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更新于：2025-04-18
Nipocalimab
尼卡利单抗
更新于：2025-04-18
概要
基本信息
药物类型 单克隆抗体 |
别名 anti-FcRn monoclonal antibody(Momenta Pharmaceuticals)、Immunoglobulin g1, anti-(human neonatal fc receptor) (human monoclonal m281 .gamma.-1 chain), disulfide with human monoclonal m281 .lambda.-chain, dimer、Nipocalimab (USAN) + [4] |
靶点 |
作用方式 拮抗剂、调节剂 |
作用机制 FcRn拮抗剂(IgG受体FcRn大亚基p51拮抗剂)、免疫调节剂 |
在研适应症 |
非在研适应症- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、罕见儿科疾病 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (中国)、孤儿药 (日本) |
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结构/序列
Sequence Code 19395495L
来源: *****
Sequence Code 19395504H
来源: *****
关联
32
项与 尼卡利单抗 相关的临床试验NCT04883619
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).
开始日期2026-01-15 |
ISRCTN14534389
A randomized, placebo-controlled, double-blind, multicenter phase 3 protocol to assess the efficacy and safety of nipocalimab in adults with moderate to severe Sjogren's disease (SjD)
开始日期2025-05-05 |
NCT06533098
Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
开始日期2025-02-10 |
100 项与 尼卡利单抗 相关的临床结果
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100 项与 尼卡利单抗 相关的转化医学
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100 项与 尼卡利单抗 相关的专利（医药）
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项与 尼卡利单抗 相关的文献（医药）2025-12-31·mAbs
Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties
Article
作者: Sukumaran, Siddharth ; Xu, Rui ; Abouzahr, Katie ; Ling, Leona E. ; Avery, William ; Roy, Sucharita ; Beavers, Traymon ; Choudhury, Amit ; Sihapong, Samuel ; Price, Karen ; Narayanaswami, Pushpa ; Kumar, Sujatha ; Markowitz, Lynn ; DuPrie, Matthew ; Bhattacharya, Sayak ; Brown, Julia ; Tyler, Steven ; Seth, Nilufer P. ; Daly, Thomas ; Rutitzky, Laura ; Cochran, Edward ; Meador, James ; Hubbard, Jonathan J. ; Pao, Yvonne ; Elwood, Fiona ; Parge, Viraj ; Duffner, Jay ; Wang, Yang ; Chen, Hsin
Nipocalimab is a human immunoglobulin G (IgG)1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn) with high specificity and high affinity at both neutral (extracellular) and acidic (intracellular) pH, resulting in the reduction of circulating IgG levels, including those of pathogenic IgG antibodies. Here, we present the molecular, cellular, and nonclinical characteristics of nipocalimab that support the reported clinical pharmacology and potential clinical application in IgG-driven, autoantibody- and alloantibody-mediated diseases. The crystal structure of the nipocalimab antigen binding fragment (Fab)/FcRn complex reveals its binding to a unique epitope on the IgG binding site of FcRn that supports the observed pH-independent high-binding affinity to FcRn. Cell-based and in vivo studies demonstrate concentration/dose- and time-dependent FcRn occupancy and IgG reduction. Nipocalimab selectively reduces circulating IgG levels without detectable effects on other adaptive and innate immune functions. In vitro experiments and in vivo studies in mice and cynomolgus monkeys generated data that align with observations from clinical studies of nipocalimab in IgG autoantibody- and alloantibody-mediated diseases.
2025-02-01·LANCET NEUROLOGY
Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study
Article
作者: Bril, Vera ; De Bleecker, Jan ; Sun, Hong ; Youssef, Eriene ; Grudniak, Mariusz ; Sevilla, Teresa ; Sheehan, John J ; Ramchandren, Sindhu ; Zhu, Yaowei ; Sanga, Panna ; Karcher, Keith ; Sivakumar, Kumaraswamy ; Farmakidis, Constantine ; Minks, Eduard ; Yang, Huan ; Hoffmann, Sarah ; Smilowski, Marek ; Vu, Tuan ; Antozzi, Carlo ; Park, Jin-Sung ; Nowak, Richard J ; Suzuki, Yasushi
BACKGROUND:
Given burdensome side-effects and long latency for efficacy with conventional agents, there is a continued need for generalised myasthenia gravis treatments that are safe and provide consistently sustained, long-term disease control. Nipocalimab, a neonatal Fc receptor blocker, was associated with dose-dependent reductions in total IgG and anti-acetylcholine receptor (AChR) antibodies and clinically meaningful improvements in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale in patients with generalised myasthenia gravis in a phase 2 study. We aimed to assess the safety and efficacy of nipocalimab in a phase 3 study.
METHODS:
Vivacity-MG3 was a phase 3, randomised, double-blind, placebo-controlled, phase 3 study conducted at 81 outpatient centres with expertise in myasthenia gravis in 17 countries in Asia-Pacific, Europe, and North America. Adults (aged ≥18 years) with generalised myasthenia gravis inadequately controlled with standard-of-care therapy (MG-ADL score ≥6) were randomly assigned (1:1) to either nipocalimab (30 mg/kg loading dose then 15 mg/kg every 2 weeks for maintenance dosing) or placebo infusions every 2 weeks, added to standard-of-care therapy in both groups, for 24 weeks. Randomisation was stratified by antibody status, day 1 MG-ADL total score, and region. The sponsor, investigators, clinical raters, and participants were masked to treatment assignment. The primary endpoint was the difference between nipocalimab and placebo based on least-squares mean change from baseline in MG-ADL total score averaged over weeks 22, 23, and 24 in the intention-to-treat population of patients who were antibody-positive (for AChR, anti-muscle-specific tyrosine kinase [MuSK], or anti-low-density lipoprotein receptor-related protein 4 [LRP4]). Adverse events were assessed in patients who received at least one dose of study drug. This study is registered at ClinicalTrials.gov, NCT04951622; the double-blind phase is completed and an open-label extension phase is ongoing.
FINDINGS:
Between July 15, 2021, and Nov 17, 2023, 199 patients were enrolled, and 196 patients received study drug (98 in the nipocalimab group and 98 in the placebo group); of these, 153 (77 in the nipocalimab group and 76 in the placebo group) were antibody-positive. The least-squares mean change in MG-ADL score from baseline to weeks 22, 23, and 24 was -4·70 (SE 0·329) in the nipocalimab group versus -3·25 (0·335) in the placebo group (difference -1·45 [95% CI -2·38 to -0·52]; p=0·0024). The incidence of adverse events was similar between groups (82 [84%] of 98 in both the nipocalimab and placebo groups), including infections (42 [43%] of 98 in the nipocalimab group and placebo group) and headache (14 [14%] of 98 in the nipocalimab group and 17 [17%] of 98 in the placebo group). Serious adverse events were reported for nine (9%) of 98 patients in the nipocalimab group and 14 (14%) of 98 patients in the placebo group, three of which had a fatal outcome (nipocalimab: myasthenic crisis; placebo: cardiac arrest and myocardial infarction).
INTERPRETATION:
Results from the completed double-blind phase of Vivacity-MG3 support the role of nipocalimab, added to standard-of-care therapies, as a safe treatment for sustained disease control over 6 months for a broad population of patients with generalised myasthenia gravis who are antibody-positive. The ongoing open-label extension phase should provide longer term sustained safety and efficacy data with nipocalimab.
FUNDING:
Janssen Research & Development, LLC, a Johnson & Johnson company.
2024-12-01·Journal of clinical neuromuscular disease
What Is in the Neuromuscular Junction Literature?
Review
作者: Lacomis, David
Abstract:
This update starts with an interesting series of children and adults with congenital myasthenic syndrome with a DOK7 variant. The next section is on autoimmune myasthenia gravis (MG) epidemiology, cost of care, and hospitalizations. A number of studies on the newer treatments are discussed including a phase 2 trial of nipocalimab and recommendations for using some of these drugs. A large trial emphasizing the negative effects of pyridostigmine in muscle-specific kinase MG is covered. A study on the incidence of taste disorders and alopecia in MG follows. The update ends with the topic of the burden of disease in MG and Lambert–Eaton myasthenic syndrome.
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项与 尼卡利单抗 相关的新闻（医药）2025-04-18
4月17日，赛诺菲一口气拿下Earendil Labs两款“同类首创双抗”全球独家权：HXN-1002（α4β7和TL1A）和HXN-1003（TL1A和IL23），Earendil Labs将获得1.25亿美元预付款，以及总额高达17.2亿美元的里程碑付款等。自免，无疑是2025年的热门词汇！早在3月21日，BiG联合上海浦东生命科学产业发展有限公司举办了BiG Moment｜TL1A/FcRn靶点能否成为自免市场的又一个“爆点”？本文将带您深度拆解TL1A/FcRn的破局潜力！相关阅读：TL1A靶点：两全其美的自免炎症通路放大器能否通过成药性考验？一文了解新生儿Fc受体（FcRn） 01 TL1A/FcRn靶点是否具备“爆点基因”？1.1 TL1A靶点：通路放大器与抗纤维化双重作用TL1A（TNF-like ligand 1A）如同炎症通路的"智能放大器"，通过与其唯一配体死亡受体3（DR3）的结合激活一系列炎症信号通路。包括调节Th17细胞分化、上调促炎细胞因子（如IL-17A、IL-6）的表达，并影响成纤维细胞的活性。从临床路径来看，TL1A既是炎症通路的放大器，也是抗纤维化的解决方案。在炎症性肠病（IBD）中，TL1A在溃疡性结肠炎（UC）和克罗恩病（CD）患者的肠黏膜中广泛上调，这使其成为精准治疗的关键靶点。此外，研究显示，中和TL1A可逆转结肠纤维化进程，限制促纤维化因子如TGF-β1等的表达，这为早期干预IBD相关性纤维化提供了理论依据。图1.TL1A和DR3在免疫应答中的角色1.2 FcRn靶点：IgG代谢调控的精准干预点与TL1A针对炎症通路不同，FcRn（新生儿Fc受体）则扮演着抗体代谢的"智能管家"。它能通过pH值依赖的循环机制，将IgG抗体从溶酶体降解途径中抢救回来。但在自身免疫疾病中，这个生理机制反而延长了致病抗体的寿命。通过阻断FcRn（开发FcRn的抑制剂），可以实现对多种自身抗体的"无差别清除"，堪称自身免疫领域的"万能钥匙"。应用广泛，涵盖重症肌无力（MG）、特发性血小板减少性紫癜（ITP）等疾病。图2.FcRn抑制剂作用机制 02 临床需求：自免赛道的痛点与机会2.1 炎症性肠病未满足的治疗需求炎症性肠病（IBD）是一种导致消化道长期炎症的疾病，主要包括溃疡性结肠炎（UC）和克罗恩病（CD）。目前，现有抗TNF药物尽管疗效突出，但全球范围内约有40%的IBD患者对抗TNF生物制剂治疗呈现原发性或继发性失应答。此外，长期炎症带来的肠纤维化问题普遍存在，超过50%的IBD患者在五年以上病程中合并纤维化并发症，而现有靶向疗法对纤维化干预的效果有限。前面已经提到，TL1A既是炎症通路的放大器，也是抗纤维化的解决方案。抑制TL1A不仅可以减少成纤维细胞数量，还能逆转纤维化相关指标。2.2 FcRn靶点适应症扩展潜力FcRn靶点体现了“一药多治”的潜力。除了在MG和ITP中的有效应用，其进一步扩展至系统性红斑狼疮（SLE）、视网膜病变等疾病。不仅如此，其与现有免疫调节剂的联合治疗方案也受到业界极大的关注。 03 商业化路径：从靶点到市场的转化逻辑3.1 TL1A靶点药物临床表现全球范围内尚无靶向TL1A的药物获批上市，正在临床阶段的同靶点候选药物均由国外药企研发。目前至少有十余款TL1A靶点药物在研，包括单抗和双抗，6项临床试验正在进行，其中进展最快的是tulisokibart，3期适应症为溃疡性结肠炎（UC）、克罗恩病（CD）和系统性硬化症相关的间质性肺部疾病（SSc-ILD）。表1.MNC现有主要TL1A管线布局随着前三条管线（duvakitug、RG6631和tulisokibart）陆续披露临床数据，TL1A靶点潜力被进一步释放。✔ TL1A靶点有较好的临床治疗效果：在UC患者中，duvakitug、RG6631和tulisokibart临床缓解率分别为47.8%、29%、26.5%；在CD患者中，duvakitug、RG6631和tulisokibart内镜响应率分别为47.8%、26%、26%。 ✔ TL1A靶点有可控的安全性和耐受性：duvakitug、RG6631和tulisokibart均显示出良好的耐受性和安全性，没有报告严重的不良事件。 三条管线比较下来，疗效上duvakitug具有优势，但是到底谁是best-in-class药物，还需要看更大规模的3期临床数据表现。前面也提到，4月17日，赛诺菲获得了Earendil Labs自主研发的两款潜在同类首创双特异性抗体HXN-1002（α4β7和TL1A）和HXN-1003（TL1A和IL23）的全球独家权利，Earendil Labs将获得1.25亿美元预付款，以及总额高达17.2亿美元的开发和商业化里程碑付款，以及产品销售的分层特许权使用费。图3.Earendil Labs与赛诺菲达成了一项全球独家许可协议值得一提的是，三生国健的重组抗TL1A单抗SSGJ-627成为国内首个进入IND阶段的TL1A单抗，临床前研究显示，SSGJ-627 与 TL1A 具有高亲和力及特异性的结合，在不同动物模型中展示出显著的药效。同时，SSGJ-627 具备良好、可接受的安全性。图4.三生国健SSGJ-627进入IND3.2 FcRn抑制剂市场的表现阻断FcRn通路的药物包括靶向FcRn单克隆抗体药物和体外重组的Fc片段蛋白，相关领域的药物产品包括：Fc重组蛋白药物Efgartigimod 、单抗 Rozanolixizumab、M281和 SYNT001等。 图5.FcRn抑制剂研究布局① Efgartigimod（艾加莫德，Argenx公司），作为全球首款获批的FcRn抑制剂，其在重症肌无力患者中的疗效不俗，真实世界证据显示治疗方案的应答率达70%以上。其商业化潜力也得到验证，2024年海外年销售额已经突破20亿美元，同比增长84%。Efgartigimod是人源IgG1的Fc结构的体外重组蛋白片段。该产品利用Argenx的专有的点突变技术分别在5个位点对Fc片段的序列进行了突变，突变后的Fc蛋白和FcRn的结合力在中性和酸性的条件下得到了显著增强。2020年5月底Argenx公司宣布，Efgartigimod在治疗抗乙酰胆碱受体（AChR）抗体阳性全身性重症肌无力（gMG）患者的关键性3期临床试验中，达到了主要研究终点。2021年12月，Efgartigimod作为全球首款FcRn拮抗剂获美国食品药品监督管理局(FDA)批准。2021年1月再鼎医药与Argenx达成独家授权合作，负责Efgartigimod在大中华区的开发和商业化工作。图6.首个周期输注完成后的疗效② Nipocalimab(M281)是美国生物医药公司Momenta的核心产品管线。其分子本质是去糖基化的全人源IgG1抗体，靶向FcRn，去掉了抗体的Fc功能。Nipocalimab在预防胎儿和新生儿溶血性疾病方面获得了孤儿药认定和罕见儿科疾病认定。目前已经处于临床 III 期研究阶段。2020年 8 月 ，强生宣布以 65 亿美元收购Momenta，从而将该产品纳入到旗下。③ Rozanolixizumab(UCB-7665)是来自布鲁塞尔生物技术公司UCB Biopharma的一种皮下给药的人源化IgG4抗体，能特异性结合人FcRn，阻断FcRn与IgG的相互作用，抑制循环中的IgG，诱导致病性IgG自身抗体的清除。II 期临床研究显示，其总IgG和抗-AChR抗体滴度平均降低68%，目前正处于 III 期研究中。④ Batoclimab(RVT1401)是来自和铂医药的一种完整的人源单克隆抗体，与FcRn结合，阻断FcRn-IgG相互作用以加速自身抗体的降解，治疗各种致病性IgG介导的自身免疫疾病。该产品曾在中国被纳入突破性治疗品种，目前正在开展多种适应症的临床研究。 04 MNC的商业布局与竞赛多家跨国公司（MNC）已完成针对TL1A或FcRn的巨额交易：● 默沙东2023年以108亿美元收购Prometheus Biosciences，将tulisokibart列为核心管线。● 罗氏同年以71亿美元收购Telavant，重点开发RG6631。● 赛诺菲同年与梯瓦（Teva Pharmaceuticals）达成合作协议，以15亿美元投入Duvakitug研发。● 2021年1月，再鼎医药与Argenx达成独家授权合作，负责Efgartigimod在大中华区的开发和商业化工作。● 2020年 8 月 ，强生宣布以 65 亿美元收购Momenta，从而将Nipocalimab(M281)纳入旗下。FcRn赛道已有产品上市，并且强生、argenx等多家大型药企布局。TL1A领域则因全球尚无获批产品而呈现高度开放的市场环境，默沙东、罗氏、赛诺菲等MNC已先后启动研发并取得关键进展，这些交易不仅代表了MNC对该靶点机制的认可，也再次说明其百亿美元市场潜力。 05 TL1A/FcRn靶点下一步开发趋势如何？5.1 临床设计的创新：个性化与联合终点多终点设计：TL1A在IBD治疗中可结合内镜改善、生物标志物动态变化等复合终点，以更全面评估疗效。这一设计可显著提高新药通过III期试验的概率。分层治疗：FcRn抑制剂可基于循环IgG水平、生物标志物特征制定个体化给药方案，提高疗效稳定性。5.2 靶点联合开发：从单一疗法到组合拳新靶点间的协同效应成为创新热点。例如：TL1A靶点可尝试与IL-23抑制剂或JAK抑制剂联合构成“炎症双阻断”，并与抗纤维化药物联合治疗IBD并发症；FcRn抑制剂亦可与免疫抑制剂或肿瘤免疫药物形成联合方案。 写在最后 当TL1A遇见FcRn，这不仅是两个靶点的邂逅，更是免疫治疗范式革命的序章。在这个百亿美元级的竞技场上，中国药企正奋勇直追。虽然前路仍有科学迷雾（如TL1A的肠外效应、FcRn的免疫稳态平衡），但敢于在"无人区"探索的勇者，终将收获创新的馈赠。让我们共同期待，这些"免疫调节器"如何改写人类对抗自免疾病的史诗！参考资料[1] Earendil Labs Announces Worldwide Exclusive License Agreement with Sanofi for Next-Generation Bispecific Antibodies for Autoimmune and Inflammatory Bowel Diseases[2] 国家药品监督管理局药品审评中心，信息公开[3] TL1A靶点：两全其美的自免炎症通路放大器能否通过成药性考验？BiG生物医药创新社[4] 一文了解新生儿Fc受体（FcRn）。小药说药共建Biomedical创新生态圈！如何加入BiG会员？
引进/卖出
2025-04-17
·求实药社
4月15日，强生发布2025一季度财报，营业收入218.93亿美元，同比增长2.4%。超出华尔街预期的215.8亿美元；净利润达109.99亿美元，同比激增237.9%，主要得益于创新药业务的高利润贡献及成本控制优化。调整后每股收益为2.77美元，同比增长2.2%，同样高于市场预期。公司同时宣布将股息上调4.8%，连续第63年提高股东分红。 图片来源：强生官方公众号肿瘤战场：56.78亿美元销售额的“三驾马车”创新药部门营收138.73亿美元（占总营收63%），同比增长2.3%。其中肿瘤领域销售额56.78亿美元，同比增17.9%，远超整体业务增速。这一增长主要由三款重磅产品驱动：1.“百亿神药” CD38单抗Darzalex：作为全球首款靶向CD38的单克隆抗体，Darzalex在2024年销售额首次突破百亿美元大关，其适应症从多发性骨髓瘤逐步扩展至自身免疫疾病，成为强生肿瘤领域的“现金牛”。2.BCMA CAR-T疗法CARVYKTI®（西达基奥仑赛）：与传奇生物合作开发的CAR-T产品一季度销售额达3.69亿美元，约合26.5亿元，同比增长135%。其中美国市场收入3.18亿美元，同比增长127%。该疗法凭借二线适应症获批及产能扩张，成为首个在多发性骨髓瘤前线治疗中挑战传统干细胞移植的创新疗法。2024年4月，CARVYKTI®获美国FDA批准用于多发性骨髓瘤（MM）的二线治疗，覆盖患者群体从末线（4线及以上）扩展至更早期的复发或难治性患者（1-3线治疗），潜在适用人群扩大3-5倍114。临床试验CARTITUDE-4显示，与标准治疗相比，CARVYKTI®将患者疾病进展或死亡风险降低59%（HR=0.41），中位无进展生存期（PFS）显著延长。该产品于2024年年中在中国上市，2025年3月11日，传奇生物发布公告，其CAR-T疗法CARVYKTI®2024年第四季度和全年的净贸易销售额分别约为3.34亿美元和9.63亿美元。3.EGFR/cMET双抗Rybrevant：通过与化疗联用方案在非小细胞肺癌（NSCLC）中的广泛应用，Rybrevant成为EGFR突变患者的一线无化疗治疗选择，进一步巩固强生在肺癌领域的竞争力。临床缓解率较传统化疗提升3倍，或成下一个10亿美元级产品。首席执行官华金・杜阿托（Joaquin Duato）在周二上午特别提到，埃万妥单抗Rybrevant是强生本季度强生成功的 “大功臣”之一。万妥单抗（Rybrevant）和治疗小细胞肺癌的联合用药拉兹库祖（Lazcluze）取得的临床里程碑进展。在 3 月份公布结果的一项三期头对头试验里，这对 “黄金搭档” 的表现直接把阿斯利康（AstraZeneca）的肺癌主打药物奥希替尼（Tagrisso）比了下去，患者总生存率显著提高。这联合用药的销售额也从去年同期的 4700 万美元，涨到了 1.41 亿美元，成绩相当亮眼。自免领域有了新支柱2025年第一季度，强生自免板块营收37.07亿美元，同比下降12.7%，成为创新药业务中唯一负增长的板块。这一下滑主要归因于核心产品Stelara（乌司奴单抗）的专利到期与生物类似药竞争。Stelara Q1销售额仅16.3亿美元，同比暴跌34%，其美国市场收入占比高达61%，而欧洲市场已受到三星生物与山德士合作的生物类似药SB17冲击。不过，强生通过Tremfya（古塞奇尤单抗）的快速增长部分抵消了颓势：Tremfya Q1销售额达9.56亿美元，成为自免领域新支柱。Tremfya作为全球首个选择性IL-23抑制剂，2025年Q1销售额同比增速超市场预期。其成功得益于适应症扩展。为应对Stelara收入缺口，强生采取“外源并购+内部研发”双轨策略：1. 斥资10亿美元从Protagonist引进，预计2025年提交银屑病适应症上市申请，峰值销售额或达50亿美元。2. 通过收购Proteologix和Yellow Jersey，获得PX128（IL-13/TSLP双抗）、NM26（IL-31/IL-4Rα双抗）等管线，瞄准特应性皮炎（AD）和哮喘细分市场。3. 2024年以65亿美元收购Momenta获得的Nipocalimab（尼卡利单抗），已提交重症肌无力（MG）上市申请，并拓展至干燥综合征（SjD）等适应症，预计峰值销售额50亿美元，对标Argenx的Efgartigimod（2024年销售额21.86亿美元）。550亿美元豪掷未来强生宣布未来四年在美投资550亿美元，剑指三大战略高地：1.细胞治疗“军备竞赛”：投入30亿美元扩建CAR-T生产基地，目标将生产周期从120天压缩至60天，患者等待时间缩短50%。2.手术机器人“弯道超车”：Ottava微创机器人获FDA突破性设备认定，借助6自由度机械臂技术，在前列腺手术精度上挑战直觉外科达芬奇系统。3.ADC药物“押注式布局”：通过收购Ambrx获得定点偶联技术，针对HER2低表达乳腺癌的ARX788三期临床数据即将揭盲，或成下一个爆点。光鲜背后的暗雷涌动强生光鲜财报背后，多重风险正在累积：滑石粉诉讼“无底洞”：累计和解金额超89亿美元，新泽西法院最新裁定可能引发新一轮5.3万起诉讼潮。CAR-T的“达摩克利斯之剑”：FDA收到127例CARVYKTI®相关神经毒性报告，其中9例致死案例或引发适应症使用限制。医保谈判“价格绞杀”：美国《通胀削减法案》首批10款药价谈判落地，强生抗凝血药Xarelto面临最高68%降价压力。亮眼开局：2.4%增速背后的抉择肿瘤药物销售额同比激增17.9%，贡献超半数增长，而专利到期的免疫药物Stelara销售额暴跌34%，单款产品拖累整体增速8.1个百分点。净利润109.99亿美元的超常增长，源于砍掉15条低效产线、关闭3家工厂的“外科手术式”成本优化，以及高利润CAR-T疗法占比提升。当56.78亿美元的肿瘤药物营收背后，是550亿美元的转型赌注和89亿美元的法律风险，这个百年巨头的每一步抉择，都在为行业书写新的生存教科书。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们SIT 2025展位火热预定中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩！
免疫疗法细胞疗法财报临床3期上市批准
2025-04-15
2025 First-Quarter reported sales growth of 2.4% to $21.9 Billion with operational growth of 4.2%* and adjusted operational growth of 3.3%* 2025 First-Quarter earnings per share (EPS) increased to $4.54 which includes the reversal of special charges and adjusted EPS increased to $2.77 or 2.2%* Significant new product pipeline progress including approval of TREMFYA in Crohn’s disease, data for RYBREVANT/LAZCLUZE overall survival in non-small cell lung cancer and icotrokinra in plaque psoriasis, and initiation of the clinical trial for a general surgery robotic system, OTTAVA Company increases Full-Year 2025 operational sales2,5 guidance to reflect the addition of CAPLYTA following the completion of the Intra-Cellular Therapies acquisition Including tariff costs, dilution from the Intra-Cellular Therapies acquisition, and updated foreign exchange, Company maintains Full-Year 2025 adjusted reported EPS4 outlook of 6.2%* growth at the mid-point
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2025. “The power of Johnson & Johnson’s uniquely diversified portfolio was on full display this quarter, with strong operational sales growth reinforcing our confidence in 2025 guidance,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “During the quarter, we fortified our position as an innovation powerhouse with major advancements across our pipeline, including TREMFYA in IBD, RYBREVANT plus LAZCLUZE in non-small-cell lung cancer, and OTTAVA, our soft tissue surgical robotic system, and further enhanced our leading neuroscience portfolio with the completion of the Intra-Cellular Therapies acquisition.”
Overall financial results
Q1
($ in Millions, expect EPS)
2025
2024
% Change
Reported Sales
$21,893
$ 21,383
2.4%
Net Earnings
$10,999
$3,255
237.9%
EPS (diluted)
$4.54
$1.34
238.8%
Q1
Non-GAAP* ($ in Millions, except EPS)
2025
2024
% Change
Operational Sales1,2
4.2%
Adjusted Operational Sales1,3
3.3%
Adjusted Net Earnings1,4
$6,706
$6,580
1.9%
Adjusted EPS (diluted)1,4
$2.77
$2.71
2.2%
Free Cash Flow6,7
~$3,400
$2,850
1
Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2
Excludes the impact of translational currency
3
Excludes the net impact of acquisitions and divestitures and translational currency
4
Excludes intangible amortization expense and special items
5
Excludes COVID-19 Vaccine
6
Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings.
7
First-quarter 2025 is estimated as of April 15, 2025
Regional sales results
Q1
% Change
($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S.
$12,305
$11,620
5.9%
5.9
-
4.4
International
9,588
9,763
(1.8)
2.1
(3.9)
1.9
Worldwide
$21,893
$21,383
2.4%
4.2
(1.8)
3.3
1
Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2
Excludes the impact of translational currency
3
Excludes the net impact of acquisitions and divestitures and translational currency
Segment sales results
Q1
% Change
($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine
$13,873
$13,562
2.3%
4.2
(1.9)
4.4
MedTech
8,020
7,821
2.5
4.1
(1.6)
1.3
Worldwide
$21,893
$21,383
2.4%
4.2
(1.8)
3.3
1
Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2
Excludes the impact of translational currency
3
Excludes the net impact of acquisitions and divestitures and translational currency
First-Quarter 2025 segment commentary:
Operational sales* reflected below excludes the impact of translational currency.
Innovative Medicine
Innovative Medicine worldwide operational sales grew 4.2%* driven primarily by DARZALEX, CARVYKTI, ERLEADA, and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, SPRAVATO in Neuroscience, and XARELTO in Cardiovascular/Metabolism/Other. Growth was partially offset by an approximate (810) basis points impact from STELARA in Immunology.
MedTech
MedTech worldwide operational sales grew 4.1%*, with net acquisitions and divestitures positively impacting growth by 2.8%. Growth was driven primarily by Abiomed in Cardiovascular and wound closure products in General Surgery. Growth was partially offset by Spine, Sports & Other in Orthopaedics.
Full-year 2025 guidance:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP.
($ in Billions, except EPS)
April 2025
January 2025
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
2.0% – 3.0% / 2.5%
2.0% – 3.0% / 2.5%
Operational Sales2,5 / Mid-point
Change vs. Prior Year / Mid-point
$91.6B – $92.4B / $92.0B
3.3% – 4.3% / 3.8%
$90.9B – $91.7B / $91.3B
2.5% – 3.5% / 3.0%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$91.0B – $91.8B / $91.4B
2.6% – 3.6% / 3.1%
$89.2B – $90.0B / $89.6B
0.5% – 1.5% / 1.0%
Adjusted Operational EPS (Diluted)2,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
$10.75 – $10.95 / $10.85
7.7% – 9.7% / 8.7%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
1
Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2
Non-GAAP financial measure; excludes the impact of translational currency
3
Calculated using Euro Average Rate: April 2025 = $1.10 and January 2025 = $1.04 (Illustrative purposes only)
4
Non-GAAP financial measure; excludes intangible amortization expense and special items
5
Excludes COVID-19 Vaccine
Other modeling considerations will be provided on the webcast.
Notable announcements in the quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com.
Regulatory
European Commission approves subcutaneous RYBREVANT (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer1
Press Release
European Commission approves Johnson & Johnson’s subcutaneous DARZALEX (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility1
Press Release
U.S. FDA approves TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease
Press Release
Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren's disease, has now received Fast Track designation
Press Release
Data Releases
Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA Robotic Surgical System1
Press Release
Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill1
Press Release
Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG)1
Press Release
TREMFYA (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis1
Press Release
Johnson & Johnson MedTech to Highlight Latest Advancements in Heart Disease Treatment with Impella at ACC.25
Press Release
RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer
Press Release
New nipocalimab data and real-world research at AAN 2025 highlight positive Phase 3 results and commitment to people living with generalized myasthenia gravis (gMG)
Press Release
RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025
Press Release
Johnson & Johnson MedTech Showcases New Era of Digital Orthopaedics at AAOS 2025
Press Release
Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients
Press Release
Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis
Press Release
TREMFYA (guselkumab) subcutaneous (SC) induction data support potential to be the first and only in its class to offer the option of both intravenous and SC induction therapy in ulcerative colitis
Press Release
New nipocalimab data published in mAbs journal details differentiated molecular design, clinical profile and potential of nipocalimab to treat IgG-driven alloantibody and autoantibody diseases
Press Release
Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalized myasthenia gravis (gMG) published in The Lancet Neurology
Press Release
Product Launch
Shockwave Medical Launches Novel Forward Intravascular Lithotripsy Platform in U.S. to Transform Treatment of Difficult-to-Cross Calcified Lesions
Press Release
Other
Johnson & Johnson Closes Landmark Intra-Cellular Therapies, Inc. Acquisition to Solidify Neuroscience Leadership1
Press Release
Johnson & Johnson to Return to Tort System to Defeat Meritless Talc Claims1
Press Release
Johnson & Johnson Increases U.S. Investment to More than $55 Billion Over the Next Four Years
Press Release
Johnson & Johnson Announces Darren Snellgrove as Vice President, Investor Relations
Press Release
Webcast information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations.
About Johnson & Johnson:
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. Learn more at www.jnj.com.
Non-GAAP financial measures:
* “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results.
Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results.
Note to investors concerning forward-looking statements:
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. 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. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; and increased scrutiny of the health care industry by government agencies. 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. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Percent Change
2025
2024
Total
Operations
Currency
$
8,092
7,612
6.3
%
6.3
-
5,781
5,950
(2.9
)
1.5
(4.4
)
13,873
13,562
2.3
4.2
(1.9
)
4,213
4,008
5.1
5.1
-
3,807
3,813
(0.2
)
3.0
(3.2
)
8,020
7,821
2.5
4.1
(1.6
)
12,305
11,620
5.9
5.9
-
9,588
9,763
(1.8
)
2.1
(3.9
)
$
21,893
21,383
2.4
%
4.2
(1.8
)
Percent Change
2025
2024
Total
Operations
Currency
$
12,305
11,620
5.9
%
5.9
-
5,110
5,163
(1.0
)
2.2
(3.2
)
1,167
1,194
(2.3
)
9.2
(11.5
)
3,311
3,406
(2.8
)
(0.6
)
(2.2
)
9,588
9,763
(1.8
)
2.1
(3.9
)
$
21,893
21,383
2.4
%
4.2
(1.8
)
2025
2024
Percent
Percent
Percent
Increase
Amount
to Sales
Amount
to Sales
(Decrease)
$
21,893
100.0
$
21,383
100.0
2.4
7,357
33.6
6,511
30.4
13.0
14,536
66.4
14,872
69.6
(2.3
)
5,112
23.3
5,257
24.6
(2.8
)
3,225
14.7
3,542
16.6
(8.9
)
(128
)
(0.6
)
(209
)
(1.0
)
(7,321
)
(33.4
)
2,404
11.2
17
0.1
164
0.8
13,631
62.3
3,714
17.4
267.0
2,632
12.1
459
2.2
473.4
$
10,999
50.2
$
3,255
15.2
237.9
$
4.54
$
1.34
238.8
2,423.8
2,430.1
19.3
%
12.4
%
$
8,011
36.6
$
7,877
36.8
1.7
$
6,706
30.6
$
6,580
30.8
1.9
$
2.77
$
2.71
2.2
16.3
%
16.5
%
2025
2024
$10,999
$3,255
(6,966)
2,726
1,120
1,078
55
171
132
148
39
(20)
-
51
-
9
1,315
(856)
12
18
$6,706
$6,580
2,423.8
2,430.1
$2.77
$2.71
$2.81
1
2
2.3%
2.5%
2.4%
6.3%
5.1%
5.9%
(2.9)%
(0.2)%
(1.8)%
(1.9)
(1.6)
(1.8)
-
-
-
(4.4)
(3.2)
(3.9)
4.2%
4.1%
4.2%
6.3%
5.1%
5.9%
1.5%
3.0%
2.1%
(3.3)
(1.2)
(5.1)
(1.8)
(1.4)
(0.5)
0.2
0.5
0.3
0.0
0.9
0.3
0.4
0.2
0.3
4.4%
1.3%
3.3%
6.3%
0.9%
4.4%
1.9%
1.8%
1.9%
REPORTED SALES vs. PRIOR PERIOD ($MM)
2025
2024
Reported
Operational (1)
Currency
$ 3,013
2,383
26.4
%
26.4
%
-
2,664
2,430
9.6
%
14.4
%
-4.8
%
5,678
4,814
17.9
%
20.4
%
-2.5
%
318
140
*
*
-
51
16
*
*
*
369
157
*
*
*
1,829
1,464
24.9
%
24.9
%
-
1,409
1,228
14.7
%
19.8
%
-5.1
%
3,237
2,692
20.3
%
22.5
%
-2.2
%
292
285
2.5
%
2.5
%
-
479
404
18.5
%
23.1
%
-4.6
%
771
689
11.9
%
14.6
%
-2.7
%
235
265
-11.5
%
-11.5
%
-
474
518
-8.5
%
-4.2
%
-4.3
%
709
784
-9.5
%
-6.7
%
-2.8
%
113
36
*
*
-
28
11
*
*
*
141
47
*
*
*
68
50
35.2
%
35.2
%
-
18
8
*
*
*
86
58
48.4
%
50.2
%
-1.8
%
105
101
4.9
%
4.9
%
-
46
33
38.8
%
45.9
%
-7.1
%
151
133
13.3
%
15.0
%
-1.7
%
7
9
-24.3
%
-24.3
%
-
118
172
-31.3
%
-28.5
%
-2.8
%
125
181
-30.9
%
-28.3
%
-2.6
%
47
33
42.9
%
42.9
%
-
42
41
4.6
%
10.1
%
-5.5
%
89
73
21.7
%
24.7
%
-3.0
%
REPORTED SALES vs. PRIOR PERIOD ($MM)
2025
2024
Reported
Operational (1)
Currency
2,196
2,453
-10.5
%
-10.5
%
-
1,510
1,794
-15.8
%
-11.5
%
-4.3
%
3,707
4,247
-12.7
%
-10.9
%
-1.8
%
314
266
18.1
%
18.1
%
-
10
27
-64.2
%
-64.2
%
-
143
141
1.3
%
6.8
%
-5.5
%
467
434
7.5
%
9.3
%
-1.8
%
292
254
14.8
%
14.8
%
-
366
299
22.4
%
29.7
%
-7.3
%
659
554
18.9
%
22.9
%
-4.0
%
981
1,396
-29.8
%
-29.8
%
-
644
1,055
-38.9
%
-35.8
%
-3.1
%
1,625
2,451
-33.7
%
-32.3
%
-1.4
%
599
509
17.6
%
17.6
%
-
356
299
19.2
%
24.4
%
-5.2
%
956
808
18.2
%
20.1
%
-1.9
%
1
0
*
*
-
0
0
-
-
-
1
0
*
*
-
968
1,054
-8.1
%
-8.1
%
-
679
749
-9.3
%
-5.5
%
-3.8
%
1,647
1,803
-8.6
%
-7.0
%
-1.6
%
38
41
-7.4
%
-7.4
%
-
110
136
-18.9
%
-15.2
%
-3.7
%
148
177
-16.3
%
-13.4
%
-2.9
%
625
765
-18.2
%
-18.2
%
-
277
292
-4.9
%
-1.1
%
-3.8
%
903
1,056
-14.5
%
-13.5
%
-1.0
%
276
191
45.0
%
45.0
%
-
43
34
25.0
%
31.7
%
-6.7
%
320
225
41.9
%
42.9
%
-1.0
%
28
58
-50.6
%
-50.6
%
-
248
287
-13.4
%
-9.8
%
-3.6
%
277
345
-19.6
%
-16.7
%
-2.9
%
REPORTED SALES vs. PRIOR PERIOD ($MM)
2025
2024
Reported
Operational (1)
Currency
744
766
-2.9
%
-2.9
%
-
281
283
-0.6
%
3.2
%
-3.8
%
1,025
1,049
-2.3
%
-1.2
%
-1.1
%
363
356
2.1
%
2.1
%
-
159
169
-6.0
%
-2.5
%
-3.5
%
522
524
-0.5
%
0.6
%
-1.1
%
365
392
-6.9
%
-6.9
%
-
86
76
13.4
%
17.5
%
-4.1
%
451
468
-3.6
%
-2.9
%
-0.7
%
15
18
-12.7
%
-12.7
%
-
37
39
-4.6
%
-0.3
%
-4.3
%
52
56
-7.2
%
-4.3
%
-2.9
%
315
324
-2.8
%
-2.8
%
-
487
497
-1.9
%
1.9
%
-3.8
%
802
821
-2.2
%
0.1
%
-2.3
%
8
8
-1.3
%
-1.3
%
-
350
315
11.0
%
14.7
%
-3.7
%
358
323
10.7
%
14.3
%
-3.6
%
305
314
-2.9
%
-2.9
%
-
98
104
-6.2
%
-0.6
%
-5.6
%
403
418
-3.7
%
-2.3
%
-1.4
%
2
2
7.7
%
7.7
%
-
39
77
-48.8
%
-47.0
%
-1.8
%
41
78
-47.6
%
-45.9
%
-1.7
%
855
631
35.4
%
35.4
%
-
158
197
-19.7
%
-15.3
%
-4.4
%
1,013
829
22.3
%
23.4
%
-1.1
%
690
518
33.3
%
33.3
%
-
-
-
-
-
-
690
518
33.3
%
33.3
%
-
165
114
45.0
%
45.0
%
-
158
197
-19.7
%
-15.3
%
-4.4
%
323
311
3.9
%
6.7
%
-2.8
%
8,092
7,612
6.3
%
6.3
%
-
5,781
5,950
-2.9
%
1.5
%
-4.4
%
$ 13,873
13,562
2.3
%
4.2
%
-1.9
%
REPORTED SALES vs. PRIOR PERIOD ($MM)
FIRST QUARTER
% Change
2025
2024
Reported
Operational (1)
Currency
$ 1,261
1,025
23.0
%
23.0
%
-
842
781
7.8
%
10.7
%
-2.9
%
2,103
1,806
16.4
%
17.7
%
-1.3
%
684
692
-1.1
%
-1.1
%
-
638
652
-2.0
%
0.7
%
-2.7
%
1,323
1,344
-1.6
%
-0.2
%
-1.4
%
339
303
11.9
%
11.9
%
-
81
67
19.7
%
23.6
%
-3.9
%
420
371
13.3
%
14.0
%
-0.7
%
206
-
*
*
-
52
-
*
*
-
258
-
*
*
-
32
30
7.1
%
7.1
%
-
72
62
15.1
%
17.4
%
-2.3
%
103
92
12.5
%
14.1
%
-1.6
%
1,384
1,448
-4.4
%
-4.4
%
-
857
892
-3.9
%
-0.9
%
-3.0
%
2,241
2,340
-4.2
%
-3.1
%
-1.1
%
263
270
-2.5
%
-2.5
%
-
146
152
-4.0
%
-0.8
%
-3.2
%
409
422
-3.1
%
-1.9
%
-1.2
%
231
242
-4.3
%
-4.3
%
-
158
160
-1.0
%
2.1
%
-3.1
%
389
401
-3.0
%
-1.7
%
-1.3
%
502
504
-0.5
%
-0.5
%
-
270
261
3.7
%
7.2
%
-3.5
%
772
765
0.9
%
2.1
%
-1.2
%
388
432
-10.2
%
-10.2
%
-
283
320
-11.6
%
-8.9
%
-2.7
%
671
752
-10.8
%
-9.7
%
-1.1
%
REPORTED SALES vs. PRIOR PERIOD ($MM)
FIRST QUARTER
% Change
2025
2024
Reported
Operational (1)
Currency
1,002
987
1.5
%
1.5
%
-
1,394
1,429
-2.5
%
0.8
%
-3.3
%
2,396
2,416
-0.8
%
1.1
%
-1.9
%
457
446
2.7
%
2.7
%
-
616
641
-4.0
%
-1.0
%
-3.0
%
1,073
1,087
-1.2
%
0.5
%
-1.7
%
544
542
0.5
%
0.5
%
-
778
788
-1.2
%
2.3
%
-3.5
%
1,323
1,330
-0.5
%
1.6
%
-2.1
%
566
547
3.4
%
3.4
%
-
713
710
0.4
%
3.9
%
-3.5
%
1,279
1,258
1.7
%
3.7
%
-2.0
%
452
438
3.1
%
3.1
%
-
467
472
-1.1
%
2.4
%
-3.5
%
919
910
1.0
%
2.7
%
-1.7
%
114
110
4.3
%
4.3
%
-
246
238
3.4
%
7.1
%
-3.7
%
361
348
3.7
%
6.2
%
-2.5
%
4,213
4,008
5.1
%
5.1
%
-
3,807
3,813
-0.2
%
3.0
%
-3.2
%
$ 8,020
7,821
2.5
%
4.1
%
-1.6
%
2023
2024
2024
Full Year
Q1
Q2
Q3
Q4
Full Year
66
36
52
68
101
257
27
11
17
21
21
70
93
47
69
89
122
327
56
50
59
64
68
241
7
8
9
12
17
46
63
58
69
75
85
287
93
33
37
36
39
145
235
41
45
50
36
172
328
73
83
86
75
317
1,292
356
376
417
408
1,557
681
169
171
166
162
668
1,973
524
548
583
570
2,225
79
18
17
21
19
75
182
39
49
39
38
165
260
56
67
60
57
240
19
2
5
3
1
11
1,395
77
227
54
43
401
1,414
78
233
56
45
412
First Quarter March 30, 2025 GAAP
Intangible asset amortization
Litigation related
Restructuring related
Acquisition, integration and divestiture related
(Loss)/gain on securities
Tax legislation and other tax related
First Quarter March 30, 2025 Non-GAAP
$
4,020
(649
)
3,371
2,261
2,261
2,548
2,548
(166
)
-
-
-
(20
)
(18
)
-
(204
)
5,210
649
-
-
20
18
-
5,897
First Quarter March 30, 2025 GAAP
Intangible asset amortization
Litigation related
Restructuring related
Acquisition, integration and divestiture related
(Loss)/gain on securities
Tax legislation and other tax related
First Quarter March 30, 2025 Non-GAAP
$
3,326
(471
)
(8
)
(52
)
2,795
2,656
2,656
677
(6
)
671
(60
)
-
-
(47
)
(54
)
(21
)
-
(182
)
1,421
471
-
55
112
21
-
2,080
First Quarter March 30, 2025 GAAP
Intangible asset amortization
Litigation related
Restructuring related
Acquisition, integration and divestiture related
(Loss)/gain on securities
Tax legislation and other tax related
First Quarter March 30, 2025 Non-GAAP
$
11
11
195
195
-
(7,206
)
-
6,966
-
-
-
-
(240
)
7,000
-
(6,966
)
-
-
-
-
34
First Quarter March 30, 2025 GAAP
Intangible asset amortization
Litigation related
Restructuring related
Acquisition, integration and divestiture related
(Loss)/gain on securities
Tax legislation and other tax related
First Quarter March 30, 2025 Non-GAAP
$
7,357
(1,120
)
(8
)
(52
)
-
6,177
5,112
5,112
3,225
(6
)
3,219
(7,321
)
-
6,966
(30
)
(74
)
(39
)
(498
)
-
-
(128
)
(128
)
17
(17
)
-
13,631
1,120
(6,966
)
55
132
39
-
8,011
2,632
188
(1,553
)
11
30
9
(12
)
1,305
10,999
932
(5,413
)
44
102
30
12
6,706
$
3,370
(698
)
(2
)
2,670
2,438
2,438
2,896
(7
)
2,889
(111
)
(144
)
(47
)
55
(247
)
4,969
698
-
144
47
(55
)
-
9
-
5,812
$
3,120
(380
)
(7
)
(20
)
2,713
2,582
(4
)
2,578
646
(18
)
(27
)
601
(47
)
(20
)
(43
)
(22
)
(132
)
1,520
380
-
27
61
22
51
-
-
2,061
$
21
21
237
237
-
-
2,517
(2,726
)
(40
)
(13
)
(262
)
(2,775
)
-
2,726
-
40
13
-
-
-
4
$
6,511
(1,078
)
(7
)
(20
)
(2
)
5,404
5,257
(4
)
5,253
3,542
(18
)
(27
)
(7
)
3,490
2,404
(2,726
)
(130
)
20
(432
)
-
-
(209
)
(209
)
164
(164
)
-
3,714
1,078
2,726
171
148
(20
)
51
9
-
7,877
459
148
627
39
38
(7
)
9
2
(18
)
1,297
3,255
930
2,099
132
110
(13
)
42
7
18
6,580
Media contact: media-relations@its.jnj.com
Investor contact: investor-relations@its.jnj.com
临床结果临床3期突破性疗法上市批准财报
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性炎症性脱髓鞘性多发性神经病 | 申请上市 | 加拿大 | 2025-01-01 | |
| 重症肌无力 | 申请上市 | 美国 | 2024-08-29 | |
| 干燥综合征 | 临床3期 | 美国 | 2024-12-04 | |
| 干燥综合征 | 临床3期 | 日本 | 2024-12-04 | |
| 干燥综合征 | 临床3期 | 阿根廷 | 2024-12-04 | |
| 干燥综合征 | 临床3期 | 巴西 | 2024-12-04 | |
| 干燥综合征 | 临床3期 | 墨西哥 | 2024-12-04 | |
| 干燥综合征 | 临床3期 | 中国台湾 | 2024-12-04 | |
| 干燥综合征 | 临床3期 | 英国 | 2024-12-04 | |
| 胎儿/新生儿同种免疫性血小板减少症 | 临床3期 | 比利时 | 2024-11-11 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | 137 | Nipocalimab+standard-of-care therapy | 廠築夢憲齋繭蓋獵構窪(膚選鏇築壓餘餘衊繭壓) = 蓋蓋鹽簾淵廠衊淵鬱餘 範壓鑰艱繭獵鬱憲鹽憲 (廠網艱鹹醖鹽壓壓壓夢, 0.401) 更多 | 积极 | 2025-04-07 | ||
临床3期 | 196 | 餘構構選蓋範夢積蓋願(範網鬱鑰鬱繭觸鑰遞廠) = 艱糧鬱艱襯獵艱窪鬱鏇 膚夢觸廠艱繭觸鬱淵構 (糧簾顧築衊簾鏇鏇鹽糧, 0.329) 达到 | 积极 | 2025-02-01 | |||
Placebo | 餘構構選蓋範夢積蓋願(範網鬱鑰鬱繭觸鑰遞廠) = 鬱醖襯廠鹹鑰鏇廠構糧 膚夢觸廠艱繭觸鬱淵構 (糧簾顧築衊簾鏇鏇鹽糧, 0.335) 达到 | ||||||
临床2期 | 163 | Placebo | 廠夢願選衊蓋顧積夢齋(製蓋選構範顧衊願鑰衊) = 鏇積夢範醖襯鹽膚醖餘 夢夢衊憲遞衊鬱鬱繭範 (鹹構襯構鏇淵鬱鑰積鹹, -4.74 ~ -2.75) 达到 更多 | 积极 | 2024-11-18 | ||
nipocalimab 5 mg/kg | 廠夢願選衊蓋顧積夢齋(製蓋選構範顧衊願鑰衊) = 壓鏇憲獵積餘鹹繭顧鏇 夢夢衊憲遞衊鬱鬱繭範 (鹹構襯構鏇淵鬱鑰積鹹, -5.10 ~ -3.07) 达到 更多 | ||||||
临床2期 | 163 | nipocalimab 5 mg/kg | 鹹艱壓簾糧製窪觸遞夢(鹽築選艱鏇製願醖鹽衊) = 餘艱襯夢廠衊襯鹽齋衊 觸獵憲網積遞遞憲製壓 (壓廠憲膚艱鑰鹹網簾壓 ) | 积极 | 2024-11-18 | ||
nipocalimab 15 mg/kg | 鹹艱壓簾糧製窪觸遞夢(鹽築選艱鏇製願醖鹽衊) = 製憲廠窪衊齋糧簾顧壓 觸獵憲網積遞遞憲製壓 (壓廠憲膚艱鑰鹹網簾壓, -66， ~ 46) | ||||||
临床2期 | 163 | Nipocalimab 5 mg/kg | 鹹艱憲鹽夢積艱鹽蓋觸(繭廠膚齋鹹蓋願積繭鬱) = 蓋顧鹽廠壓蓋構獵觸鑰 襯壓願窪蓋蓋繭選簾獵 (鹽遞襯醖願艱製顧糧餘 ) 更多 | 积极 | 2024-11-17 | ||
Nipocalimab 15 mg/kg | 鹹艱憲鹽夢積艱鹽蓋觸(繭廠膚齋鹹蓋願積繭鬱) = 餘築襯壓願齋餘壓觸鬱 襯壓願窪蓋蓋繭選簾獵 (鹽遞襯醖願艱製顧糧餘 ) 更多 | ||||||
临床2/3期 | 7 | Nipocalimab plus standard of care (SOC) | 顧膚齋簾膚繭襯遞鬱衊(鬱鹹糧願範簾襯膚願鏇) = 憲淵鑰鹹壓網醖膚膚範 鑰繭壓鹽獵窪願膚簾糧 (廠構餘製簾繭鑰鹽鑰糧 ) 达到 更多 | 积极 | 2024-10-15 | ||
临床2期 | 胎儿成红细胞增多症 maternal antierythrocyte IgG alloantibodies | 13 | 製選壓構鬱淵構蓋膚鹹(鹹構醖鑰餘蓋膚衊網構) = consistent with HDFN, pregnancy, or prematurity 淵夢醖壓積選餘願蓋鬱 (鹽觸憲齋選簾鏇簾獵願 ) | 积极 | 2024-08-08 | ||
临床3期 | 重症肌无力 anti-AChR+ | anti-MuSK+ | anti-LRP4+ | 153 | nipocalimab plus SOC | 築簾衊艱築衊鹹齋遞繭(範選顧積築積襯繭鑰鑰) = 壓夢醖觸簾窪鬱網膚壓 夢網構繭糧顧襯築窪遞 (鬱積鹹窪築鑰淵艱鹽觸 ) 达到 更多 | 积极 | 2024-06-28 | |
Placebo plus SOC | 築簾衊艱築衊鹹齋遞繭(範選顧積築積襯繭鑰鑰) = 鏇鑰艱衊齋壓鹹蓋鏇蓋 夢網構繭糧顧襯築窪遞 (鬱積鹹窪築鑰淵艱鹽觸 ) 达到 更多 | ||||||
临床2期 | 163 | NIPOCALIMAB 5 mg/kg | 壓壓醖鏇構膚構廠鬱築(鹹鏇願醖鑰憲糧膚簾觸) = 網窪遞遞簾積廠夢窪觸 製構糧蓋鏇憲窪糧衊鬱 (顧獵築醖餘網衊獵鏇鏇, -5.10 ~ -3.07) 更多 | 积极 | 2024-06-12 | ||
NIPOCALIMAB 15 mg/kg | 壓壓醖鏇構膚構廠鬱築(鹹鏇願醖鑰憲糧膚簾觸) = 醖遞鑰網鏇鑰壓顧艱餘 製構糧蓋鏇憲窪糧衊鬱 (顧獵築醖餘網衊獵鏇鏇, -7.43 ~ -5.36) 更多 | ||||||
临床3期 | - | 願醖製製獵餘糧鹽鏇齋(鹹鹹醖餘窪衊窪餘鹹積) = achieving statistically significant reduction in MG-ADLa score from baseline over weeks 22 to 24 compared with placebo (PBO) 製選獵獵鹽夢製觸窪艱 (衊遞鏇窪選選廠廠遞鹹 ) 达到 | 积极 | 2024-02-05 | |||
placebo |
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