An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects

The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.

开始日期2024-08-06

申办/合作机构

Amgen, Inc.

NCT06527404

/ Active, not recruiting临床3期

A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies

The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).

开始日期2024-07-18

申办/合作机构

Amgen, Inc.

NCT06376045

/ Active, not recruiting临床2期

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma

The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

开始日期2024-05-24

申办/合作机构

Amgen, Inc.

100 项与诺卡替利单抗相关的临床结果

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100 项与诺卡替利单抗相关的专利（医药）

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项与诺卡替利单抗相关的文献（医药）

2026-02-01·Dermatology and Therapy

Psychometric Evaluation of Worst Pruritus Numeric Rating Scale in Adults With Moderate-to-Severe Atopic Dermatitis

Article

作者: Blauvelt, Andrew ; Williams, Angela ; McLeod, Lori ; Deininger, Kimberly M ; Qin, Shanshan ; Nelson, Lauren

INTRODUCTION:

Atopic dermatitis (AD) is a chronic, inflammatory skin disease with a hallmark symptom of pruritus. We developed Worst Pruritus Numeric Rating Scale (NRS)-a single-item, patient-reported outcome measure-to assess itch severity in clinical trial populations of adults with moderate-to-severe AD. The objective of this study was to evaluate the psychometric properties of Worst Pruritus NRS and determine its appropriateness for use in clinical trials assessing the efficacy of treatments among adults with moderate-to-severe AD.

METHODS:

We used data from a subset of 267 participants in a phase 2 clinical trial of rocatinlimab (NCT03703102; N = 274) to confirm reliability, validity, and ability to detect change in Worst Pruritus NRS. We estimated and confirmed a meaningful within-patient change (MWPC) threshold using anchor- and distribution-based methods.

RESULTS:

All intraclass correlation coefficients (ICCs) were ≥ 0.86, providing robust evidence for test-retest reliability. Evidence supported construct validity, including known-groups validity (all P < 0.0001). There were moderate, positive correlations between scores on Worst Pruritus NRS and supportive measures at week 16, including Dermatology Life Quality Index (DLQI) question 1 (itch item) (r = 0.78), DLQI (r = 0.66), Eczema Area and Severity Index (EASI) (r = 0.50), Investigator's Global Assessment (IGA) (r = 0.46), Body Surface Area of Involvement (BSA) (r = 0.40), and SCORing Atopic Dermatitis (SCORAD) itch item (r = 0.97). On average, patients with better DLQI question 1 scores, EASI, and IGA classifications achieved better (i.e., lower) scores on Worst Pruritus NRS at week 16 (P < 0.0001). Ability to detect change was supported with moderate-to-strong and positive correlations between Worst Pruritus NRS change scores and changes in supporting measures. MWPC estimates confirmed the commonly applied 4-point threshold value and a range of 3 to 4 points as indicative of meaningful within-patient change.

CONCLUSIONS:

Worst Pruritus NRS is a reliable and valid patient-reported outcome measure to assess itch severity in clinical trial settings among adults with moderate-to-severe AD.

2026-02-01·JOURNAL OF INVESTIGATIVE DERMATOLOGY

Molecular differentiation of OX40 and OX40L targeted biologics using AlphaFold3 and molecular dynamics simulations

Article

作者: Nolden, Kelsey ; Batista, Victor S ; Shi, Yuanjun ; Bunick, Christopher G

Atopic dermatitis is a chronic inflammatory skin disorder that affects over 200 million people worldwide. Although disease etiology is multifaceted, the immune checkpoint molecules OX40 and OX40L have a critical role in disease development. Recent clinical trials demonstrated that the OX40-targeting antibodies rocatinlimab (KHK4083/AMG-451) and telazorlimab (GBR-830/ISB-830), and the OX40L-targeting antibody amlitelimab (KY1005), significantly improve symptoms of atopic dermatitis. However, the epitopes where these antibodies bind OX40 and OX40L remain unclear, and therefore, so do the mechanisms by which they specifically disrupt OX40-OX40L signaling. To address this, computational modeling was performed to predict antibody-protein co-complexes, and their interaction interfaces were characterized. Binding free energy of specific OX40 or OX40L residue-residue interactions within 5 Å of the antibody binding interface were analyzed using MM-PBSA with a per-residue energy decomposition analysis. Our analysis suggests rocatinlimab and amlitelimab directly inhibit OX40-OX40L interactions by physically blocking the cognate OX40-OX40L interface via steric occlusion, whereas telazorlimab disrupts a critical OX40-OX40L bond. Together, this work provides molecular characterization of the epitopes of OX40 and OX40L targeted biologics emerging in dermatology.

2026-01-01·LANCET

Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials

Article

作者: Herranz-Pinto, Pedro ; Stein Gold, Linda ; Chovatiya, Raj ; Hong, H Chih-Ho ; Schwartz-Sagi, Liat ; Bissonnette, Robert ; Worm, Margitta ; Arai, Takahiro ; Kern, Johannes S ; Yang, Yiping ; Luna, Paula C ; Magnolo, Nina ; Guttman-Yassky, Emma ; Bernstein, Jonathan A ; Ehst, Benjamin D ; Kabashima, Kenji ; Barragan, Carolina ; Shi, Rebecca ; Kricorian, Greg ; Esfandiari, Ehsanollah ; Sofen, Howard ; Pink, Andrew E

BACKGROUND:

Rocatinlimab is a T cell rebalancing therapy that inhibits and reduces the number of pathogenic T cells by targeting the OX40 receptor expressed on the surface of activated T cells. Two global phase 3 studies were performed to assess the efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in adults.

METHODS:

ROCKET-IGNITE (IGNITE) and ROCKET-HORIZON (HORIZON) were 24-week randomised, double-blind, placebo-controlled phase 3 trials conducted in 19 countries each. Eligible patients were 18 years and older with confirmed atopic dermatitis (American Academy of Dermatology Consensus Criteria) diagnosed 1 year or longer before study entry with moderate-to-severe disease activity, defined by an Eczema Area and Severity Index (EASI) score of 16 and over, validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 (moderate) or 4 (severe), and affected body surface area of 10% and above. In IGNITE, patients were randomly allocated in a 3:2:2 ratio to receive subcutaneous 300 mg rocatinlimab, 150 mg rocatinlimab, or placebo; in HORIZON, patients were randomised 3:1 to receive subcutaneous 300 mg rocatinlimab or placebo. Randomisation was stratified by baseline disease severity (vIGA-AD score of 3 vs 4) and geographical region (Japan vs non-Japan Asian countries vs rest of world). Across both trials, 24-week treatment was administered at weeks 0, 2, and 4 and then every 4 weeks thereafter with the last dose at week 20. The coprimary endpoints for both trials were EASI-75 response (≥75% improvement in EASI score from baseline) at week 24 and vIGA-AD score of 0 or 1 (defined as a score of 0 [clear skin] or 1 [almost clear skin], representing a ≥2-point improvement from baseline) at week 24. Rescue therapy use, including topical therapy, phototherapy, and systemic therapy, was permitted from day 1; all patients who received rescue therapy were considered non-responders for all visits after the first use of rescue therapy but could generally continue study treatment unless prohibited per protocol. Efficacy analyses were conducted in all randomised patients; safety analyses were conducted in all patients who received one or more dose of study treatment, with patients grouped according to actual treatment received. The trials were registered at ClinicalTrials.gov: ROCKET-IGNITE (NCT05398445) and ROCKET-HORIZON (NCT05651711).

FINDINGS:

Between May 31, 2022, and June 12, 2024, 769 patients were randomised in IGNITE (two patients were enrolled under an earlier protocol before study re-design and excluded from the analysis; after the protocol update, 328 were included in the 300 mg rocatinlimab group; 217 in the 150 mg rocatinlimab group; and 222 in the placebo group) and between Dec 14, 2022, and Dec 12, 2023, 726 patients were randomised in HORIZON (543 in 300 mg rocatinlimab and 183 in placebo). Both trials met their coprimary endpoints. Rocatinlimab treatment resulted in statistically significant improvements in EASI-75 response in comparison with placebo at week 24 in IGNITE (138 [42%] of 326 patients on 300 mg rocatinlimab; 78 [36%] of 215 on 150 mg rocatinlimab; and 28 [13%] of 219 on placebo; percentage difference vs placebo: 300 mg rocatinlimab 29·5% [95% CI 22·3-36·1], p<0·001 and 150 mg rocatinlimab 23·4% [15·4-30·9], p<0·001) and HORIZON (rocatinlimab, 178 [33%] of 543 vs placebo, 25 [14%] of 183; percentage difference 19·1% [95% CI 12·4-25·2], p<0·001). Statistically significant improvements with rocatinlimab treatment in comparison with placebo were also observed at week 24 for vIGA-AD score of 0 or 1 response in IGNITE (77 [24%] of 326 patients on 300 mg rocatinlimab; 41 [19%] of 215 patients on 150 mg rocatinlimab; and 19 [9%] of 219 patients on placebo; percentage difference vs placebo 14·9% [95% CI 8·8-20·6], p<0·001 for 300 mg rocatinlimab and 10·3% [3·8-16·6], p=0·002 for 150 mg rocatinlimab) and HORIZON (105 [19%] of 543 for 300 mg rocatinlimab vs 12 [7%] of 183 for placebo; percentage difference 12·8% [95% CI 7·6-17·3], p<0·001). The incidences of treatment-emergent adverse events were generally similar across rocatinlimab and placebo treatment groups in IGNITE and HORIZON. The most frequently reported adverse events in patients receiving rocatinlimab (defined as occurring in ≥4% of patients in any rocatinlimab treatment group and at a rate ≥2 times that of placebo) included pyrexia (105 [12%] of 870 for 300 mg rocatinlimab and 26 [12%] of 214 for 150 mg rocatinlimab), chills (48 [6%] of 870 and five [2%] of 214 for the 300 mg and 150 mg doses, respectively), and aphthous ulcers (38 [4%] of 870 and six [3%] of 214, respectively). Most events of pyrexia and chills were considered injection-related reactions; events were generally mild or moderate in severity and primarily occurred after the first dose. Serious adverse events were reported in 2% to 5% of patients in the rocatinlimab groups and 4% to 6% of patients in the placebo groups. No deaths were reported.

INTERPRETATION:

Rocatinlimab treatment resulted in statistically significant and clinically meaningful improvements across clinical endpoints, including the coprimary endpoints of EASI-75 response and vIGA-AD score of 0 or 1, in comparison with placebo and had a clinically acceptable safety profile in adult patients with moderate-to-severe atopic dermatitis.

FUNDING:

Amgen and Kyowa Kirin.

237

项与诺卡替利单抗相关的新闻（医药）

2026-03-13

·搜狐新闻

Biosimilar迎来新一轮增长周期：2026生物药研发趋势与科研机遇

随着生物技术的持续发展，单克隆抗体、融合蛋白、基因治疗等创新型生物药，正在重塑疾病治疗的格局。与此同时，生物类似药（Biosimilar）——与已获批上市的原研生物药在氨基酸序列、高级结构、生物活性、安全性、有效性等关键属性上高度相似的生物制品，已成为全球生物医药产业不可或缺的组成部分。一、生物医药产业升级：Biosimilar市场持续扩展在2026年中国政府工作报告中，生物医药产业被明确提出从“战略性新兴产业”向“支柱产业”转变。这一定位变化反映出国家层面对生物医药产业长期发展的重视，同时也意味着生物药研发将成为医药创新的重要方向。从全球药物研发格局来看，生物药在新药审批中的比例也在不断提升。过去几年，美国FDA与CDER批准的新药中生物药占比持续上升，而未来十年这一增长趋势仍将延续。行业分析预测，到2030年，生物药和基因治疗产品在新药批准中的占比可能超过60%。Figure 1. The number of drugs approved in the U.S. by CDER by molecule type and the percentage shared by biologics (2000-2025).随着生物药整体市场规模的持续扩大，大量已上市的单克隆抗体、融合蛋白产品正陆续迎来专利悬崖。对于医药产业而言，这不仅打破了原研药的市场垄断格局，更直接推动了Biosimilar研发与商业化的高速增长。Biosimilar的规模化发展，一方面能显著降低生物药的临床使用成本，大幅提升高端生物治疗的患者可及性；另一方面也为更多药企搭建了进入生物药研发领域的阶梯，推动生物药上下游产业链、生产工艺、质量控制体系的全面升级，实现整个产业生态的扩容与迭代。二、2026生物药研发趋势：免疫与自身免疫疾病成为核心领域从近期行业预测来看，2026年可能获批的一批关键生物药呈现出一个非常明显的趋势：免疫系统调控成为新一代生物药研发的核心方向。在这些生物药中，超半数品种聚焦于自身免疫疾病与免疫炎症疾病领域，包括干燥综合征、特应性皮炎、泛发性脓疱型银屑病、IgA肾病等。这类疾病多为慢性进展性疾病，核心发病机制为免疫调控异常，具备明确的靶向干预位点，是生物药研发的高价值赛道。从作用机制来看，当前研发重点在四大免疫调控核心通路，直接作用于适应性免疫系统的关键调控节点，也是未来Biosimilar研发的核心潜力靶点：BAFF/BAFF-R通路：调控B细胞存活与分化，在多种自身免疫疾病中发挥关键作用OX40共刺激信号通路：参与T细胞活化与免疫记忆形成IL-36炎症信号通路：在银屑病等炎症性皮肤疾病中发挥重要作用BAFF/APRIL双通路：参与抗体产生及B细胞成熟随着这些创新生物药逐渐进入临床应用阶段，其后续的Biosimilar开发也将成为未来生物医药产业的重要研究方向。三、2026年值得关注的自身免疫疾病生物药1. Ianalumab：靶向BAFF-R的B细胞调控策略Figure 2. Interaction and expression of BAFF.（DOI: 10.1016/j.cyto.2015.07.014）Ianalumab是由Novartis开发的一种靶向BAFF receptor（BAFF-R）的单克隆抗体，被认为是近年来自身免疫疾病领域最具潜力的候选药物之一。BAFF（B-cell activating factor）是维持B细胞存活和分化的重要细胞因子，在多种系统性自身免疫疾病中表达水平显著升高。过量的BAFF信号能够促进自反应性B细胞存活并持续产生自身抗体，从而驱动疾病进展。与传统仅阻断BAFF配体的治疗策略不同，Ianalumab直接靶向BAFF-R受体，既能高效阻断BAFF信号通路，还可通过抗体依赖的细胞毒作用（ADCC），选择性清除体内异常活化的B细胞群体，具备更强的免疫调控与疾病干预能力。在针对干燥综合征（Sjögren’s disease）的两项全球III期临床试验中，该药成功达到主要终点，在疾病活动度评分方面显示出显著改善，这也是该疾病领域首次有靶向疗法在大规模临床试验中取得积极结果。此外，最新研究还显示Ianalumab能够延缓免疫性血小板减少症（ITP）患者的治疗失败时间，进一步扩大了其潜在应用范围。随着相关数据逐步提交监管机构，该药有望在2026年前后迎来重要审批节点。2. Rocatinlimab：针对OX40信号通路的T细胞免疫调控Figure 3. The summary of the impact of the OX40–OX40L interaction on T cell subsets.（Doi: 10.1016/j.apsb.2019.08.010）特应性皮炎（Atopic dermatitis）是当前生物药竞争最为激烈的炎症性皮肤疾病之一，但仍有相当比例患者对现有治疗方案反应不足。Rocatinlimab（AMG-451）是一种靶向OX40的单克隆抗体，由Amgen与Kyowa Kirin联合开发。OX40是活化T细胞表面的一种共刺激受体，在维持致病性T细胞反应以及形成免疫记忆过程中发挥重要作用。Rocatinlimab通过抑制OX40信号，能够减少致病性T细胞的持续激活，从而从上游调控炎症反应。与主要靶向IL-4/IL-13通路的现有治疗药物相比，这一机制提供了一种不同的治疗策略。在III期临床试验中，该药在多个剂量组均达到主要终点，并在皮损清除率等关键指标上取得显著改善。同时，长期随访数据显示部分患者能够维持较长时间的疾病缓解状态。由于其可能实现更长给药间隔和持续疗效，Rocatinlimab被认为有望成为特应性皮炎治疗中的重要补充选择。3. Imsidolimab：靶向IL-36受体的炎症控制Figure 4.Figure 4. Inflammatory pathways and factors involved in IL-36-associated inflammation in the skin.（DOI: 10.1007/s40259-023-00587-5）与常见的慢性炎症性皮肤病不同，广泛性脓疱型银屑病（Generalized pustular psoriasis，GPP）是一种进展迅速且可能危及生命的罕见疾病，其发病机制与IL-36炎症通路密切相关。IL-36属于IL-1细胞因子家族，在角质形成细胞及免疫细胞之间形成强烈的炎症放大循环。该信号异常激活时，会迅速诱导中性粒细胞浸润并导致严重皮肤炎症。Imsidolimab是一种针对IL-36 receptor的单克隆抗体，通过阻断该信号通路抑制炎症级联反应。在III期临床实验中，该药表现出快速而显著的疗效，可在短时间内控制皮肤炎症并维持病情缓解。4. Atacicept：BAFF/APRIL双靶点策略Figure 5. BAFF and APRIL receptor interactions.（DOI: 10.1080/08830185.2016.1276903）另一种值得关注的免疫调控药物是Atacicept，这是一种TACI-Fc融合蛋白，可同时结合BAFF和APRIL两种B细胞因子。与单一靶点抑制策略相比，这种双靶点机制能够更全面地抑制B细胞及浆细胞相关免疫反应，因此在抗体介导疾病中具有潜在优势。目前该药正在用于IgA nephropathy等疾病的临床研究。早期研究数据显示，其能够显著降低蛋白尿水平并改善肾功能相关指标，显示出良好的治疗潜力。随着临床研究的推进，Atacicept有望成为针对B细胞驱动型自身免疫疾病的重要治疗方案。四、Biosimilar的产业价值与研究意义随着全球重磅生物药专利到期潮的持续推进，Biosimilar已成为全球医药市场的核心增长引擎，其价值不仅体现在临床与产业端，更在科研领域发挥着不可替代的作用。1 产业与临床价值提升药物可及性：Biosimilar可大幅降低生物药的治疗成本，让更多患者用上高端生物治疗药物，缓解医保与患者的支付压力；推动产业技术升级：Biosimilar的研发与生产，对细胞培养工艺、蛋白纯化技术、质量分析与控制体系提出了极高要求，反向推动生物药上下游产业链的技术迭代；完善生物医药产业生态：Biosimilar为药企提供了切入生物药赛道的成熟路径，培育了大量生物药研发、生产、质控领域的专业人才，为创新生物药研发奠定了产业基础。2 科研应用价值在基础科研与药物研发领域，Biosimilar类分子已成为不可或缺的核心研究工具，广泛应用于药物作用机制研究、靶点验证、体内外药效学实验、生物分析方法开发等场景，为生物药创新研发提供了稳定、可靠的实验材料支撑。五、abinScience Research Biosimilar产品随着生物药研发的不断深入，Biosimilar类分子在药物机制研究、靶点验证以及生物药开发相关研究中发挥着越来越重要的作用。abinScience可提供种类齐全，稳定可靠的科研级Research Biosimilar产品，可用于多种疾病的研究。更多Research Biosimilar相关研究产品欢迎咨询或发邮件给我们： support@abinscience.com References[1] Tuszyner, A. (2026, March 2). The 2026 biologics wave: Which innovations will break through? Contract Pharma. https://www.contractpharma.com/the-2026-biologics-wave-which-innovations-will-break-through/[2] Wei F, Chang Y, Wei W. The role of BAFF in the progression of rheumatoid arthritis. Cytokine. 2015 Dec;76(2):537-544. doi: 10.1016/j.cyto.2015.07.014. Epub 2015 Jul 18. PMID: 26198030.[3] Fu Y, Lin Q, Zhang Z, Zhang L. Therapeutic strategies for the costimulatory molecule OX40 in T-cell-mediated immunity. Acta Pharm Sin B. 2020 Mar;10(3):414-433. doi: 10.1016/j.apsb.2019.08.010. Epub 2019 Sep 3. PMID: 32140389; PMCID: PMC7049610.[4] Fukaura R, Akiyama M. Targeting IL-36 in Inflammatory Skin Diseases. BioDrugs. 2023 May;37(3):279-293. doi: 10.1007/s40259-023-00587-5. Epub 2023 Mar 3. PMID: 36867370.[5] Samy E, Wax S, Huard B, Hess H, Schneider P. Targeting BAFF and APRIL in systemic lupus erythematosus and other antibody-associated diseases. Int Rev Immunol. 2017 Jan 2;36(1):3-19. doi: 10.1080/08830185.2016.1276903. PMID: 28215100.本文所提供的所有产品与服务均仅供科研使用，不得用于人体诊断或治疗。 For Research Use Only. Not for use in diagnostic or therapeutic procedures.返回搜狐，查看更多

基因疗法生物类似药上市批准免疫疗法

2026-03-12

·AD家园

协和麒麟叫停OX40单抗Rocatinlimab全部临床，自免重磅药折戟上市前夕

协和麒麟叫停OX40单抗Rocatinlimab全部临床，自免重磅药折戟上市前夕医药圈再爆重磅突发消息。当地时间3月3日，日本药企协和麒麟（Kyowa Kirin）正式发布公告，宣布立即停止旗下核心OX40靶点新药、潜在重磅炸弹Rocatinlimab的所有正在进行的临床试验，且明确表态，这款曾被寄予厚望的自身免疫疾病新药，后续重启研发、推进上市的可能性极低。消息一出，直接震动全球自免药物研发赛道。要知道，Rocatinlimab是全球首个完成多项III期临床的抗OX40单抗，更是距离上市仅一步之遥、被视为特应性皮炎等难治性自免疾病新希望的明星药物，如今骤然全面停摆，背后究竟发生了什么？对患者、对整个OX40靶点研发赛道又意味着什么？核心事件速览：协和麒麟因临床试验中出现新增恶性肿瘤安全性信号，紧急终止Rocatinlimab全部临床研究；此前仅1个月，跨国巨头安进刚宣布退出该药物合作研发，这款耗资超十亿美元研发的重磅药，彻底倒在了上市前夕。从万众瞩目到紧急刹车，Rocatinlimab的“高光与陨落” 在此次紧急叫停前，Rocatinlimab绝对是自免领域的“天之骄子”，承载着无数药企与患者的期待。作为一款全人源抗OX40单克隆抗体，它靶向免疫调节关键通路，区别于传统自免药物，主打通过精准调控病理性T细胞活性，实现长效缓解中重度特应性皮炎、结节性痒疹、哮喘等难治性自身免疫疾病的效果，被行业冠以“潜在重磅炸弹”的称号。回顾它的研发历程，每一步都带着资本与行业的厚望： 2021年：跨国药企安进以4亿美元首付款+最高8.5亿美元里程碑付款，拿下Rocatinlimab日本以外的全球开发与商业化权益，单笔合作金额创下当时自免赛道新高；临床阶段：顺利完成多项关键III期临床试验，在中重度特应性皮炎患者中，疗效显著优于安慰剂，多项核心临床终点达标，是全球进展最快的OX40靶点药物；上市规划：协和麒麟原本计划2026年上半年向美国FDA提交上市申请，目标成为全球首款获批上市的抗OX40单抗，填补赛道空白。哪怕今年1月30日，安进以“战略组合优先级调整”为由，宣布终止合作、退还全部权益，协和麒麟依旧表态将独立推进后续研发与上市，坚守这款核心管线。谁也没料到，短短一个月后，等来的却是全面终止临床的终局。紧急叫停的核心原因：恶性肿瘤安全性信号，患者安全优先协和麒麟在官方公告中明确说明了停摆原因：临床试验安全性审查中，发现新的恶性肿瘤相关安全性信号，经多方评估，认定药物潜在风险超过患者治疗获益。据披露，在Rocatinlimab的临床试验队列中，除此前已记录的1例卡波西肉瘤病例外，近期新增1例确诊卡波西肉瘤、1例疑似卡波西肉瘤病例。卡波西肉瘤是一种与免疫功能、病毒感染相关的软组织恶性肿瘤，虽目前官方未完全确认药物与肿瘤发生的直接因果关系，但这类恶性不良事件的集中出现，已足以引发严重的安全性担忧。协和麒麟高管在声明中强调：患者安全永远是第一位的，基于审慎原则，必须立即停止所有临床研究，保障受试患者的安全。同时公司坦言，目前重启临床试验、继续推进上市的可能性极低，后续将联合安进全面梳理分析现有临床数据，给行业与患者一个完整交代。值得关注的是，这并非OX40靶点药物首次出现此类安全性隐患，同赛道另一款核心药物，此前也在临床试验中出现过类似恶性肿瘤病例，这也让整个OX40靶点研发，瞬间蒙上阴影。不止安全隐患：这款重磅药折戟，还有这些深层原因恶性肿瘤风险是压垮Rocatinlimab的最后一根稻草，但回顾其研发历程，这款药物的陨落，早有伏笔。1. 疗效优势不突出，难以撼动现有格局尽管Rocatinlimab的III期临床数据达标，疗效优于安慰剂，但与目前特应性皮炎领域的“金标准”药物达必妥相比，并未展现出突破性的疗效优势，无论是皮损清除率、症状缓解深度，还是长效维持效果，都未能实现超越，市场竞争力大打折扣。2. 不良反应明显，临床耐受性存短板临床试验数据显示，使用Rocatinlimab的患者中，约12%出现发热、6%出现寒战等全身性不良反应，这类注射相关反应发生率偏高，对于需要长期用药的慢性自免疾病患者而言，会直接影响用药依从性，也成为其商业推广的一大障碍。3. 靶点机制争议，免疫平衡难把控 OX40是免疫系统的“双向调节靶点”，在肿瘤领域需激活通路增强免疫杀伤，在自免领域需抑制通路阻断炎症，一旦调控过度，极易打破免疫平衡，削弱机体对肿瘤的监视能力，这也是此次出现恶性肿瘤安全性信号的核心机制隐患。对患者与行业的影响：希望落空，赛道重新洗牌对于广大中重度特应性皮炎、结节性痒疹等难治性自免疾病患者而言，Rocatinlimab的突然停摆，无疑是一次沉重的打击。很多患者将其视为摆脱反复瘙痒、皮损顽固的新希望，如今新药上市无望，只能继续依赖现有传统疗法。而对于全球医药研发行业，这一事件更是一记警钟：靶点研发需更谨慎：OX40靶点的安全性争议，将倒逼全球药企重新评估该靶点的研发价值，后续相关管线推进势必更加严苛；自免药研发回归本质：疗效与安全必须兼顾，慢性疾病药物尤其看重长期安全性，单纯追求临床终点达标，忽视长期耐受性与潜在风险，终究难以走远；创新药研发风险凸显：哪怕是进入III期临床、临近上市的重磅药物，依旧存在全盘折戟的可能，创新药研发始终是高投入、高风险的漫长征途。从备受瞩目的重磅新药，到骤然终止的失败案例，Rocatinlimab的结局令人唏嘘。这一事件也再次印证，医药创新的终极核心永远是患者安全，哪怕投入数十亿资金、耗费数年光阴，只要触及安全红线，就必须果断叫停。对于自免疾病患者而言，虽此次希望暂时落空，但全球医药研发的脚步从未停止，相信随着更安全、更高效靶点的突破，更多优质新药终将问世，帮助患者摆脱病痛困扰。特应性皮炎患者的关爱家园扫码关注AD家园微信公众号扫码加入AD家园病友微信群扫码添加AD家园管家助手

2026-03-11

·研在云资讯

特应性皮炎（AD）药物研发热潮：谁能撼动度普利尤单抗的王者地位？| 行业动态

导语： 2025年，赛诺菲与再生元联合开发的度普利尤单抗（Dupilumab）销售额达到惊人的157.14亿欧元，同比增长25.2%。作为全球首款针对IL-4Rα靶点的生物制剂，度普利尤单抗不仅在特应性皮炎（AD）领域确立了无可争议的一线地位，更成为自免领域的“药王”。然而，随着越来越多的新药进入临床，尤其是中国创新药企的快速崛起，这场围绕AD的“围剿战”正愈演愈烈。一、AD市场的巨大潜力与未满足需求 1. 患者基数庞大全球患者规模：约有20%的儿童和7%-14%的成人患有AD，其中30%以上的患者为中重度AD。中国患者情况：成人AD患病率为3%-8%，儿童为10%-15%，且增长明显。 2. 长期治疗需求尽管AD不致命，但其反复发作的剧烈瘙痒与皮损严重影响患者的睡眠、心理与生活质量。传统治疗方法如外用激素与系统性免疫抑制剂疗效有限且副作用显著，长期治疗需求仍未被充分满足。二、度普利尤单抗的成功与挑战 1. 商业化表现首发适应症：2017年获批上市，凭借EASI-75、瘙痒控制及长期维持治疗上的稳定疗效，迅速确立一线首选地位。 2025年销售额：达157.14亿欧元，同比增长25.2%，AD仍是其最核心的收入来源。 2. 留给后来者的空间尽管度普利尤单抗表现出色，但在疗效、起效速度、注射频次、结膜炎等不良反应方面仍存在优化空间，这为后来者提供了竞争机会。三、多靶点探索与新药研发加速 1. IL-4Rα靶点优化国产突破：康诺亚的司普奇拜单抗、三生国健的SSGJ-611等同靶点药物已在安全性、复发率等关键指标上实现优化。司普奇拜单抗：结膜炎发生率约为5.2%，停药8周后的复发率低至0.9%。对比度普利尤单抗：后者在多项真实世界队列中的结膜炎发生率大于10%。 2. 其他免疫靶点挖掘 IL-13靶点：LEO Pharma的Tralokinumab与礼来的Lebrikizumab均是靶向IL-13的单抗，显示出稳定的疗效与良好的依从性。 Tralokinumab：四年随访数据显示近七成患者瘙痒减轻至轻度或消失。 Lebrikizumab：每四周一次的维持方案，大幅提升患者长期依从性。 IL-31靶点：Galderma的Nemolizumab通过直接阻断IL-31瘙痒的神经信号传导，在48小时内显著缓解瘙痒，满足患者最紧迫的需求。 3. JAK抑制剂的竞争已获批药物：艾伯维的Rinvoq、辉瑞的Cibinqo和礼来的Olumiant。优势与挑战：口服、起效快、瘙痒改善明显，但潜在严重不良反应（血栓、心脏病）限制了其长期使用。 4. 双抗与多抗探索强生的JNJ-5939：同时靶向IL-4Rα与IL-31，理论上既可长期改善皮损，又可快速止痒，但因疗效问题被提前终止。 OX40/OX40L靶点：赛诺菲的Amlitelimab与协和麒麟的Rocatinlimab曾尝试，但因疗效不佳或安全性问题被终止或暂停。四、中国创新药企的崛起与差异化策略 1. 国产药物的突破 IL-4Rα靶点：康诺亚的司普奇拜单抗、先声药业/康乃德的乐德奇拜单抗、康哲药业/麦济生物的柯美奇拜单抗、智翔金泰的泰利奇拜单抗等已通过上市申请。 JAK抑制剂：恒瑞医药的艾玛昔替尼已于2025年顺利上市，凌科药业的泽普昔替尼也展示了良好的安全性。 2. 差异化策略 TYK2抑制剂：诺诚健华的ICP-332是全球进展最快的TYK2新药，正在开展治疗中重度AD的3期临床试验。多靶点探索：国内企业在IL-2、IL-7、IL-18、IL-33等免疫靶点上也有布局，试图找到新的突破口。五、未来展望：谁将破局？ 1. 多靶点联合疗法随着对AD免疫机制的深入理解，未来的治疗趋势可能是多靶点联合疗法，以实现更好的疗效与更低的副作用。 2. 安全性与依从性无论是生物制剂还是小分子药物，提高安全性与依从性将是未来竞争的关键。对于需要终身用药的AD患者来说，长期的安全性尤为重要。 3. 新技术的应用基因治疗、RNA干扰等新技术的应用也可能为AD治疗带来新的希望，进一步提升疗效并减少副作用。结语：AD赛道的未来之战面对度普利尤单抗这座难以逾越的大山，后来者们必须拿出颠覆性的成果才能真正破局。而在这一过程中，中国创新药企凭借庞大的患者基数与快速的研发推进，正逐渐成为不可忽视的力量。这场围绕特应性皮炎的“围剿战”，不仅是对度普利尤单抗的挑战，更是对整个AD治疗格局的重塑。谁能在这场激烈的竞争中脱颖而出，我们拭目以待。免责声明：所载内容、图片来源互联网，微信公众号等公开渠道，我们对文中观点保持中立，仅供参考、交流之目的。转载的稿件版权归原作者和机构所有，如有侵权，请联系我们删除。本公众号原创文章，欢迎转载，转载时请注明出处。

100 项与诺卡替利单抗相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
结节性痒疹	临床3期	美国	Amgen, Inc.	2024-07-08
中度特应性皮炎	临床3期	美国	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	中国	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	日本	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	阿根廷	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	巴西	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	加拿大	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	克罗地亚	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	捷克	Amgen, Inc.	2022-05-31
中度特应性皮炎	临床3期	德国	Amgen, Inc.	2022-05-31

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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


NCT05724199 (ROCKET-SHUTTLE, Company_Website) 人工标引	临床3期	重度特应性皮炎	746	Rocatinlimab higher dose + TCS/TCI	獵糧糧範襯鏇願獵遞顧(窪觸夢廠壓淵壓壓廠觸) = 襯簾齋壓積膚齋衊糧鏇築齋繭鬱淵膚衊鑰醖網 (願齋壓範餘壓鹹廠蓋構 ) 达到更多	积极	2025-03-08
				Rocatinlimab lower dose + TCS/TCI	獵糧糧範襯鏇願獵遞顧(窪觸夢廠壓淵壓壓廠觸) = 獵廠憲醖淵選鹽獵淵艱築齋繭鬱淵膚衊鑰醖網 (願齋壓範餘壓鹹廠蓋構 ) 达到更多
NCT05398445 (ROCKET-IGNITE, Company_Website) 人工标引	临床3期	特应性皮炎	769	Rocatinlimab higher dose	繭鏇憲積壓憲艱鹹夢範(鹽鹽餘鬱襯廠糧壓壓膚) = 網醖鬱鑰願襯選簾鹹醖遞壓製製範衊憲網遞網 (齋膚鹹繭選遞壓齋夢襯 ) 达到更多	积极	2025-03-08
				Rocatinlimab lower dose	繭鏇憲積壓憲艱鹹夢範(鹽鹽餘鬱襯廠糧壓壓膚) = 醖餘構憲鹹膚膚餘選蓋遞壓製製範衊憲網遞網 (齋膚鹹繭選遞壓齋夢襯 ) 达到更多
NCT05651711 (ROCKET HORIZON, Company_Website) 人工标引	临床3期	重度特应性皮炎	726	Rocatinlimab	遞衊鹹齋簾窪鹹積膚膚(艱醖鹹積製簾壓淵願夢) = 製鹹構窪鹽鹹淵鏇鏇衊簾範鹹鹹齋鑰積簾憲選 (艱選網選鹹範淵鹹夢鏇 ) 达到更多	积极	2024-09-25
				Placebo	遞衊鹹齋簾窪鹹積膚膚(艱醖鹹積製簾壓淵願夢) = 糧鏇窪糧網選網蓋糧獵簾範鹹鹹齋鑰積簾憲選 (艱選網選鹹範淵鹹夢鏇 ) 达到更多
NCT05651711 (ROCKET HORIZON, Corporate Publications) 人工标引	临床3期	特应性皮炎	726	Rocatinlimab	窪選繭簾繭餘製壓繭淵(鏇餘醖簾醖選鹹壓衊鏇) = 夢網繭鹽積鹹鏇餘窪顧醖範繭顧襯衊蓋齋夢鹹 (鑰製夢構鹽夢範鑰蓋醖 ) 达到更多	积极	2024-09-25
				Placebo	窪選繭簾繭餘製壓繭淵(鏇餘醖簾醖選鹹壓衊鏇) = 艱鏇淵蓋製齋衊夢壓壓醖範繭顧襯衊蓋齋夢鹹 (鑰製夢構鹽夢範鑰蓋醖 ) 达到更多
NCT03703102 (CTgov)	临床2期	中度特应性皮炎 \| 重度特应性皮炎	274	KHK4083 (KHK4083 150 mg SC Q4W)	艱鬱積淵構範膚壓齋築(顧鹽網遞築觸廠鏇廠淵) = 顧製糧餘網憲積蓋築糧壓築鹽積願餘網醖網窪 (窪構製餘願蓋獵糧鹹鏇, 繭積艱範醖鑰糧鏇簾廠 ~ 鹽築蓋蓋繭艱壓窪壓蓋) 更多	-	2022-06-09
				KHK4083 (KHK4083 600 mg SC Q4W)	艱鬱積淵構範膚壓齋築(顧鹽網遞築觸廠鏇廠淵) = 遞築鹹衊憲鬱願窪選膚壓築鹽積願餘網醖網窪 (窪構製餘願蓋獵糧鹹鏇, 繭遞選廠鏇遞蓋淵網醖 ~ 壓願壓網鬱憲鑰夢顧膚) 更多
NCT02647866 (CTgov)	临床2期	腹痛 \| 溃疡性结肠炎	66	KHK4083 (KHK4083 Cohort 1)	艱淵齋衊窪衊製衊餘鑰 = 艱膚鹽鑰壓鑰廠艱獵窪範願獵憲壓廠獵範糧醖 (襯糧鬱簾選窪廠醖顧願, 齋範壓窪選鬱鏇遞鬱積 ~ 襯窪構獵顧齋網夢廠壓) 更多	-	2020-03-05
				KHK4083 (KHK4083 Cohort 2)	艱淵齋衊窪衊製衊餘鑰 = 構顧窪艱艱顧醖簾製鹽範願獵憲壓廠獵範糧醖 (襯糧鬱簾選窪廠醖顧願, 衊鹽夢糧鏇構簾醖觸顧 ~ 鑰齋淵鏇繭憲獵憲顧廠) 更多