The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab.
If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities.
All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.

开始日期2024-10-01

申办/合作机构

National Jewish Health, Inc.

[+1]

NCT06437171

/ Recruiting临床4期IIT

The Use of Exhaled Nitric Oxide as a Predictive Marker of Allergic Reactions to Oral Food Challenge and Clinical Response of Omalizumab Treatment in Subjects With Multiple Food Allergies

This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA.

开始日期2024-06-03

申办/合作机构-

NCT06771934

/ Active, not recruitingN/AIIT

Efficacy and Safety Evaluation of Omalizumab Combined With Standardized Allergen Specific Immunotherapy in Moderate to Severe Allergic Asthma

The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (AIT) in patients with moderate to severe asthma in the Chinese population.

开始日期2024-06-01

申办/合作机构

山东第一医科大学第一附属医院（山东省千佛山医院、山东省牙病防治指导中心）

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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3,700

项与奥马珠单抗相关的文献（医药）

2025-12-01·CURRENT ALLERGY AND ASTHMA REPORTS

Olfactory Dysfunction in Chronic Rhinosinusitis with Nasal Polyps: Effect of Treatment with Emphasis on Biological Therapy

Review

作者: Reitsma, Sietze ; Fokkens, Wytske Johanna ; Otten, Josje Janna

PURPOSE OF REVIEW:

Olfactory dysfunction significantly impacts quality of life that affects a majority of the patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The aim of this review is to explore the impact of various treatment regimens on olfactory dysfunction in patients diagnosed with CRSwNP.

RECENT FINDINGS:

Accurate assessment of olfactory dysfunction remains challenging and should incorporate both psychophysical tests and patient-reported outcomes. Patients with CRSwNP appear capable of reliably evaluating their olfactory function. Standard treatment such as intranasal corticosteroids and surgery have limited capability of restoring the sense of smell. Oral corticosteroids have a far greater potency, albeit short-lived and at the cost of adverse events and side effects. Recent studies on registered biological agents- specifically dupilumab, mepolizumab, and omalizumab- indicate their effectiveness in restoring olfactory function in severe CRSwNP. According to meta-analyses and indirect comparisons, dupilumab shows superiority; however, direct comparative studies are necessary.

2025-02-01·LARYNGOSCOPE

Impact of Biologics on Surgery in Chronic Rhinosinusitis with Polyps and Allergic Fungal Sinusitis

Article

作者: Bentan, Mihai A. ; Lee, Lawrance ; Schuman, Theodore ; Fitzpatrick, Thomas ; Pingree, Graham

Objective:

To compare the efficacy of th2‐targeted biologic medications (dupilumab, omalizumab, and mepolizumab) on absolute risk reduction (ARR) of functional endoscopic sinus surgery (FESS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and allergic fungal rhinosinusitis (AFRS).

Methods:

The TriNetX Research Network database was queried for each mAb's market lifespan through March 2024. Adults with CRSwNP were propensity score matched against non‐mAb controls based on age, sex, race, and asthma diagnosis. The primary outcome was rate of FESS, with secondary outcomes including inpatient admission, emergency department (ED) visit, and incidence of acute sinusitis. Subgroup analysis was performed for patients with AFRS.

Results:

All mAbs decreased FESS risk (dupilumab, ARR 11.48%, 95% CI 9.82%–13.15%, p < 0.001; omalizumab, ARR 12.02%, 95% CI 4.36%–19.68%, p = 0.002; mepolizumab, ARR 10.32%, 95% CI 5.24%–15.40%, p < 0.001) in CRSwNP patients. Only dupilumab also reduced risk of inpatient admission (ARR 8.59%, 95% CI 7.04%–10.15%, p < 0.001), ED visit (ARR 5.94%, 95% CI 4.28%–7.61%, p < 0.001), and acute sinusitis (ARR 2.60%, 95% CI 1.09%–4.12%, p = 0.001). In AFRS patients, only dupilumab reduced the risk of all outcomes: FESS (ARR 6.97%, 95 CI 2.86%–11.09%, p = 0.001), inpatient admission (ARR 16.93%, 95% CI 11.30%–22.57%, p < 0.001), ED visit (ARR 13.15%, 95% CI 7.15%–19.14%, p < 0.001), and acute sinusitis (ARR 7.17%, 95% CI 2.18%–12.17%, p = 0.005).

Conclusion:

Although all mAbs reduced FESS risk in CRSwNP, only dupilumab reduced secondary outcomes as well. Similarly, only dupilumab improved all outcomes in AFRS patients. These data demonstrate the potential of mAbs in reducing disease burden and enhancing patient outcomes in CRSwNP and AFRS.

Level of Evidence:

NA Laryngoscope, 135:593–601, 2025

2025-02-01·The journal of allergy and clinical immunology. Global

Utility of serum biomarkers in real-world practice for predicting response to omalizumab therapy in patients with chronic spontaneous urticaria

Article

作者: Bernstein, Jonathan A ; Cain, Wesley V ; Jandarov, Roman A ; Priya, Mohana ; Rao, Marepalli

Background:

Omalizumab (OMA), a recombinant humanized IgG monoclonal anti-IgE antibody, is approved for treatment for chronic spontaneous urticaria (CSU) refractory to second-generation H₁-antihistamine (SGAH) therapy. However, currently, there are no validated serum biomarkers to reliably predict response to OMA treatment.

Objective:

We explored the real-world clinical utility of using serum biomarkers for predicting response to OMA for CSU patients with disease refractory to high-dose SGAH therapy.

Methods:

A single-center, retrospective chart review of CSU patients treated with OMA enrolled patients who had at their initial evaluation collection of a basophil histamine release assay for detecting IgG antibodies targeting FcεR1α subunit before starting OMA treatment. In addition, total IgE, IgG-anti-thyroid peroxidase (TPO), C-reactive protein, and absolute eosinophil count, if available, were analyzed as predictors for OMA response. The validated Outcome and Assessment Information Set Database (OASIS-D) rating system was used to assess responsiveness to OMA.

Results:

High levels of IgG-anti-TPO were significantly associated with a poor response to OMA. However, basophil histamine release assay, total IgE, C-reactive protein, and absolute eosinophil count, as well as IgG-anti-TPO/total IgE ratios, were not predictive of a response to OMA therapy.

Conclusions:

This real-world study confirms previous reports that a high IgG-anti-TPO level is a reliable predictor of poor response to OMA. However, better validation of basophil histamine release assay and other immunoassays that measure IgG antibodies to FcεR1α subunit are required before they can be recommended as predictors for OMA response. Whether any of these biomarkers are relevant for predicting response to novel advanced therapeutics under current development requires further investigation.

388

项与奥马珠单抗相关的新闻（医药）

2025-02-05

·药事纵横

诺华2024年财报解读，营收同比增长11%

近日，诺华正式发布了2024年年报，是全球首家发布正式年报的制药公司。诺华全年营收517亿美元，其中销售额503亿美元，同比增长11%。诺华在2024年获得的毛利为374.90亿美元，毛利水平为74.51%，其中市场和一般管理费支出125.66亿美元（占销售额的24.97%），研发投入100.22亿美元（占销售额的19.92%），营业利润为145.44亿美元（占销售额的23.73%），净利润为119.39亿美元（占总营收的23.08%）。产品销售方面，诺华的业务分“心血管、肾病及代谢”，“免疫”，“神经科学”，“抗肿瘤”和“成熟药品”五大业务。“心血管、肾病及代谢”是诺华最大的业绩亮点，2024年销售额同比增长34%至85.76亿美元。该管线主要包括诺欣妥、Leqvio两大产品，2024年销售额分别为78.22亿美元和7.54亿美元。“神经科学”是诺华业绩的第二大亮点，同比增长30%至47.50亿美元，该管线拥有拥有Kesimpta、Zolgensma和Aimovig三大产品，2024年销售额分别为32.24亿美元、12.14亿美元和3.14亿美元，其中Kesimpta（增长49%）是主要的驱动力；免疫领域拥有Cosentyx、Xolair和Ilaris三大产品，2024年销售额分别为61.41亿美元、16.43亿美元和15.09亿美元，分别同比增长23%、12%和11%。抗肿瘤是诺华的传统优势，2024年的总营收为147.4亿美元，同比增长了15%。抗肿瘤管线产品较多，是典型的多点开花局面，主力产品Kisqali、Promacta/Revolade、Tafinlar + Mekinist、Jakavi、Tasigna、Pluvicto和Pluvicto的销售额分别为30.33亿美元、22.16亿美元、20.58亿美元、19.36亿美元、16.71亿美元和13.92亿美元。收购与比例方面，诺华在过去的一年里收购了Kate Therapeutics、Mariana Oncology和MorphoSys，其中前二者是临床前抗肿瘤技术开发的公司，而后者拥有晚期阶段的项目pelabresib，三笔交易总额达58亿美元。作为资产置换，诺华剥离了利他司特的销售权。诺华2024年的产品销售额（百万美元）药事纵横征稿启事

财报并购

2025-02-04

·PRNewswire

Latitude Food Allergy Care Opens Third New York Clinic to Expand Food Allergy Treatment Access

New clinic is the first and only dedicated food allergy office in Westchester County; Led by Dr. Zoya Treyster RYE BROOK, N.Y., Feb. 4, 2025 /PRNewswire/ -- Latitude Food Allergy Care, the leading network of food allergy clinics in the United States, has opened a new location in Westchester County – its third location in the New York area. As part of the opening, Dr. Zoya Treyster, has joined the Latitude medical staff and will lead the clinical team in Westchester. She brings over 15 years of dedicated allergy and immunology clinical experience to the practice. Food allergies continue to surge in the U.S., yet access to accurate diagnosis and care remains a critical gap in helping children and adults undergo life-changing treatments. In the Westchester County regional area, it is estimated there are more than 16,000 people navigating food allergies. Many patients travel far distances or wait for many months to see food allergy specialists as traditional allergists are not equipped or simply do not have the time to offer treatment to patients. With Latitude, families in New Jersey, Connecticut and New York can easily schedule appointments in either their Westchester, Manhattan or Brooklyn offices, avoiding delays that they're typically accustomed to with traditional care options. "Food allergy care needs to be accessible to all patients. Latitude is committed to expanding our footprint across the U.S., so we can help even more people live without fear, and experience life unburdened by the limitations of food allergies," said Kimberley Yates, co-founder and CEO of Latitude Food Allergy Care. "Our clinics have a proven track record with successful outcomes for thousands of patients — many who are now able to eat and enjoy foods and activities they'd previously been avoiding." Founded in 2018, Latitude was born from the first-hand experiences of its founders' food allergy families and driven by the expertise of board-certified allergists. Now with seven locations, Latitude is giving families the freedom and control they deserve. Each clinic offers comprehensive, accurate testing and treatment tailored to the individual needs and goals of their patients and families – this can include a combination of treatments including oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and Xolair. "As a food allergy mom, I am acutely familiar with how food allergies can impact daily life. When my son was diagnosed with a tree nut allergy, I knew that I needed to start oral immunotherapy as soon as possible. Early intervention is critical for the best outcomes in food allergy. I quickly realized that there was a gap in access to oral immunotherapy locally," said Zoya Treyster, MD, FACAAI, lead allergist at the Westchester office. "I've joined Latitude to address this critical service gap in Westchester. Latitude's treatments can help people like my son overcome the burden of food allergies, and live a life with less restriction and stress." The clinic's temporary location is at 800 Westchester Avenue, Suite N-611, Rye Brook, NY 10573. To book an appointment, email [email protected] or call (914) 898-9575. Appointments are available now. This spring, Latitude will open its permanent office in White Plains. About Latitude Food Allergy Care Latitude Food Allergy Care is the leading network of clinics dedicated to treating food allergies. Led by board-certified allergists, Latitude redefines care through advanced diagnostics, evidence-based approaches such as OIT, and personalized treatment plans. Latitude offers world-class care in-network with most PPO insurance plans and many HMO plans in California and New York. Learn more at latitudefoodallergycare.com and follow Latitude on Instagram, Facebook, and Linkedin. SOURCE Latitude Food Allergy Care WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法

2025-02-04

·药时代

罗氏砍掉十条管线？彻底放弃TIGIT？

正文共： 4763字 19图预计阅读时间： 10分钟大药企的管线及其调整是备受关注的焦点，药时代持续跟踪报道，其中包括罗氏的管线。罗氏在研产品众多，其中关注度非常高的一款产品就是TIGIT单抗RG6058（tiragolumab）。它是全球范围内推进最快的TIGIT抑制剂，被“全村”寄予了厚望。可惜进展和预期有很大的距离，也正因为如此，这款“开路先锋”得到格外大的关注。近日，两篇文章吸引了我们的注意力。一篇的题目是“罗氏：砍掉十条管线”，发布于2025年2月2日，阅读量已经1.4万。第二篇的题目是“罗氏：彻底放弃TIGIT”，发布于1月31日，目前阅读量接近6000。这两篇文章的题目让我们心里立即咯噔了一下，因为就在2024年12月11日，我们报道了罗氏2024年第三季度停止了4项乙肝在研产品，分别为RG6449、RG7854、RG6346及RG6084。这些项目分别处于I期/II期临床阶段，并在早前有部分临床试验数据公布。据罗氏官网披露信息显示，这四个产品很可能是罗氏已披露的乙肝管线的全部。【相关报道】罗氏停止多项乙肝新药管线！我们的反应就是：“怎么？罗氏又砍产品了？TIGIT彻底完了？” 情况真的是这样的吗？我们立即查看了长达76页的罗氏2024年全年财报PPT，希望从中找到答案。在第69页，罗氏披露了在2024年第四季度公司再次调整其管线，有增有减。临床1期增加了5个NME产品，分别为：RGXXXX*（P-MUC1C-ALLO1，实体瘤）、RG6810（DLL3 ADC，小细胞肺癌）、RG6620（KRAS G12D抑制剂，实体瘤）、RG6561（新分子实体，实体瘤）、CHU BRY10（慢性病）。 2024年11月26日，罗氏公司官宣15亿美元收购Poseida Therapeutics，该收购已经于2025年1月8日正式完成。此次收购将为罗氏带来Poseida的创新管线，P-MUC1C-ALLO1便是其中的一款产品。作为一种全同种异体CAR-T细胞疗法，P-MUC1C-ALLO1专门针对MUC1-C表位，这种表位在多种上皮来源的实体肿瘤中广泛表达。P-MUC1C-ALLO1在临床前研究中显示出对MUC1-C阳性肿瘤细胞的强大细胞毒性，同时对正常MUC1-C阳性的人类原代细胞的杀伤作用最小。靶向DLL3的ADC产品RG6810则是从中国信达生物引进的。 CHU BRY10是一款基于罗氏旗下中外制药公司开发的循环抗体®技术开发的抗体药物。管线瘦身方面，罗氏终止了一些产品的临床开发，原因包括：（1）未达公司内部研发标准：10个NME因未满足内部研发标准而被淘汰；（2）公司战略聚焦调整：部分管线因资源重新分配至高潜力项目（如CAR-T、ADC）而退出。 5个新分子实体（NMEs）被停止临床1期开发，它们是：（1）RG7827（FAP/4-1BB双抗，针对实体瘤）、（2）RG6194（Runimotamab，HER2/CD3双抗，针对乳腺癌）、（3）RG6323（efbalropendekin alfa，IL15/IL15Ra-Fc双特异性融合蛋白，针对血液瘤和实体瘤）、（4）GPC3/CD3双抗（来自中外制药，针对实体瘤，尤其是肝细胞癌）、（5）SPYK04（口服小分子药物，由中外制药研发，针对实体瘤）。这基本上意味着这5个NME的命运就此结束，除非后期有机会被“复活”。此外，备受关注的TIGIT单抗RG6058（tiragolumab）针对不同适应症的5个临床试验被终止，其中包括1个一期、2个二期、2个三期。所以，严格地讲，“罗氏砍掉十条管线”好像不是很准确。那么，罗氏彻底放弃TIGIT了吗？经历了2024年Q4调整后的罗氏管线如下：可以很清晰地看到，RG6058的三个三期临床试验还在其中，分别为：（1）联合Tecentriq用于治疗局部晚期食管癌；（2）联合Tecentriq用于一线治疗不可切除的III期非小细胞肺癌；（3）联合Tecentriq和Avastin用于一线治疗肝细胞癌。相应地，罗氏NDA/BLA递交计划这一页中依旧包括RG6058，其中，联合Tecentriq用于一线治疗不可切除的III期非小细胞肺癌的BLA计划2025年递交，另外两个都是2026年递交。基于以上信息和分析，我们认为罗氏还没有彻底放弃TIGIT。我们将继续密切关注还在管线中的三个三期临床试验，及时报道。专利悬崖则是备受关注的第二个焦点。2024年，罗氏受到专利到期（LOE）的影响，因Avastin、Herceptin等重磅药物专利到期损失10亿瑞士法郎，2025年预计进一步影响12亿瑞士法郎。罗氏通过精简管线集中资源于肿瘤（如Divarasib）、神经（如Trontinemab）及代谢（CT-388）等领域，与此同时，通过licensing引进有价值有协同潜力的创新药产品，进行“腾笼换鸟”、升级迭代，期间蕴藏着很多BD机会。中国企业可关注其开放合作机会（如ADC、双抗），争取达成更多的合作，实现更多的出海。时间、水平有限，今天的分析就到这里。欢迎批评指正！也欢迎感兴趣的朋友们继续阅读下面更多的财报分析内容。如果您希望保存一份76页PPT自己认真学习，请在本文的评论区留下您的工作邮箱地址，我们上班后统一密送。谢谢！~ 一、核心财务表现：超预期增长，现金流强劲收入与利润集团销售额：2024年实现销售额605亿瑞士法郎（+7%，恒定汇率CER），超出中单位数增长指引，基础业务（排除新冠产品及专利到期影响）增长达9%。分部表现：制药业务销售额462亿瑞郎（+8% CER），诊断业务143亿瑞郎（+4% CER；排除新冠产品后+8%）。盈利能力：核心营业利润（Core OP）增长14%，利润率提升2.1个百分点至34.4%；核心每股收益（Core EPS）增长12%（排除税务争议后）。现金流：运营自由现金流（OFCF）同比增长34%至212亿瑞郎，体现强劲的运营效率。关键驱动与挑战新冠产品收入下滑：新冠相关诊断及治疗药物销售额减少11亿瑞郎，符合预期。专利到期（LOE）影响：因Avastin、Herceptin等重磅药物专利到期损失10亿瑞郎，2025年预计进一步影响12亿瑞郎。汇率波动：美元/欧元兑瑞郎贬值拖累销售额增长约4个百分点，但2025年预计汇率影响趋缓。二、制药业务：创新产品驱动增长，管线布局前瞻核心产品表现肿瘤/血液病领域：Polivy（DLBCL）销售额增长39%，患者份额达29%；Hemlibra（血友病）患者份额42%，增长稳健。神经科学：Ocrevus（多发性硬化症）销售额67亿瑞郎（+9%），新剂型（皮下注射）快速渗透市场；Evrysdi（脊髓性肌萎缩症）增长18%。免疫与眼科：Xolair（过敏）因食物过敏适应症获批推动增长16%；Vabysmo（眼底病）销售额增长68%，预充注射器在美转化率超85%。新兴产品与管线亮点肿瘤：Giredestrant（ER+/HER2-乳腺癌）、Divarasib（KRAS突变实体瘤）III期数据读出。神经退行性疾病：Trontinemab（阿尔茨海默病）与Prasinezumab（帕金森病）临床进展。代谢与免疫：CT-388（GLP-1/GIP双激动剂）肥胖适应症进入II期，抗TL1A单抗拓展至克罗恩病与纤维化疾病。 2024年上市产品：Itovebi（PI3Kα突变乳腺癌）与PlaSky（阵发性睡眠性血红蛋白尿症）表现初显，后者获美欧批准。 2025年关键里程碑：战略合作与技术突破 CAR-T疗法：与Poseida合作开发通用型CAR-T，覆盖肿瘤、自身免疫及神经系统疾病，首款产品P-BCMA-ALLO1获FDA孤儿药认定。 ADC布局：通过信达生物合作引入DLL3 ADC（小细胞肺癌），强化实体瘤管线。三、诊断业务：基础业务韧性凸显，数字化与近患者护理发力区域与细分市场核心实验室（Core Lab）：免疫诊断（+9%）与临床化学（+8%）推动增长，占诊断收入的56%。分子诊断：血筛业务增长17%，新冠检测收入下滑但基础病毒检测增长10%。新兴市场：拉美增长22%，亚太受新冠检测退潮拖累（-5%）。创新产品与平台近患者护理（PoC）：Accu-Chek® SmartGuide CGM（连续血糖监测）获CE认证，cobas® Liat系统扩展呼吸道与性传播感染检测菜单。数字化病理：DP600扫描仪获美FDA初步诊断许可，推动病理实验室收入增长17%。质谱技术：cobas® i601系统上市，瞄准30亿瑞郎的LDT市场，目标2030年收入突破10亿瑞郎。四、战略与风险：聚焦长期增长，挑战犹存核心战略方向研发聚焦：2025年计划12项III期临床数据读出，4款新分子实体（NME）提交上市申请，包括抗纤维化药物astegolimab（COPD）及眼科药物vamikibart（糖尿病黄斑水肿）。数字化转型：navify®数字病理与分析平台升级，提升实验室效率；AI算法（如胸痛分诊、肾病风险评估）加速落地。可持续发展：推进绿色制造与供应链减碳，目标2030年实现运营碳中和。潜在风险与挑战专利悬崖：2025年LOE影响扩大，需依赖新产品填补收入缺口。竞争加剧：肿瘤领域面临PD-(L)1抑制剂生物类似药冲击，眼科市场需应对Vabysmo与Eylea的份额争夺。政策压力：全球药价管控趋严，美国《通胀削减法案》或影响高价药市场准入。五、中国视角：合作深化，市场潜力待释放本地化进展产品引入：Valpysmo（眼底病）、Lunsumio（淋巴瘤）等新药在华申报提速，2025年计划提交Elevidys（杜氏肌营养不良）上市申请。研发合作：与再鼎医药、信达生物等本土企业合作开发ADC与双抗，加速管线本土化。投资启示关注创新药企：罗氏在肿瘤、神经科学领域的开放合作模式（如CAR-T、ADC）为国内Biotech提供商业化契机。警惕政策风险：带量采购与医保谈判压力下，需评估罗氏高价创新药在中国市场的支付能力与准入策略。六、总结与展望罗氏2024年交出了一份“稳健增长与创新突破并存”的答卷，核心业务增长抵消了新冠退潮与专利到期的影响，现金流与股息连续38年增长彰显财务韧性。2025年，随着Giredestrant、Divarasib等重磅管线数据读出，以及数字化与近患者护理的深化，罗氏有望进一步巩固全球药企龙头地位。对中国市场而言，加速创新药引入、深化本土合作将是其增长关键，但需警惕政策与竞争的双重挑战。参考资料：罗氏2024年财报罗氏官网药时代已发表文章其它公开资料封面图来源：网络推荐阅读 DeepSeek预测：2035-2040年间，首位华人跨国药企CEO有望诞生 2025-02-03 2018-2024 | 全球知名VC公司如何看待生物制药江湖的这些年？ 2025-02-03 用火热的DeepSeek帮助设计1期临床试验方案。您对结果满意吗？ 2025-02-02 FDA会大规模裁员吗？快来看看投票结果！ 2025-02-02 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击这里，查看更多商机!~

细胞疗法免疫疗法抗体药物偶联物财报并购

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
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
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
女性不孕症	临床2期	丹麦	Novartis AG	2019-01-01
急性肾小管间质性肾炎	临床2期	美国	Genentech, Inc.	2018-06-01

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临床结果

适应症

分期

评价

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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


NCT06316414 (Pubmed \| Allergy)	N/A	重度哮喘 total IgE levels	65	Omalizumab	顧醖製餘積選廠簾夢顧(艱鬱憲齋夢簾遞遞衊艱) = 蓋鏇淵膚鏇餘憲繭鑰繭艱鹹願廠夢築積鹽廠鬱 (顧積範選構鬱遞獵醖製 ) 更多	积极	2024-09-16
				Placebo	顧醖製餘積選廠簾夢顧(艱鬱憲齋夢簾遞遞衊艱) = 觸壓鹽齋蓋觸壓顧廠選艱鹹願廠夢築積鹽廠鬱 (顧積範選構鬱遞獵醖製 ) 更多
NCT01287117 \| NCT01292473 (ASTERIA I and ASTERIA II, Pubmed \| World Allergy Organ J)	临床3期	慢性荨麻疹	-	Omalizumab 300 mg	淵廠蓋選積窪網鹹糧獵(簾構壓簾願選鏇鏇積鑰) = 積積積壓遞選鏇醖觸築積蓋範獵襯窪醖選獵構 (蓋鏇憲繭壓顧壓夢網窪 )	积极	2024-08-01
				Omalizumab 150 mg	淵廠蓋選積窪網鹹糧獵(簾構壓簾願選鏇鏇積鑰) = 觸觸鏇鹹網鏇憲範積襯積蓋範獵襯窪醖選獵構 (蓋鏇憲繭壓顧壓夢網窪 )
AAAAI2024	N/A	慢性荨麻疹 total serum IgE \| hypothyroidism \| anti-TPO antibodies ... 更多	94	Omalizumab 300 mg/month	壓簾壓網積窪壓醖構膚(蓋衊觸襯廠築夢艱獵襯) = 顧積鹹構選獵願蓋艱夢選遞選艱窪觸餘鹹築願 (鏇遞壓齋廠窪鏇願製網 )	积极	2024-02-23
				Omalizumab >300 mg/month	壓簾壓網積窪壓醖構膚(蓋衊觸襯廠築夢艱獵襯) = 夢遞鹹鏇膚選願糧齋鹽選遞選艱窪觸餘鹹築願 (鏇遞壓齋廠窪鏇願製網 )
AAAAI2024	N/A	食物过敏维持 IgE antibody	533	Omalizumab	遞窪夢廠願遞壓廠蓋廠(構窪鹽製鹹鬱餘鑰製顧) = 齋蓋廠網鬱衊蓋築築觸選蓋膚鬱鹽鑰觸構艱鏇 (餘鑰鹹廠願觸網網淵壓 ) 更多	积极	2024-02-23
NCT03881696 (OUtMATCH, FDA) 人工标引	临床3期	食物过敏	165	XOLAIR	淵窪淵遞鹹醖糧鏇觸範(憲蓋膚築製遞膚鹽壓選) = 艱選衊糧鹽餘壓遞繭艱獵壓鹹齋簾壓醖憲淵夢 (觸鹽觸鏇構鹽積蓋遞窪 ) 更多	积极	2024-02-16
				Placebo	淵窪淵遞鹹醖糧鏇觸範(憲蓋膚築製遞膚鹽壓選) = 醖選壓艱齋簾獵積繭壓獵壓鹹齋簾壓醖憲淵夢 (觸鹽觸鏇構鹽積蓋遞窪 ) 更多
NCT03881696 (OUtMATCH, GlobeNewswire) 人工标引	临床3期	食物过敏	165	Xolair	範蓋製製鹹糧廠餘夢膚(蓋鹽願鏇鏇顧艱鹽網積) = These interim results showed that, compared to placebo, Xolair significantly increased the amount of peanut (primary endpoint) and milk, egg and cashew (key secondary endpoints) 蓋鑰糧製製鏇衊衊觸願 (鹹壓鬱夢願艱淵憲遞網 ) 更多	积极	2023-12-19
				placebo
EADV2023	N/A	大疱性类天疱疮 IgE levels	36	Omalizumab 300 mg	鬱艱範鏇鬱顧齋遞憲選(廠淵醖餘艱淵遞廠鏇積) = 積遞壓網蓋選蓋夢鬱構憲遞糧淵網夢壓選願夢 (廠網餘繭構夢膚鹹鏇築 )	积极	2023-10-11
EADV2023	N/A	慢性荨麻疹	57	Omalizumab de-intensified regimen	憲製鹹衊繭繭廠憲觸繭(製鏇願艱淵鹹遞憲繭艱) = 窪艱繭衊範窪壓醖鏇膚鑰網選積網膚鏇夢衊鹹 (簾範繭餘廠製網艱糧壓 ) 更多	积极	2023-10-11
				Omalizumab discontinuation	憲觸製憲鬱窪鹹廠遞簾(窪觸範淵餘窪繭積顧襯) = 鹽窪製觸糧憲襯積鏇蓋鏇範鬱鏇鑰糧膚壓廠範 (獵鑰簾餘網艱糧壓顧夢 ) 更多
EADV2023	N/A	慢性荨麻疹	93	Omalizumab	憲蓋艱夢繭餘製餘願觸(觸願構積壓築積醖艱餘) = 觸醖憲廠選淵積遞遞蓋構積廠範艱顧憲夢製醖 (鹽壓憲鹽觸積鏇觸餘築 )	-	2023-10-11
WCD2023	N/A	晒伤	100	Omalizumab	醖齋膚齋築鏇衊鬱廠壓(窪築膚窪鹽積鑰淵鏇簾) = Periorbital edema, short term asthenia, mild local site reaction and gastrointestinal intolerance were the adverse events reported across 4% of patients 築願壓範觸艱製鬱築網 (簾構築獵選築願簾壓築 )	积极	2023-07-07