SHENZHEN, Sept 28, 2025 - (ACN Newswire via SeaPRwire.com) - China Medical System Holdings Limited (“CMS”) is pleased to announce that its subsidiaries, Dermavon Holdings Limited (“Dermavon”, an innovative pharmaceutical company specialized in skin health which is applying for a separate listing on the Main Board of The Stock Exchange of Hong Kong Limited, please refer to the announcement published by CMS on 22 April 2025 for details) together with its subsidiaries, obtained positive results from the phase 3 clinical trial (the “Trial”) of ruxolitinib cream (the “Product”) in patients with mild to moderate atopic dermatitis (AD) in China.The Trial is a randomized, double-blind, placebo-controlled, multi-centre clinical trial, with 192 patients enrolled in total, aiming to evaluate the safety and efficacy of the Product in patients with mild to moderate AD. The leading institution is Shanghai Dermatology Hospital, and the principal investigator is Professor Shi Yuling.The phase 3 clinical trial of ruxolitinib cream in patients with mild to moderate AD in China met its primary endpoint, demonstrating that a significantly higher proportion of patients treated with ruxolitinib cream achieved IGA (Investigator's Global Assessment) of 0 or 1 with at least two grades of reduction from baseline at week 8, compared with placebo (63.0% vs 9.2%, P<0.001). For the key secondary endpoint, the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index score (EASI 75) of treatment with ruxolitinib cream was also significantly higher than placebo, at week 8 (78.0% vs 15.4%, P<0.001). In terms of safety, the severity of treatment-emergent adverse events (TEAE) during the treatment period was mostly mild or moderate, with no TEAEs leading to discontinuation of the study drug. Overall, the ruxolitinib cream was safe and well-tolerated.CMS is actively moving forward the Product’s new drug application (NDA) in China.About ADAD is a chronic, recurrent and inflammatory dermatologic disease, with the main clinical manifestations of dry skin, chronic eczema-like lesions and obvious itching or pruritus, which may seriously affect the quality of life of patients. It is estimated that there are over 54 million AD patients in China by 2024. Based on SCORAD scores, the proportions of mild, moderate, and severe AD in China in 2024 was 73%, 25%, and 2%, respectively[1]. Topical drugs are the most basic treatment for AD. Traditional topical medications such as topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs) have clinical pain points with long-term adverse reactions or limited efficacy, therefore novel treatments are urgently needed.About Ruxolitinib CreamRuxolitinib cream (Opzelura®) is a novel cream formulation made of selective JAK1/JAK2 inhibitor ruxolitinib developed by Incyte (NASDAQ: INCY), which is the first topical JAK inhibitor approved for use in the United States by the U.S. Food and Drug Administration (FDA)[2]. Ruxolitinib cream is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older and for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The Product is also approved in Europe for the treatment of adolescents and adults from 12 years of age with non-segmental vitiligo with facial involvement.The NDA for vitiligo indication of the Product has been accepted by the National Medical Products Administration of China (NMPA). Furthermore, the marketing authorization application have been approved in Hong Kong Special Administrative Region and Macau Special Administrative Region, and the Product was approved by the Guangdong Provincial Medical Products Administration through the “Hong Kong and Macau Medicine and Equipment Connect” policy, which officially introduced ruxolitinib cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age, providing a novel treatment option for patients with relevant indication into designated medical institutions in the Mainland of Greater Bay Area.CMS, through a subsidiary of Dermavon entered into a Collaboration and License Agreement with Incyte for ruxolitinib cream on 2 December 2022, obtaining an exclusive license to develop, register and commercialize the Product in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-exclusive license to manufacture the Product in the Territory. The subsidiary of Dermavon has sublicensed the relevant rights for the Product outside Mainland China to CMS (excluding Dermavon and its subsidiary).Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States and Europe as Opzelura®. Opzelura® and the Opzelura® logo are registered trademarks of Incyte.About CMSCMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries, strengthening the competitiveness of the cardio-cerebrovascular/ gastroenterology/ ophthalmology/ skin health businesses. Among them, the skin health business has become a leading enterprise in its field, bringing economies of scale in specialty therapeutic fields. Meanwhile, CMS continuously deepens its business development in Southeast Asia and the Middle East regions, further escorting the sustainable and healthy development.References:1. China Insights Consultancy’s industrial report2. Drug approval information can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-creamCMS Disclaimer and Forward-Looking StatementsThis press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.Media ContactBrand: China Medical System Holdings Ltd.Contact: CMS Investor RelationsEmail: ir@cms.net.cnWebsite: https://web.cms.net.cn/en/home/ Copyright 2025 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com
深圳，2025年9月28日 - (亚太商讯 via SeaPRwire.com) - 康哲药业控股有限公司（"康哲药业"）欣然宣布，旗下德镁医药有限公司（"德镁医药"，专业聚焦皮肤健康的创新型医药企业，正申请于香港联合交易所有限公司主板独立上市，详见康哲药业日期为2025年4月22日发布的公告）连同其附属公司取得磷酸芦可替尼乳膏（"芦可替尼乳膏"或"产品"）轻中度特应性皮炎（AD）的中国三期药物临床研究（"试验"）积极结果。该试验是一项在中国人群开展的随机、双盲、安慰剂对照、多中心的临床研究，共入组192例患者，旨在评估产品治疗轻中度AD的安全性和有效性。该研究组长单位为上海市皮肤病医院，主要研究者为史玉玲教授。产品用于轻中度特应性皮炎的中国三期临床研究成功达到主要终点，即使用芦可替尼乳膏治疗8周，达到研究者整体评估（IGA）评分为0或1分，且较基线改善≥2分的受试者比例，显著高于安慰剂（63.0% vs 9.2%，P<0.001）。关键次要终点，芦可替尼乳膏治疗8周达到湿疹面积及严重程度指数评分较基线至少改善75%（EASI 75）的受试者比例亦显著优于安慰剂（78.0% vs 15.4%，P<0.001）。安全性方面，治疗期出现的不良事件（TEAE）的严重程度大多数为轻度或中度，未发生导致研究药物用药终止的治疗期出现的不良事件（TEAE），整体安全耐受性良好。康哲药业正积极推进产品在中国的新药上市申请（NDA）工作。关于ADAD是一种慢性、复发性、炎症性的皮肤疾病，临床主要表现为皮肤干燥、慢性湿疹样皮损和明显瘙痒，可能严重影响患者的生活品质。据估算，2024年中国特应性皮炎患者超过5,400万人，基于SCORAD评分，轻度、中度、重度特应性皮炎的占比分别为73%、25%和2%[1]。外用药物是AD最基本的治疗方法。传统外用药物如外用糖皮质激素（TCS）及外用钙调神经磷酸酶抑制剂（TCIs）有长期用药的不良反应或疗效有限的临床痛点，临床亟需新的治疗选择。关于芦可替尼乳膏芦可替尼乳膏（Opzelura(R)）是Incyte（Nasdaq: INCY）开发的选择性JAK1/JAK2抑制剂芦可替尼制成的一种创新型乳膏制剂，是目前经美国食品和药物管理局（FDA）批准的首款局部JAK抑制剂[2]，可用于局部治疗成人及12岁及以上患者的非节段型白癜风，及成人及2岁及以上非免疫力功能低下患者的轻度至中度AD的局部短期和非连续性慢性治疗，这些患者的疾病无法通过局部处方疗法或不被建议的疗法而得到充分控制。产品亦于欧洲获批使用，用于治疗成人及12岁及以上患者伴面部受累的非节段型白癜风。此前，芦可替尼乳膏白癜风适应症新药上市许可申请已获得中国国家药品监督管理局（NMPA）受理。此外，芦可替尼乳膏已于香港特别行政区及澳门特别行政区获批上市，并通过"港澳药械通"政策获得广东省药品监督管理局批准，正式落地粤港澳大湾区内地指定医疗机构，用于治疗成人及12岁及以上患者伴面部受累的非节段型白癜风，为非节段型白癜风适应症患者提供了全新治疗选择。康哲药业于2022年12月2日，通过德镁医药的附属公司与Incyte就芦可替尼乳膏订立合作和许可协议，获得在中国大陆、香港特别行政区、澳门特别行政区、台湾地区及东南亚11国（"区域"）研发、注册及商业化产品的独家许可权利，以及在区域内生产产品的非独家许可权利。德镁医药的附属公司已将芦可替尼乳膏除中国大陆外其他区域的相关权利再许可予康哲药业（不包括德镁医药及其附属公司）。Incyte拥有芦可替尼乳膏全球开发和商业化权利，在美国及欧洲以Opzelura(R)的名称销售。Opzelura(R)和Opzelura(R)标识是Incyte的注册商标。关于康哲药业康哲药业是一家链接医药创新与商业化，把控产品全生命周期管理的开放式平台型企业，致力于提供有竞争力的产品和服务，满足尚未满足的医疗需求。康哲药业专注于全球首创（FIC）及同类最优（BIC）的创新产品，并高效推进创新产品临床研究开发和商业化进程，赋能科研成果向诊疗实践的持续转化，造福患者。康哲药业聚焦专科领域，拥有被验证的商业化能力，广泛的渠道覆盖和多疾病领域专家资源，核心在售产品已获领先的学术与市场地位。康哲药业围绕优势专科领域不断纵深发展，以巩固心脑血管/消化/眼科/皮肤健康业务竞争力，其中皮肤健康业务已成为该细分领域的龙头企业，带来专科规模效率。同时，康哲药业持续深化东南亚及中东区域业务发展，助力高质量持续健康发展。参考文献/资料1. 灼识咨询行业报告2. FDA批准信息可在Incyte官网查询，网址：https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-cream康哲药业免责与前瞻性声明本新闻无意向您做任何产品的推广，非广告用途。本新闻不对任何药品和医疗器械和/或适应症作推荐。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。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。由康哲药业编制的此新闻不构成购买或认购任何证券的任何要约或邀请，不形成任何合约或任何其他约束性承诺的依据或加以依赖。本新闻由康哲药业根据其认为可靠之资料及数据编制，但康哲药业并无进行任何说明或保证、明述或暗示，或其他表述，对本新闻内容的真实性、准确性、完整性、公平性及合理性不应加以依赖。本新闻中讨论的若干事宜可能包含涉及康哲药业的市场机会及业务前景的陈述，该等陈述分别或统称为前瞻性声明。该等前瞻性声明并非对未来表现的保证，存在已知及未知的风险、不明朗性及难以预知的假设。康哲药业并不采纳本新闻包含的第三方所做的任何前瞻性声明及预测，康哲药业对该等第三方声明及预测不承担责任。 Copyright 2025 亚太商讯 via SeaPRwire.com. All rights reserved. www.acnnewswire.com
