China Medical System’s Innovative Drug Highly Selective TYK2 Inhibitor CMS-D001 is Approved for Drug Clinical Trials for Systemic Lupus Erythematosus

Date:
2026-09-14
Category:
Company News
  • CMS-D001 is an oral highly selective TYK2 inhibitor. Compared with pan-JAK inhibitors, it has less impact on other JAK family kinases,and, is expected to lower safety risks while maintaining efficacy. Compared with marketed injectable biologics, it offers the advantages of oral administration and no risk of anti-drug antibody formation, providing potential treatment convenience for patients.

 

  • If approved, CMS-D001 will provide a new treatment option for patients with SLE in Chinaand create strong synergies with innovative drugs such as Metoject, further enhancing the Group’s competitiveness in the field of autoimmune diseases.

 

China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that, on 11 September 2026, the innovative drug CMS-D001 Tablets (“CMS-D001” or the “Product”) has been granted the Drug Clinical Trial Approval Notice by the National Medical Products Administration of the People’s Republic of China (“NMPA”). The approval notice was obtained on 14 September 2026. The NMPA grants consent to conduct clinical trials evaluating the safety and efficacy of CMS-D001 for the treatment of systemic lupus erythematosus.

 

About 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, thereby inhibiting the pathological process of autoimmune diseases. CMS-D001 can reduce the impact on other JAK family kinases and reduce adverse effects while maintaining efficacy.

 

About Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosus (“SLE”) is a chronic autoimmune disease that can affect multiple organs, including the skin, joints, kidneys, blood and nervous system. The disease alternates between remission and relapse and can cause irreversible damage to vital organs. According to the China Systemic Lupus Erythematosus Development Report 2020 and the 2009–2019 registry study of the Chinese SLE Treatment and Research Group, there are approximately one million people with SLE in the Chinese mainland[1], with nearly 200,000 new cases annually. Moderate to severe cases account for 32.6% of patients, and the 25- to 30-year survival rate is below 30%[2-4]. Currently available treatments for SLE include glucocorticoids, antimalarial drugs (such as hydroxychloroquine), conventional immunosuppressants (such as cyclophosphamide) and biologics (such as belimumab). However, disease relapse, cumulative organ damage and the risk of infection remain major challenges, underscoring the urgent clinical need for safer and more effective treatment options[5-6].

 

Focusing on Unmet Clinical Needs, Continuously Expanding High-Quality In-house R&D Pipeline

As a highly selective TYK2 inhibitor, CMS-D001 has less impact on other JAK family kinases than pan-JAK inhibitors, allowing it to maintain efficacy in long-term disease control while reducing related safety risks. Compared with marketed injectable biologics, orally administered CMS-D001 offers the advantages of better patient adherence and no risk of anti-drug antibody formation. If approved for marketing, CMS-D001 will provide a new treatment option for patients with SLE in China. It will also synergize with the Group’s marketed products, such as the innovative drug Metoject (Methotrexate Injection), by leveraging the Group’s existing expert network and market resources in rheumatology and autoimmune diseases, collectively enhancing the Group’s competitiveness and market position in this field.

 

CMS-D001 is self-developed by the Group’s subsidiary, Dermavon Holdings Limited (“Dermavon”). CMS-D001 was granted approval for drug clinical trials for the indications of psoriasis, atopic dermatitis, ulcerative colitis and Crohn’s disease. Phase II clinical trials for the psoriasis and atopic dermatitis indications are currently ongoing. Dermavon has exclusively licensed the relevant rights relating to SLE and inflammatory bowel disease (including but not limited to the ulcerative colitis and Crohn’s disease indications) to the Group (excluding Dermavon).

 

The Group has consistently positioned in-house R&D as the core driver of long-term value growth. Currently, six self-developed products have entered the clinical stage, including CMS-D001 (TYK2 inhibitor), CMS-D002 (GnRH receptor antagonist) and CMS-D008 (INHBE inhibitor), while over 20 self-driven R&D projects are steadily advancing through preclinical research, further strengthening the Group’s innovative asset reserves. Going forward, the Group will continue to focus on unmet clinical needs in specialty areas, continuously enhance clinical development efficiency and accelerate the translation and value realization of its in-house R&D pipeline, enabling innovative solutions to benefit a broad range of patients sooner.

 

Reference:

  1. Xinping T, Mengtao L, Xiaofeng Z. Seeking Possible Solutions from the Current Status of Diagnosis and Treatment of Systemic Lupus Erythematosus in China — Insights from the China Systemic Lupus Erythematosus Development Report 2020.Med J PUMCH.2022,13(2):169-173.
  2. Zhanyun D, Haiye C. 2025 Chinese guidelines for the Diagnosis and Treatment of Systemic Lupus Erythematosus.Journal of Diagnostics Concepts & Practice.2025,24(6):613-620.
  3. Li M, Wang Y, Zhao J, et al.Chinese SLE Treatment and Research Group (CSTAR) Registry 2009-2019: Major Clinical Characteristics of Chinese Patients with Systemic Lupus Erythematosus.Rheumatol Immunol Res. 2021 Apr 13;2(1):43-47.
  4. Xin Z, Shengnan Z, Xuebing F. Current Status and Challenges in the Diagnosis and Treatment of Systemic Lupus Erythematosus in China.Journal of Diagnostics Concepts & Practice.2024,23(3):257-262.
  5. Fanouriakis A, Tziolos N, Bertsias G, et al.Update on the diagnosis and management of systemic lupus erythematosus. Ann Rheum Dis. 2021 Jan;80(1):14-25.
  6. Rodziewicz M, Dyball S, Lunt M, et al, British Isles Lupus Assessment Group Biologics Register (BILAG-BR) consortium. Early infection risk in patients with systemic lupus erythematosus treated with rituximab or belimumab from the British Isles Lupus Assessment Group Biologics Register (BILAG-BR): a prospective longitudinal study. Lancet Rheumatol. 2023 May;5(5):e284-e292.

 

CMS Disclaimer and Forward-Looking Statements

This 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.