Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).
Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.
For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.
The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

开始日期2025-06-26

申办/合作机构

AbbVie, Inc.

NCT06865105

/ Recruiting临床2期

A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms.
The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

开始日期2025-04-18

申办/合作机构

AbbVie, Inc.

NCT06606808

/ Recruiting临床1/2期

Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease

Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Risankizumab is a human monoclonal antibody against IL23 p19, part of a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to its receptor. Primary non-response to risankizumab is high in both CD and UC. Currently, there are no predictors of response to risankizumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of risankizumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled risankizumab (risankizumab-800CW). This study aims to assess the safety and the optimal dose of risankizumab-800CW to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).

开始日期2024-11-08

申办/合作机构

University Medical Center Groningen

100 项与利生奇珠单抗相关的临床结果

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100 项与利生奇珠单抗相关的转化医学

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100 项与利生奇珠单抗相关的专利（医药）

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605

项与利生奇珠单抗相关的文献（医药）

2025-04-10·encephalitis

Acyclovir-induced sinus bradycardia: a case report and literature review

Article

作者: Mikerov, Gregory ; Darwish, Ilyse ; Goldman, Gail

In this report, we describe the case of a 51-year-old female who presented to our emergency department with varicella zoster infection. Her relevant medical history included rheumatoid arthritis which was treated with risankizumab. Intravenous acyclovir therapy was initiated due to concern for disseminated disease as she was experiencing T4 dermatomal involvement and new-onset scalp pain. On day 3 of antiviral therapy, the patient developed a sinus bradycardia of 35 beats/min. This persisted until 3 days after the discontinuation of acyclovir. This is the third reported case of sinus bradycardia potentially linked to acyclovir administration. Thus, clinicians should consider intravenous acyclovir as a possible cause of de novo sinus bradycardia.

2025-04-05·CHINESE MEDICAL JOURNAL

Epidemiology, pathogenesis, diagnosis, and treatment of inflammatory bowel disease: Insights from the past two years

Review

作者: Liu, Dan ; Zhang, Hao ; Zhou, Jiaming ; Wang, Zhuo ; Wan, Jian ; Xie, Shengmao ; Wu, Kaichun

Abstract:

Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease, is a chronic inflammation of the gastrointestinal tract with unknown etiology. The cause of IBD is widely considered multifactorial, with prevailing hypotheses suggesting that the microbiome and various environmental factors contribute to inappropriate activation of the mucosal immune system in genetically susceptible individuals. Although the incidence of IBD has stabilized in Western countries, it is rapidly increasing in newly industrialized countries, particularly China, making IBD a global disease. Significant changes in multiple biomarkers before IBD diagnosis during the preclinical phase provide opportunities for earlier diagnosis and intervention. Advances in technology have driven the development of telemonitoring tools, such as home-testing kits for fecal calprotectin, serum cytokines, and therapeutic drug concentrations, as well as wearable devices for testing sweat cytokines and heart rate variability. These tools enable real-time disease activity assessment and timely treatment strategy adjustments. A wide range of novel drugs for IBD, including interleukin-23 inhibitors (mirikizumab, risankizumab, and guselkumab) and small-molecule drugs (etrasimod and upadacitinib), have been introduced in the past few years. Despite these advancements, approximately one-third of patients remain primary non-responders to the initial treatment, and half eventually lose response over time. Precision medicine integrating multi-omics data, advanced combination therapy, and complementary approaches, including stem cell transplantation, psychological therapies, neuromodulation, and gut microbiome modulation therapy, may offer solutions to break through the therapeutic ceiling.

2025-04-04·Journal of Crohns & Colitis

Corticosteroid-sparing effects of risankizumab efficacy and safety in patients with moderately to severely active ulcerative colitis

Article

作者: Duan, Weijiang Rachel ; Hecht, Patrick M ; Louis, Edouard ; Barrachina, Elena Marced ; Vladea, Ramona ; Sharma, Dolly ; Reinisch, Walter ; Loftus, Edward V ; Panaccione, Remo ; Zhang, Yafei ; Kalabic, Jasmina ; Schreiber, Stefan ; Rubin, David T

Abstract:

Background and aims:

This post hoc analysis evaluated the corticosteroid-sparing effects of risankizumab (RZB) therapy in patients with moderate-to-severe ulcerative colitis in the phase 3 induction and maintenance studies, INSPIRE and COMMAND.

Methods:

Patients were randomized (2:1) to 12 weeks of intravenous RZB or placebo (PBO) induction therapy; responders to intravenous RZB were randomized (1:1:1) to receive subcutaneous RZB 180 mg, 360 mg, or PBO (RZB withdrawal) maintenance therapy. Baseline corticosteroid doses were maintained during induction, with a mandatory taper beginning at maintenance week 0. Efficacy outcomes were evaluated by baseline corticosteroid use at induction week 12, while corticosteroid-free clinical and endoscopic outcomes were assessed at maintenance week 52 among the overall population and among patients on corticosteroids at baseline. Safety was also assessed.

Results:

At baseline, 35.7% (348/975) of patients were taking corticosteroids. At induction week 12, greater rates were observed for clinical, endoscopic, and patient-reported outcomes in RZB 1200 mg-treated patients compared with PBO, regardless of baseline corticosteroid use. RZB 180 mg and 360 mg treatment resulted in higher corticosteroid discontinuation rates (RZB 180 mg 64.9% [48/74]; RZB 360 mg 54.2% [32/59]; PBO [withdrawal] 36.8% [25/68], P ≤ .01) and corticosteroid-free clinical, endoscopic, and patient-reported outcomes at week 52, compared with PBO (withdrawal). The rates of treatment-emergent adverse events were similar regardless of baseline corticosteroid use during induction and maintenance.

Conclusions:

The efficacy of RZB induction therapy was independent of corticosteroid use, with high rates of corticosteroid-free outcomes observed in the overall population and among patients with baseline corticosteroid use, reaffirming the potential of RZB to serve as a corticosteroid-sparing therapy for patients with ulcerative colitis.

Clinicaltrial.gov numbers:

NCT03398148 and NCT03398135

682

项与利生奇珠单抗相关的新闻（医药）

2025-04-08

·生物制药进展杂评

口服自免！又一个医药爆点正在崛起

自免领域写过一些列文章，可参考文末链接，基本是大分子抗体药物为主，小分子还是JAK/TYK为主，这次看到这篇小分子文章，抓哪里供大家分享。MNC们不仅争抢口服小分子GLP-1，还有风口正盛的自免口服药。多年来，强生、赛诺菲、礼来等大药企纷纷布局这一赛道，自免口服药的诱惑力为何这么大？一直以来，自身免疫疾病的治疗面临着诸多临床痛点，而在不断解决痛点的同时自免药物也在不断迭代：从最初抗风湿药、非甾体抗炎药和糖皮质激素等疗法，存在起效慢疗效有限、副作用多等问题；到后来传统小分子靶向药弥补了上述局限性的同时，却出现了个体疗效差异、耐药与整体有效性不足等问题；最后，单克隆抗体等生物制剂以强大的疗效优势成为主流，以至于后来不断涌现一系列更精准的IL-2/17/23/4等生物药，却仍难逃患者顺应性不足、生产成本高、治疗经济负担重等问题。‌如今，随着当下医药基础研究水平的上涨，当口服小分子药物拥有了媲美生物制剂的疗效，且安全性问题良好，那么时代又还能否继续变化？目前来看，这样的口服小分子药物正好符合了市场对“疗效接近生物药、选择性强、安全性高”的自免口服药的临床需求。因此，口服小分子靶向药再一次站上了自免新药研发的风口，自免赛道也因此大幅掀起“剂型创新”的研发热潮，无数制药企业纷纷加入了这场押注。口服自免药，为何吃香？近几年来，越来越多MNC药企开始注意到自免口服药这个全新的赛道，且已逐渐成为MNC巨头的必争之地。自2017年以来，这一领域接连发生收并购和BD交易，其中不乏强生、礼来、赛诺菲、艾伯维等全球制药巨头纷纷押注。多肽创新：2017年，强生旗下杨森制药以近10亿美元与Protagonist Therapeutics签订独家许可合作协议，共同开发口服IL-23受体拮抗剂JNJ-2113（Icotrokinra，前称PN-235）。PROTAC创新：2020年，赛诺菲以总交易额20亿美元与Kymera达成合作，共同开发靶向IRAK4的PROTAC降解剂KT-474，用于治疗免疫炎症疾病。之后双方在2024年7月再次达成合作，扩大KT-474治疗化脓性汗腺炎、特应性皮炎两项Ⅱ期临床试验。小分子靶点创新：2022年，武田制药豪掷60亿美元收购Nimbus Lakshmi，获得了治疗银屑病和IBD疾病的口服TYK2抑制剂Zasocitinib（TAK-279）。小分子靶点创新：2024年，艾伯维先后收购Landos Biopharma、Nimble公司，将口服NLRX1激动剂NX-13和口服IL23R抑制剂纳入囊中。可见，MNC巨头们在自免口服药领域的布局，呈现出技术路径多元、靶点选择差异化的鲜明特征。其中，强生押注环肽技术开发IL-23受体拮抗剂，延续了其在免疫调控领域的传统优势；赛诺菲通过PROTAC技术开辟蛋白降解新维度；武田豪赌TYK2抑制剂的广谱抗炎潜力；礼来则切入IL-17和整合素α4β7双靶点，展现其组合拳策略；艾伯维更是以连续收购构建“NLRX1激动剂+IL23R抑制”的免疫调控网络，形成多机制协同的独特布局。这种百花齐放的技术布局，既是巨头们对差异化竞争的深刻洞察，也是对自免疾病临床痛点的不同解法，为患者提供了多层次的治疗选择。毕竟，自免疾病机制复杂，单一技术难以覆盖所有临床需求。数据来源：海通证券研报、公开数据整理可自免口服药为什么这么吃香？其主要的原因在于其具备“依从性”和“疗效优势”。根据强生的调研数据显示：约有50-70%的匹配银屑病/IBD患者未选择使用自免生物制剂，其中约30%正是由于注射给药方式的问题；而且还约有75%正在使用注射类药物的患者愿意在安全性和疗效类似的情况下，切换到口服药物。从这一点上看，在自免疾病领域口服药以其诸多优势，在临床端的需求巨大且迫切：有效性：靶向精准，快速起效。安全性：副作用可控，长期风险低。顺应性：用药便捷，依从性高。经济性：成本优势显著，市场渗透潜力大。另一方面，由于当前市场获批的自免口服药较少，竞争格局较为缓和，安全有效的口服类药物也更容易进入前线，对于研发企业而言，对应的市场空间也就更大。数据来源：公开数据整理以强生的JNJ-2113为例，其在横向对比（非头对头）已上市的安进阿普米斯特片（Otezla）、BMS的Sotyktu之时，其16周数据中无论是PASI-90还是SPGA (0/1)，其疗效数据均明显更高。同时，虽然对比银屑病领域在售生物制剂，JNJ-2113的有效性数据虽不及依奇珠单抗、古塞奇尤单抗、利生奇珠单抗等强势疗法，但却也明显超过了阿达木单抗与乌司奴单抗等疗法。同时，考虑到临床中有一定比例生物制剂经治患者，所以它的定位或许还是针对在意便捷性的银屑病患者。相近的疗效数据，便利的用药便捷性，均决定了自免口服药成为MNC们的必争之地。大药频出频频的大动作，让MNC们囊括了许多潜在重磅管线，主要体现在银屑病、炎症性肠病（IBD）领域。以银屑病口服药为例。安进豪掷134亿美元收购的阿普米司特（Otezla），是一种新型的口服PDE4抑制剂，目前已在50多个国家和市场获批，用于治疗银屑病性关节炎、中重度斑块状银屑病等适应症，最近几年全球销售额均超过20亿美元。另外，百时美施贵宝（BMS）原研的全球首个口服TYK2抑制剂Sotyktu（氘可来昔替尼），仅凭斑块状银屑病这一适应症，2024年实现收入2.46亿美元。值得一提的是，Sotyktu在治疗斑块状银屑病的头对头试验中击败了安进的阿普米司特。目前，Sotyktu治疗银屑病关节炎的两项III期研究已成功，未来有望加速放量，BMS预测其2030年将达到40亿美元销售额。武田也看中口服TYK2抑制剂，斥资60亿美元收购了Zasocitinib，目前该药正在开展治疗银屑病和IBD的临床研究，预计2026年提交上市申请及披露治疗克罗恩病（CD）和溃疡性结肠炎（UC）的IIb期研究数据。武田预计其峰值销售额在30亿至60亿美元之间。图源：国联证券研报不过，值得一提的是，强生的口服IL-23R多肽Icotrokinra，在治疗中重度斑块状银屑病的头对头试验中击败了BMS的Sotyktu，或将改写银屑病治疗历史。此外，Icotrokinra在治疗IBD的Ⅱb期研究也取得了积极临床结果，强生预计其销售峰值有望超过50亿美元。在研管线花样多诚如上文所讲，近年来，口服给药在自免领域正在掀起革命性浪潮，MNC加速布局这一赛道，相较于传统注射制剂，口服药物在提高患者依从性、降低治疗成本及简化用药管理方面优势显著，尤其为长期用药的自身免疫患者带来福音。目前，全球自免口服相关研发管线中，根据其技术类型布局的不同，可差异性的分布为四大主要类型，即口服小分子制剂、口服多肽药物、口服核酸药物与口服抗体药物，其因各自技术特点、临床潜力及市场前景，受到全球制药领域关注。从技术优劣方面来看，四个主要类型间均存在明显的差异化优势，以及目前亟待解决的局限性问题。药物类型优势劣势口服小分子技术成熟、成本低、易规模化生产靶点特异性不足，可能伴随多靶点副作用（如JAK抑制剂的血栓风险）口服多肽高生物活性、低免疫原性，适合复杂靶点调控口服稳定性差，需通过环肽修饰或递送技术优化口服核酸精准靶向致病基因，从源头阻断疾病进程（如TNF-α相关炎症）递送系统（如LNP）效率待提升，长期安全性数据仍需积累口服抗体高特异性结合靶点，肠道局部给药可规避全身暴露风险大分子吸收障碍显著，需依赖单域抗体或片段化设计突破生物利用度难题数据来源：公开数据整理从各类型口服自免新药的管线占比情况来看：口服小分子靶向药：约占口服自免新药管线的‌60%‌，是当前研发的主流方向，主要涉及靶点有TNF-α、IL-17、IL-23等主导炎症因子抑制剂，适应症集中于银屑病、类风湿性关节炎、炎症性肠病等领域。口服多肽药物：约占口服自免新药管线的‌10%‌，处于早期研发阶段，但临床进展活跃。比如强生的JNJ-2113，其目前已处于临床III期阶段，通过环肽技术优化稳定性，有望在炎症调控中展现独特优势。靶点适应症集中于银屑病、特应性皮炎等领域。口服核酸类药物：约占口服自免新药管线的‌5%‌，技术尚不成熟，但其但其在基因沉默疗法中的精准靶向性（如siRNA/mRNA技术）使其成为未来增长点。口服抗体类药物：约占口服自免新药管线的‌5%‌，研发难度较大，IL-17、IL-23等，银屑病、炎症性肠病等。总体上来看，口服自免细分领域中，口服小分子靶向药作为现阶段赛道领跑者，研发进展最快，如赛诺菲的IL-23抑制剂‌SAR441566等新药已经处于临床后期阶段，数据已接近现有常规疗法。预计未来5年有望占据自免领域30%以上的市场份额，尤其在银屑病、类风湿性关节炎等慢性自免大适应症中；而口服多肽药物作为目前口服自免领域新的突破点，比肩生物制剂的免疫调节能力之下，副作用却更小，未来可能填补传统小分子和生物制剂之间的疗效空白。之后，口服核酸类药物，目前发展尚处于初期阶段，但随着口服递送技术的逐步成熟，已有针对炎症因子的候选药物进入早期临床，其精准靶向致病基因的特点，也难保其不会成为未来自免新药市场的颠覆性存在；至于口服抗体领域，作为创新新药概念，其主要应用场景偏向自免消化道疾病，通常情况下，是通过设计低皮摩尔级别大小与工程化设计出使大分子化合物难以发挥作用的蛋白酶来实现。目前，Sorriso Pharmaceuticals开发的TNFα/IL-23双抗SOR102，首次成功证明口服抗体能够产生临床疗效，有潜力为溃疡性结肠炎患者提供一种有效且便捷的口服治疗选择。很显然，随着制剂技术（如纳米晶体、渗透泵片）与生物工程（如分子嫁接、单域抗体）的协同发展，口服自免药物正从“概念验证”走向“临床落地”，推动了治疗范式从“广谱抑制”向“精准调控”转变。而药企作为众多口服自免新药的载体，未来具备差异化技术储备的药企（如口服多肽、核酸递送平台、口服抗体专利）或将在竞争中脱颖而出。国内药企的机会当然，面对自免口服药这块巨大的市场蛋糕，国内药企自然不会错过，主要围绕TYK2抑制剂进行研发，入局者包括益方生物、诺诚健华、海思科、翰森制药等。图源：首创证券研报益方生物自研的TYK2抑制剂D-2570，正在开展治疗银屑病（Ⅱ期）和溃疡性肠炎（Ⅰ期）的临床试验，其中针对银屑病治疗的II期临床已取得积极结果，疗效显著优于安慰剂组，且安全性良好。根据海通证券研报披露，TYK2抑制剂针对银屑病治疗的PASI100临床有效率为10-33%，当前应用广泛的IL-17、IL-23生物制剂有效率为29-51%，整体口服药物的有效率为3-40%，整体生物制剂有效率为13-51%。D-2570低中高三个剂量组12周PASI100应答率达39-50%，肩对肩比较来看，其不仅展现出BIC TYK2抑制剂潜力（此前最好的是武田制药Zasocitinib，有效率33%），而且将口服药物的有效率提升至生物制剂水平。图源：海通证券研报诺诚健华布局了多款自免口服药，包括ICP-332（口服TYK2 JH1抑制剂）、ICP-488（口服TYK2变构抑制剂）、ICP-923（口服IL-17A拮抗剂）等。ICP-332正在开展治疗特应性皮炎（AD）的Ⅲ期研究，目前全球尚无TYK2抑制剂获批治疗AD，先发优势显著。据II期研究结果显示，ICP-332单药治疗4周后EASI75（皮损面积和严重程度改善≥75%）应答率达到64%。对比来看，乌帕替尼（JAK1抑制剂）单药治疗16周EASI75提升约50%。值得一提的是，乌帕替尼是强生的畅销药，2024年销售额同比增长50.4%至59.71亿美元。ICP-488治疗银屑病的III期注册临床试验已完成首例患者给药。根据2025年美国皮肤病学会年会公布的临床数据显示，在治疗中重度斑块状银屑病的II期研究中，ICP-488在每天一次（QD）6毫克和每天一次9毫克的剂量下对银屑病患者均具有显著疗效，且展现出良好的安全性和耐受性，为中重度银屑病患者提供了有价值的治疗选择。 ICP-923靶向自免赛道的“明星靶点”IL-17，处于临床前阶段。IL-17药物领域的大药，是诺华的IL-17A抑制剂Cosentyx（司库奇尤单抗），2024年销售额达到61.41亿美元，不过采用皮下注射方式给药。与注射剂型相比，采用口服给药的ICP-923具备差异化优势。海思科研发的ESK-001，是一款高选择性且有BIC潜力的TYK2抑制剂。2021年，FL2021-001公司（Alumis的前身）以总交易额1.8亿美元，买下了ESK-001所属专利和权益。目前，ESK-001治疗中重度斑块状银屑病已处于Ⅲ期临床，治疗系统性红斑狼疮（SLE）和非传染性葡萄膜炎均已处于Ⅱ期阶段。翰森制药的TYK2选择性变构抑制剂HS-10374，治疗中重度斑块状银屑病已处于III期临床。据Ⅱ期研究结果显示，HS-10374的总体安全性与其他TYK2抑制剂相似，且“皮肤及皮下组织类疾病”不良事件的发生率低于安慰剂组。结语这场围绕自免口服药的研发竞赛，本质上是临床需求与技术创新的双重驱动。各家药企正基于自身技术积累和战略判断，在“剂型创新”的大框架下开辟专属赛道。自免口服药的故事，恰似免疫系统的微观剧场：强生凭借环肽技术弯道超车、赛诺菲豪赌PROTAC降解剂、礼来的产品组合正在蓄力爆发、艾伯维剑走偏锋探索NLRX1新靶点等等。另外，国内药企的TYK2抑制剂火种已点燃创新原野，未来或将有更多新型药物登场，参与角逐。“百花齐放”技术路径的多样性，将为患者提供多层次的治疗选择，且有望催生多个细分领域的大药。可以肯定的说，谁能率先攻克“疗效比肩生物药，安全性更优”的终极目标，谁就能在这场价值千亿美元的战役中，书写下一段医药传奇。参考资料：1.各家公司的财报、公告、官微2.开源证券、海通证券、首创证券研报自免系列文章阅读康诺亚IL-4R 单抗上市，力拼三年窗口期，8个III期产品虎视眈眈，适应症拓展速度决定未来成败IL-17 抗体国产新药上市，3年新药窗口期，竞争大战中定价能否出新低？自免系列6：IL-5/IL-5Rα未来如何立项突围？恒瑞vs正大天晴，新药对决生物类似药自免系列5：IL-23靶向药利生奇珠单抗头对头研究结果好，国内仅信达进入临床Ⅲ期自免系列4：度普利尤单抗COPD领域取得进展，预计2024年中国销售额超20亿自免系列3：乌司奴单抗百亿美元市场，康方、百奥泰、荃信争上市自免系列2：国内IL-17单抗市场超20亿，自免市场已打开，智翔金泰和恒瑞抢先撞线自身免疫专题系列开篇（1）：常见疾病、重磅药物及靶点7、自免靶点JAK1：阿斯利康的JAK1抑制剂AZD4604分子设计和优化详解6、证明Me-better？四款IL-23抗体非临床研究比较5、自免明星靶点IL-17：从发现到靶向治疗4、大交易频繁，IL-2摇摆在肿瘤免疫和自身免疫领域的舞者3、特异性皮炎药物之一：Dupilumab（度普利尤单抗）2、Dupilumab会否是下一个阿达木，IL-4R靶点适应症的拓展1、IL13——哮喘还是特应性皮炎？纠结中前行~~~自身免疫疾病综述相关文章：7、特异性皮炎（湿疹）的江湖6、特异性皮炎药物之一：Dupilumab（度普利尤单抗）5、特异性皮炎4、溃疡性结肠炎（UC）市场概览：肿瘤之后，自免领域的必争之地3、银屑病靶向药现状及研发前沿2、2019年战“狼”（SLE）药物频传喜讯（上）1、2019年战“狼”（SLE）药物频传喜讯（下）下面是我的咨询业务，欢迎多来勾搭~~公众号有个实名群，有兴趣可以加一下，虽然都喜欢潜水，不定时也会分享点报告

并购临床2期蛋白降解靶向嵌合体免疫疗法

2025-04-07

·BiG生物创新社

2024 TOP12制药巨头畅销榜，哪些药物更赚钱？

作者｜momo在全球医药产业持续创新驱动与精准战略布局的背景下，2024年医药行业延续稳健增长态势，核心治疗领域呈现明显分化特征。默沙东Keytruda以创纪录的294.82亿美元年销售额巩固其PD-1抑制剂市场霸主地位，强生Darzalex（达雷妥尤单抗）则通过差异化多发性骨髓瘤治疗方案实现19.8%的同比增速。值得关注的是，代谢疾病领域迎来爆发式增长，礼来GLP-1/GIP双受体激动剂Mounjaro凭借卓越的减重疗效实现销售三连跳，而诺和诺德司美格鲁肽通过口服剂型创新及心血管获益证据扩展，构建起超200亿美元的市场护城河，共同推动糖尿病/肥胖治疗市场规模突破千亿美元大关。图1.2024年制药巨头最畅销药物在这里，我们将根据2024年销售趋势介绍制药巨头销售额前三名的药品（图1），并探索它们成功背后的因素。 TOP 1：强生 2024年总营收：888.21亿美元销售额前三名药物：Darzalex、Stelara、Invega Sustenna/Xeplion/Invega Trinza/Trevicta状元：Darzalex2024年销售额：116.7亿美元Darzalex（达雷妥尤单抗）是一款靶向CD38的人源化单克隆抗体。CD38在多发性骨髓瘤细胞上过表达，Darzalex通过清除有CD38的细胞起到杀伤多发性骨髓瘤癌细胞的作用。2015年，FDA批准Darzalex用于接受过过往治疗的多发性骨髓瘤治疗。2024年Darzalex持续放量，全年销售额高达116.7亿美元，同比增长19.8%。这是该药自2015年上市以来，销售额首次突破百亿美元，成为强生旗下最畅销的药物。榜眼：Stelara2024年销售额：103.61亿美元Stelara（乌司奴单抗）是治疗自身免疫性疾病的药物，对银屑病、克罗恩病等病症有着出色的疗效，通过精准调节免疫系统来减轻炎症反应。它主要是通过靶向特定的免疫相关通路发挥作用。2009年，Stelara获FDA批准上市。在欧洲，它也被广泛用于相关疾病的治疗。在全球市场，Stelara已成为众多自身免疫病患者的重要治疗选择之一。根据强生公司公告，2024年Stelara在全球实现了103.61亿美元高额销售额，为强生公司在自免药物领域的营收做出了重要贡献。然而，由于欧洲等市场生物类似药竞争，2024年Stelara全年销售额出现了明显下滑。探花：Invega Sustenna/Xeplion/Invega Trinza/Trevicta2024年销售额：42.22亿美元Invega Sustenna/Xeplion/Invega Trinza/Trevicta是强生旗治疗精神分裂的系列药物，是强生在神经科学板块最核心的产品，2024年全年营收40.22亿美元，占比8%，同比增长10.1%。 TOP 2：罗氏 2024年总营收：688.92亿美元销售额前三名药物：Ocrevus、Hemlibra、Vabysmo状元：Ocrevus2024年销售额：76.80亿美元Ocrevus （奥瑞利珠单抗）是一种靶向CD20阳性B细胞单克隆抗体，用于治疗多发性硬化症（MS）。临床前研究显示，Ocrevus可与表达在某些B细胞表面上的CD20蛋白结合，但不与干细胞或浆细胞结合，因此患者仍可维持其免疫系统的重要功能。在神经领域，多发性硬化症药物Ocrevus多年稳坐罗氏的头牌。2024年，Ocrevus销售额高达76.80亿美元，同比增长9%。为了巩固Ocrevus地位，罗氏于在欧美推出Ocrevus的皮下制剂。此外，罗氏还在开发更高剂量的Ocrevus，已处于III期临床阶段，有望于2025年申报上市。榜眼：Hemlibra2024年销售额：51.28亿美元Hemlibra（艾美赛珠单抗）是罗氏开发的一款重组人源化双抗，通过连接FX和FIXa恢复缺失的FVIII的功能，以恢复A型血友病患者的凝血功能。目前该产品已在欧、美、日、中等全球多国获批上市。2024年，Hemlibra以约51.28亿美元的销售额（+12%）位居罗氏畅销药榜单的第二名。探花：Vabysmo2024年销售额：44.00亿美元适应症：Vabysmo（法瑞西单抗）是一种抗血管内皮生长因子（VEGF）和血管生成素-2（Ang-2）的人源化双特异性免疫球蛋白G1（IgG1）抗体，用于治疗由于视网膜静脉阻塞（RVO）引起的黄斑水肿导致的视力损害、新生血管性年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）。该药物于2022年1月在美国获批上市，上市第三年，其全球销售额已达44.00亿美元，同比增长68%，正式成为罗氏的增长支柱。 TOP 3：辉瑞 2024年总营收：636.27亿美元销售额前三名药物：Eliquis、Prevnar family、Paxlovid状元：Eliquis2024年销售额：73.66亿美元Eliquis（阿哌沙班）是BMS和辉瑞公司联合研发的一种新型凝血因子Xa抑制剂，2012 年获得FDA批准用于非瓣膜性心房颤动患者，以降低中风和血栓的风险。2014年，它被批准用于治疗深静脉血栓形成（DVT）和肺栓塞（PE）。现主要用于多种血栓栓塞性疾病的临床使用。2024年全年销售额73.66亿美元，同比增长9%，继续在抗凝血药物市场中占据重要地位。该产品在美国和欧洲的某些市场或因非瓣膜性房颤适应症份额增加，部分抵消了仿制药竞争造成的影响，营收增速相较2023年小幅提升。榜眼：Prevnar family2024年销售额：64.11亿美元Prevnar family肺炎球菌疫苗（Prevnar 20&13）2024年共创收64.11亿美元，同比减少1%。得益于美国和国际发达国家市场需求，Prevnar family为辉瑞2024年业绩增长提供了强劲驱动力。探花：Paxlovid2024年销售额：57.16亿美元Paxlovid（帕罗韦德）是辉瑞研发的一款口服抗病毒药物，该药为口服小分子新冠病毒治疗药物，用于治疗成人伴有进展为重症高风险因素的轻至中度新型冠状病毒肺炎（COVID-19）患者。2024年，Paxlovid和Comirnaty两款新冠产品为辉瑞带来超110亿美元销售额。 TOP 4：默沙东 2024年总营收：641.68亿美元销售额前三名药物：Keytruda、Gardasil/Gardasil 9、Lynparza状元：Keytruda2024年销售额：294.82亿美元Keytruda（帕博利珠单抗）是一款PD-1免疫检查点蛋白抑制剂，目前已在美国、欧洲、中国、日本及全球其他国家和地区获批用于治疗转移性或不可切除、复发性头颈部鳞状细胞癌患者。2024年，Keytruda以18%的增长速度创收294.82亿美元，登顶全球药王宝座，其销售额约占默沙东总营收的46%。为巩固其地位，默沙东通过拓展早期适应症、进行联用布局以及开发皮下制剂等策略试图将K药的临床价值和商业化价值最大化。榜眼：Gardasil/Gardasil 92024年销售额：85.83亿美元Gardasil是第一款获批的人乳头瘤病毒（HPV）预防性疫苗，于2006年获美国FDA批准上市，包括四价疫苗Gardasil和九价疫苗Gardasil 9。Gardasil/Gardasil是默沙东的另一王牌产品，2024年全年销售额为85.83亿美元，同比下降3%。在2024Q3财报中，Gardasil系列产品就初显颓势，主要原因在于中国地区的需求减少。而需求减少的背后，与激烈的竞争息息相关，国产九价已在路上，二价HPV疫苗更是陷入价格战。探花：Lynparza2024年销售额：13.11亿美元Lynparza（奥拉帕利）则是一种“first-in-class”的PARP抑制剂，也是首个合成致死靶向治疗药物，用于靶向带有同源重组修复（HRR）缺陷的细胞/肿瘤。目前，Lynparza已在美国、欧盟、日本及许多其他国家和地区获批，用于治疗gBRCAm、HER2阴性高危早期乳腺癌或gBRCAm、HER2阴性转移性乳腺癌。2024年，Lynparza则为默沙东带来了13.11亿美元的收入。 TOP 5：艾伯维 2024年总营收：563.34亿美元销售额前三名药物：Skyrizi、Humira、Rinvoq状元：Skyrizi2024年销售额：117.18亿美元Skyrizi（利生奇珠单抗）是一种白细胞介素 - 23（IL - 23）抑制剂，主要用于治疗中重度斑块状银屑病、银屑病关节炎等自身免疫性疾病。它通过精准作用于特定靶点，有效减轻皮肤炎症和关节症状。Skyrizi已在全球多个国家和地区获批上市，包括美国、欧洲等地。在临床应用中，为众多自身免疫疾病患者带来了新的治疗选择。2023年Skyrizi全球销售额合计77.63亿美元，2024年销售额接近120亿美元，同比增长50.9%，成为艾伯维继Humira之后的下一个百亿大单品。凭借在炎症性肠病和皮肤病治疗等领域广泛的应用前景，该产品被《Nature》预测将进入2025年全球畅销榜前五名。2024年6月，Skyrizi获得FDA批准用于治疗中度至重度活动性溃疡性结肠炎成人患者，至此该产品已斩获含斑块状银屑病、银屑病关节炎、克罗恩病等在内的7项适应症。榜眼：Humira2024年销售额：89.93亿美元Humira（阿达木单抗）是一种全人源化抗肿瘤坏死因子 - α（TNF - α）单克隆抗体，用于治疗多种自身免疫性疾病，包括类风湿关节炎、强直性脊柱炎、银屑病、克罗恩病等。它能特异性地与 TNF - α结合，从而抑制炎症反应。1998年，Humira在美国获批上市，之后在全球众多国家和地区广泛应用，极大地改善了患者的病情和生活质量。近年来，阿达木单抗多年来一直是全球销售额领先的药物之一，为艾伯维公司创造了巨大的收益。然而，因专利到期和生物类似药竞争影响，2024年Humira销售额以37.6%的下滑速度降至89.93亿美元。尽管优势逐渐减弱，但Skyrizi和Rinvoq依然保持超过50%的增速。同时，艾伯维开始更加关注外部交易以扩大自免管线布局。探花：Rinvoq2024年销售额：59.71亿美元Rinvoq（乌帕替尼）是一种口服的选择性 Janus 激酶（JAK）抑制剂，用于治疗多种自身免疫性疾病，包括类风湿关节炎、银屑病关节炎、特应性皮炎、溃疡性结肠炎等。它通过抑制 JAK 信号通路，从而减少炎症反应，缓解患者症状。据艾伯维2024年业绩报告显示，Rinvoq 2024年销售额为59.71亿美元，同比增长50.5%，是艾伯维在自免领域的重要支柱产品。 TOP 6：阿斯利康 2024年总营收：540.73亿美元销售额前三名药物：Farxiga、Tagrisso、Imfinzi状元：Farxiga2024年销售额：77.17亿美元Farxiga（达格列净）是一款“first-in-class”钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂。作为饮食调节和运动的辅助措施用于改善成人T2D患者的血糖控制。此外，它还用于治疗心力衰竭和慢性肾病（CKD）成人患者。Farxiga在2024年仍旧保持着高收入增长率，全年收入77.17亿美元，同比增长31%。Farxiga的制剂专利和晶型专利将在2027-2028年到期，为了应对专利悬崖，阿斯利康就Farxiga开发了一系列复方药物进一步扩大达格列净在心肾领域的影响力。榜眼：Tagrisso2024年销售额：65.80亿美元Tagrisso（奥希替尼）是第三代不可逆EGFR-酪氨酸激酶抑制剂（TKI），因其治疗非小细胞肺癌的有效性而得到认可。阿斯利康持续探索Tagrisso治疗不同阶段转移性EGFR突变NSCLC患者的潜力。包括美国、欧盟（EU）、中国和日本在内的100多个国家已批准Tagrisso作为独立疗法。据阿斯利康2024年财报显示，Tagrisso阿斯利康在抗肿瘤领域的顶梁柱，全年销售额达65.80亿美元，同比增长13%。探花：Imfinzi2024年销售额：47.17亿美元Imfinzi（度伐利尤单抗）是一种人源化的单克隆抗体。通过与PD-L1的结合，阻断PD-L1与PD-1和CD80蛋白的结合，进而抑制肿瘤的免疫逃逸机制。Imfinzi是唯一一款适用于广泛期小细胞肺癌（ES-SCLC）和局限期小细胞肺癌（LS-SCLC）的免疫药物，并进一步覆盖了早期NSCLC患者的围手术期治疗。2024年，Imfinzi取得了瞩目的销售成绩，全年创收47.17亿美元，同比增长21%，实现了强劲的双位数增长。 TOP 7：拜耳 2024年总营收：503.43亿美元销售额前三名药物：Xarelto、Eylea、Nubeqa状元：Xarelto2024年销售额：37.59亿美元Xarelto（利伐沙班）是一款口服凝血因子Xa抑制剂，用于治疗或预防血栓。作为拜耳的拳头药物，2024年Xarelto为拜耳贡献了 37.59 亿美元的销售额。但由于利伐沙班在中国的专利已经到期，并将于 2026 年和 2027 年在欧洲和美国失去专利保护，迎来仿制药冲击，利伐沙班的销售额快速下滑 14.7%。榜眼：Eylea2024年销售额：35.71亿美元Eylea（阿柏西普）是一种主要成分为VEGF抑制剂的眼部注射剂。它的作用机制为通过阻断参与血管生成的生长因子VEGF-A与胎盘生长因子（PLGF），进而阻断新生血管生成，并降低眼内血管通透性。2024年Eylea销售额为35.71亿美元，同比增长2.3%，然而，由于Eylea的专利也将陆续到期，来自仿制药的竞争压力与日俱增，未来该药的销售额也恐将大幅缩水。探花：Nubeqa2024年销售额：16.45亿美元Nubeqa（达罗他胺）是一款口服雄激素受体抑制剂（ARi），能够与雄激素受体以高亲和力结合并且表现出强力的拮抗活性，抑制雄激素受体向细胞核内转移，和其介导的基因表达，从而达到抑制前列腺癌细胞增殖的目的。2019年7月获得美国FDA批准用于治疗非转移性去势抵抗性前列腺癌（nmCRPC）患者。2024 年销售额为16.45亿美元，大幅增长75.3%。 TOP 8：诺华 2024年总营收：503.17亿美元销售额前三名药物：Entresto、Cosentyx、Kesimpta状元：Entresto2024年销售额：78.22亿美元Entresto（沙库巴曲缬沙坦）是诺华开发的一种血管紧张素Ⅱ受体阻断剂，2015年7月获FDA批准用于治疗射血分数下降心衰（HFrEF）患者，又在2017年7月获NMPA批准用于治疗射血分数下降心衰（HFrEF）患者。Entresto 是迄今为止首个获批用于治疗两种主要类型慢性心衰的药物。Entresto作为诺华在心血管领域的王牌产品已上市10年，其销售额连续攀升，每年保持着两位数或以上的增长率，2024年全年收入达78.22亿美元，同比增长31%。然而，Entresto不久将面临专利到期和进入美国第一轮医保谈判降价名单的威胁。诺华已开始全面调整其商业化战略。诺华已裁员数百人，并转而将重点放在其他潜力心血管药物上。榜眼：Cosentyx2024年销售额：61.41亿美元Cosentyx（司库奇尤单抗）被广泛用于治疗多种自身免疫性疾病，包括中重度斑块状银屑病、银屑病关节炎和强直性脊柱炎等。它通过特异性地阻断白细胞介素 - 17A（IL - 17A）信号通路，抑制炎症反应，从而减轻疾病症状。2024年销售额为61.41亿美元，同比增长25%，化脓性汗腺炎（HS）适应症和静脉制剂的推出为该药的增长带来了新的动力。Cosentyx针对风湿性多肌痛（PMR）和巨细胞动脉炎（GCA）的III期临床研究预计会在2025年公布结果，未来该药还有进一步增长的机会，诺华预计其销售峰值有望突破70亿美元。探花：Kesimpta2024年销售额：32.24亿美元Kesimpta（奥法妥木单抗）是一种抗人CD20的全人源免疫球蛋白G1单克隆抗体，靶向CD20分子，通过诱导B细胞溶解达到治疗作用。用于治疗成人复发型多发性硬化（RMS），包括临床孤立综合征、复发缓解型多发性硬化和活动性继发进展型多发性硬化。Kesimpta作为首个患者可以自行注射使用的CD20单抗，其在市场上保持着强劲的增长势头，2024年收入32.24亿美元，同比增长49%。 TOP 9：百时美施贵宝 2024年总营收：483.00亿美元销售额前三名药物：Eliquis、Opdivo、Revlimid状元：Eliquis2024年销售额：133.33亿美元Eliquis（阿哌沙班）在2024年扛起BMS的业绩大旗，创造了133.33亿美元的收入，同比增长9%。然而，Eliquis仍然要面临其核心专利到期的风险。榜眼：Opdivo2024年销售额：93.04亿美元Opdivo（纳武利尤单抗）是一种PD-1免疫检查点抑制剂，旨在帮助恢复抗肿瘤免疫反应，利用人体自身的免疫系统来对抗癌症。Yervoy则靶向抑制CTLA-4。CTLA-4抗体通过增强T细胞活性来提高肿瘤杀伤能力。该产品已于2011年获得美国FDA批准治疗晚期黑色素瘤，是全球首个获批上市的CTLA-4抗体药物。2024年，Opdivo的全球销售额为93.04亿美元，同比增长3%，是BMS第二大创收产品。虽然Opdivo的专利独占权将于2028年到期，BMS也采取了积极的举措来延长Opdivo产品生命周期，比如领先K药推出了皮下制剂。探花：Revlimid2024年销售额：57.73亿美元Revlimid（来那度胺）是一种免疫调节剂，不仅能抑制肿瘤细胞增殖，还能增强T细胞和自然杀伤细胞的活性，进一步巩固免疫系统对肿瘤的攻击能力。用于治疗多发性骨髓瘤、骨髓增生异常综合征以及套细胞和滤泡性淋巴瘤。Revlimid长期以来一直是多发性骨髓瘤的一线治疗药物，也是BMS的最佳治疗药物，它的专利保护使它在十多年的时间里占据了市场的主导地位。然而，在2022年专利到期，仿制药的引入导致去年BMS的销量下降。2024年，Revlimid全年销售额为57.73亿美元，同比下降5%。 TOP 10：礼来 2024年总营收：450.43亿美元销售额前三名药物：Mounjaro、Verzenio、Trulicity状元：Mounjaro2024年销售额：115.40亿美元Mounjaro（替尔泊肽）是首个双作用葡萄糖依赖性胰岛素性多肽（GIP）和GLP-1受体激动剂，被批准用于治疗2型糖尿病。它以GIP受体为靶点，补充GLP-1的作用，改善胰岛素调节和血糖控制。2023年11月，FDA还批准用于成人肥胖患者的慢性体重管理（Zepbound）。Mounjaro问世即进入爆发期，在上市当年畅销近5亿美元，第二年便高涨至51.63亿美元，2024年更是直接冲破百亿美元大关（115.401亿美元，+124%），荣升为礼来的第一款超级重磅产品。榜眼：Verzenio2024年销售额：53.07亿美元Verzenio（阿贝西利）是一种CDK4/6抑制剂。在HR+乳腺癌细胞系中，细胞周期蛋白D1和CDK4/6促进细胞周期进展和细胞增殖。Verzenio能够阻断细胞周期的进展，导致细胞衰老和凋亡。它已经被FDA批准作为一线疗法治疗HR+，HER2-晚期乳腺癌患者。得益于拓展了早期乳腺癌人群，2024年Verzenio延续高增长率，全年收入达到53.07亿美元，同比增长37%。探花：Trulicity2024年销售额：52.54亿美元Trulicity（度拉糖肽）是一种GLP-1受体激动剂，可增强葡萄糖依赖型胰岛素的分泌，在控制成人2型糖尿病患者的血糖水平方面发挥关键作用，2014年9月获批用于2型糖尿病患者。Trulicity是礼来保持糖尿病市场竞争力的上一代重磅武器，其销售额在2022年达到峰值（74.40亿美元），自此以后开始下降，2024年收入缩减至52.535亿美元（-26%）。这主要是由于GLP-1R/GIPR激动剂替尔泊肽的强势入场所致。度拉糖肽的中国序列专利已在2024年到期，美国序列专利将在2027年到期。 TOP 11：赛诺菲 2024年总营收：445.61亿美元销售额前三名药物：Dupixent、Polio/Pertussis/Hib vaccines & Boosters、Influenza vaccines状元：Dupixent2024年销售额：141.79亿美元作为赛诺菲和再生元合作开发的核心自免药物，自上市以来一直是医药领域的焦点。这款针对自身免疫疾病的重磅药物在中重度特应性皮炎、中重度哮喘、慢性鼻炎等多种适应证中表现出卓越疗效，成为了这些领域治疗的重要选择。它是全球首个获批治疗中重度特应性皮炎的生物制剂，适应证拓展能力极强。2024年，Dupixent销售额高达141.79亿美元，同比增长23.1%，成为新一代的自免“药王”，为赛诺菲和再生元带来了可观的收入。后续随着适应证进一步拓展和市场渗透率的提高，Dupixent在未来无疑将持续巩固其在自免药物领域的领先地位，销售额有望持续攀升。榜眼：Polio/Pertussis/Hib vaccines & Boosters2024年销售额：29.60亿美元脊髓灰质炎、百日咳乙型肝炎疫苗Polio/Pertussis/Hib vaccines & Boosters成为赛诺菲畅销药榜单的第二名。2024年全年销售额高达29.60亿美元，同比增长1.2%。探花：Influenza vaccines2024年销售额：27.60亿美元Influenza Vaccines是用来预防流行性感冒病毒引起的流行性感冒的疫苗。2024年Influenza vaccines位居赛诺菲畅销药榜单的第三名，全年销售额高达27.60亿美元。 TOP 12：诺和诺德 2024年总营收：421.49亿美元销售额前三名药物：Ozempic、Wegovy、Rybelsus司美格鲁肽是一种长效GLP-1类似物，它与天然GLP-1的氨基酸序列具有94%的同源性，能起到GLP-1受体激动剂的作用。2024年，司美格鲁肽大卖293亿美元，同比增长38.18%，几乎追平K药，有望成为下一届药王。具体来看，降糖用司美格鲁肽注射液Ozempic在2024年销售174.66亿美元，同比增长26%；口服司美格鲁肽片Rybelsus销售33.82亿美元，同比增长26%；减肥用司美格鲁肽注射液Wegovy创收84.48亿美元，同比增长86%。参考资料[1]各大公司财报、公告、官微、官网，各种公开资料[2]https://www.linkedin.cn/共建Biomedical创新生态圈！如何加入BiG会员？

生物类似药上市批准

2025-04-04

·investor.jnj.com

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 arthritis

TREMFYA® demonstrated clinically meaningful and statistically significant efficacy in patients with active psoriatic arthritis at risk for structural damage in Phase 3b study Topline results demonstrate efficacy across multiple domains at Week 24, reinforcing TREMFYA® as a first-line treatment option for patients with active psoriatic arthritis SPRING HOUSE, Pa., April 4, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the TREMFYA® (guselkumab) Phase 3b APEX study achieved both its primary endpoint (ACR20a) of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis (PsA), compared to placebo.1 TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis.2,3,4,5,6 In the Phase 3b APEX study, TREMFYA®-treated patients also exhibited significantly less progression of structural damage versus patients receiving placebo at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score, which includes joint space narrowing and erosion subscores. Data were consistent with the well-established safety profile of TREMFYA® with no new safety signals identified.1 "Psoriatic arthritis can be a progressive and debilitating disease, and without early identification and treatment, patients may experience irreversible joint damage that significantly impacts their daily activities," said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. "These new topline data highlight the importance of addressing both inflammation and structural damage at the source as early as possible. As the only IL-23 treatment to show significant inhibition of structural damage, TREMFYA equips healthcare providers with critical data so their patients do not have to compromise their future joint health." APEX is a Phase 3b study with long-term extension data through three years that will further assesses the sustained efficacy of TREMFYA® on inhibition of structural damage in patients with active PsA. Results from the APEX study are being prepared for presentation at upcoming medical congresses. Editor's notes: a. ACR20 response is defined as both at least 20 percent improvement from baseline in the number of tender and number of swollen joints, and a 20 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein.7 ABOUT APEX STUDY (NCT04882098) APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up.8 ABOUT PSORIATIC ARTHRITIS Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).9,10,11 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.12 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.13 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.14 Studies show up to 30% of people with plaque PsO also develop PsA.11 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease.10 TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: www.tremfya.com. IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: o fainting, dizziness, feeling lightheaded (low blood pressure) o swelling of your face, eyelids, lips, mouth, tongue or throat o trouble breathing or throat tightness o chest tightness o skin rash, hives o o itching Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: o fever, sweats, or chills o muscle aches o weight loss o cough o warm, red, or painful skin or sores on your body different from your psoriasis o diarrhea or stomach pain o shortness of breath o blood in your phlegm (mucus) o burning when you urinate or urinating more often than normal Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: o unexplained rash o vomiting o tiredness (fatigue) o yellowing of the skin or the whites of your eyes o nausea o stomach pain (abdominal) o loss of appetite o dark urine Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. 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 https://www.jnj.com/ or at https://innovativemedicine.jnj.com/ Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS 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. 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. 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. 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. REFERENCES 1 Data on file2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504.3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc.6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.7 Felson, D. T., & LaValley, M. P. The ACR20 and defining a threshold for response in rheumatic diseases: too much of a good thing. Arthritis Research & Therapy, 2014:16(1), 101. https://doi-org.libproxy1.nus.edu.sg/10.1186/ar4428 8 ClinicalTrials.gov. A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: https://clinicaltrials.gov/study/NCT04882098. Accessed March 2025. 9 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: https://creakyjoints.org/symptoms/what-is-dactylitis/. Accessed March 2025. 10 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/31102105/. Accessed March 2025. 11 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/physical-effects/enthesitis-and-psa. Accessed March 2025. 12 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis/. Accessed March 2025. 13 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: https://doi-org.libproxy1.nus.edu.sg/10.1136/ard.2008.098202. Accessed March 2025. 14 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: https://doi-org.libproxy1.nus.edu.sg/10.5041/RMMJ.10279. Accessed March 2025. 15 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf Accessed March 2025. Media contact:Craig Stoltz cstoltz@its.jnj.com Investor contact:Lauren Johnsoninvestor-relations@its.jnj.com View original content to download multimedia:https://www.prnewswire.com/news-releases/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-arthritis-302420476.html SOURCE Johnson & Johnson

临床3期临床结果上市批准

100 项与利生奇珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	利生奇珠单抗	L04AC18	DB14762

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
活动性中度克罗恩病	中国	AbbVie, Inc.	2025-03-04
活动性重度克罗恩病	中国	AbbVie, Inc.	2025-03-04
溃疡性结肠炎	日本	AbbVie, Inc.	2022-09-26
克罗恩病	澳大利亚	AbbVie Pty Ltd.	2019-07-16
活动性中度溃疡性结肠炎	澳大利亚	AbbVie Pty Ltd.	2019-07-16
活动性重度溃疡性结肠炎	澳大利亚	AbbVie Pty Ltd.	2019-07-16
斑块状银屑病	加拿大	AbbVie, Inc.	2019-04-17
银屑病关节炎	日本	AbbVie, Inc.	2019-03-26
红皮病性银屑病	日本	AbbVie, Inc.	2019-03-26
寻常性银屑病	日本	AbbVie, Inc.	2019-03-26
脓疱型银屑病	日本	AbbVie, Inc.	2019-03-26
手掌和足底脓疱病	日本	AbbVie, Inc.	2019-03-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
幼年特发性关节炎	临床3期	美国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	澳大利亚	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	加拿大	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	法国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	德国	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	意大利	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	波兰	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	西班牙	AbbVie, Inc.	2024-07-08
幼年特发性关节炎	临床3期	英国	AbbVie, Inc.	2024-07-08
掌跖角化病	临床3期	美国	AbbVie, Inc.	2021-02-26

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临床结果

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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


NCT03105128 (MOTIVATE, ADVANCE, FORTIFY, Pubmed \| Clin Gastroenterol Hepatol)	临床3期	克罗恩病引起的肛周瘘 anti-interleukin-23 p19 monoclonal antibody	-	Risankizumab 1200 mg IV	鑰遞網鬱範獵蓋築蓋遞(齋夢構簾糧蓋餘齋願襯) = 膚積顧鹽獵憲獵觸衊醖憲鑰築齋遞鑰獵繭艱繭 (壓艱夢餘衊構繭餘鹹簾 ) 更多	积极	2025-02-01
				Risankizumab 180 mg SC	鑰遞網鬱範獵蓋築蓋遞(齋夢構簾糧蓋餘齋願襯) = 衊簾鏇鏇積蓋獵鹹襯襯憲鑰築齋遞鑰獵繭艱繭 (壓艱夢餘衊構繭餘鹹簾 ) 更多
FORTIFY (Pubmed \| Gastro Hep Adv)	临床3期	克罗恩病维持	-	Risankizumab	構糧壓鏇餘憲窪鬱網繭(鹽鬱繭網範糧齋網齋廠) = 襯窪獵齋淵積鏇鹹廠鹽築鏇鹹觸餘鹽廠鏇窪積 (積選觸餘築糧繭獵繭繭 )	积极	2025-01-01
NCT03047395 (LIMMitless, CTgov)	临床3期	斑块状银屑病	2,170	Risankizumab	積鑰夢憲鬱築艱鏇觸製 = 鬱繭願製積積糧觸獵齋鑰壓醖製鬱襯獵膚衊蓋 (鑰襯廠鏇壓顧憲製廠鏇, 遞網願範醖廠獵淵積襯 ~ 繭淵鹹簾鬱簾廠鏇鹹選) 更多	-	2024-12-11
NCT04524611 (SEQUENCE, UEGW2024)	临床3期	克罗恩病	-	Risankizumab	廠鏇簾夢餘積蓋淵淵願(構襯衊壓製餘繭築簾夢) = 選艱齋簾齋壓鬱築鏇獵醖膚襯鹹淵簾窪蓋襯鹹 (夢艱醖獵壓窪糧顧蓋鹹 ) 更多	积极	2024-10-13
				Ustekinumab	廠鏇簾夢餘積蓋淵淵願(構襯衊壓製餘繭築簾夢) = 餘網構鏇願艱衊醖艱憲醖膚襯鹹淵簾窪蓋襯鹹 (夢艱醖獵壓窪糧顧蓋鹹 ) 更多
NCT04524611 (SEQUENCE, UEGW2024)	临床3期	克罗恩病	-	Risankizumab	壓願願鹽鑰簾糧淵願窪(齋繭醖膚範構廠夢簾觸) = 鏇鹽膚餘襯蓋齋壓艱艱廠鬱糧襯淵顧網繭壓夢 (蓋簾襯淵遞餘憲鏇製憲, 48.2 ~ 79.6) 更多	积极	2024-10-13
				Ustekinumab	壓願願鹽鑰簾糧淵願窪(齋繭醖膚範構廠夢簾觸) = 顧糧壓製糧製遞窪鏇願廠鬱糧襯淵顧網繭壓夢 (蓋簾襯淵遞餘憲鏇製憲, 36.2 ~ 66.1) 更多
NCT03105102 (FORTIFY, UEGW2024)	临床3期	活动性中度克罗恩病维持 interleukin-23 p19 subunit	710	Risankizumab 180 mg	鑰鹹艱選鹽網鹹觸鹽夢(醖築顧餘網壓襯膚醖範) = 範選築壓醖壓築淵築鹽鏇廠糧觸淵繭廠壓網蓋 (鹹製鏇淵壓襯鹹鏇獵鹹 ) 更多	积极	2024-10-13
				Risankizumab 360 mg	鑰鹹艱選鹽網鹹觸鹽夢(醖築顧餘網壓襯膚醖範) = 鹹糧積選壓觸艱選鹽蓋鏇廠糧觸淵繭廠壓網蓋 (鹹製鏇淵壓襯鹹鏇獵鹹 ) 更多
NCT03398148 \| NCT03398135 (INSPIRE \| COMMAND, UEGW2024)	临床3期	溃疡性结肠炎维持 high-sensitivity C-reactive protein	650	Risankizumab 1200 mg IV	鬱襯壓鬱醖觸鏇鹽構願(遞積簾糧獵構窪鹽繭膚) = 鹽選醖鑰遞鏇壓顧憲衊鹹壓夢餘簾積淵範網鑰 (積觸製觸簾鹹壓衊醖鹹, 18.4 ~ 26.8) 更多	积极	2024-10-13
				Placebo IV	鬱襯壓鬱醖觸鏇鹽構願(遞積簾糧獵構窪鹽繭膚) = 醖網繭蓋齋夢蓋製簾醖鹹壓夢餘簾積淵範網鑰 (積觸製觸簾鹹壓衊醖鹹, 4.1 ~ 11.9) 更多
UEGW2024	N/A	活动性中度溃疡性结肠炎	-	Risankizumab 1200 mg IV	顧選積窪鹹築觸鹹遞網(願膚遞範構繭觸鹽鏇餘) = 選積觸醖網鹽製獵築餘蓋構艱選衊觸製襯膚繭 (構繭鑰觸鹹積衊蓋願餘 )	-	2024-10-13
				Placebo IV	顧選積窪鹹築觸鹹遞網(願膚遞範構繭觸鹽鏇餘) = 淵夢艱憲膚網窪顧襯構蓋構艱選衊觸製襯膚繭 (構繭鑰觸鹹積衊蓋願餘 )
NCT04524611 (SEQUENCE, UEGW2024)	临床3期	克罗恩病 high-sensitivity C-reactive protein \| fecal calprotectin	-	Risankizumab	齋膚遞窪獵遞衊艱築鬱(獵顧簾鹽構製鬱願艱廠) = 鑰鏇壓艱艱鏇鏇艱願獵鏇鏇糧蓋鹽選鹹簾膚淵 (憲築築製襯蓋蓋窪蓋憲, 22.0 ~ 35.6) 更多	积极	2024-10-13
				Ustekinumab	齋膚遞窪獵遞衊艱築鬱(獵顧簾鹽構製鬱願艱廠) = 構選壓網製醖範顧廠淵鏇鏇糧蓋鹽選鹹簾膚淵 (憲築築製襯蓋蓋窪蓋憲, 8.8 ~ 18.9) 更多
NCT03671148 \| NCT03896581 \| NCT03675308 \| NCT03895203 (Pubmed \| Rheumatol Ther) 人工标引	临床3期	银屑病关节炎	-	Bimekizumab	衊窪鬱積鏇衊壓糧艱繭(壓膚鑰衊糧鬱鹹淵淵鏇): OR = 1.52 (95% CI, 1.11 ~ 2.09) 更多	积极	2024-08-09
				Risankizumab