责任公司、杨森生物科技公司和/或强生公司的预期和预测有重大差异。风险和不确定性包括但不限于：产品研发和开发中的挑战和不确定性，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、竞争对手推出的新产品和获得的专利；专利面临的挑战；因产品功效或安全问题导致的产品召回或监管行动；医疗卫生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、不确定性和其他因素的进一步列表和描述可以在强生公司最近的年度报告 Form 10-K 中找到，包括标题为“关于前瞻性陈述的警示说明”和“项目1A. 风险因素”的部分，以及强生公司随后的季度报告 Form 10-Q 和其他提交给证券交易委员会的文件中。

Copies of these filings are available online at .

这些文件的副本可在线获取。

www.sec.gov

www.sec.gov

, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

，www.jnj.com 或根据要求从 Johnson & Johnson 获取。Janssen Research & Development, LLC、Janssen Biotech, Inc. 以及 Johnson & Johnson 均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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Media contact:

媒体联系人：

Bridget Kimmel

布里吉特·金梅尔

bkimmel@its.jnj.com

bkimmel@its.jnj.com

Investor contact:

投资者联系人：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com

投资者关系@its.jnj.com

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来源：强生公司