BAAR, Switzerland--(

BAAR，瑞士--(

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)--Stallergenes Greer, a biopharmaceutical company specialising in allergen immunotherapy (AIT), announces that the European Commission (EC) has approved the extension of indication of Palforzia® (defatted powder of

)--专门从事过敏原免疫治疗（AIT）的生物制药公司Stallergenes Greer宣布，欧盟委员会（EC）已批准延长Palforzia®（脱脂粉末）的适应症

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treatment of toddlers (ages 1 through 3) with a confirmed diagnosis of peanut allergy. The marketing authorisation covers all 27 European member states and the three European Economic Area states (Iceland, Liechtenstein and Norway).

对确诊为花生过敏的幼儿（1至3岁）进行治疗。上市许可涵盖所有27个欧洲成员国和三个欧洲经济区国家（冰岛、列支敦士登和挪威）。

This approval of the extension of indication of Palforzia® to toddlers, follows the July 2024 approval by the U.S. Food and Drug Administration (FDA). Palforzia® is the first and only EMA and FDA approved oral immunotherapy for toddlers with a confirmed diagnosis of peanut allergy.

美国食品和药物管理局（FDA）于2024年7月批准将Palforzia®适应症扩展至幼儿。Palforzia®是第一个也是唯一一个经EMA和FDA批准用于确诊为花生过敏的幼儿的口服免疫疗法。

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Peanut allergy is one of the most frequent food allergies. Early intervention is crucial to reduce the risks of accidental exposure and may be very important in improving long-term outcomes. The approval of Palforzia for toddlers represents for the medical community a meaningful advancement in managing allergy at a pivotal stage in a child’s development,”.

花生过敏是最常见的食物过敏之一。早期干预对于降低意外暴露的风险至关重要，对于改善长期结果可能非常重要。Palforzia对幼儿的批准代表了医学界在儿童发展的关键阶段管理过敏方面取得的有意义的进步”。

stated Dr Katharina Blümchen, Professor at the University of Medicine of Frankfurt, Clinic for Pediatric and Adolescent Medicine, Department of Pneumology, Allergology, Infectiology, and Gastroenterology.

法兰克福医科大学（University of Medicine of Frankfurt）、儿科和青少年医学诊所（Clinic for Pediatric and青少年医学）、肺病学、变态反应学、传染病学和胃肠病学系（Department of肺病学、变态反应学、传染病学和胃肠病学）教授凯瑟琳·布吕姆琴（KatharinaBlümchen）博士表示。

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The approval of Palforzia® by the European Commission highlights the need for a treatment to help alleviate the burden of peanut allergy for young patients and their family,”

欧盟委员会对Palforzia®的批准突出表明，需要一种治疗方法来帮助减轻年轻患者及其家人对花生过敏的负担。”

said Michele Antonelli, CEO of Stallergenes Greer. “

Stallergenes Greer首席执行官米歇尔·安东内利（MicheleAntonelli）表示。“”

In addition to the risk of severe reactions from accidental exposure, peanut allergy can have significant psychological consequences on disease sufferers and their families while negatively impacting quality of life. We are proud of this milestone which highlights Stallergenes Greer’s commitment to the patients and healthcare professionals we serve.”.

除了意外接触导致严重反应的风险外，花生过敏还可能对疾病患者及其家人产生重大的心理后果，同时对生活质量产生负面影响。我们为这一里程碑感到骄傲，它突显了Stallergenes Greer对我们服务的患者和医疗保健专业人员的承诺。”。

Palforzia® is designed to gradually increase the body’s ability to tolerate small amounts of peanut (desensitisation) through carefully controlled and supervised initial dose escalation, up-dosing and maintenance. The extension of the indication enables treatment to be initiated at an earlier age, thus offering young children and their families the opportunity to reduce the risk of severe allergic reactions from accidental exposure to peanut allergens, with adjustment of contraindications..

Palforzia®旨在通过精心控制和监督初始剂量递增、上调剂量和维持，逐步提高身体耐受少量花生（脱敏）的能力。适应症的延长使治疗能够在较早的年龄开始，从而为幼儿及其家人提供了机会，通过调整禁忌症，降低意外接触花生过敏原导致严重过敏反应的风险。。

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The approval is based on data from the Phase 3 POSEIDON (

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) study that was published in the New England Journal of Medicine Evidence in 2023. The study evaluated the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years old, meeting all its primary and secondary efficacy endpoints and demonstrating a favourable safety profile.

)这项研究于2023年发表在《新英格兰医学证据杂志》上。该研究评估了Palforzia®对1至3岁花生过敏儿童的疗效和安全性，满足其所有主要和次要疗效终点，并显示出良好的安全性。

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Palforzia®’s broader accessibility highlights Stallergenes Greer’s mission to bring innovative therapies to patients across all stages of life. Beyond food allergy treatments, the company offers a diverse portfolio, including sublingual and subcutaneous immunotherapies for respiratory and insect venom allergies..

Palforzia®更广泛的可及性突显了Stallergenes Greer的使命，即为患者的各个生命阶段带来创新疗法。除了食物过敏治疗外，该公司还提供多种组合，包括针对呼吸道和昆虫毒液过敏的舌下和皮下免疫疗法。。

ABOUT PALFORZIA®

关于帕尔福齐亚®

Palforzia® is indicated by the European Medicine Agency (EMA) in all 27 European member states, Iceland, Liechtenstein and Norway, for the treatment of patients aged 1 to 17 years with a confirmed diagnosis of peanut allergy. It is indicated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., and by Swissmedic in Switzerland for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy.

Palforzia®由欧洲药品管理局（EMA）在冰岛、列支敦士登和挪威等所有27个欧洲成员国指定，用于治疗确诊为花生过敏的1至17岁患者。英国药品和保健品监管局（MHRA）和瑞士Swissmedic指定用于治疗确诊为花生过敏的4至17岁患者。

Palforzia® may be continued in patients 18 years of age and older. Palforzia® should be used in conjunction with a peanut-avoidant diet..

Palforzia®可能会在18岁及以上的患者中继续使用。Palforzia®应与避免花生的饮食结合使用。。

Palforzia® is also approved by the U.S. Food and Drug Administration (FDA) for ages 1-17 years for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. The treatment is approved for use in patients with a confirmed diagnosis of peanut allergy; Initial Dose Escalation may be administered to patients aged 1 through 17 years.

Palforzia®也被美国食品和药物管理局（FDA）批准用于缓解过敏反应，包括意外接触花生可能发生的过敏反应，年龄为1-17岁。该疗法被批准用于确诊为花生过敏的患者；初始剂量递增可用于1至17岁的患者。

Up-Dosing and Maintenance may be continued in patients 1 year of age and older. Palforzia® is to be used in conjunction with a peanut-avoidant diet. Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis..

1岁及以上的患者可以继续服用和维持。Palforzia®将与避免花生的饮食结合使用。使用限制：不适用于过敏反应的紧急治疗，包括过敏反应。。

ABOUT POSEIDON PHASE 3 STUDY

关于波塞冬3期研究

POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.gov number NCT03736447) is an international, randomized (2:1), double-blind, placebo-controlled Phase 3 study that evaluated the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years of age in North America and Europe..

波塞冬（花生口服免疫疗法脱敏早期干预研究，clinicaltrials.gov编号NCT03736447）是一项国际性，随机（2:1），双盲，安慰剂对照的3期研究，评估了Palforzia®在北美和欧洲1至3岁花生过敏儿童中的疗效和安全性。。

The POSEIDON study was completed by Aimmune Therapeutics, part of Nestlé Health Science before Nestlé divested Palforzia® to Stallergenes Greer in September 2023.

在2023年9月雀巢将Palforzia®剥离给Stallergenes Greer之前，海神研究由雀巢健康科学的一部分Aimmune Therapeutics完成。

Enrollment was based on several entry criteria, including a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single doses of peanut protein >3 to ≤300 mg in a positive double-blind, placebo-controlled food challenge..

入选是基于几个入选标准，包括记录的花生过敏临床病史，阳性皮肤点刺试验和/或花生抗体血液水平升高，以及在阳性双盲安慰剂对照食物挑战中食用单剂量花生蛋白>3至≤300 mg后的剂量限制症状。。

In POSEIDON, patients underwent a dose-escalation period of approximately 22 weeks to reach a dose of 300 mg per day of Palforzia® or placebo, then continued that dose for approximately six months. At the end of the trial, patients underwent an exit double-blind, placebo-controlled food challenge (DBPCFC)..

在波塞冬，患者接受了大约22周的剂量递增期，以达到每天300毫克的Palforzia®或安慰剂剂量，然后继续该剂量约六个月。在试验结束时，患者接受了退出双盲安慰剂对照食物挑战（DBPCFC）。。

ABOUT STALLERGENES GREER INTERNATIONAL AG

关于STALLERGENES GREER INTERNATIONAL AG

Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of respiratory, food and venom allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc.

Stallergenes Greer International AG总部位于瑞士巴尔，是一家全球医疗保健公司，通过过敏原免疫治疗产品和服务的开发和商业化，专门从事呼吸道、食物和毒液过敏的诊断和治疗。Stallergenes Greer International AG是Greer Laboratories，Inc.的母公司。

(whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit .

（注册办事处位于美国）和Stallergenes SAS（注册办事处位于法国）。有关更多信息，请访问。

www.stallergenesgreer.com

www.stallergenesgreer.com

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Summary of Product Characteristics. Rev 19 dec 2024

产品特性总结。2024年12月19日修订

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https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300145

https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300145

Palforzia®: © 2025, Société des Produits Nestlé S.A. or its affiliates

帕尔福齐亚®: © 2025年，雀巢产品公司或其附属公司