Roflumilast

近日，华东医药全资子公司杭州中美华东制药有限公司（简称“中美华东”）获得创新皮肤外用制剂0.3%罗氟司特乳膏（ZORYVE®）中国斑块状银屑病Ⅲ期临床试验的顶线数据。初步结果表明，0.3%罗氟司特乳膏（ZORYVE®）在中国6岁及以上的斑块状银屑病患者中表现出积极的疗效和良好的安全性，达成研究主要终点。本研究为一项多中心、随机、双盲、赋形剂对照的Ⅲ期临床研究，以评估每日一次0.3%罗氟司特乳膏在≥6岁中国斑块状银屑病受试者中的有效性、安全性和PK特征。研究由北京大学人民医院的张建中/周城教授牵头，在全国31家临床中心开展，实际入组190例受试者，其中试验组128例，赋形剂组62例。近日，该研究已完成了顶线分析。主要终点是第8周达到研究者总体评估（IGA）治疗成功的受试者比例，治疗组为38.8%，赋形剂组为10.3%(P<0.0001)。IGA成功定义为评分为“0”或“1”分且较基线改善≥2分。次要终点指标：治疗8周的银屑病皮损面积与严重程度指数（PASI）-75（即PASI较基线期降低≥75%）达标率，治疗组为43.6%，赋形剂组为7.0%(P<0.0001)。此外，其他次要终点指标包括间擦区域研究者总体评估（I-IGA）、最严重瘙痒-数字评分 (WI-NRS)等，治疗8周后治疗组均显著优于赋形剂组。研究结果显示，0.3%罗氟司特乳膏（ZORYVE®）在受试者中安全性、耐受性良好，整体安全性特征与合作方Arcutis Biotherapeutics公司海外研究数据类似，没有发生治疗相关的严重不良事件（SAE），未发现新增安全性信号。本次0.3%罗氟司特乳膏中国斑块状银屑病适应症的Ⅲ期临床达到主要研究终点，是该系列产品研发进程中的重要里程碑，将进一步提升公司在自身免疫领域和皮肤外用制剂领域的核心竞争力。公司正积极准备递交该适应症的中国上市申请。关于ZORYVE®ZORYVE®乳膏是由Arcutis Biotherapeutics, Inc.开发，中美华东于2023年引进的创新皮肤外用制剂，中美华东拥有该产品在大中华区及东南亚的独家许可，包括开发、注册、生产及商业化权益。ZORYVE®乳膏的活性成分Roflumilast（罗氟司特）是一种磷酸二酯酶-4（PDE4）抑制剂。PDE4作为一种细胞内酶，可增加促炎介质的生成并减少抗炎介质的生成，抑制PDE4可减轻炎症反应。同时，0.15%罗氟司特乳膏中国轻度至中度特应性皮炎适应症Ⅲ期临床试验已完成全部随访，即将取得研究数据。声明1、本新闻旨在分享公司（或合作伙伴）研发工作的前沿进展资讯，非广告用途，相关信息并非针对患者，仅供医疗卫生专业人士参考使用；2、本新闻稿中内容不涉及对任何药品和/或适应症作推荐；3、本新闻稿中涉及的信息仅供参考，具体信息以公司在深圳证券交易所发布的文件为准。公司新闻稿和公告不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导；4、截至本文发布，ZORYVE®（罗氟司特）尚未被国家药品监督管理局批准上市；5、本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

The American Academy of Dermatology (AAD) provided evidence-based recommendation for the use of ZORYVE® (roflumilast) cream 0.15% in adults with mild to moderate atopic dermatitis (AD) Recommendation reflects ZORYVE’s proven efficacy, safety, and tolerability as a next-generation, steroid-free, topical phosphodiesterase-4 (PDE4) inhibitor Among newly evaluated branded topical therapies, ZORYVE is the only treatment with a strong recommendation for adults with mild to moderate atopic dermatitis in AAD’s focused guideline update ZORYVE is the first FDA-approved branded topical PDE4 inhibitor indicated for AD, plaque psoriasis, and seborrheic dermatitis AD impacts over 16 million adults in the United States WESTLAKE VILLAGE, Calif, June 26, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, today announced that ZORYVE® (roflumilast) cream 0.15% has received a strong recommendation in the focused guideline update for the management of adult AD from AAD. The recommendation highlights ZORYVE’s ability to deliver clinically meaningful improvements in pruritus and disease severity, its favorable tolerability profile, and low rates of treatment discontinuation, offering adults and pediatric patients 6 years of age and older with mild to moderate AD an effective, non-steroid option for daily disease management. “The AAD’s focused update highlights therapies that meet rigorous standards for efficacy, safety, and tolerability for adults living with AD,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “The inclusion of ZORYVE in these recommendations validates what healthcare professionals have already experienced with ZORYVE in their practice – a next-generation, steroid-free topical that delivers meaningful improvement for people with AD. It marks important progress in providing individuals with AD and their healthcare providers evidence-based choices that are suitable for all areas, including sensitive and hard-to-treat areas of the body.” The AAD’s strong recommendation helps guide clinicians and patients toward treatments that deliver clinically meaningful improvements in disease severity while being safe and well tolerated for long-term use. The focused update incorporates newly Food and Drug Administration (FDA)-approved topical and biologic therapies into existing guidelines to ensure that the dermatology community has access to the most current, evidence-based recommendations for managing this chronic condition. For more information on ZORYVE, including full prescribing information, please visit www.zoryve.com. About Atopic DermatitisAD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. AD is a chronic, relapsing, and genetically predisposed inflammatory skin disease that has unique clinical presentations across the lifespan. The disease typically appears as a red, intensely itchy rash that can occur anywhere on the body. It presents differently in infants, children, and adults. About ZORYVE® (roflumilast) ZORYVE is the first and only branded topical therapy for three major inflammatory dermatoses — AD, seborrheic dermatitis, and plaque psoriasis. ZORYVE is a next generation topical PDE4 inhibitor. PDE4, an established target in dermatology, is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. ZORYVE (roflumilast) cream 0.3% is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. ZORYVE (roflumilast) cream 0.15% is approved by the FDA for the topical treatment of mild to moderate AD in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Eczema Product.” ZORYVE (roflumilast) topical foam 0.3% is uniquely formulated for use anywhere on the body, including hair-bearing areas, and is indicated for treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, as well as seborrheic dermatitis in patients 9 years of age and older. Recently, both ZORYVE cream 0.3% and ZORYVE foam 0.3% were awarded the National Psoriasis Foundation’s Seal of Recognition —the first FDA-approved product to receive the honor. Investigational ZORYVE (roflumilast) cream 0.05% for the topical treatment of mild to moderate AD in children 2 years to 5 years old is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025. INDICATIONS ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for plaque psoriasis include headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam. About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including AD and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for ZORYVE cream 0.15% as a treatment for adult AD patients. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts Media Amanda Sheldon, Head of Corporate Communications media@arcutis.com Investors Brian Schoelkopf, Head of Investor Relationsir@arcutis.com