Ruxolitinib phosphate cream is the first and only targeted drug approved in China for the treatment of vitiligo, bringing new hope to millions of vitiligo patients in China and marking a significant milestone.

Both overseas Phase III clinical trials of the product for the treatment of vitiligo met their primary endpoints: after 24 weeks of treatment, the proportion of patients with F-VASI 75 was 29.9%, significantly higher than the 7.5% and 12.9% in the placebo group. Continued use up to 52 weeks showed sustained repigmentation.

Furthermore, real-world studies in China also showed positive efficacy, consistent with the results of pivotal clinical studies abroad; all secondary efficacy endpoints in both domestic and international clinical studies showed a benefit trend consistent with the primary efficacy endpoint, and the treatment effect continued to improve with the extension of treatment duration.

This approval will further enrich Demag Pharmaceuticals' product portfolio and is expected to create synergies with its existing product mix, enhancing its position in the skin health field.

Kangzhe Pharmaceutical Holdings Limited (“Kangzhe Pharmaceutical” or the “Group”) is pleased to announce that its subsidiary, DeMei Pharmaceuticals Limited (“DeMei Pharmaceuticals”, an innovative pharmaceutical company focusing on skin health, currently applying for a separate listing on the Main Board of the Hong Kong Stock Exchange, see the Group’s announcement dated April 22, 2025), received approval from the National Medical Products Administration (NMPA) of China on January 30, 2026 for its New Drug Application (NDA) for ruxolitinib phosphate cream (for vitiligo) (the “Product”). The Product is indicated for the treatment of non-segmental vitiligo with facial involvement in children aged 12 years and older and adult patients. It is the first and only targeted therapy approved in China for the treatment of vitiligo, meeting a significant unmet clinical need.

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Ruxolitinib phosphate cream is the first and only drug approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for repigmentation of non-segmental vitiligo [1,2] . Prior to the formal NDA approval of the product, the Group benefited from the "first-mover advantage" policy, the "Hong Kong and Macao Drug and Medical Device Access" policy, and the clinically urgently needed imported drug policy of the Beijing and Tianjin Free Trade Zones, and had launched a pilot application of ruxolitinib phosphate cream. Currently, Boao Super Hospital has prescribed ruxolitinib phosphate cream to more than 7,000 patients with non-segmental vitiligo, and more than 20 hospitals in Guangzhou, Shenzhen, Dongguan, Foshan, Zhongshan, Zhuhai, Jiangmen, Huizhou, Beijing and Tianjin have provided prescription services for this drug, demonstrating its clinical value.

The product has shown positive results in both overseas clinical studies and real-world studies in China: In two phase III double-blind, randomized, placebo-controlled studies (TRuE-V1 and TRuE-V2) with the same design conducted overseas, the proportion of patients who achieved at least a 75% improvement in the primary efficacy endpoint of facial vitiligo area score index (F-VASI 75) after 24 weeks of treatment with the product was 29.9%, which was significantly higher than 7.5% and 12.9% in the placebo group. The repigmentation effect continued for up to 52 weeks [3] . According to the relevant regulations of the pilot project for the application of real-world data of drugs in the Lecheng Pilot Zone, ruxolitinib phosphate cream was studied in China and showed positive efficacy, which was consistent with the results of key clinical studies overseas. All secondary efficacy endpoints in domestic and overseas clinical studies showed a benefit trend consistent with the primary efficacy endpoint, and the treatment effect of vitiligo continued to improve with the extension of the treatment course. At the same time, according to the safety monitoring data of the Lecheng Pilot Zone, no new safety events were found, no adverse events (AEs) leading to discontinuation or withdrawal occurred, and no serious adverse events (SAEs) related to the study drug occurred.

The approval of this product for vitiligo treatment will bring new hope to millions of vitiligo patients in China and meet the urgent clinical needs of the market. At the same time, the product will further enrich Demag Pharmaceuticals' product portfolio in the field of skin treatment and is expected to synergize with existing commercialized innovative drugs such as Yiluqu (tirekizumab injection), the proprietary drug Hirudoid (mucopolysaccharide polysulfate cream), as well as a series of investigational innovative drugs and dermatological-grade skincare products, in terms of expert networks and market resources, thereby enhancing Demag Pharmaceuticals' position in the field of skin health.

Furthermore, the Group's Phase III clinical trial in China of ruxolitinib phosphate cream for the treatment of mild to moderate atopic dermatitis has yielded positive results. Currently, the Group is actively pursuing a new drug application for ruxolitinib phosphate cream for the treatment of atopic dermatitis in China. If approved, it will provide a new treatment option for the vast population of atopic dermatitis patients in China.

Indications for vitiligo

Vitiligo is a chronic autoimmune disease characterized by loss of skin pigmentation, caused by the absence of pigment-producing cells, namely melanocytes. It is estimated that about 10.3 million people in China suffer from vitiligo, of which about 8.2 million suffer from non-segmental vitiligo [4] . Existing treatments, such as topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs), have clinical defects, with adverse reactions or limited efficacy with long-term use. The NDA approval of ruxolitinib phosphate cream successfully filled the gap in targeted drug treatment for vitiligo and has significant landmark significance.

More information about ruxolitinib phosphate cream

Ruxolitinib phosphate cream (Opzelura® ) is an innovative cream formulated with ruxolitinib, a selective JAK1/JAK2 inhibitor developed by Incyte. In the United States, it is approved for the topical treatment of non-segmental vitiligo in adults and patients aged 12 years and older, and for the short-term and intermittent chronic treatment of mild to moderate atopic dermatitis in patients aged 2 years and older without immunodeficiency. In Europe, ruxolitinib phosphate cream is approved for the treatment of non-segmental vitiligo affecting the face in adults and adolescents aged 12 years and older.

On December 2, 2022, the Group, through a subsidiary of Demag Pharmaceuticals, entered into a collaboration and licensing agreement (the “License Agreement”) with Incyte for ruxolitinib phosphate cream, obtaining exclusive license rights to research, register, and commercialize the product in Mainland China, Hong Kong SAR, Macao SAR, Taiwan, and eleven Southeast Asian countries (the “Regions”), as well as a non-exclusive license right to manufacture the product in the Regions. Demag Pharmaceuticals’ subsidiary has sublicensed the relevant rights to ruxolitinib phosphate cream in other Regions outside Mainland China to the Group (excluding Demag Pharmaceuticals and its subsidiaries).

Incyte owns the global rights to develop and commercialize ruxolitinib phosphate cream, which is sold in the United States and Europe under the name Opzelura® . Opzelura® and the Opzelura® logo are registered trademarks of Incyte.

About Kangzhe Pharmaceutical

About CMS

Kangzhe Pharmaceutical is an open platform company that links pharmaceutical innovation and commercialization and controls the entire product lifecycle. It is committed to providing competitive products and services to meet unmet medical needs.

Kangzhe Pharmaceutical focuses on first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, empowering the continuous transformation of scientific research results into clinical practice and benefiting patients.

Kangzhe Pharmaceutical focuses on specialized medical fields, possessing proven commercialization capabilities, extensive channel coverage, and expert resources across multiple disease areas. Its core products have achieved leading academic and market positions. Kangzhe Pharmaceutical continues to deepen its development in its advantageous specialized fields to solidify its competitiveness in cardiovascular, gastroenterology, ophthalmology, and dermatology, bringing economies of scale and efficiency to these areas. Its dermatology business (Demag Pharmaceuticals) has become a leading enterprise in its segment and plans to list independently on the Hong Kong Stock Exchange. Simultaneously, Kangzhe Pharmaceutical continues to promote the operation and development of its entire R&D, production, and sales value chain in Southeast Asia and the Middle East to capture incremental growth in emerging markets and contribute to the Group's high-quality and sustainable development.
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