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

/ 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2025-03-01

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 FEF 75 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 FEV 1 /FVC, FEF 75 , FEF 50 and MMEF ( p < .05). It is worth noting that FEF 75 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.

2024-08-12·ACTA OTO-LARYNGOLOGICA

The impact of adverse reactions on adherence to sublingual immunotherapy for Japanese cedar pollinosis and house dust mite allergy in Japan

Article

作者: Masuno, Satoru

BACKGROUND:

Allergen immunotherapy is the only treatment that can achieve remission for allergic diseases.

AIMS/OBJECTIVES:

To investigate the three-year adherence to sublingual immunotherapy for Japanese cedar pollinosis and house dust mite allergy at a clinic in Japan and identify factors that influence adherence and severe adverse reactions.

MATERIAL AND METHODS:

In total, 174 patients aged 12 years or older who started sublingual immunotherapy for Japanese cedar pollinosis (n = 72), house dust mite allergy (n = 55), or both (n = 47) between May 2017 and June 2018. Patient age, sex, type of pharmacotherapy used, adverse reactions, blood test results, and duration of continuous treatment were investigated.

RESULTS:

The three-year treatment continuation rate was 40.8%. Adverse reaction rates were 12.6% for cedar pollinosis and 40.2% for house dust mite allergy. Patients with dose reductions due to severe reactions had lower first-year continuation rates. In the MITICURE^® group, patients with severe reactions had significantly higher serum total IgE levels. Severe reactions were more common in MITICURE^® patients with seven or more positive antigen types.

CONCLUSIONS AND SIGNIFICANCE:

Severe adverse reactions reduced early adherence.

项与尘螨变应原（ALK-Abello A/S）相关的新闻（医药）

2026-04-03

·金赛药业

从打针到含服！全球顶级循证新药尘螨变应原舌下片（Acarizax®）落地广州三甲医院，脱敏治疗迎来新突破

春季气温回升，尘螨、花粉等过敏原进入繁殖活跃期，过敏性鼻炎、哮喘等过敏性疾病迎来全年就诊高峰。在华南地区，尘螨过敏患病率高达 70%，位居全国首位，反复打喷嚏、流清涕、鼻塞憋气、夜间憋醒等症状，看似 “小毛病”，却长期侵蚀着患者的生活质量，甚至可能逐步进展为不可逆的气道损伤。近日，第二十四届全国标准化过敏原特异性免疫治疗（AIT）培训班在广州医科大学附属第一医院（以下简称“广医一院”）国家呼吸医学中心举办。会上同步传来重磅消息：依托 “港澳药械通” 政策红利，全球领先的尘螨变应原舌下片（Acarizax®）已在广医一院正式落地临床应用，为大湾区乃至全国的过敏患者，带来了无需注射、儿童可用、可居家完成的脱敏治疗新选择。小过敏大烦恼：误诊误治普遍，传统皮下注射治疗有“痛点” “从初中开始，我就一直被流鼻涕、头晕的症状困扰，村里 80 多岁的老中医一直当感冒给我治，吃了无数感冒药，症状从来没断过。”来自广州番禺的患者安安（化名），被过敏性鼻炎纠缠了二十余年，是过敏性疾病诊疗中最典型的 “走弯路” 患者。安安从青少年时期便受过敏性鼻炎困扰，夏天不敢吹风扇、空调，整日随身携带纸巾，鼻子反复擦拭到破皮，严重时夜间鼻塞到只能用嘴呼吸，晨起舌头干得像硬块，甚至出现半夜窒息憋醒的情况。但多年来，她始终把这个病当成 “体质差、爱感冒”，直到 2024年症状急剧加重，才在广医一院确诊重度尘螨过敏性鼻炎。确诊后，医生第一时间向她推荐了过敏原特异性免疫治疗，而当时国内主流的方案，是需要长期到院注射的皮下脱敏治疗。但这个方案，安安却一直难以接受。 “我天生就怕打针，看到针头就浑身发紧，更别说要坚持三年定期打针了。” 安安坦言，除了对注射的恐惧，时间成本更是她无法跨越的门槛，她在幼儿园上班，日常带班根本抽不出时间，传统治疗前期要每周跑一次医院，稳定期也要每月复诊，她根本没法频繁请假，只能无奈放弃了皮下脱敏的方案。在临床中，像安安这样的患者比比皆是。长期以来，标准化皮下脱敏治疗作为经典的过敏对因治疗方案，疗效确切且临床应用成熟，为众多过敏患者带来了规范的病因治疗获益；但在临床应用中也存在一定诊疗痛点，使得部分本可通过对因治疗摆脱过敏困扰的患者难以长期坚持。直到一款全球领先的尘螨变应原舌下片（Acarizax®）出现，让脱敏治疗从 “医院专属治疗” 变成了 “居家自主可及”，也为无数像安安一样的过敏患者，带来了安全、便捷、有效的治疗新选择。规范诊疗筑根基：AIT（过敏原特异性免疫治疗）推动脱敏治疗从“止症状”到“治根源” 过敏性疾病诊疗的规范化，是摆脱患者困境的核心前提。广医⼀院作为国家呼吸医学中心，牵头举办的全国标准化 AIT 培训班已走过 24 个年头，核心是把国际前沿的 AIT 诊疗理念、国内统一的标准化操作规范传递给全国的临床医护人员，尤其是大湾区的从业者。 “过敏性疾病的治疗，不能只停留在‘止症状’，更要做到‘治根源’。” 广州医科大学附属第一医院教授、广州呼吸疾病健康研究院变态反应科主任李靖介绍，过敏原特异性免疫治疗（AIT），是目前全球指南公认的唯一能从病因层面改变过敏性疾病自然进程的治疗方式。它的原理如同 “打疫苗”，通过让患者逐步、低剂量接触标准化的过敏原提取物，诱导机体免疫系统产生免疫耐受，最终让患者再次接触过敏原时，不再出现过敏症状，实现真正的 “治标又治本”。李靖介绍，AIT培训班不仅能快速提升大湾区过敏疾病诊疗的同质化水平，更能以点带面推动全国 AIT 治疗的规范化发展，让更多过敏患者能享受到安全、标准、有效的对因治疗，填补国内过敏疾病规范化诊疗的行业空白。而此次培训班上重点推介的新型的脱敏制剂尘螨变应原舌下片（Acarizax®），正是依托 “港澳药械通” 政策落地的国际前沿成果，为国内 AIT 治疗体系补上了关键的一块拼图，也让培训班的标准化诊疗成果，有了更贴合患者需求的落地载体。尘螨变应原舌下片（Acarizax®）是国际上临床应用超 15 年的成熟脱敏制剂，2017 年便写入国际诊疗指南，更是唯一被美国 FDA 批准的尘螨过敏治疗变应原制剂。相较于传统脱敏治疗，尘螨变应原舌下片（Acarizax®）实现了全方位的革命性突破：其搭载的 SQ 标准化速崩技术，药片置于舌下1秒崩解，15-30秒内释放全部变应原，吸收更精准，彻底解决了传统舌下给药的剂量丢失痛点；一日一次，便携方便，可常温保存的特性，无需冰袋冷藏，完美适配出差、旅行等多场景使用需求；尘螨变应原舌下片（Acarizax®）同时拥有累计约9000例样本量的全球最大规模过敏性鼻炎及过敏性哮喘随机对照试验（RCT），更是充分证实了它的疗效与安全性，这一循证优势是目前全球任何一款 AIT 产品都无法做到的，为尘螨过敏患者带来了划时代的治疗新选择。过敏患者治疗新体验：告别针头和奔波，居家就能治疗 28 岁的广州人许凯（化名），被过敏性鼻炎合并哮喘困扰了二十余年，是广医一院首批使用尘螨变应原舌下片（Acarizax®）的患者。小学时，许凯便出现反复喘息、流涕的症状，却被误诊为支气管炎，严重发作时，只能找个角落跪在地上缓解呼吸困难。这一扛，就是二十多年。 “那时候不懂，就靠自己在网上学腹式呼吸，练了七八年，靠这个平缓呼吸，从来没正经用过对症的药。”许凯说，疫情之后，他才通过网络信息意识到，自己的症状大概率是哮喘。最终，他通过多个人工智能平台综合筛选，选择了广医一院李靖教授的团队就诊，确诊重度尘螨过敏。面对医生给出的 “皮下注射脱敏” 和 “舌下含服脱敏” 两个方案，他毫不犹豫地选择了后者。 “首先是怕打针，更重要的是，我创业工作太忙，根本没时间每周跑医院打针。” 他坦言，尘螨变应原舌下片（Acarizax®）彻底解决了他的核心痛点，在家就能自主用药，每天含服一片，完全不影响工作节奏。对于这款刚在大湾区落地的新药，他没有丝毫顾虑：“我查过资料，这个药在国外已经上市十多年，有大量的使用经验，国家能批准引进，安全性肯定有保障。” 来自清远连州的马军（化名），家住广东最北部，距离广州 300 多公里，尘螨引发过敏性鼻炎已经困扰了他 5 年。只是传统皮下注射脱敏需要频繁往返医院，这让他难以持续配合治疗。 “最严重的时候，两个鼻子轮流堵，只能单边呼吸，晚上睡觉打鼾、憋气，经常被憋醒，不光睡不好，还导致血压升高了。” 马军说，起初他没把这个 “小毛病” 放在心上，直到症状越来越重，当地医院开的药效果甚微，他才下定决心到广医一院就诊。 “传统治疗方式，初始阶段 7 天就要去一趟医院，进入维持阶段后也要一个半月去一次，我家离广州 300 多公里，跑一趟要大半天，很难坚持下来，只能一直拖着。”马军坦言，由于当地医院没有标准化脱敏中心，异地就医的奔波，是他迟迟没能规范治疗的主要原因。如今，有了尘螨变应原舌下片（Acarizax®），马军彻底解决了奔波的难题。“这个药太方便了，放到舌下瞬间就化了，一点不适感都没有。医生给我开了一个月的药，我在家就能自己用，一个月之后再来复诊就行，再也不用频繁跑广州了。” 重塑过敏治疗新格局：新药实现三重突破，大湾区数十家医院将陆续引入在李靖看来，新药尘螨变应原舌下片（Acarizax®）实现了三重突破。一是给药方式的革新，实现从 “医院专属治疗” 到 “居家自主用药” 的跨越。传统皮下脱敏需要患者定期到院，由医护人员完成注射，而这款新药采用舌下含服的形式，患者在家就能自主完成用药，无需频繁往返医院。二是起效速度与长期疗效的双重保障，破解患者 “坚持难”的核心痛点。传统脱敏治疗往往有较长的剂量递增期，很多患者因迟迟看不到效果放弃治疗。这款新药已有全球15年临床验证、130万患者应用经验，并获得超过9000例随机对照试验证据支持,最快 8 周就能与对照组显示出统计学差异，患者能快速感受到打喷嚏、流涕、鼻塞等症状的缓解，建立治疗信心。三是安全性与适配性的全面升级，覆盖全年龄段患者需求。舌下黏膜免疫的给药方式，让全身不良反应发生率大幅降低，用药安全性更高；无需冷藏的方式，符合现代人快节奏的需求，出差、旅行携带方便。此次，广医一院率先落地这款舌下脱敏含片，不仅完善了医院“皮下注射 + 舌下含服” 的多元化脱敏治疗体系，更成为 “港澳药械通” 政策惠及民生的生动实践。此前，这款药物仅在港澳、欧美等地区上市，内地患者想要使用，只能远赴海外或海南博鳌医疗先行区。而通过 “港澳药械通” 政策，大湾区患者在家门口的国家呼吸医学中心，就能同步享受到全球领先的脱敏治疗方案，大幅降低了就医的时间成本与经济成本。据了解，后续大湾区内符合 “港澳药械通” 政策要求的数十家医院，将陆续引入这款舌下脱敏片剂。 “尘螨过敏并不可怕，早筛查、早诊断、早规范对因治疗是关键。” 李靖提醒广大过敏患者，不要把 “小过敏” 拖成 “大问题”，正视过敏性疾病的危害，选择适合自己的脱敏方案并坚持规范治疗，就能摆脱过敏困扰，重获健康呼吸。用药两天，马军已经感受到了轻微的症状缓解。他说，自己已经做好了坚持完整个疗程的准备，最大的心愿，就是能把鼻子的问题治好，晚上睡个安稳觉，血压也能稳定下来，再也不用被这个 “小毛病” 折腾了。同样，如今已经戒烟、规范开启治疗的许凯也对未来充满信心：“硬扛了二十多年，现在终于有了能去根、又方便的治疗办法，每天含一片药，我肯定能坚持完整个疗程，彻底摆脱这个病。” 本文转载于南方＋，如有问题请联系修改。

2026-02-20

·ir.alk.net

Annual report 2025: ALK delivers 15% revenue growth and 26% EBIT margin

ALK’s (ALKB:DC / Nasdaq Copenhagen: ALK B) full-year results came in at the top end of the latest outlook, supported by solid performance in Q4 and continued commercial momentum. ALK expects sustained high organic revenue growth of 11-15% and higher earnings in 2026, with profitability at around 25%, in line with ALK’s long-term targets. The Board of Directors recommends dividend payments for 2025 of DKK 355 million, corresponding to approximately 30% of net profit after tax, to reward shareholders directly. Q4 2025 performance highlights (Comparative figures are shown in brackets. Growth rates are stated in local currencies, unless otherwise indicated) Revenue increased by 17% to DKK 1,733 million (1,499) on strong performance across all geographies Tablet sales increased by 15% to DKK 910 million (795), based on expanding patient and prescriber bases in Europe and North America, delivering tablet growth of 20% and 21%, respectively. As expected, International markets reported a 11% decline in tablet sales, impacted by phasing of products shipments to Japan. SCIT/SLIT drops sales increased 11% to DKK 607 million (552), based on shipments to China. Anaphylaxis & other products sales increased by 50% to DKK 216 million (152), driven by Jext® and neffy®. Operating profit (EBIT) increased by 88% to DKK 387 million (205) with a margin of 22%, reflecting planned growth investments. Full-year 2025 performance highlights Revenue grew 15% to DKK 6,312 million (5,537) following double digit growth in all regions. Tablets were key to growth with sales increasing by 17% to DKK 3,335 million (2,851). SCIT/SLIT drops sales increased by 5% to DKK 2,145 million (2,052). Anaphylaxis & other products sales increased by 34% to DKK 832 million (634), driven by Jext® and neffy®. EBIT increased 53% to DKK 1,654 million (1,091) on higher sales, gross margin improvements, and modest cost increases. The margin was 26% (20%). Free cash flow was positive at DKK 1,432 million (-204), largely driven by higher earnings and upfront payment from the new Chinese partnership with GenSci. Financial highlights Allergy+ strategy highlights Paediatric launches of ACARIZAX® and ITULAZAX® in 21 and 12 markets performed well above expectations with strong prescriber adoption. Ongoing roll-out of neffy® in Germany and the UK. Multiple market launches prepared for 2026. Good progress across partnerships with ARS Pharma, GenSci, Shionogi (Torii) and others. Ongoing phase 2 clinical trial with the peanut SLIT tablet on track to report topline results in Q2 2026. Shareholder remuneration The Board of Directors continuously assesses ALK’s financial resources to ensure sufficient funds for executing ALK’s strategy, including emerging business development, in-licensing, M&A, and other investment needs. At the end of 2025, net interest-bearing debt (NIBD) was DKK -822 million, and the NIBD/EBITDA ratio was -0.4, well below the long-term target of a maximum of two. Against this background, the Board of Directors recommends to the Annual General Meeting the adoption of a new shareholder remuneration programme with the aim of distributing approximately 30% of ALK’s net profit after tax to shareholders, corresponding to dividends of DKK 355 million for the year 2025 or DKK 1.6 per share. 2026 full-year outlook ALK expects to continue its trajectory of double-digit revenue growth and higher earnings in 2026. The EBIT margin is planned to remain in line with ALK’s long-term earnings ambitions reflecting that a portion of the operational leverage will be reinvested in strategic growth initiatives. Revenue is expected to grow 11–15% in local currencies EBIT margin is expected at ~25% Growth will predominantly be volume-driven, as ALK expects to treat more patients with AIT and anaphylaxis products. The EBIT margin will expectedly be impacted by a slight decline in gross margin, as the favourable impact from especially higher tablet sales in Europe is offset by higher partner-related sales at lower margins. Commenting on the full-year results, CEO Peter Halling said: “2025 was a landmark year for ALK. With revenue increasing by 15% based on strong commercial execution and an EBIT margin of 26%, we have proven the strength of our Allergy+ strategy. The successful roll-out of paediatric allergy tablets, positive feedback on the first neffy® launches, and good progress with both existing and new partnerships reflect our commitment to providing innovative treatments to more people with allergies across age groups and geographies. With a solid expansion of prescriber and patient bases, we are well-positioned for continued long-term profitable growth. This is why we recommend resuming dividend payments to shareholders.” Hørsholm, 20 February 2026 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 1.30 p.m. (CET) on 20 February 2026 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 1.25 p.m. (CET). Attachments Company release_02_26UK_200226_ALK annual report 2025 alk-2025-12-31-en

财报

2026-01-22

·自由鼻肺站

过敏反复用药？金赛药业近15亿元引进ACARIZAX等脱敏治疗产品

自由鼻肺站导读 2025年9月17日，长春高新发布公告，旗下核心子公司金赛药业与丹麦生物制药公司ALK达成合作，引进三款变应原特异性免疫治疗产品。交易总额约1.78亿欧元，折合人民币近15亿元。此次引进的三款产品分别为： l 屋尘螨变应原制剂（商品名：安脱达） l 螨变应原皮肤点刺试剂盒（商品名：安刺） l 尘螨变应原舌下片（商品名：ACARIZAX®）根据协议，金赛药业将从2025年10月1日起负责前两款产品在中国大陆的销售与推广。舌下片产品则将在国内获批后启动商业化。合作期限将持续至2039年12月31日。为什么金赛药业选择此时转型？金赛药业长期以来依赖重组人生长激素产品，但该业务增长已显现乏力。2024年，公司营收同比下降3.73%，归母净利润下降40.67%。2025年上半年净利润仍处于下滑态势。与此同时，生长激素市场竞争日趋激烈，多家企业已有新产品获批或即将上市。在这一背景下，寻找第二条增长曲线成为金赛药业的现实选择。什么是脱敏治疗？脱敏治疗，学名“变应原特异性免疫治疗”，是通过让患者逐渐接触过敏原，帮助免疫系统逐渐适应，从而减轻或消除过敏症状的治疗方式。与仅能缓解症状的传统抗组胺药物相比，该疗法旨在从机制上调整免疫反应。尘螨是常见的室内过敏原，与过敏性鼻炎、哮喘等疾病密切相关。据统计，2024年中国过敏性鼻炎患者人数约2.458亿，市场规模较大，但其中接受脱敏治疗的患者比例仍很低，市场尚处早期阶段。合作方ALK：过敏治疗领域的领先企业丹麦ALK公司专注于过敏治疗领域，拥有百年历史，其变应原免疫治疗产品在全球市场份额超过45%。此次引进的舌下片剂型在海外已应用多年，因其使用方便、患者依从性较高而受到认可。例如尘螨变应原舌下片目前已在多国上市，在欧洲名为ACARIZAX，在日本名为MITICURE，在印度名为Sensimune。到目前为止，该药片已在欧洲和日本获准供儿童使用，加拿大目前正在进行相应的监管审查。鼻肺新药分享： 1.尘螨变应原舌下含片（ACARIZAX）丹麦原研药，国外已上市（以欧美药价换算约为1200+元），其Ⅲ期临床试验正在全国范围内招募尘螨过敏患者。项目周期8个月左右，补贴4000+。丹麦 ALK 原研 + 国外已上市！尘螨变应原舌下含片（ACARIZAX®）Ⅲ期临床全国招募 2.欧脱克ORALTEK® MM09舌下喷雾剂，III期，国外已上市，12-65周岁，招募中重度过敏性鼻炎患者，用药14-21个月，补贴2000+。若抽中安慰剂，补贴一年价值约2w的药物使用。国外已上市！MM09舌下喷雾剂Ⅲ期全国招募过敏性鼻炎患者，补贴可观！ 3.礼来Lebrikizumab（来瑞组单抗）白介素13，香港已经上市，欧盟等地区已经获批了用于中重度特应性皮炎，Ⅲ期招募鼻炎患者，2年用药，补贴5000+。吃氯雷他定、喷辅舒良还老犯鼻炎？新药来瑞组单抗招募患者，有一定补贴！、临床均在三甲医院开展，符合条件的患者体检用药均不收费，有一定补贴。【更多新药报名咨询】展望与挑战值得关注的是，金赛药业原有的生长激素业务主要面向儿童群体，而过敏性疾病在儿童中同样高发。这意味着金赛在儿科渠道、医患资源等方面具备一定基础，业务延伸具备天然优势。此次合作是金赛药业在主营业务承压背景下的一次重要战略布局。脱敏治疗在中国市场潜力较大，尤其儿童过敏领域仍有待进一步开发。不过，新产品落地仍面临一些实际挑战，包括注册审批进度、市场教育、医生认知以及医保支付等环节。能否成功开辟第二增长曲线，还需持续观察。金赛药业的这次转型，既是对市场变化的应对，也反映了企业对中国过敏治疗市场未来的判断。我们期待这些产品能为更多中国过敏患者提供新的治疗选择。新药临床分享目前，针对过敏性鼻炎、慢性鼻窦炎、哮喘、慢阻肺等疾病，国内外仍有多种新药（包括特泽鲁单抗同靶点/美泊利珠单抗同原理生物制剂、国外上市喷剂含片等）处于临床试验阶段。参与临床研究的患者，体检用药费用均由项目组承担，并有一定的补贴。参与临床试验全攻略：从筛选到结束的完整流程+关键注意事项【添加客服享更多资讯福利】关注我们，后续将持续更新药物的最新进展，让更多患者摆脱困扰！本文仅做参考，不构成对任何药物或诊疗方案的推荐、推广或宣传，也不可替代专业医疗建议。如有问题，请咨询医疗卫生专业人士。材料图片等源自网络，侵删。往期回顾鼻塞、闻不着味？当心，你的“性”福可能正被过敏性鼻炎偷走医保续约敲定！50% 患者实现长期控制，奥马珠治疗中重度过敏性哮喘报销后需自费多少？点赞分享本文，让更多患者受益~ 点分享点收藏点在看点点赞

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,

后查看更多信息

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,

后查看更多信息

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
过敏反应	临床3期	白俄罗斯	Abbott Laboratories	2015-10-01
过敏反应	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	網獵範願鬱觸選壓夢糧(築範膚窪窪選壓鏇壓夢): Difference = 1.0 (95% CI, 0.5 ~ 1.4), P-Value = < 0.0001 更多	积极	2024-11-26
				Placebo
NCT04145219 (MATIC \| phase 3 \| MT-12, CTgov)	临床3期	由于尘螨引起的过敏性鼻炎 \| 鼻结膜炎 \| 哮喘	1,460	HDM (HDM SLIT-tablet (12 SQ-HDM))	觸製願觸鏇壓窪餘糧蓋(簾艱窪選夢鏇鹹願鏇糧) = 觸壓鹽構鹹遞淵鬱簾夢窪鏇餘淵簾鏇蓋鹹艱醖 (積遞觸鑰築製艱鹽願遞, 0.3) 更多	-	2024-06-12
				Placebo (Placebo SLIT-tablet)	觸製願觸鏇壓窪餘糧蓋(簾艱窪選夢鏇鹹願鏇糧) = 糧網築齋齋壓窪構艱蓋窪鏇餘淵簾鏇蓋鹹艱醖 (積遞觸鑰築製艱鹽願遞, 0.3) 更多
NCT03654976 (MT-11 \| 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))	鬱製餘憲壓選鏇憲餘膚(鬱製鬱鑰窪襯憲鹹艱淵) = 願窪膚鏇積積選願顧廠築鏇淵餘觸網壓顧顧選 (構醖膚積襯齋餘範鑰醖, 淵鬱網壓鏇獵獵膚鑰糧 ~ 觸衊膚獵遞構糧鹹鹹鏇) 更多	-	2023-10-19
				Placebo (Placebo SLIT-tablet)	鬱製餘憲壓選鏇憲餘膚(鬱製鬱鑰窪襯憲鹹艱淵) = 網築鹽鹹膚鑰淵膚鹹選築鏇淵餘觸網壓顧顧選 (構醖膚積襯齋餘範鑰醖, 窪簾壓廠鬱製積鬱齋襯 ~ 蓋窪鹹齋網繭鬱壓顧顧) 更多
NCT04541004 (AMASE, CTgov)	临床3期	鼻结膜炎 \| 哮喘 \| 过敏性鼻炎	253	HDM SLIT-tablet	範鏇製積鹹觸網醖鹹繭 = 顧憲襯廠淵糧簾鬱遞壓膚製積淵淵簾衊鏇醖願 (窪壓鹹築遞壓鹽蓋鏇簾, 廠襯製淵膚鏇製衊壓鏇 ~ 憲選簾積憲選鹹衊廠夢) 更多	-	2023-07-03
NCT02596321 (CTgov)	临床3期	过敏性鼻炎 \| 过敏性哮喘 \| 过敏反应	112	Mitizax (Mitizax ALK HDM Tablet)	壓觸遞鑰膚繭製簾壓選(廠遞夢衊構積網餘繭鹹) = 鬱築觸鑰築觸廠壓衊鬱鬱繭製鑰顧鏇願糧壓壓 (襯憲鏇鑰簾窪廠憲衊窪, 1.183) 更多	-	2017-12-18
				Placebo (Placebo Tablet)	壓觸遞鑰膚繭製簾壓選(廠遞夢衊構積網餘繭鹹) = 窪鹽衊顧醖鏇廠遞構蓋鬱繭製鑰顧鏇願糧壓壓 (襯憲鏇鑰簾窪廠憲衊窪, 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)	簾鬱窪觸簾窪鬱鹹簾廠(觸遞獵網網壓繭鏇遞範) = 積壓願鏇襯醖願網憲鬱顧壓簾構製願鏇壓鹽築 (顧鬱窪衊鹽膚範夢選遞, 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)	簾鬱窪觸簾窪鬱鹹簾廠(觸遞獵網網壓繭鏇遞範) = 選範製製願範製鹹範鹽顧壓簾構製願鏇壓鹽築 (顧鬱窪衊鹽膚範夢選遞, 3.82) 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)	簾廠遞膚廠鏇積鏇蓋觸(範餘遞鑰醖餘廠襯鏇觸) = 鏇壓獵醖觸願簾築膚艱餘糧鬱製選醖膚構齋遞 (獵觸齋襯鹽簾獵鏇襯遞, 網製繭願淵鏇鑰艱廠構 ~ 獵範積鹹糧鑰願簾襯顧) 更多	-	2017-02-13
				Placebo (Placebo)	簾廠遞膚廠鏇積鏇蓋觸(範餘遞鑰醖餘廠襯鏇觸) = 醖構餘糧觸膚夢艱襯簾餘糧鬱製選醖膚構齋遞 (獵觸齋襯鹽簾獵鏇襯遞, 衊網鏇衊窪襯鏇簾範顧 ~ 廠憲膚鏇範築衊憲觸簾) 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)	艱餘糧簾艱築壓鏇鏇襯 = 積壓選憲齋簾蓋餘積遞淵鏇範淵鏇淵網築遞製 (願憲淵廠衊窪願憲鹹觸, 獵窪膚襯顧簾顧夢鏇廠 ~ 顧選構壓網窪鹹淵齋廠) 更多	-	2017-02-13
				MK-8237 6 DU (MK-8237 6 DU)	艱餘糧簾艱築壓鏇鏇襯 = 願範獵窪餘鏇網窪鹽鑰淵鏇範淵鏇淵網築遞製 (願憲淵廠衊窪願憲鹹觸, 醖蓋壓鑰遞糧鹹齋選獵 ~ 鹽遞膚糧襯艱顧範醖廠) 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))	繭夢繭鏇簾廠築製窪構(願獵壓醖鑰壓範餘夢鑰) = 鑰淵壓觸願鹹顧遞簾夢範窪鹽製蓋窪餘積觸襯 (醖鹹齋鹹繭鬱積築襯獵, 製糧鏇齋夢齋淵選獵鏇 ~ 顧餘醖醖糧廠糧觸衊觸) 更多	-	2017-02-13
				Placebo (NAC + Placebo (Part 2))	繭夢繭鏇簾廠築製窪構(願獵壓醖鑰壓範餘夢鑰) = 衊鹹築觸積衊淵夢繭遞範窪鹽製蓋窪餘積觸襯 (醖鹹齋鹹繭鬱積築襯獵, 簾繭選齋蓋糧鹽壓獵製 ~ 鬱積憲積獵願艱鹹鏇鏇) 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	繭鬱餘顧壓獵遞蓋壓製(願簾範糧積鏇膚鏇範憲) = 壓願艱襯窪窪淵醖範夢廠憲艱遞糧壓觸壓獵築 (壓製選製網廠壓築網餘, 10 ~ 25) 更多	积极	2016-12-01
				Placebo	-