CMS (867.HK/8A8.SG): Innovative Drug Oral JAK1 Inhibitor Povorcitinib Has Been Included in the List of Breakthrough Therapeutic Drugs in China

China, 22nd Dec 2025 – China Medical System Holdings Limited (“CMS”, or the “Group”) is pleased to announce that its subsidiary, Dermavon Holdings Limited (“Dermavon”, an innovative pharmaceutical company specialized in skin health which is applying for an independent listing on the Main Board of The Stock Exchange of Hong Kong. Limited, please refer to the announcement of the Company dated 22 April 2025 for details), has obtained the relevant licensing rights to the innovative oral JAK1 inhibitor povorcitinib (proposed English generic name: Povorcitinib Phosphate Tablets) (“povorcitinib” or the “Product”), which has been included in the list of Breakthrough.

Povorcitinib NMPA Breakthrough Status

The Center for Drug Evaluation of the National Medical Products Administration of the People’s Republic of China (“NMPA”) has recognized povorcitinib as a Breakthrough Therapeutic Drug for adult patients with non-segmental vitiligo. This designation could accelerate the product’s development and review process.

Povorcitinib is a selective oral small-molecule JAK1 inhibitor. It holds compound and use patents in certain countries within the Territory. Currently, povorcitinib is in Phase 3 trials for non-segmental vitiligo, moderate to severe hidradenitis suppurativa (HS), and prurigo nodularis outside China. Additionally, a Phase 2 trial for asthma treatment is ongoing.

In March 2023, Incyte reported that povorcitinib met the primary endpoint in a global Phase 2b trial for non-segmental vitiligo. After 24 weeks, patients receiving daily doses experienced significant total body repigmentation compared with vehicle. Extended results showed further improvement in total body and facial repigmentation, with a favorable tolerability profile.

Clinical Development In China

In August 2025, Dermavon received approval from NMPA to conduct clinical trials for povorcitinib in non-segmental vitiligo and other indications. Dermavon has begun its clinical development in China and may expand trials to treat HS and prurigo nodularis in the future.

Vitiligo is a chronic autoimmune disease causing depigmentation due to melanocyte loss. China has an estimated 10.3 million vitiligo patients, including 8.2 million with non-segmental vitiligo. Current treatments are limited, particularly for moderate to severe cases.

If approved, povorcitinib could offer a differentiated treatment for non-segmental vitiligo patients. The Breakthrough Therapeutic Drugs designation may accelerate its review in mainland China. The product could complement Dermavon’s ILUMETRI, Hirudoid, and ruxolitinib phosphate cream, supporting faster clinical and commercial impact.

Licensing And Market Potential

If approved, povorcitinib with topical ruxolitinib phosphate cream will provide comprehensive and differentiated treatment options for vitiligo.

Dermavon’s subsidiary signed a Collaboration and License Agreement with Incyte on 31 March 2024. This agreement grants an exclusive license to research, develop, register, and commercialize povorcitinib in Mainland China, Hong Kong, Macao, Taiwan, and eleven Southeast Asian countries. The license also includes non-exclusive manufacturing rights in the Territory.

The subsidiary has sublicensed relevant rights outside Mainland China to the Group, excluding Dermavon and its subsidiaries.

About CMS

CMS links pharmaceutical innovation with commercialization, offering strong product lifecycle management. The company provides competitive products and services to meet unmet medical needs.

CMS focuses on global first-in-class (FIC) and best-in-class (BIC) innovations. It efficiently promotes clinical research, development, and commercialization, turning scientific research into clinical practice to benefit patients.

CMS engages in specialty therapeutic fields, leveraging proven commercialization capabilities, expert networks, and market presence. Its skin health business (Dermavon) leads the field and is proposed for independent SEHK listing. The Group also develops its integrated R&D, manufacturing, and commercialization chain in Southeast Asia and the Middle East, capturing emerging market opportunities.

Reference：

1. Results from a global multi-center Phase 2b clinical trial of the product for non-segmental vitiligo indication can be found on the Incyte official website: https://investor.incyte.com/news-releases/news-release-details/incyte-announces-data-phase-2b-study-evaluating-povorcitinib
2. Datas are from the China Insights Consultancy (CIC) report

Company Details

Organization: China Medical System Holdings Ltd.

Contact Person: CMS Investor Relations

Website: https://web.cms.net.cn/en/home/

Email: Send Email

Country: China

Release Id: 22122539399