China Medical System Holdings Limited (the “Group” or “CMS”) is pleased to announce that innovative drug CMS-D001 tablets (“CMS-D001”) self-developed by 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 the Group on 22 April 2025 for details) together with its subsidiaries, has been granted approval for drug clinical trials by National Medical Products Administration of the People’s Republic of China (“NMPA”) on 11 July 2025. The NMPA grants the consent to conduct a clinical trial evaluating the safety and efficacy of CMS-D001 for the treatment of atopic dermatitis (AD).
CMS-D001
CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor. TYK2 is a member of the JAK kinase family, which is an important component in immune cell signaling. CMS-D001 specifically inhibits the activation of TYK2 and blocks cell signal transduction mediated by inflammatory cytokines such as IL-23, IL-12 and Type I interferons[1], thereby inhibiting the pathological processes of autoimmunity and inflammation. Selective TYK2 inhibitors can reduce the impact on other JAK family kinases and reduce adverse effects while maintaining efficacy[2]. Previously, CMS-D001 was granted approval for drug clinical trials by NMPA on 18 January 2024 and Dermavon is steadily advancing the Phase I clinical study for the indication of psoriasis. Recently, CMS-D001 has once again received approval from the NMPA for clinical trials, expanding the scope of indications to AD. In addition to psoriasis and AD, CMS-D001 is also planned to be developed for the treatment of immune-inflammatory diseases such as systemic lupus erythematosus[3] in the future.
AD 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[4], which may seriously affect the quality of life of patients. In 2017, a sampling survey conducted across 31 provinces in China found that the prevalence rate of AD adults in the country was 2.42%[5], that is, 33.88 million people. Currently, the marketed systemic therapeutic drugs for AD include oral antihistamines, immunosuppressants (such as cyclosporine, azathioprine, etc.) and glucocorticoids[6] which generally have problems such as insufficient convenience, efficacy or safety, therefore novel treatments are urgently needed.
Preclinical study data suggests that CMS-D001 is expected to become an oral drug with reliable efficacy and good safety, providing patients with better treatment options. CMS-D001 will synergize with Dermavon’s products in the field of skin health in terms of team, expert network and market resources. It will form a multi-dimensional portfolio with Dermavon’s products for AD indications, such as under development products innovative drug ruxolitinib cream, the long-acting anti-IL-4Rα monoclonal antibody MG-K10 and the marketed dermatology-grade skincare products of Heling soothing product series. This portfolio aims to meet the diverse treatment and care needs of patients with skin diseases. Dermavon is actively preparing for initiating the relevant clinical trials and strives to launch the Product as soon as possible.
Reference
- Schwartz DM, et al. Nat Rev Drug Discov. 2017 Dec;16(12):843-862
- Krueger JG, et al. J Am Acad Dermatol. 2022 Jan;86(1):148-157
- Banerjee S, et al. Drugs. (2017) 77:521–46
- Chinese Society for Dermatology and Venereology, Immunology Group. Chinese Guideline for Diagnosis and Treatment of Atopic Dermatitis (2020) [J]. Chinese Journal of Dermatology, 2020, 53(2): 81-88.
- Mao D, Li J, Liu S, et al. Prevalence and risk factors of atopic dermatitis in Chinese adults: a nationwide population-based cross-sectional study. Chin Med J (Engl). 2023;136(5):604-606.
- China Dermatologist Association, Chinese Society of Dermatology, Dermatology Branch of China International Exchange and Promotive Association for Medical and Health Care, et al. Expert consensus on the application and management of therapeutic drugs for atopic dermatitis(2024) [J]. Chinese Journal of Dermatology, 2024, 57(02): 97-108.
CMS Disclaimer and Forward-Looking Statements
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