BALLERUP, Denmark--(BUSINESS WIRE)--GLOBAL RELEASE – NOT INTENDED FOR DISTRIBUTION IN THE UK

丹麦巴勒鲁普——（商业新闻短讯）——全球发布——不打算在英国发行

LEO Pharma A/S, a global leader in medical dermatology, today announces positive results from the Enstilar® phase 3 trial in China in adult patients living with stable plaque psoriasis.

LEO Pharma A/S是医学皮肤病学领域的全球领导者，今天宣布在中国进行的Enstilar®3期临床试验对患有稳定斑块型银屑病的成年患者取得了积极的结果。

The trial is a phase 3, randomised, investigator-blind, active controlled, parallel group, multicentre trial comparing the efficacy and safety of once daily application with Enstilar (LEO 90100) and Daivobet® ointment for 4 weeks of treatment in adult Chinese subjects with stable plaque psoriasis. A total of 604 patients were recruited across 39 sites in China.1.

该试验是一项3期，随机，研究者盲，主动对照，平行组，多中心试验，比较了每日一次使用Enstilar（LEO 90100）和Daivobet®软膏治疗4周稳定斑块型银屑病的成年中国受试者的疗效和安全性。在中国的39个地点共招募了604名患者。

The primary objective of the study was to evaluate the efficacy of Enstilar (LEO 90100) compared with Daivobet® ointment on severity and extent of stable plaque psoriasis. The secondary objective evaluated treatment safety. Exploratory objectives included evaluating health-related quality of life.1

该研究的主要目的是评估Enstilar（LEO 90100）与Daivobet®软膏相比对稳定斑块型银屑病严重程度和程度的疗效。次要目标评估治疗安全性。探索性目标包括评估与健康相关的生活质量。1

The topline results show that Enstilar demonstrated superiority to Daivobet ointment in the primary objective.

topline结果显示，Enstilar在主要目标上优于Daivobet软膏。

“With these inspiring clinical results, we are very happy to be able to proceed towards submission of Enstilar to the Chinese authorities, but I am equally pleased that we will now proceed towards hopefully providing Chinese patients with a new treatment option for their psoriasis in addition to the existing portfolio offering from LEO Pharma China,” says Byron Yin, General Manager for LEO Pharma in China..

“有了这些鼓舞人心的临床结果，我们很高兴能够向中国当局提交Enstilar，但我同样高兴的是，我们现在将有望为中国患者提供一种新的牛皮癣治疗选择，除了LEO Pharma China现有的产品组合外，”LEO Pharma中国总经理拜伦·尹表示。。

Professor Zhang Jianzhong from Peking University People's Hospital, the leading principal investigator of this study, states:

这项研究的首席首席研究员、北京大学人民医院的张建中教授表示：

“In China, approximately 7 million patients are affected by this condition2. Topical medications are the basic treatment for psoriasis and are suitable for most patients. As a principal investigator in this study, I am delighted to see that Enstilar has achieved its primary and secondary endpoints in the Phase III clinical trial in Chinese patients, demonstrating superior efficacy to Daivobet with a good safety profile.

“在中国，大约有700万患者受到这种情况的影响2。局部用药是牛皮癣的基本治疗方法，适用于大多数患者。作为这项研究的主要研究者，我很高兴看到Enstilar在中国患者的III期临床试验中实现了其主要和次要终点，证明其优于Daivobet，具有良好的安全性。

I look forward to sharing detailed data from this high-quality study in the near future. I look forward to sharing detailed data from the study soon and hope it will help us provide another treatment option to psoriasis patients in China.”.

我期待着在不久的将来分享这项高质量研究的详细数据。我期待着很快分享这项研究的详细数据，并希望它能帮助我们为中国的牛皮癣患者提供另一种治疗选择。”。

Dual brand trial shows LEO Pharma’s strength in China

双品牌试验显示利奥制药在中国的实力

Enstilar – a calcipotriol/betamethasone cutaneous foam – is an improved formulation of Daivobet ointment, which is one of the current standard treatment options in China for adults living with stable plaque psoriasis.3

Enstilar是一种钙泊三醇/倍他米松皮肤泡沫，是Daivobet软膏的改进配方，是中国目前稳定斑块型银屑病成人的标准治疗选择之一。3

The trial completed recruitment four months ahead of schedule and is a commitment to LEO Pharma’s increasing presence and activities in China.

该试验提前四个月完成了招聘，这是对利奥制药在中国不断扩大业务和活动的承诺。

“The results of this trial are very encouraging for LEO Pharma’s presence in China. Not only do we see superiority in the results, but we also see that both portfolio products were efficacious and well tolerated. This is a key market for LEO Pharma – with dermatology growing rapidly in the country and our revenue steadily increasing through a strong performance from our team in China.

“这项试验的结果对于LEO Pharma在中国的业务非常令人鼓舞。我们不仅看到了结果的优越性，而且还看到这两种组合产品都是有效且耐受性良好的。这是LEO Pharma的关键市场-皮肤病在中国迅速增长，我们在中国团队的出色表现使我们的收入稳步增长。

This trial is a good example of how LEO Pharma is leveraging our deep dermatology knowledge to expand both our innovative and core portfolios in China,” says Becki Morison, Executive Vice President, Global Product Strategy & International Operations for LEO Pharma..

LEO Pharma全球产品战略和国际运营执行副总裁贝基·莫里森（Becki Morison）表示：“这项试验是一个很好的例子，说明了LEO Pharma如何利用我们深厚的皮肤病学知识，扩大我们在中国的创新和核心投资组合。”。。

Following the results, LEO Pharma will proceed with preparations to submit Enstilar for approval with the Chinese authorities.

根据结果，LEO Pharma将继续准备提交Enstilar供中国当局批准。

Detailed results from the Enstilar China trial will be submitted for scientific presentation and publication at a later date. For more information on the Enstilar trial (NCT05919082) go to clinicaltrials.gov.

Enstilar中国试验的详细结果将在晚些时候提交科学报告和发表。有关Enstilar试验（NCT05919082）的更多信息，请访问clinicaltrials.gov。

About Enstilar®

Enstilar®

Enstilar® is an aerosol spray foam containing calcipotriol monohydrate 50 mcg/g and betamethasone dipropionate 0.5 mg/g. In the EU, it is indicated for the treatment of psoriasis vulgaris in adults for up to 4 weeks. Patients who have responded at 4 weeks’ treatment using Enstilar once daily are suitable for long-term maintenance treatment.

Enstilar®是一种气溶胶喷雾泡沫，含有钙泊三醇一水合物50 mcg/g和倍他米松二丙酸盐0.5 mg/g。在欧盟，它适用于治疗成人寻常型银屑病长达4周。每天一次使用Enstilar治疗4周后有反应的患者适合长期维持治疗。

3-6.

3-6.

About Psoriasis

关于牛皮癣

Psoriasis is a chronic, inflammatory skin disease, which is frequently accompanied by multiple physical and/or psychological comorbidities (the presence of one or more additional diseases), such as psoriatic arthritis, diabetes, cardiovascular disease and depression.7 8

银屑病是一种慢性炎症性皮肤病，常伴有多种身体和/或心理合并症（存在一种或多种其他疾病），如银屑病关节炎，糖尿病，心血管疾病和抑郁症

About LEO Pharma

关于LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities.

利奥制药是一家全球性公司，致力于提高护理标准，为皮肤病患者及其家人和社会造福。LEO Pharma成立于1908年，由LEO基金会拥有多数股权。LEO Pharma致力于数十年的研究和开发，以推动皮肤病学的发展。如今，该公司为所有严重疾病提供了广泛的治疗方法。

LEO Pharma is headquartered in Denmark with a global team of 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion..

利奥制药（LEO Pharma）总部位于丹麦，拥有4200人的全球团队，为全球数百万患者提供服务。2023年，该公司净销售额为114亿丹麦克朗。。

References

参考文献

ClinicalTrials.gov: A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis | ClinicalTrials.gov (Accessed May 2024)

ClinicalTrials.gov：一项研究，旨在调查LEO 90100与Daivobet®软膏在中国成年稳定斑块型银屑病患者中的疗效和安全性| ClinicalTrials.gov（2024年5月访问）

Ding, XL et al. Prevalence of psoriasis in China: A population-based study in six cities. European Journal of dermatology: EJD 22(5):663-7

丁，XL等。中国银屑病患病率：六个城市的人群研究。欧洲皮肤病学杂志：EJD 22（5）：663-7

Zhang, XJ et al., Chin J Dermatol, July 2023, Vol. 56, No. 7, Guideline for the diagnosis and treatment of psoriasis in China (2023 edition)

张晓杰等，《中国皮肤病杂志》，2023年7月，第56卷，第7期，《中国银屑病诊治指南》（2023年版）

Enstilar® EU Summary of Product Characteristics July 2022.

Enstilar®欧盟产品特性总结2022年7月。

Koo J, et al. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris—A randomized phase II study. Journal of Dermatological Treatment. 2016;27(2):120-127.

Koo J等人。卡泊三烯和倍他米松二丙酸气雾剂泡沫与软膏在寻常型银屑病患者中的优越疗效-一项随机II期研究。皮肤病治疗杂志。2016年；27（2）：120-127。

Leonardi C, et al. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris—a Randomized Phase III Study (PSO-FAST). J Drugs Dermatol. 2015;14(12):1468-1477.

Leonardi C等人。卡泊三烯联合倍他米松二丙酸气雾剂泡沫治疗寻常型银屑病的疗效和安全性-一项随机III期研究（PSO-FAST）。J药物皮肤病。2015年；14（12）：1468-1477年。

Lebwohl M, et al. Fixed Combination Aerosol Foam Calcipotriene 0.005% (Cal) Plus Betamethasone Dipropionate 0.064% (BD) is More Efficacious than Cal or BD Aerosol Foam Alone for Psoriasis Vulgaris: A Randomized, Double-blind, Multicenter, Three-arm, Phase 2 Study. J Clin Aesthet Dermatol. 2016;9(2):34-41..

Lebwohl M等人。固定组合气雾剂泡沫钙泊三烯0.005%（Cal）加倍他米松二丙酸盐0.064%（BD）比单独使用Cal或BD气雾剂泡沫对寻常型银屑病更有效：一项随机，双盲，多中心，三臂，2期研究。临床皮肤病杂志。2016年；9（2）：34-41。。

National Psoriasis Foundation. Comorbidities associated with psoriatic disease. Available www.psoriasis.org/about-psoriasis/related-conditions. Last accessed May 2024

国家牛皮癣基金会。与银屑病相关的合并症。可从www.psoriasis.org/about-psoriasis/related-conditions获得。上次访问时间为2024年5月

MAT-73304 May 2024

MAT-73304 2024年5月