Cisen Pharmaceutical: Ruxolitinib Phosphate Cream (Bai Lu Tuo®) has been prescribed for the first time to patients with vitiligo in multiple regions across China
On March 12, 2026, Cisen Pharmaceutical Co., Ltd. ('Cisen Pharmaceutical') is pleased to announce that its subsidiary, Dermag Therapeutics Co., Ltd. ('Dermag Therapeutics,' an innovative pharmaceutical company specializing in skin health and currently applying for a separate listing on the Main Board of the Hong Kong Stock Exchange), has issued the first prescriptions of its innovative prescription drug Ruxolitinib Phosphate Cream (Bai Lu Tuo®) ('the product,' marketed as Opzelura® in the US, Europe, and Canada) to vitiligo patients across 30 provincial administrative regions nationwide. The product is available in over a thousand influential public and private medical institutions in the fields of skin health and disease management, including Huashan Hospital Affiliated with Fudan University, Shanghai Skin Disease Hospital, Dermatology Hospital of Southern Medical University, Chengdu Second People's Hospital, Bethune First Hospital of Jilin University, Xiangya Second Hospital of Central South University, and United Family Healthcare Group*. It is also accessible at more than 1,300 offline pharmacies and simultaneously via JD.com’s e-commerce platform.
*The ranking of hospitals is not in any particular order
Ruxolitinib Phosphate Cream is the first topical JAK inhibitor approved in China for the treatment of vitiligo. Today marks the official start of the product's large-scale clinical application, signifying a breakthrough in the field of vitiligo treatment in China, ushering in a new era of precision-targeted therapy. With safety and efficacy fully validated through clinical trials, the product will bring renewed hope to millions of vitiligo patients seeking repigmentation.
The rapid commercialization progress of Ruxolitinib Phosphate Cream not only demonstrates Cisen Pharmaceutical's exceptional product operation capabilities but also fully reflects the strong support from national pharmaceutical policy reforms in accelerating patient access to urgently needed innovative drugs. Benefiting from the integrated advantages of Hainan Free Trade Port's healthcare industry and the 'Clinical Urgent Import' policy, the product was first used clinically at Boao Super Hospital within the Boao Lecheng International Medical Tourism Pilot Zone in August 2023. Subsequent pilot applications gradually expanded to designated medical institutions in the Guangdong-Hong Kong-Macao Greater Bay Area, Beijing-Tianjin region, and other areas. Supported by procedures related to China’s real-world data application pilots for pharmaceuticals, as well as by the Hainan Provincial Drug Administration and the Boao Lecheng International Medical Tourism Pilot Zone Administration, the product accumulated real-world clinical data through ‘pilot-first’ clinical applications. This greatly accelerated the clinical development, registration, and approval process, leading to the successful acquisition of the Drug Registration Certificate on January 30, 2026 (with an approval date of January 27, 2026).
Since its approval, it took less than 1.5 months (including the Spring Festival holiday) for ruxolitinib phosphate cream to achieve the first batch of prescriptions in multiple hospitals across the country. This is also the result of the efficient collaboration and joint efforts of various departments of ChemShine Pharma, relevant regulatory authorities, and partners. Under the strong guarantee of the inter-departmental cooperation mechanism of the Joint Management Committee of Beijing Daxing Airport Economic Zone, within 24 hours of meeting import conditions, the product completed customs clearance approval, drug sampling, and customs procedures, and obtained the drug inspection report within seven working days, showcasing the highly efficient and pragmatic 'China Innovative Drug Acceleration.' During this process, the Beijing Municipal Medical Products Administration proactively provided full-process guidance on commercial-scale batch policies, while the government service center efficiently completed customs clearance filing. The Beijing Institute for Drug Control ensured rapid progress by conducting pre-methodology pre-inspection, establishing a special channel for innovative drugs, and continuously operating during the Spring Festival. Daxing Airport Customs provided specialized guidance on drug declaration elements in advance, swiftly completing customs declaration review and drug release. All parties worked in synergy with parallel processes, jointly pressing the 'fast-forward button' for the launch of ruxolitinib phosphate cream, helping this urgently needed innovative drug reach a wide range of patients.
As the product enters the stage of large-scale clinical application, it will further strengthen Dermai Healthcare's comprehensive solutions for skin diseases and enhance its brand value. Leveraging its leading position in the field of skin health, Dermai Healthcare will continue to promote the benefits of ruxolitinib phosphate cream for more vitiligo patients, steadfastly protecting public skin health with innovative strength.
About Vitiligo
Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin, caused by the loss of melanocytes, the pigment-producing cells. Depigmented areas typically expand over time and can affect any part of the skin, impacting the patient’s appearance, especially prominent areas such as the face and neck. According to a study involving over 1,000 diagnosed vitiligo patients, more than 45% had facial involvement, and over 20% had neck involvement[1]. The conspicuous presence of white patches can lead patients to feel their appearance is compromised, significantly affecting their social activities and resulting in a marked increase in the incidence of mental health disorders. Thus, there is an urgent need for vitiligo treatment[2].
It is estimated that about 10.3 million people in China suffer from vitiligo, among which approximately 8.2 million have non-segmental vitiligo[1]. Current therapies, such as topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs), have clinical limitations, with long-term use associated with adverse effects or limited efficacy. Ruxolitinib phosphate cream successfully fills the gap in targeted drug treatments for vitiligo, marking a significant milestone.
More information about Lurcatinib phosphate cream
Ruxolitinib phosphate cream (Opzelura®) is an innovative cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib. It is the first and only drug approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for repigmentation in non-segmental vitiligo[3,4]. In the United States, the product is approved for the topical treatment of non-segmental vitiligo in adults and children aged 12 years and older; and for short-term and non-continuous chronic topical treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children aged 2 years and older and adults when other topical medications are not well-controlled or advisable. In Europe, ruxolitinib phosphate cream is approved for the topical treatment of non-segmental vitiligo with facial involvement in adults and adolescents aged 12 years and older. In China, apart from the vitiligo indication, the product's indication for mild to moderate AD in children aged 2 years and older and adults is currently under NDA review, and this NDA has been included in the priority review list, potentially accelerating the product's AD indication market approval process.
On December 2, 2022, ChemShine Pharma, through a subsidiary of Dermai Healthcare, entered into a collaboration and license agreement (“License Agreement”) with Incyte for ruxolitinib phosphate cream, obtaining exclusive rights to research, register, and commercialize the product in mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, Taiwan region, and eleven Southeast Asian countries (“Region”), as well as non-exclusive rights to manufacture the product within the region. A subsidiary of Dermai Healthcare has sublicensed the rights related to ruxolitinib phosphate cream in regions outside mainland China to ChemShine Pharma (excluding Dermai Healthcare and its subsidiaries).
Incyte holds global development and commercialization rights to ruxolitinib phosphate cream (excluding exclusively licensed regions) and markets it under the name Opzelura® in the US and Europe. Opzelura® and the Opzelura® logo are registered trademarks of Incyte.
About China Medical System Holdings
Cisen Pharmaceutical is an open platform enterprise that links pharmaceutical innovation with commercialization, managing the entire lifecycle of products. It is committed to providing competitive products and services to meet unmet medical needs.
Cisen Pharmaceutical focuses on First-in-Class (FIC) and Best-in-Class (BIC) innovative products and efficiently advances clinical research, development, and commercialization processes for innovative products. By empowering the continuous transformation of research achievements into clinical practice, it benefits patients.
Pharmaceutical Company A focuses on specialized fields, possessing proven commercialization capabilities, extensive channel coverage, and expert resources across multiple disease areas. Its core products already hold leading academic and market positions. The company continues to deepen its presence in key specialized areas such as cardio-renal metabolism, gastroenterology, ophthalmology, and skin health, strengthening its competitive edge. Its skin health business (Company B) has become a leader in its niche and is preparing for an independent listing on the stock exchange. Meanwhile, Pharmaceutical Company A actively promotes the entire industry chain, including R&D, production, and sales, expanding into Southeast Asia and the Middle East to capture incremental growth in emerging markets and support the group’s high-quality sustainable development.
References/Resources
1. Data sourced from CIC Report
2. Wang G, Qiu D, Yang H, Liu W. The prevalence and odds of depression in patients with vitiligo: a meta-analysis[J]. Journal of the European Academy of Dermatology and Venereology, 2018,32(8):1343-1351. DOI:10.1111/jdv.14739.
3. FDA approval information can be found on Incyte's official website at:
1. EMA approval information can be found on Incyte's official website at:
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