A Randomised Double-blind Placebo-controlled Phase III Field Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Chinese Participants Aged 12-65 Years With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.

开始日期2025-09-01

申办/合作机构

ALK-Abello A/S

NCT07013123

/ Not yet recruiting临床3期IIT

Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab

The aim of this drug trial is to evaluate the annualized asthma exacerbation rate under treatment with Acarizax versus placebo. The trial is intended for adults aged 18 to 65 with severe uncontrolled asthma and a house dust mite allergy. The study will involve 32 patients (up to 38 with study dropouts) recruited from French hospitals, in pulmonology and allergology departments.
Initially, all participants will receive Tezepelumab for 3 to 6 months (M-3/-6) to control asthma symptoms. If asthma is not controlled after 6 months, the participant will be excluded from the study and will continue on standard treatment.
Once their asthma is controlled, patients will be randomized in two groups:
* Group A: Tezepelumab + Acarizax®
* Group B: Tezepelumab + Placebo After 6 months of treatment with Acarizax or placebo (M6), Tezepelumab will be stopped and participants will continue treatment with Acarizax or placebo alone for a further 12 months (up to M18/End of search).
The study will include 5 visits during regular consultations (M-3/M-6, D0, M6, M12 and M18), as well as 2 follow-up telephone calls M3 and M9).

开始日期2025-07-15

申办/合作机构

University Hospital of Montpellier

[+4]

TCTR20250107010

/ Not yet recruiting临床2期

Efficacy of Alternate-Day Dosing House dust mite Sublingual Immunotherapy Compared to Daily Dosing in Allergic Rhinitis Patients

开始日期2025-01-13

申办/合作机构

Abbott Laboratories (Pakistan) Ltd.

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100 项与尘螨变应原（ALK-Abello A/S）相关的专利（医药）

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项与尘螨变应原（ALK-Abello A/S）相关的文献（医药）

2025-01-01·PEDIATRIC PULMONOLOGY

Effect and mechanism of allergen‐specific immunotherapy on small airway dysfunction in children with asthma

Article

作者: Lin, Jie ; Dong, Wenfang ; Yin, Yong ; Wu, Jinhong ; Hong, Li ; Zhang, Lei ; Zhong, Wenwei ; Ying, Xiaolan ; Yang, Lin

Abstract:

Background:

The purpose of this study was to investigate the effectiveness of allergen‐specific immunotherapy (AIT) on small airway dysfunction (SAD) and the underlying mechanism with a special focus on basophils.

Methods:

Sixty‐five children with mild to moderate asthma who were under regular inhaled corticosteroid (ICS) treatment for more than 1 year but whose FEF75 remained below 65% of the predicted value and had positive results for serum Der p or Der f were enrolled. Children with asthma underwent house dust mite (HDM) subcutaneous immunotherapy (SCIT) treatment for 1 year. Clinical symptoms and lung function were evaluated every 3 months during HDM SCIT treatment. Basophil activation test (BAT) was carried out before and after HDM SCIT treatment. RNA sequencing was performed in isolated basophils from peripheral blood after 6 months of HDM SCIT treatment, followed by GO term and KEGG pathway enrichment analysis between patients with and without HDM SCIT treatment.

Results:

HDM AIT treatment ameliorated clinical symptoms while concurrently improved lung function parameters, such as FEV1/FVC, FEF75, FEF50 and MMEF (p < .05). It is worth noting that FEF75 values showed a highly significant, gradual and persistent increase (from 49.55 ± 1.27% at baseline to 71.89 ± 2.64% after 1 year of therapy) and 22 of 35 patients no longer had SAD after 1 year of treatment. BAT results revealed that AIT treatment significantly reduced basophil activity to the inhalant allergen mixtures containing HDM in vitro challenge from baseline. GO term and KEGG pathway enrichment analysis of basophils revealed that downregulated genes were mainly involved in immune cell activation, antigen presentation, and Th2 cell differentiation.

Conclusions:

Our study demonstrated that HDM AIT not only improved SAD related lung function parameters, but also reduced basophil activity. RNA sequencing revealed the inhibition of phagocytosis and the phagosome pathway in basophils which may affect the polarization of Th2 cell differentiation after HDM AIT.

2025-01-01·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

The Efficacy of Sublingual Immunotherapy in Patients With House Dust Mite Allergic Asthma—A Systematic Review

Review

作者: Rysgaard, Anne Sofie ; Ulrik, Charlotte Suppli ; Rovsing, Alma Holm ; Hegner, Pernille Vigand

Background and objective:

Patients' with allergy-driven symptoms of asthma may not achieve adequate symptom control on inhaled pharmacotherapy alone, therefore, allergen-immunotherapy may be a relevant add-on treatment. The aim of the present review is to provide an update on the current evidence of efficacy of sublingual immunotherapy (SLIT) for the treatment of house dust mite (HDM)-driven allergic asthma.

Methods:

Systematic review performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses-Statement (PRISMA) guidelines.

Results:

A total of 15 studies fulfilled the predefined criteria and were included, all assessing the efficacy of the HDM SLIT-tablet in patients with HDM-driven asthma. Of the 15 studies, 13 reported significant improvements in asthma symptoms, while 2 found no changes. Ten studies assessed lung function (that is FEV₁, PEF and FEV₁/FVC) with 6 reporting significant improvements and 4 reporting no significant changes. Eight of the 15 studies measured the impact on prescribed asthma controller medication, of which 6 studies reported a significant reduction in daily mean dose of inhaled corticosteroid (ICS) (up to a reduction of 300+ µg/day), 1 found a significant reduction in medication use (according to the GINA steps), while 1 showed no significant reduction.

Conclusion:

In the majority of studies, HDM SLIT was associated with improvements in asthma symptom control and a reduction in daily dose of ICS. On the other hand, the findings addressing treatment induced changes in lung function are conflicting.

2025-01-01·Lancet Regional Health-Europe

Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial

Article

作者: Emeryk, Andrzej ; Gagnon, Remi ; Schuster, Antje ; Caimmi, Davide ; Pfaar, Oliver ; Foss-Skiftesvik, Majken Hougaard ; Nolte, Hendrik ; Østerdal, Anne Sofie ; Mikler, Jan ; Novakova, Silviya

Background:

Allergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child's quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children.

Methods:

Phase III, randomised, double-blind, placebo-controlled trial in younger children (5-11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for ∼1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (∼1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22.

Findings:

A total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p < 0.0001) corresponding to a relative reduction of 22.0% (95% CI: 12.0, 31.1). Key secondary outcomes (DSS, DMS, TCS, PRQLQ) showed statistically significant reductions in symptoms and medication use, and improved disease-related quality of life for SQ HDM SLIT-tablet versus placebo. Improvements in asthma symptoms and reduced asthma medication use indicated an additional effect of SQ HDM-SLIT tablet versus placebo. The SQ HDM SLIT-tablet showed a higher event rate for treatment-related adverse events (AEs) than placebo. Most events were of mild or moderate severity and few subjects discontinued due to AEs (2.5%).

Interpretation:

The trial confirmed the efficacy and safety of the SQ HDM SLIT-tablet for treating HDM AR/C in younger children (5-11 years) with or without asthma. The safety profile supports daily self-administration of the SQ HDM SLIT-tablet in children.

Funding:

ALK-Abellό, Hørsholm, Denmark.

项与尘螨变应原（ALK-Abello A/S）相关的新闻（医药）

2025-05-06

·ir.alk.net

Three-month interim report (Q1) 2025 (unaudited)

ALK delivers 12% organic revenue growth with operating profit up 50% in Q1 Q1 results were strong as expected. Revenue increased on double-digit sales growth in all sales regions, including 22% growth in tablet sales. The operating profit margin of 31% partly reflected seasonality in ALK’s earnings. Free cash flow almost tripled. Outlook remains unchanged. Performance highlights Comparative figures for Q1 2024 are shown in brackets. Growth rates are stated in local currencies, unless otherwise indicated. Total revenue increased by 12% to DKK 1,522 million (1,351). Europe and International markets delivered growth rates of 10% and 24% respectively. Revenue in North America bounced back with growth of 14%. Global tablet sales grew by 22% to DKK 857 million (706) on double-digit growth in all sales regions. European tablet sales grew by 17%, largely due to increase in new patients, while the positive growth impact of pricing decreased as anticipated compared to last year. Global SCIT and SLIT drops sales were unchanged at DKK 500 million (500), while sales of Other products and services was up 11% to DKK 165 million (145). Operating profit (EBIT) increased by 50% to DKK 469 million (316), driven by sales growth, improved gross margin, and cost savings after last year’s optimisation initiatives. The capacity cost-to-revenue ratio was down to 36% (42%). The EBIT margin of 31% (23%) partly reflected that Q1 typically is ALK’s most profitable quarter. Free cash flow almost tripled to DKK 330 million (111) mainly driven by increased earnings. CAPEX was unchanged at DKK 57 million (59). Financial highlights Allergy+ strategy highlights The launch of the house dust mite tablet for children positively impacted sales growth in Q1, and initial market response exceeded expectations. The tablet is currently available for young children in 12 countries. The tree tablet ITULAZAX® has recently been approved in Europe for treatment of young children and adolescents aged five to 17. Efforts to secure market access for the neffy®adrenaline nasal spray is progressing well, and ALK expects the first launches in Europe to start in Q3 2025. Initial market feedback has been encouraging. ALK has entered into a four-year agreement with US-based ARS Pharma to co-promote the neffy® adrenaline (epinephrine) nasal spray in the USA. The clinical phase 2 of the peanut allergy tablet is on track and patient recruitment continues. 2025 full-year outlook The full-year outlook remains unchanged, demonstrating a continuous, robust improvement in profitability: Revenue is still expected to grow by 9-13% driven by growth across all sales regions and product groups. Growth will predominantly be attributable to higher volumes, as ALK expects to treat more patients with its allergy immunotherapy (AIT) and anaphylaxis products. The EBIT margin is still expected to improve by 5 percentage points to around 25%, driven by revenue growth, improving gross margin, and optimisation efforts. Commenting on the Q1 results, CEO Peter Halling said: “ALK is off to a very good start in 2025, with sustained revenue growth, a significant increase in operating profit, and steady progress on our strategic agenda. The initial market response to the launch of our house dust mite tablet, ACARIZAX®, for use in young children has been encouraging, and we are excitedly preparing to launch neffy®, the new adrenaline nasal spray. Despite the turmoil in the markets from trade wars and tariffs, we remain optimistic about the year ahead, anticipating only a modest impact from tariffs considering our current business footprint." Hørsholm, 6 May 2025 ALK-Abelló A/S For further information, contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525Media: Maiken Riise Andersen, tel. +45 5054 1434 ALK is hosting a conference call for analysts and investors at 11.00 a.m. (CEST) on 6 May 2025 at which Management will review the financial results and the outlook. The conference call will be audio cast on https://ir.alk.net where the relevant presentation will be available shortly before the call begins. To register for the conference call, please use this link and follow the registration instructions. You will receive an email from diamondpass@choruscall.com with dial-in details, including a passcode and a pin code. Please make sure to whitelist diamondpass@choruscall.com and/or check your spam filter. We advise you to register well in advance and to call in before 10.55 a.m. (CEST). Attachment Company release_10_25UK_060525_Q1 25 interim report

财报上市批准临床2期

2025-03-05

·drugs

FDA Expands Indication of Dust Mite Allergy Drug to Include Young Children

WEDNESDAY, March 5, 2025 -- The U.S. Food and Drug Administration has expanded its indication of Odactra, a house dust mite allergen tablet, for the treatment of house dust mite-induced allergic rhinitis, with or without conjunctivitis, to include children ages 5 through 11 years. Odactra is an allergy immunotherapy and is administered sublingually as a small tablet that dissolves under the tongue. The approval was based on data from a phase 3 clinical trial that included 1,460 children ages 5 to 11 years old with persistent allergic rhinitis symptoms for a year, despite receiving symptom-relieving medication. Children randomly assigned to Odactra experienced a relative reduction in total combined rhinitis score of 22 percent versus placebo. Four patients receiving Odactra experienced severe treatment-related adverse events, including oral and ear itchiness, burning or tingling sensation in the mouth, lip swelling, and abdominal pain. However, no participants reported treatment-related anaphylaxis or adverse events requiring treatment with epinephrine. "The pediatric indication for Odactra is significant because it provides physicians and parents a new option for treating these younger patients," Jackie Eghrari-Sabet, M.D., an allergist and immunologist at George Washington University in Washington, D.C., said in a statement . "In addition to the convenience of sublingual administration, Odactra has been shown to reduce their allergy symptoms and reliance on symptomatic medications." Expanded approval of Odactra was granted to ALK. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果临床3期免疫疗法上市批准

2025-03-04

·蒲公英Ouryao

Paul's Insight｜解读国际法规药事(02.24-03.02)

◆ ◆ ◆ ◆ Paul's Insight 2025年2月24日-3月2日 ◆ ◆ ◆ ◆ 随着全球医药行业的持续进步，各国药品监管机构和制药公司在推进创新药物的审批、上市和安全管理方面不断加速步伐。本期动态（2月24日至3月2日）涵盖了美国FDA、欧洲EMA以及其他机构，从药品上市、安全风险和监管创新等各个方面，反映出全球药事新闻中的多样性与紧迫感。让我们一起走进这一波全球药事新闻，看看各大药品监管机构如何推动药品安全与疗效的平衡，同时，行业协会的新思考也让我们对未来医药行业的变革与发展有更多期待。美国FDA 新药物审批与安全管理的双重进步 1. FDA批准Odactra扩展适应症：为儿童群体带来新希望美国FDA最近批准了屋尘螨过敏药片Odactra的适应症扩展，使其适用于5-11岁的儿童群体。之前，该药物仅获得批准用于12-65岁人群，用于治疗由屋尘螨过敏引发的过敏性鼻炎（无论是否伴随结膜炎）。图：FDA批准了屋尘螨过敏药片Odactra的适应症扩展据统计，全球约有超过千万5至11岁儿童受到屋尘螨过敏的困扰，而屋尘螨是引发过敏性鼻炎和哮喘的重要原因之一。通过FDA的批准，更多孩子将能够获得这款药物的治疗，减轻呼吸道过敏症状，提升生活质量。图：全球约有超过千万5至11岁儿童受到屋尘螨过敏的困扰（参考：https://www.fda.gov/news-events/press-announcements/fda-roundup-february-28-2025） 2. 睾酮产品标签更新：确保药物使用更安全另一项关键决策是，FDA对所有睾酮产品生产商发布了新的标签更新要求，要求将TRAVERSE临床试验和血压监测（ABPM）研究结果纳入标签。TRAVERSE试验是一项评估睾酮替代疗法对性腺功能低下男性主要心血管不良事件发生率和疗效措施影响的研究。图：FDA对所有睾酮产品生产商发布了新的标签更新要求这一变化的核心在于，在所有睾酮产品标签上添加TRAVERSE试验数据，明确指出试验对年龄相关性低睾酮治疗的安全性结论。此外，FDA还保留了年龄相关性低睾酮适应症说明，以确保临床医生和患者正确理解药物的适用范围。同时，FDA更新了标签中的心血管风险警示语，以反映最新的临床证据。这项更新不仅传递了精准的药品疗效信息，也有助于减少不必要的恐慌，促进安全合理的用药实践，确保患者在获得疗效的同时降低潜在的健康风险。图：新英格兰医学杂志发表TRAVERSE试验结果，成为FDA的重要参考（参考：https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products） 3. FDA紧急召回通知：药品安全第一在药品召回方面，FDA近期发布了针对一家药房配药设施（CAPS）生产的苯肾上腺素注射剂的紧急召回通知。部分批次产品被检测出含有黑色颗粒，可能源自原料供应链问题。含有颗粒的注射药物可能引发局部刺激、血管堵塞，甚至导致心脏、肺部或脑部血管阻塞，带来严重的健康风险。此次召回涉及多个批次，已经通知相关经销商和医院，要求医护人员和患者立即停止使用，并按照规定进行退货或销毁处理。作为一家配药药房，CAPS的经营类似于药品生产商，但这些配药药房并未向联邦政府注册或遵守同样的安全法律。历史上，新英格兰配药中心出产的受污染醋酸甲级强的松龙（Methylprednisolone acetate），共造成47例死亡，660例患病，酿成美国历史上最严重的药品灾难之一。图：一家药房配药设施生产的苯肾上腺素注射剂被紧急召回（参考：https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/central-admixture-pharmacy-services-caps-issues-nationwide-recall-phenylephrine-40-mg-added-09） 4. 谷歌智能手表“失脉检测”功能获FDA批准：技术创新为健康加分此外，FDA还批准了谷歌智能手表的关键功能“失脉检测”在美国市场的上线。该功能能够在用户心跳骤停时自动触发报警并呼叫紧急救援，之前该功能已经在欧洲市场推广，但因美国的监管要求一直未能开放。通过结合光学心率传感器、红外传感器和运动传感器，该功能不仅能够检测心跳停止，还能够进行二次确认，提高报警准确性。FDA认为，这项功能可挽救生命，特别适用于独居或行动不便的高风险人群。这项批准标志着医疗器械和消费电子产品在健康监测领域的逐步融合，也为未来健康管理技术的发展铺平了道路。图：谷歌智能手表“失脉检测”功能获FDA批准（参考：https://pharmaphorum.com/news/fda-clears-lifesaving-feature-googles-pixel-watch-3）美国PDA 助力药品安全性与合规性提升 2月26日，美国注射剂协会（PDA）发布了最新的《制药行业质量文化评估指南》，该指南提出了五大核心主题：领导承诺、沟通与协作、员工参与、持续改进和技术卓越。指南的发布不仅帮助制药企业评估现有质量文化，还确保企业与监管机构的期望一致，为全球药品的安全性和合规性提供了重要参考。图：PDA发布质量文化评估指南（参考：https://www.pda.org/about-pda/press-releases/press-release-detail/just-released-pda-ansi-standard-06-2025-quality-culture-assessment-of-quality-culture-guidance-documents-models-and-tools）欧洲EMA 药品创新加速，监管更加高效 1. 上市后变更试点计划：提升药品审批效率在欧洲，欧洲药品管理局（EMA）也在近期推出了一项重要举措——“依托应用：上市后变更试点计划”。该计划的目的是加速药品上市后变更的审批流程，使制药企业在调整药品质量、生产工艺或配方时能够借助已认可的监管评估数据，减少重复审查，从而加快审批进程。这一举措不仅提高了监管效率，还促进了跨国监管合作与经验共享，为全球药品的创新和上市提供了更为高效的监管支持。图：EMA发布试点计划，促进了跨国监管合作与经验共享（参考：https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/reliance-applied-post-autorisation-changes-pilots-pharmaceutical-industry） 2. CHMP会议亮点：新药上市推荐在EMA的人用药品委员会（CHMP）会议上，CHMP推荐了四种新药的上市申请，其中包括全球首个外用基因治疗产品——Vyjuvek，这款药物是为了治疗营养不良性大疱性表皮松解症而开发的。 Vyjuvek作为全球首个外用基因治疗产品，得到了EMA的优先药物（PRIME）计划支持，为罕见遗传性皮肤病患者带来了新的治疗希望。此外，Deqsiga（用于免疫缺陷患者的免疫球蛋白）、Lynozyfic（用于复发性多发性骨髓瘤的治疗）以及Trabectedin Accord（用于晚期软组织肉瘤和复发性卵巢癌的仿制药）也都获得了EMA的推荐，为患者提供了更多的治疗选择。图：Vyjuvek为全球首个外用基因治疗产品（参考：https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-february-2025）英国MHRA 为老年人健康护航在英国，英国药品和健康产品管理局（MHRA）近期批准了Moderna公司研发的mRESVIA mRNA疫苗。该疫苗旨在为60岁及以上人群预防呼吸道合胞病毒（RSV）感染。RSV是一种严重的呼吸道病毒，每年会导致全球超过17万名60岁以上老人住院，并造成1.4万例死亡。图：英国MHRA批准了Moderna公司研发的mRESVIA mRNA疫苗 mRESVIA是一款针对RSV的mRNA疫苗，由编码稳定融合前F糖蛋白的mRNA序列组成。其与2024年5月获得美国FDA批准，是Moderna公司第二项获批的mRNA疫苗。mRESVIA的临床试验数据显示，接种疫苗约 4 个月后，与接种安慰剂的人相比，接种 RSV疫苗的人患RSV引起的下呼吸道疾病的风险降低了 79%，为高风险老年群体带来了极大的福音。MHRA的批准标志着mRNA技术在疫苗领域的再次成功应用。图：RSV 疫苗为高风险老年群体带来了极大的福音（参考：https://www.gov.uk/government/news/mresvia-rsv-vaccine-approved-to-protect-patients-aged-60-and-over） ICH 加强临床试验监管日前，国际人用药品注册技术协调会（ICH）发布了《药物临床试验管理规范》（GCP）修订版的官方培训材料，讲解了ICH E6(R3)的修订、结果和变化内容。这一新指南强调了基于风险管理的临床试验设计，推动数据共享和国际协调，鼓励“以患者为中心”的试验模式。图：ICH发布 E6(R3)修订版的官方培训材料（参考：https://www.ich.org/news/ich-e6r3-introductory-training-presentation-now-available-ich-website） ISPE 无菌生产数据管理要求 ISPE最新文章强调数据管理在无菌药品生产中的关键作用，特别是在欧盟GMP附录1修订版发布后。文章指出，数据管理不仅对于验证和风险管理至关重要，还涉及到ALCOA++原则的具体应用，以确保数据的完整性和可靠性。文章强调了数据生命周期管理的重要性，并提出了确保无菌生产过程中数据准确性的一些最佳实践。图：ISPE最新文章强调数据管理在无菌药品生产中的关键作用（参考: https://ispe.org/pharmaceutical-engineering/ispeak/data-management-requirements-sterile-manufacturing）结语药品安全与创新的双重驱动从FDA到EMA，再到MHRA、ICH，我们看到全球药品监管机构在不断推动药品审批效率的同时，确保药品的安全性与有效性。在技术的不断进步和全球合作的加强下，创新药物和健康管理工具正迅速走向市场。无论是新药的上市、临床试验的规范，还是质量管理的提升，全球药事领域正朝着更加高效、透明和创新的方向发展。我们有理由相信，未来药品监管和创新将继续携手并进，为全球公众的健康保驾护航。 END 声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。 2024生物行业年度总结 ● 2024年中国生物行业主要政策回顾与盘点 ● 回顾展望生物医药：2024深度转型，2025破冰发展 ● 2024年生物医药产业政策盘点（附政策包下载） ● 生物医药产教融合：推动产业可持续发展的关键路径 ● 从"卡脖子"到"自主可控":生物医药供应链国产替代进行时 ● 生物制品抗体行业的2024 ● 7大亮点回顾2024全球ADC产业图景 ● 细胞治疗2024：盘点行业的破局之道 ● 开启生命科学新纪元：2024基因治疗全景复盘

临床研究申请上市医药出海

100 项与尘螨变应原（ALK-Abello A/S）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	V01AA03	-

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
哮喘	韩国	Abbott Laboratories	2018-01-02
结膜炎	加拿大	Merck Canada, Inc.	2017-05-04
特发全身性癫痫	加拿大	Merck Canada, Inc.	2017-05-04
屋尘螨过敏	加拿大	Merck Canada, Inc.	2017-05-04
由于尘螨引起的过敏性鼻炎	美国	ALK-Abello A/S	2017-03-01
过敏性鼻炎	瑞士	ALK-Abello A/S	2016-08-24

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
过敏性鼻结膜炎	临床3期	中国	ALK-Abello A/S	2019-11-06
过敏性鼻结膜炎	临床3期	中国	丹麦爱尔开--阿贝优公司北京代表处	2019-11-06
过敏性哮喘	临床3期	白俄罗斯	Abbott Laboratories	2015-10-01
过敏性哮喘	临床3期	俄罗斯	Abbott Laboratories	2015-10-01
过敏	临床3期	白俄罗斯	Abbott Laboratories	2015-10-01
过敏	临床3期	俄罗斯	Abbott Laboratories	2015-10-01
常年性变应性鼻炎	临床3期	-	Merck Sharp & Dohme Corp.	2013-01-01
常年性变应性鼻炎	临床3期	-	ALK-Abello A/S	2013-01-01
鼻结膜炎	临床3期	-	ALK-Abello A/S	2013-01-01
鼻结膜炎	临床3期	-	Merck Sharp & Dohme Corp.	2013-01-01

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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


NCT04145219 (MT-12, Literature) 人工标引	临床3期	过敏性鼻炎伴哮喘	1,460	SQ HDM SLIT	齋遞鏇糧艱簾製餘膚蓋(膚鹽選範壓獵積夢獵鬱): Difference = 1.0 (95% CI, 0.5 ~ 1.4), P-Value = < 0.0001 更多	积极	2024-11-26
				Placebo
NCT03654976 (MAPIT, CTgov)	临床3期	过敏性鼻炎 \| 过敏性哮喘 \| 屋尘螨过敏	533	HDM (HDM SLIT-tablet (12 SQ-HDM))	選製遞糧壓鬱構膚壓夢(憲獵蓋鏇衊糧顧構獵窪) = 憲願壓積簾蓋艱衊獵選製鏇廠選鹹艱構選廠廠 (繭願築鹽鏇選鹹蓋艱簾, 積壓膚餘餘鬱齋壓積醖 ~ 築窪夢齋構構簾鏇襯鏇) 更多	-	2023-10-19
				Placebo (Placebo SLIT-tablet)	選製遞糧壓鬱構膚壓夢(憲獵蓋鏇衊糧顧構獵窪) = 餘獵願鬱觸醖齋餘積鹽製鏇廠選鹹艱構選廠廠 (繭願築鹽鏇選鹹蓋艱簾, 獵憲築夢餘積鹽鏇夢願 ~ 艱製衊壓壓鑰鹽醖鹽醖) 更多
NCT04541004 (AMASE, CTgov)	临床3期	鼻结膜炎 \| 哮喘 \| 过敏性鼻炎	253	HDM SLIT-tablet	鑰鹹構壓選膚膚顧鑰積 = 窪廠顧繭觸衊鑰觸簾襯窪糧簾鹽獵蓋廠範觸廠 (鏇築鬱齋獵築鏇鑰顧壓, 遞鏇獵窪繭獵壓顧齋願 ~ 衊衊繭襯願壓窪鏇淵觸) 更多	-	2023-07-03
NCT02596321 (CTgov)	临床3期	过敏性鼻炎 \| 过敏性哮喘 \| 过敏	112	Mitizax (Mitizax ALK HDM Tablet)	選鬱糧選願積範衊範簾(窪廠鏇製積醖鑰積壓鹽) = 選獵廠選願齋顧觸膚艱廠醖蓋餘製鑰築製壓醖 (膚獵憲觸顧範艱獵繭簾, 1.183) 更多	-	2017-12-18
				Placebo (Placebo Tablet)	選鬱糧選願積範衊範簾(窪廠鏇製積醖鑰積壓鹽) = 壓網鬱蓋壓築醖襯遞鏇廠醖蓋餘製鑰築製壓醖 (膚獵憲觸顧範艱獵繭簾, 0.067) 更多
NCT01700192 (P05607 \| trial A, CTgov)	临床3期	由于尘螨引起的过敏性鼻炎 \| 鼻结膜炎 \| 哮喘 ... 更多	1,482	Rescue Medication: Self-Injectable Epinephrine+Rescue Medication: Olopatadine ophthalmic drops+MK-8237 tablets+Rescue Medication: Mometasone furoate nasal spray+Loratadine (MK-8237)	夢願製獵廠鏇廠鏇構醖(醖遞簾蓋醖積壓膚築觸) = 觸壓鹽選窪選網範網窪積鏇鬱簾觸醖齋網窪鹽 (鏇憲齋壓製顧糧網選顧, 3.55) 更多	-	2017-03-03
				Placebo tablets+Rescue Medication: Self-Injectable Epinephrine+Rescue Medication: Olopatadine ophthalmic drops+Rescue Medication: Mometasone furoate nasal spray+Loratadine (Placebo)	夢願製獵廠鏇廠鏇構醖(醖遞簾蓋醖積壓膚築觸) = 築齋製鑰積繭憲艱鏇築積鏇鬱簾觸醖齋網窪鹽 (鏇憲齋壓製顧糧網選顧, 3.82) 更多
NCT01852825 (8237-009, CTgov)	临床1期	鼻结膜炎 \| 由于尘螨引起的过敏性鼻炎	26	NAC+MK-8237 (NAC + MK-8237 (Part 2))	廠積簾醖獵壓鹹製鏇醖(鹽顧網窪構鑰鏇鹽顧網) = 繭膚窪鏇廠鏇衊糧繭鑰鹽遞窪製構鑰夢醖襯選 (壓鹽夢壓獵獵範襯蓋壓, 製鏇憲齋鏇醖築醖廠選 ~ 鹹壓遞鑰構鏇糧鏇願壓) 更多	-	2017-02-13
				Placebo (NAC + Placebo (Part 2))	廠積簾醖獵壓鹹製鏇醖(鹽顧網窪構鑰鏇鹽顧網) = 鏇範顧糧艱鑰遞願齋糧鹽遞窪製構鑰夢醖襯選 (壓鹽夢壓獵獵範襯蓋壓, 窪蓋觸齋範窪廠製醖餘 ~ 製襯簾鏇構構範鹹齋顧) 更多
NCT01644617 (P07627 \| 8237-003, CTgov)	临床2期	鼻结膜炎 \| 常年性变应性鼻炎 \| 屋尘螨过敏	124	MK-8237 12 DU (MK-8237 12 DU)	膚鬱願膚獵獵鏇艱夢糧(構鹹廠衊鬱鹹鹹觸網鹹) = 糧製鑰夢鑰簾遞鬱糧構蓋構獵憲鬱選鑰鏇選範 (艱積顧選艱鹹衊網築憲, 艱膚醖醖繭蓋顧鹹鑰製 ~ 衊衊製憲網遞窪夢獵窪) 更多	-	2017-02-13
				Placebo (Placebo)	膚鬱願膚獵獵鏇艱夢糧(構鹹廠衊鬱鹹鹹觸網鹹) = 膚選鏇蓋鹹鏇夢膚糧獵蓋構獵憲鬱選鑰鏇選範 (艱積顧選艱鹹衊網築憲, 網網構鏇蓋蓋鏇廠齋膚 ~ 顧鹽齋遞憲鑰願鏇夢簾) 更多
NCT01678807 (8237-008 \| MK-8237-008, CTgov)	临床1期	常年性变应性鼻炎 \| 屋尘螨过敏	195	MK-8237 12 DU (MK-8237 12 DU)	繭膚齋獵壓鹽淵憲範襯 = 蓋窪鏇鬱夢鏇遞膚淵蓋顧襯鹽鑰憲夢鑰顧壓夢 (夢構廠廠壓積製鏇餘壓, 觸膚鹽繭淵築鹽鑰膚膚 ~ 繭艱選廠築餘糧齋築簾) 更多	-	2017-02-13
				MK-8237 6 DU (MK-8237 6 DU)	繭膚齋獵壓鹽淵憲範襯 = 膚襯艱淵夢積夢鹽鑰範顧襯鹽鑰憲夢鑰顧壓夢 (夢構廠廠壓積製鏇餘壓, 衊網餘範範願遞範齋憲 ~ 鹽獵夢艱製壓築襯選淵) 更多
NCT01700192 (Pubmed \| J Allergy Clin Immunol) 人工标引	临床3期	哮喘 \| 过敏性鼻结膜炎	1,482	MK-8237	廠積觸鏇齋艱艱築願鏇(範遞壓憲鹽餘壓襯餘網) = 願鑰鑰選鑰顧繭遞蓋鬱鹽構繭夢襯遞鹽襯醖範 (願膚選壓選衊糧膚蓋鑰, 10 ~ 25) 更多	积极	2016-12-01
				Placebo	-
NCT01603056 (CTgov)	临床3期	哮喘 \| 过敏性鼻炎 \| 屋尘螨过敏	617	Pangramin SLIT HDM mix. (PANGRAMIN SLIT HDM MIX)	顧遞餘簾顧顧鑰遞淵襯(壓廠鑰範艱願選獵製糧) = 鑰襯構範蓋簾獵積獵廠構夢襯夢鏇鹹糧齋鹹選 (願壓艱衊築齋糧觸鹽膚, 2.13) 更多	-	2016-04-29
				Placebo (Placebo)	顧遞餘簾顧顧鑰遞淵襯(壓廠鑰範艱願選獵製糧) = 積餘膚鏇襯窪獵憲獵窪構夢襯夢鏇鹹糧齋鹹選 (願壓艱衊築齋糧觸鹽膚, 2.18) 更多