China Medical System’s Innovative Drug Highly Selective TYK2 Inhibitor CMS-D001 is Approved for Drug Clinical Trials for Ulcerative Colitis and Crohn’s Disease

Date:
2026-05-26
Category:
Company News

 

  • CMS-D001 is an oral highly selective TYK2 inhibitor. It can reduce the impact on other JAK family kinases, and is expected to lower safety risks while maintaining efficacy.

 

  • Currently, no TYK2 inhibitor has been approved globally for the indications of ulcerative colitis and Crohn’s disease. CMS-D001 proactively positions in the gastroenterologytherapeutic area, and is expected to become an emerging oral therapy for ulcerative colitis and Crohn’s disease; it can synergise with the Group’s marketed products Salofalk and the exclusive product Bioflor, strengthening whole-cycle, whole-disease-course management of intestinal diseases, and enhancing the Group’s competitive position in the gastroenterology therapeutic area.

 

China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that, on 22 May 2026, the innovative drug highly selective TYK2 (tyrosine kinase 2) inhibitor 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 was obtained on 25 May 2026. The NMPA grants consent to conduct clinical trials evaluating the safety and efficacy of CMS-D001 for the treatment of ulcerative colitis and Crohn’s disease.

 

About CMS-D001

CMS-D001 is an oral, 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 processes of autoimmune diseases[1]. CMS-D001 can reduce the impact on other JAK family kinases and reduce adverse effects while maintaining efficacy[2].

 

About Ulcerative Colitis (UC) and Crohn’s Disease (CD)

Ulcerative colitis (UC) is a chronic, non-specific inflammatory bowel disease that primarily affects the colonic mucosa. Patients often present with symptoms such as abdominal pain, diarrhea, mucopurulent bloody stools, and tenesmus. The disease course is prolonged and recurrent, which impacts patients’ quality of life[3]. According to a Frost & Sullivan report, the number of UC patients in China has been increasing year by year, from approximately 279,000 in 2015 to about 400,000 in 2019, and is expected to reach 918,000 by 2030[4].

 

Crohn’s disease (CD) is a chronic, granulomatous, inflammatory disease that can involve the entire digestive tract. Common clinical manifestations include abdominal pain, diarrhea, weight loss, intestinal fistula, and intestinal obstruction. CD often presents at a young age, follows a prolonged and recurrent disease course, is associated with a high disability rate, and is currently incurable. These factors severely affect patients’ quality of life and prognosis[3]. According to Research Progress on the Epidemiology of Inflammatory Bowel Disease in China, the incidence of CD has been increasing globally in recent years. In China, the prevalence rate of CD is approximately 1.4 – 3.0 per 100,000 population, with an annual incidence of about 0.5 – 1.0 per 100,000[5]. It is estimated that there are currently approximately 20,000 to 45,000 existing patients nationwide. Due to underdiagnosis and misdiagnosis, the actual number of patients may be higher.

 

UC and CD are the two primary subtypes of inflammatory bowel disease (IBD). Currently, the main drugs for treating mild to moderate IBD in clinical practice are aminosalicylates and glucocorticoids[3]. For moderate to severe IBD, the primary medications include biologics and small-molecule targeted drugs, among which JAK inhibitors have demonstrated the best therapeutic efficacy in clinical settings[6]. However, the highest clinical remission rate remains only 30-40%[7], highlighting the urgent need to develop novel therapeutic agents for IBD. CMS-D001 exhibits enhanced precision in targeting key pathogenic mechanisms of IBD through specific inhibition of TYK2 activation[1]. This targeted approach minimizes off-target effects on other JAK kinase-mediated signaling pathways, thereby offering a superior safety profile compared to other JAK inhibitors[2].

 

TYK2 Development Accelerates Expansion into IBD, with CMS-D001 Facilitating Whole-Disease-Course Management of Intestinal Diseases

TYK2 inhibitors have become a key development direction in various severe inflammatory and autoimmune diseases. Currently, the indication pipeline of oral TYK2 inhibitors is rapidly expanding from the dermatology field to autoimmune-related diseases such as IBD and systemic lupus erythematosus. However, to date, no TYK2 inhibitor has been approved globally for the indication of IBD (including UC and CD). Gastroenterology is a core advantaged specialty area for CMS. If approved for marketing, CMS-D001 will synergise with the Group’s marketed products such as Salofalk (Mesalazine, indicated for UC and CD) and the exclusive product Bioflor (Saccharomyces boulardii sachets, for the treatment of diarrhoea in adults and children), strengthening whole-cycle, whole-disease-course management of patients with intestinal diseases. CMS-D001 will also synergise in terms of team, expert network and market resources, 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, together with its subsidiaries (“Dermavon”). CMS-D001 was granted approval for drug clinical trials for the indications of psoriasis on 18 January 2024 and for atopic dermatitis on 11 July 2025. The Phase I study in healthy subjects for CMS-D001 has been completed, and Phase II clinical trials for psoriasis and atopic dermatitis are currently ongoing, with the first subject having been enrolled. It is also planned to be developed for the treatment of autoimmune diseases such as systemic lupus erythematosus in the future. The Product will also form pipeline synergies with the Dermavon’s products in the skin health field, such as the innovative drug under development, long-acting anti-IL-4Rα monoclonal antibody MG-K10, the marketed innovative drug ruxolitinib phosphate cream, and the dermatology-grade skincare products of the Heling soothing product series. Dermavon has exclusively licensed the relevant rights for IBD to the Group (excluding Dermavon).

 

 

Self-Developed Pipeline Acceleration, Driving the Engine for Long-Term Growth

The Group continues to deepen its exploration in the frontiers of innovation, positioning self-driven R&D as the core driver of long-term value growth. Currently, in addition to the TYK2 inhibitor (CMS-D001), six products in the self-developed pipeline have entered the clinical stage, including the GnRH receptor antagonist (CMS-D002), complement factor B inhibitor (CMS-D017), and INHBE inhibitor (CMS-D008). Furthermore, over 20 self-driven R&D projects are steadily advancing through preclinical research, systematically building a robust reservoir of high-quality innovative assets. The Group will continue to accelerate clinical trials and is committed to launching self-developed products at the earliest opportunity, thereby delivering greater value to patients.

 

Reference:

[1] Danese S, Peyrin-Biroulet L. Selective Tyrosine Kinase 2 Inhibition for Treatment of Inflammatory Bowel Disease: New Hope on the Rise. Inflamm Bowel Dis. 2021 Jun 5;27(12):2023-2030.DOI: 10.1093/ibd/izab135.

[2]Johnson B, Cheng L, Koenitzer J, Catlett IM, Schafer P. Nonclinical evaluations of deucravacitinib and Janus kinase inhibitors in homeostatic and inflammatory pathways. Front Immunol. 2024 Sep 30;15:1437512.Doi: 10.3389/fimmu.2024.1437512.

[3]Wu K C, et al. Consensus on diagnosis and treatment of inflammatory bowel disease (Beijing, 2018). Chinese Journal of Practical Internal Medicine, 2018: 796-813.

[4]According to a Frost & Sullivan report

[5]Li X F, Peng X, Zhou M H. Research progress on the epidemiology of inflammatory bowel disease in China. Modern Digestion & Intervention, 2020, 25(9): 1265-1267.DOI:10.3969/j.issn.1672-2159.2020.09.032.

[6]Shehab M, Hassan A, Alrashed F,et.al. Comparative Efficacy of Biologics and Small Molecule Therapies in Improving Patient-Reported Outcomes in Ulcerative Colitis: Systematic Review and Network Meta-Analysis. Inflamm Bowel Dis. 2025 May 12;31(5):1272-1280. Doi: 10.1093/ibd/izae163. PMID: 39137239.

[7]A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC).

https://clinicaltrials.gov/study/NCT02819635?cond=IBD&intr=Upadacitinib&viewType=Table&aggFilters=results:with&rank=4&tab=results

 

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