The goal of this clinical trial is to learn how quickly omalizumab begins to work in people with food allergy. The main question it aims to answer is:
* Does omalizumab begin to work as early as 2 to 4 weeks after after starting treatment in people with food allergy?
Researchers will compare each participant's food challenge results at baseline before starting omalizumab, 2 to 4 weeks after starting omalizumab, and 4 to 6 months after starting omalizumab treatment.
Participants will:
* Have a baseline food challenge before starting omalizumab.
* Start omalizumab treatment as prescribed by the participant's doctor as part of regular clinical care.
* Have food challenges 2 to 4 weeks after starting omalizumab and again 4 to 6 months after starting omalizumab.
* Have skin prick testing and blood tests at study visits.

开始日期2026-10-01

申办/合作机构

The Johns Hopkins University

NCT07816328

/ Recruiting临床3期

A Global, Multi-center, Open-label Study, Investigating a Remibrutinib- and Omalizumab-Based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-Antihistamines, to Achieve Fast and Well-Controlled Disease Within 24 Weeks

The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU) who are inadequately controlled by second-generation H1-antihistamines (sgH1-AH).

开始日期2026-09-21

申办/合作机构

Novartis Pharmaceuticals Australia Pty Ltd.

ChiCTR2600121053

/ Not yet recruitingN/AIIT

Efficacy and Safety of Omalizumab in Asthmatic Patients with Allergic Bronchopulmonary Aspergillosis (ABPA): A Multicenter, Randomized, Single‑Blind, Placebo‑Controlled Clinical Study

开始日期2026-04-01

申办/合作机构

宁波市第一医院

100 项与奥马珠单抗相关的临床结果

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100 项与奥马珠单抗相关的转化医学

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100 项与奥马珠单抗相关的专利（医药）

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3,763

项与奥马珠单抗相关的文献（医药）

2026-12-31·mAbs

Self-interaction nanoparticle spectroscopy predicts high-concentration viscosity of therapeutic IgG1 antibodies

Article

作者: Andersen, Nisana ; Luu, Steven ; Stephens, Nicole ; Bol, Karenna ; Mehta, Shrenik ; Heisler, Joel ; Swartz, Trevor ; Kovner, Daniel ; Rude, Erina ; Makowski, Emily ; Ibrahim, Julissa ; Zarzar, Jonathan ; Carter, Paul J. ; Stepurska, Kateryna ; Izadi, Saeed ; Baginski, Tomasz ; Paidi, Santosh Kumar ; O’Connor, Kelly

Predicting high-concentration viscosity of monoclonal antibodies is crucial for their development as therapeutics for subcutaneous delivery, but traditional experimental rheometry methods for assessing viscosity are low-throughput, which limits their utility. This study evaluates self-interaction nanoparticle spectroscopy (SINS) assays - specifically charge-stabilized SINS (CS-SINS) and PEG-stabilized SINS (PS-SINS) - for high-throughput viscosity prediction. We characterized 96 IgG₁ antibodies, assessing SINS against in silico descriptors and dynamic light scattering (DLS) data. CS-SINS showed strong correlation with charge, offering limited additional utility. In contrast, PS-SINS provided orthogonal information; integrating it with in silico data and DLS significantly improved random forest model accuracy for binary viscosity classification. PS-SINS measurements in multiple buffers captured complementary information, achieving comparable accuracy without DLS. Importantly, PS-SINS scores exhibited a strong logarithmic relationship with high-concentration viscosity in Fc variants of clinical antibodies (r = 0.72 and r = 0.85 for trastuzumab and omalizumab variants, respectively), suggesting a direct mechanistic link. Furthermore, PS-SINS performed reliably with one column-purified (protein A) samples, supporting its early-stage application. These findings establish PS-SINS as a high-throughput tool to accelerate the developability assessment of antibody candidates.

2026-12-31·ANNALS OF MEDICINE

Beyond biomarkers: the role of clinical factors associated with biologic therapy response in severe asthma

Article

作者: Lopez-Rodríguez, Raquel ; Cañas, José Antonio ; Rial, Manuel Jorge ; Mahíllo-Fernández, Ignacio

BACKGROUND:

Severe asthma carries a high burden and often requires biologic therapy targeting type 2 (T2) inflammation. However, treatment response is heterogeneous, and traditional biomarkers, such as blood eosinophils, fractional exhaled nitric oxide (FeNO), and total serum IgE, may not fully explain this variability .

OBJECTIVE:

To evaluate clinical and inflammatory characteristics associated with response to biologic therapies in a real-world cohort of severe asthma patients.

METHODS:

A single-center, ambispective observational study was conducted in the Allergology Department of A Coruña, Spain. Sixty-seven patients with severe uncontrolled asthma and treated with omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab, were included. Patients were followed for ≥12 months. Clinical variables and inflammatory biomarkers were assessed at baseline, 4-6 months, and 12 months. Comparisons between biologic subgroups and logistic regression analyses were performed to identify factors associated with response.

RESULTS:

Female sex, nasal polyposis, elevated blood eosinophils, and frequent exacerbations were associated with better response to biologics. Clinical factors such as nasal polyposis and aspirin-exacerbated respiratory disease (AERD) showed a stronger association with treatment response than standard biomarkers (FeNO, blood eosinophils). The mean diagnostic delay was 12.1 years, suggesting a potential influence on therapeutic results.

CONCLUSION:

Beyond traditional biomarkers, clinical factors particulary nasal polyposis and AERD may play a key role in understanding response patterns to biologics. Incorporating these variables into clinical assessment may help support a more personalized management approach in severe asthma.

2026-12-01·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

Monoclonal Antibodies in Pediatric Atopic Dermatitis; Efficacy and Safety

Review

作者: Noqani, Hesam ; Aminzade, Zahra ; Masoumi, Niloofar ; Soltani, Afsaneh ; Monadi, Taha ; Enderami, Seyed Ehsan

Background:

Atopic dermatitis (AD), which causes eczema, dryness, and itching, is one of the most prevalent skin diseases in children. Along with topical corticosteroids and the liberal application of emollients, monoclonal antibodies have recently been used for systemic treatment in moderate to severe cases. This study aims to review the current literature on the application of monoclonal antibodies (mAbs) in treating children with AD.

Methods:

To conduct a narrative review of the literature, we searched for the keywords (monoclonal antibodies OR biologics) AND (pediatric OR children) AND (atopic dermatitis OR eczema) in PubMed and Google Scholar.

Results:

The pathophysiology of atopic dermatitis still requires better understanding (or, remains incompletely understood). The most well-known factors contributing to the pathophysiology of AD include filaggrin gene mutations and abnormalities in Th1 and Th2 cell regulation. Cytokines, such as IL-4, IL-13, IL-17, IL-22, IL-31, and IL-33, are crucial mediators that lead to IgE antibody production and result in skin barrier degradation. Monoclonal antibodies have several advantages over other systemic therapies. Among these, dupilumab, tralokinumab, omalizumab, nemolizumab, lebrikizumab, and benralizumab have shown favorable results.

Conclusion:

A systemic immunomodulatory medication (monoclonal antibodies) is frequently required for moderate to severe AD as supplementary treatment. Dupilumab has received FDA approval for pediatric AD. Further clinical trials are needed for other mAbs before they are used in children.

1,919

项与奥马珠单抗相关的新闻（医药）

2026-10-13

·华大智造MGI

还是那个随传随到的靠谱搭子！这回产出翻了一倍

同一台机器，不换主机、不改流程，产出直接翻一倍——这是华大智造“开箱即用”小型便携式测序仪E25交出的新答卷。近日，全球首款基于自发光测序生化原理的基因测序仪E25性能再进化——新推出 FCS、FCU两种规格载片，其中FCU载片单张有效reads数突破50M，单轮测序产出最大通量站上15Gb。对比此前的25M reads / 7.5 Gb，E25搭载FCU载片后的有效读量与单轮最大产出双双翻倍。一句话总结：原来要跑两轮的活儿，现在一轮搞定，buff叠满。机器还是那台，占地还是0.1㎡，依然随时随地可用，能干的事却多了一倍——样本跑得更多、测得更深、测更完整的基因组。不用换主机、不用改实验室，升个软件就能用。FCS、FCU两种规格载片及配套试剂已完成仪器适配，即日起开放订购，供灵活选用，畅享翻倍产出。一张载片，双倍产出一张表看懂，新增FCU和FCS载片后，E25搭载各规格载片的性能参数如下：注：有效 reads 数的最大值根据特定标准文库运行所得，实际应用文库受样本类型、建库方式影响会有所波动。不止翻倍：三大效能提升 01通量翻倍，按需选配不换机、不改流程、不多占一寸地方——软件升个级，换张载片，通量直接翻倍。25M与50M两档并存：样本多、要测深，就上50M；样本少、求快，就用25M，按需求随手切换。 02成本效益，再上台阶通量翻倍，成本并未翻倍。同样一笔预算，能测的样本更多了——摊到每个样本上，检测成本显著下降。 03应用拓展，边界再打开载片更能装了，试剂也更强了，E25能干的活儿自然更多。下面这几类场景，从此不再是难题： m+t 联合检测：一次上机，两类数据——mNGS与tNGS放进同一次运行里完成，样本量更省，出结果更快；肿瘤基因分析与遗传病小panel：数据量上来了，panel可以设计得更丰富，低丰度变异也能稳稳检出；小型基因组重测序：单轮数据量最高15Gb，能扛下来的重测序种类更多；多接头灵活组合：App-D SE100同时兼容MGI与第三方文库接头，再配上25M / 50M两档通量，什么场景都能搭出合适的一套。随时随地，为现场测序而生作为全球首款“自发光”测序仪，E25自带「发光」技能——不需要外部激发光源就能产生测序信号，再配上微流控载片与集成信号采集模块，整台机器被大幅「瘦身」：结构更简单、能耗更低、说走就走。2025年1月，E25获NMPA医疗器械注册证（国械注准20253220056），得以充分发挥其“随时随地”测序的优势，在临床领域大显身手。 E25在小规模测序场景下具有高成本效益，是中小医院、各级疾控及海关、中小实验室等轻松实现测序能力布局的理想工具，可助力健康中国建设，满足人民群众日益增长的健康需求。小巧便携——机身348×312×257mm，约15kg，占桌面积仅0.1㎡。即插即测——试剂走载片自带的微流道，不经过仪器液路；跑完不用洗机器，下一轮接着上。数据不出机——碱基识别与FASTQ输出都在机器里完成；E25A还内置高性能计算模块，连生信分析都能在机内跑完，全程不联网，从根上断了数据外泄的可能。极端环境验证——E25曾登上海拔5200米的珠峰大本营，在低气压低气温的户外稳定运行，刷新最高海拔测序运行纪录。 E25还能与ATOPlex多重 PCR 建库定制平台、DNBelab-D4 数字化样本制备系统搭成自动化组合，把建库繁琐、TAT 长的痛点一并解决——上山下海，开箱即用，样本随到随测。想知道搭载新载片的E25在您的场景里到底跑得怎么样？欢迎联系华大智造当地销售或应用支持团队，我们将提供适配评估与试用方案。后续，我们也将陆续分享早期用户实测反馈，敬请期待。联系我们热线电话：4000-688-114 邮箱：MGI-service@mgi-tech.com 官网：https://www.mgi-tech.com/ · ·

并购临床1期

2026-10-12

·癌友创新药交流群

慢性鼻窦炎伴鼻息肉，终于有新靶向药了：LP-003 II 期临床招募中

"鼻窦炎鼻息肉，重在秋冬" 需要长期管理慢性鼻窦炎伴鼻息肉（CRSwNP），简单说就是：鼻窦（鼻子周围骨头里的小空腔）长期发炎，同时鼻腔和鼻窦里长出了像“小葡萄”一样的柔软肿物（鼻息肉）。它不是普通感冒，也不是单纯的鼻炎，而是一种病程超过 12 周、反复发作的慢性炎症性疾病。主要症状 #鼻窦炎 #鼻息肉鼻塞：最常见，常为双侧，逐渐加重流涕：多为黏脓性，可向后流入咽部；嗅觉减退或丧失：息肉堵塞嗅区所致；面部胀痛：鼻窦开口堵塞、压力增高，打鼾、张口呼吸、睡眠差；合并哮喘者：可能伴有喘息、咳嗽；治疗手段 1. 药物治疗（基础）鼻用糖皮质激素：一线治疗，喷鼻或冲洗，长期使用口服糖皮质激素：短期用于重者，快速缩小息肉，但不宜长期用；生理盐水冲洗：辅助清洁鼻腔 2. 手术治疗鼻内镜手术：切除息肉、开放鼻窦，适用于药物效果不佳者，但术后复发率较高，尤其伴哮喘、过敏者； 3. 生物制剂（新兴） LP-003 是人源化抗人 IgE 单克隆抗体，该抗体为 IgG1-κ，由人源框架区以及与 IgE 结合的鼠源抗体互补决定区组成。可与人免疫球蛋白 E（IgE）发生选择性结合，阻止 IgE 分子与靶细胞上的 FcεRI 结合，从而抑制过敏原诱导的早/晚期相超敏反应。注册分类为治疗用生物制品 1 类，适应症拟定为慢性鼻窦炎伴鼻息肉（CRSwNP）。临床前研究结果显示 LP-003 体外可以有效地阻断人源 IgE 和 FcεRⅠα、FcεRⅡ（CD23）受体的结合，对 FcεRIα 蛋白的阻断能力和对RBL-2H3-FcεRⅠα-NFATLuc 细胞激活的抑制能力远强于同类药物奥马珠单抗。独特优势给药频率更低，亲和力更高与当前抗 IgE 生物制剂（主要是奥马珠单抗）相比，LP-003 在数据上展现出几个值得关注的差异化特点：给药频率更低：奥马珠单抗通常需要每 2-4 周注射一次。而 LP-003 的半衰期（药物在体内浓度下降一半所需时间）长达 45-76 天，约为前者的 2-3 倍。这使得它有可能实现每 8-12 周甚至更久注射一次，极大地方便了患者。亲和力更高：有数据显示，LP-003 与 IgE 的结合亲和力比奥马珠单抗高出860 倍。这意味着更少的药物剂量可能就能达到相同的阻断效果，目前其临床研究中的剂量也显著低于奥马珠单抗。 PLAGUE PREVENTION 【入选标准】 1、年龄为 18-75 周岁（含边界值），男女不限； 2、诊断为双侧慢性鼻窦炎伴鼻息肉； 3、在筛选/导入期之前，同时持续存在下述症状≥4 周： (1) 鼻塞； (2) 其他任一症状：黏性或黏脓性鼻涕，头面部胀痛，嗅觉减退或丧失； 4、在筛选/导入期和随机前，NPS≥5 分，且每侧鼻腔的评分至少≥2 分（读取中心阅片结果）； 5、在筛选/导入期和随机前，试验参与者报告中度至重度鼻塞： 6、筛选前2年内接受过口服糖皮质激素（OCS）等SCS治疗但仍存在双鼻窦炎伴鼻息肉；和/或有 SCS 治疗的禁忌症或不耐受 SCS 治疗；和/或在筛选前 6 个月前接受过鼻息肉手术治疗但仍存在双侧鼻窦炎伴鼻息肉； 7、筛选前必须已经持续使用较稳定剂量的鼻用糖皮质激素≥4 周；研究中心遍布全国各大城市，方便志愿者访视北京、石家庄、太原、南昌、扬州、荆州、常德、成都、沈阳、朝阳、包头、烟台、济南、淄博、武汉、西安、连云港、杭州、温州、重庆、上海、佛山、深圳、上海、郑州、哈尔滨、宣城。受益群体这项研究瞄准的是病情较重、现有治疗不理想的患者。具体入组标准包括：确诊为双侧慢性鼻窦炎伴鼻息肉，且鼻息肉评分（NPS）较高（双侧总分至少 5 分，每侧至少 2 分）；有中重度鼻塞；并且过去接受过口服激素治疗但效果不佳，或对激素不耐受/有禁忌，或者做过息肉切除手术但息肉仍然复发。简单说，就是那些被鼻塞和息肉反复困扰、常规手段已经“没招了”的患者。 END 前景展望 LP-003 在季节性过敏性鼻炎的 III 期临床试验中已成功达到主要终点，并计划于 2026 年第三季度或之前在中国提交上市申请（BLA）。其在过敏性鼻炎上的成功，为其在鼻窦炎伴鼻息肉这个关联适应症上的疗效提供了有力的逻辑支撑。如果后续的 II 期及 III 期研究能够证实其安全有效，LP-003 有望成为该领域一种更长效、更便捷的治疗选择，填补部分未满足的临床需求。 #鼻息肉#鼻窦炎 #LP003#鼻窦炎伴鼻息肉#鼻窦炎生物制剂#鼻息肉临床试验#鼻息肉生物制剂#鼻窦炎患者

临床结果临床2期

2026-10-12

·自由鼻肺站

9500一针的特泽利尤单抗，重度哮喘和鼻息肉患者值得打吗？

前言有患者发现，部分医院和药店已经能开到特泽利尤单抗了。作为目前唯一作用于炎症级联反应最上游（TSLP）的生物制剂，它到底值不值得打？价格泰适卓（特泽利尤单抗注射液）上海挂网价为 9500 元/盒（210mg×1 支）。推荐剂量为每 4 周皮下注射 1 次 210mg，算下来一年治疗费用约 12.35 万元。该药目前尚未纳入国家医保目录。对多数家庭来说，这个数字确实需要认真掂量。一、特泽利尤单抗靶点作用机制特泽利尤单抗靶向胸腺基质淋巴细胞生成素（TSLP），能够直接作用于炎症通路顶端，抑制多种与气道炎症相关的生物标志物和细胞因子的表达，并且不受表型及生物标志物水平限制。传统生物制剂大多需要先检测嗜酸性粒细胞等指标才能判断是否适用，而特泽利尤单抗无需这一前置步骤。这对那些炎症驱动因素不明确、或不符合现有生物制剂条件的患者来说，治疗路径确实不一样了。机制定位：炎症级联反应的最上游 IL-4Rα、IL-5、IL-5R、IgE 等靶点分别针对特定下游炎症通路，而 TSLP 作用于炎症级联反应的顶端。通过靶向 TSLP 这一关键的上皮"预警素"，特泽利尤单抗能够实现对慢性鼻窦炎伴鼻息肉症状的快速改善，并几乎消除患者的手术需求。也正因如此，《全球支气管哮喘防治创议（2025）》（GINA 2025）在内的国内外指南共识均指出：无论炎症表型如何，均可考虑使用抗 TSLP 单抗治疗重度哮喘。二、关键临床研究数据（一）重度哮喘：DIRECTION Ⅲ 期研究 DIRECTION Ⅲ 期临床研究于中国、韩国及菲律宾开展，入组患者中 77% 来自中国。研究结果表明，与安慰剂相比，使用特泽利尤单抗治疗 52 周，亚洲患者总体人群的哮喘年急性发作率（AAER）降低 74%，具有显著统计学意义和临床意义；其中特泽利尤单抗治疗组与安慰剂组的年急性发作率分别为 0.42 和 1.63。 74% 亚洲患者 AAER 降幅 95% CI 61–83；p<0.001 0.42 vs 1.63 年急性发作率（治疗组 vs 安慰剂） 80% 中国患者亚组 AAER 降幅在中国患者亚组中，与安慰剂相比哮喘年急性发作率降低 80%。同时，特泽利尤单抗达到研究的所有关键次要终点，较基线改善患者肺功能、哮喘症状和生活质量，且安全性及耐受性良好。（二）慢性鼻窦炎伴鼻息肉：WAYPOINT Ⅲ 期研究在 WAYPOINT Ⅲ 期临床研究中，特泽利尤单抗降低了通过共同主要终点评估的鼻息肉严重程度，结果具有显著统计学及临床意义：治疗第 52 周时，鼻息肉评分（NPS）降低 2.08 分，患者自我报告鼻塞症状评分（NCS）降低 1.04 分。 2.08 鼻息肉评分 NPS 降低（分） p<0.0001 1.04 鼻塞评分 NCS 降低（分） p<0.0001 98% 鼻息肉手术需求降幅 p<0.0001 鼻息肉评分（NPS）的改善最早见于第 4 周，患者自评鼻塞症状评分（NCS）的改善最早见于第 2 周，且疗效持续至第 52 周。尤为重要的是，与安慰剂组相比，特泽利尤单抗几乎完全消除患者后续鼻息肉手术需求，降幅达 98%（p<0.0001），并显著减少患者系统性糖皮质激素使用需求，降幅达 89%（p<0.0001）。安全性在 DIRECTION 和 WAYPOINT 研究中，特泽利尤单抗的安全性和耐受性与其已知特性基本一致，未提示新的安全性信号。三、横向对比：已上市靶向药物两类药物的靶点不同，医保状态差异显著。已有多款同类靶向药获批，其中司普奇拜单抗、奥马珠单抗等已进医保，特泽利尤单抗目前为自费。慢性鼻窦炎伴鼻息肉（CRSwNP）领域哮喘领域怎么看这笔账从靶点看，特泽利尤单抗作用于炎症级联最上游、无需前置生物标志物检测，覆盖人群更广；但从花费看，其年费用约 12.35 万元且自费，远高于已进医保的同类药。是否"值得"，取决于病情严重程度、既往治疗反应，以及对自费支出的承受力——建议与主治医生结合个体情况评估。五、临床用药：新药正在招募对于鼻息肉与哮喘患者，目前已有作用机制相似的在研新药开展临床用药招募。若既往使用现有药物治疗效果不佳，或家庭经济状况难以承担长期自费治疗，可以考虑关注临床研究提供的用药机会。这类研究通常能在使用规范药物之外，提供规范化随访与新药使用通道，对控制不佳且经济压力大的人群尤其值得了解。参考文献 1.Yang X, Wang L, Huang K, et al. Efficacy and Safety of Tezepelumab in Adults With Severe, Uncontrolled Asthma in Asia: Results From the Phase 3 DIRECTION Study. J Allergy Clin Immunol Pract. 2025;13(11):3011-3020.e9. doi:10.1016/j.jaip.2025.07.0462.Lipworth, BJ, Han JK, et al. Tezepelumab in adults with severe, uncontrolled CRSwNP. N Engl J Med. 2025.3.Lipworth, BJ, Han JK, et al. Efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps: results from the Phase 3 WAYPOINT Study. [Late breaking oral presentation]. Presented at the American Academy of Allergy, Asthma & Immunology /World Allergy Organization Joint Congress 2025 (28 February – 03 March).4.Chinese Guidelines for the Prevention and Management of Bronchial Asthma (2024 Edition)5.Chinese Journal of Tuberculosis and Respiratory Diseases. 2025;48(3):208-2486.Zhonghua Nei Ke Za Zhi. 2017;56(7):481-482. doi:10.3760/cma.j.issn.0578-1426.2017.07.0017.Zhang Q, Fu X, Wang C, et al. 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PMID: 30720213; PMCID: PMC6767455.12.Denton E, et al. The journal of allergy and clinical immunology. In practice vol. 9,7 (2021): 2680-2688.e7.13.Hao D, Wu Y, Li P, et al. An Integrated Analysis of Inflammatory Endotypes and Clinical Characteristics in Chronic Rhinosinusitis with Nasal Polyps. J Inflamm Res. 2022 Sep 24;15:5557-5565.14.Håkansson, Kåre et al. “A comparative and descriptive study of asthma in chronic rhinosinusitis with nasal polyps.” American journal of rhinology & allergy vol. 28,5 (2014): 383-7. doi:10.2500/ajra.2014.28.4076.15.Global Initiative for Asthma. [Online]. Global strategy for asthma management and prevention, 2025. Available at: https://ginasthma.org/wp-content/uploads/2025/11/GINA-2025-Update-25_11_08-WMS.pdf. Accessed March 2026.16.Chinese Education Association of Chronic Airway Diseases. Natl Med J China. 2024;104(20):1759-178917.AstraZeneca news release. Tezspire approved in the US for chronic rhinosinusitis with nasal polyps. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/us-fda-approves-tezspire-in-crswnp.html. Accessed March 2026.18.AstraZeneca news release. Tezspire approved in the EU for chronic rhinosinusitis with nasal polyps. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/tezspire-approved-in-eu-for-crswnp.html. Accessed March 2026.19.AstraZeneca news release. Tezspire 210mg pre-filled syringe and auto-injector approved in Japan for CRSwNP. Available at: https://www.astrazeneca.co.jp/content/az-jp/media/press-releases1/2026/202602191.html. Accessed March 2026.20.TEZSPIRE (tezepelumab) US prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s003lbl.pdf. Accessed March 2026.21.TEZSPIRE (tezepelumab) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tezspire-epar-product-information_en.pdf. Accessed March 2026.22.AstraZeneca news release. TEZSPIRE approved in Japan for the treatment of severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html. Accessed March 2026.23.The Global Asthma Report 2018. [Online]. Available at: http://globalasthmareport.org/resources/Global_Asthma_Report_2018.pdf. [Last accessed: February 2026].24.Chung KF, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43 (2): 343-373.25.Wenzel S. Severe asthma in adults. Am J Respir Crit Care Med. 2005; 172: 149-160.26.Peters SP, et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med 2006: 100 (7): 1139-51.27.Hyland ME, et al. A Possible Explanation for Non-responders, Responders and Super-responders to Biologics in Severe Asthma. Explor Res Hypothesis Med. 2019; 4: 35–38.28.Tran TN, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016; 116: 37–42.29.Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40: 364-372.30.Chastek B, et al. Economic Burden of Illness Among Patients with Severe Asthma in a Managed Care Setting. J Manag Care Spec Pharm. 2016;22: 848–861.31.Hartert TV, et al. Risk factors for recurrent asthma hospital visits and death among a population of indigent older adults with asthma. Ann Allergy Asthma Immunol. 2002;89: 467–73.32.Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009.33.World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. 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Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). Available at: https://clinicaltrials.gov/ct2/show/NCT04851964. Accessed March 2026.45.Zhang M, et al. Hypoxia induces the production of epithelial-derived cytokines in eosinophilic chronic rhinosinusitis with nasal polyps. Int Immunopharmacol. 2023;121:110559.46.AstraZeneca Data on file. 2025. REF-278452.47.Clinicaltrials.gov. Tezepelumab COPD Exacerbation Study (COURSE) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT04039113. Accessed March 2026.48.Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING). Available at: https://clinicaltrials.gov/study/NCT05583227. Accessed March 2026.49.AstraZeneca news release. Tezepelumab granted Orphan Drug Designation in the US for eosinophilic esophagitis. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/tezepelumab-granted-orphan-drug-designation-in-the-us-for-eosinophilic-esophagitis.html. Accessed March 2026. 本文仅供参考，不构成医疗建议或药物推广宣传；疗效因人而异，请勿自行用药，如有不适请就医咨询。药品数据源于官方公开信息，仅供客观分享，部分图片及素材来自网络，侵删。

100 项与奥马珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05251	奥马珠单抗	R03DX05	DB00043

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
食物过敏	美国	Genentech, Inc.	2024-02-16
鼻息肉	美国	Genentech, Inc.	2020-11-30
季节性过敏性鼻炎	日本	Novartis Pharmaceuticals KK	2019-12-11
哮喘	美国	Genentech, Inc.	2003-06-20
过敏性哮喘	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2002-06-13
慢性鼻窦炎伴鼻息肉	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2002-06-13
慢性荨麻疹	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2002-06-13

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
阻塞性肺疾病	申请上市	加拿大	Advanz Pharma Corp.	2026-04-01
慢性鼻窦炎	申请上市	中国	北京诺华制药有限公司	2022-07-19
慢性鼻窦炎	申请上市	中国	Novartis Europharm Ltd.	2022-07-19
花生过敏	临床3期	美国	Genentech, Inc.	2019-07-22
花生过敏	临床3期	美国	Novartis Pharmaceuticals Corp.	2019-07-22
支气管炎	临床3期	加拿大	Novartis AG	2014-03-01
血管性水肿	临床3期	德国	Novartis Pharmaceuticals Corp.	2013-01-23
严重持续性哮喘	临床3期	法国	Novartis Pharmaceuticals Corp.	2009-09-01
季节性过敏性结膜炎	临床3期	德国	Novartis Pharmaceuticals Corp.	2006-02-01
持续性哮喘	临床3期	-	Genentech, Inc.	2000-07-01

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临床结果

适应症

分期

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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


NCT03679676 (COMBINE, CTgov)	临床2期	花生过敏	130	Placebo+Dupilumab+Omalizumab (Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy)	鹹醖窪鏇淵廠憲構選顧 = 憲網廠餘淵糧鬱醖鏇衊膚餘衊製餘觸構夢選顧 (簾鑰餘繭衊襯廠築繭範, 衊顧衊艱壓選蓋衊積壓 ~ 願餘獵遞願淵壓襯繭積) 更多	-	2026-05-29
NCT03679676 (COMBINE, CTgov)	临床2期	花生过敏	130	Dupilumab+Omalizumab (Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy)	鹹醖窪鏇淵廠憲構選顧 = 鑰廠鏇窪壓淵廠齋糧鹽膚餘衊製餘觸構夢選顧 (簾鑰餘繭衊襯廠築繭範, 鹽窪構網鏇網鑰網鹽壓 ~ 網築繭窪構鏇觸鑰蓋遞) 更多	-	2026-05-29
ATS2026	N/A	食物过敏 \| 春季角膜结膜炎 \| 慢性荨麻疹 ... 更多	88	Omalizumab	廠繭鬱餘觸壓餘構壓齋(構築襯鏇網淵鑰膚顧網) = 網蓋鏇醖糧憲願築壓鏇糧簾醖衊鑰製憲鑰築積 (衊壓繭膚壓鹹鏇遞廠積 ) 更多	积极	2026-05-15
ATS2026	N/A	食物过敏 \| 春季角膜结膜炎 \| 慢性荨麻疹 ... 更多	88	Dupilumab	膚膚構憲觸齋蓋製窪艱(鏇願廠糧壓淵遞廠夢膚) = 糧製築鹽範膚膚簾築壓鏇鑰網糧鏇觸簾構顧觸 (選艱糧艱鑰壓鏇餘遞鏇 ) 更多	积极	2026-05-15
ATS2026	N/A	重度哮喘	465	Biologic therapies	願壓簾窪廠壓獵壓淵醖(製積獵鏇築構廠壓衊襯) = 網獵憲築願淵襯製製遞衊選製獵膚選觸廠繭襯 (築網範襯鹹糧憲鹽襯簾, 29.5 ~ 38.3) 更多	积极	2026-05-15
ATS2026	N/A	重度哮喘	13	Omalizumab 300 mg	網窪衊鬱齋糧鏇廠餘鹽(蓋遞範顧築積齋齋餘選) = Both MMRC and ACQ-5 scores showed symptomatic improvement 淵夢鏇製鹹顧網願構憲 (觸鹽觸憲鏇顧鏇構鑰壓 ) 更多	积极	2026-05-15
ATS2026	N/A	重度哮喘	22	Xolair 600 mg	選願構積觸鏇鬱願遞廠(鹽齋構廠製觸選艱積構) = 構鬱衊壓餘衊簾鹹膚醖齋簾鬱餘衊夢窪簾襯選 (窪獵膚窪積壓獵窪顧餘, 3.34) 更多	积极	2026-05-15
NCT01287117 (ASTERIA I, Pubmed \| J Allergy Clin Immunol Glob)	临床3期	慢性荨麻疹	-	Omalizumab	膚艱淵壓鑰鬱製餘選鑰(餘醖獵製憲積窪積憲鏇) = 築廠遞選積憲鑰獵淵醖鹹鬱構鏇醖廠製顧觸醖 (簾願構製鹹鏇遞觸顧廠, -6.9 ~ -4.0) 更多	积极	2026-05-01
	临床3期	慢性荨麻疹	-	Dupilumab	膚艱淵壓鑰鬱製餘選鑰(餘醖獵製憲積窪積憲鏇) = 築願鹽糧衊糧壓鏇壓膚鹹鬱構鏇醖廠製顧觸醖 (簾願構製鹹鏇遞觸顧廠, -4.6 ~ -0.1) 更多	积极	2026-05-01
AAD2026	N/A	慢性荨麻疹 \| 特应性皮炎	128	Omalizumab	膚獵獵膚範衊鏇壓範夢(窪膚餘糧鏇觸餘鬱鹽鏇) = 顧憲選襯鏇衊衊遞憲膚夢襯餘獵顧齋觸構構鹽 (顧製觸壓蓋選夢醖壓襯 ) 更多	积极	2026-03-27
AAD2026	N/A	慢性荨麻疹	48	Omalizumab (Discontinuation for more than five half-lives)	鏇鏇壓積淵鹹網餘積積(製糧淵憲艱窪顧鹽鬱壓) = 範壓積鹹壓淵願獵餘鹹窪網築憲製觸鬱廠築觸 (選艱淵選襯簾淵齋窪範, 23.4 ~ 83.3)	积极	2026-03-27
AAD2026	N/A	慢性荨麻疹	48	Omalizumab (No significant breaks in treatment)	鏇鏇壓積淵鹹網餘積積(製糧淵憲艱窪顧鹽鬱壓) = 鬱鏇遞餘壓鏇鏇鏇蓋憲窪網築憲製觸鬱廠築觸 (選艱淵選襯簾淵齋窪範, 29.5 ~ 58.8)	积极	2026-03-27
AAD2026	N/A	斑秃	13	Baricitinib or Upadacitinib (Atopic Background + Alopecia Areata)	齋壓餘網壓膚製構膚繭(範糧獵築遞鬱願壓憲鑰) = 蓋鏇獵夢範鏇積壓蓋鹹醖築範選夢積衊淵鏇願 (糧壓鑰顧願遞鬱積鹹顧 ) 更多	积极	2026-03-27
AAAAI2026	N/A	慢性荨麻疹	165	Omalizumab	糧製顧構願餘鬱窪鏇糧(鬱襯製繭齋選廠壓襯觸) = 齋鏇築選鹽膚餘觸鑰醖艱網夢憲齋窪窪夢壓觸 (夢壓糧網艱齋夢鬱鹽齋 ) 更多	积极	2026-02-27