CMS announced that its innovative drug, the highly selective TYK2 inhibitor CMS-D001, has received a drug clinical trial approval notice from China's National Medical Products Administration (NMPA). The notice, dated May 22, 2026, was received by the company on May 25. The approval authorizes CMS to conduct clinical trials to evaluate the safety and efficacy of CMS-D001 in treating ulcerative colitis (UC) and Crohn's disease (CD).
CMS-D001 is a highly selective TYK2 (Tyrosine Kinase 2) inhibitor. TYK2 is a member of the JAK kinase family, which plays a crucial role in immune cell signaling. By specifically inhibiting TYK2 activation, CMS-D001 blocks the cellular signaling pathways of inflammatory cytokines such as IL-23, IL-12, and type I interferons, thereby suppressing the pathological processes of autoimmune diseases. This targeted mechanism aims to reduce the impact on other JAK family kinases, potentially maintaining efficacy while minimizing adverse effects.
Ulcerative colitis is a chronic, non-specific inflammatory bowel disease primarily affecting the colonic mucosa, with symptoms including abdominal pain, diarrhea, and bloody stools. The patient population in China is growing, with an estimated 918,000 patients projected by 2030. Crohn's disease is a chronic granulomatous inflammatory condition that can affect the entire digestive tract, commonly presenting with abdominal pain, diarrhea, and weight loss. It has a high disability rate and significantly impacts patients' quality of life. In China, the estimated prevalence is between 14 to 30 per million, suggesting a patient population of approximately 20,000 to 45,000, though actual numbers may be higher due to underdiagnosis.
UC and CD are the main subtypes of inflammatory bowel disease (IBD). Current treatments for moderate to severe IBD include biologics and small-molecule targeted drugs, with JAK inhibitors showing the best efficacy but a clinical remission rate of only 30-40%. There remains a significant unmet need for new IBD therapies. By precisely targeting TYK2, a key pathogenic pathway in IBD, CMS-D001 represents an emerging therapeutic target with the potential to be developed as a novel oral treatment for IBD.
If approved for market, CMS-D001 could synergize with CMS's existing portfolio, including Salofalk (mesalazine, for UC and CD) and the exclusive product Bioflor (Saccharomyces boulardii, for diarrhea). This would strengthen the company's comprehensive management of gastrointestinal diseases across the patient journey, bolstering its position in the digestive treatment field. The synergy would extend to team expertise, specialist networks, and market resources, enhancing overall competitiveness.
CMS-D001 was independently developed by CMS's subsidiary, Demai Pharmaceutical Co., Ltd. It had previously received clinical trial approvals for psoriasis and atopic dermatitis indications on January 18, 2024, and July 11, 2025, respectively. A Phase I study in healthy subjects has been completed, and Phase II trials for psoriasis and atopic dermatitis are underway with the first patients already enrolled. The product could also create pipeline synergies with Demai's dermatology assets, such as the long-acting anti-IL-4Rα monoclonal antibody MG-K10 (in research), the marketed innovative drug ruxolitinib phosphate cream, and the Haling skincare line.
Demai has exclusively licensed the IBD-related rights for CMS-D001 to the CMS group. Future development plans for CMS-D001 include exploring its use in treating other autoimmune diseases like systemic lupus erythematosus. CMS is actively preparing to commence the relevant clinical trials, striving to bring the product to market as soon as possible.