CMS(00867): Innovative drug high-selective TYK2 inhibitor CMS-D001 received approval for clinical trial notification for ulcerative colitis and Crohn's disease indications.

CMS (00867) announced that on May 22, 2026, the innovative drug CMS-D001 tablet (CMS-D001 or product) obtained the drug clinical trial approval notification issued by the National Medical Products Administration (NMPA) of China, and received the drug clinical trial approval notification on May 25. NMPA agreed to allow the group to conduct clinical trials to evaluate the safety and efficacy of CMS-D001 in treating ulcerative colitis and Crohn's disease. 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 the activation of TYK2, CMS-D001 blocks cell signaling pathways of inflammatory cytokines such as IL-23, IL-12, and type I interferon, thereby suppressing the pathogenesis of autoimmune diseases. CMS-D001 can reduce the impact on other JAK family kinases, minimizing side effects while maintaining efficacy. Ulcerative colitis (UC) is a chronic non-specific inflammatory bowel disease that mainly affects the mucous membrane of the colon. Patients often experience symptoms such as abdominal pain, diarrhea, mucus and bloody stools, and urgency. The disease course is prolonged and recurrent, affecting the quality of life. According to Frost & Sullivan's report, the number of UC patients in China has been increasing annually, with approximately 279,000 patients in 2015 and around 400,000 patients in 2019, expected to reach 918,000 by 2030. Crohn's disease (CD) is a chronic granulomatous inflammatory disease that can affect the entire digestive tract. Common clinical manifestations include abdominal pain, diarrhea, weight loss, fistulas, and intestinal obstructions. CD often starts at a young age, has a prolonged course, and high disability rate, with no cure, severely impacting the patients' quality of life and prognosis. According to the advances in the epidemiology of inflammatory bowel diseases in China, the incidence of CD has been on the rise globally. In China, the prevalence of CD is about 1.4-3.0 per 100,000 population, with an annual incidence of about 0.5-1.0 per 100,000 population, estimating about 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 main subtypes of inflammatory bowel disease (IBD). Currently, the clinical treatment for mild to moderate IBD includes aminosalicylates and glucocorticoids. For moderate to severe IBD, biological products and small molecule targeted drugs are mainly used, with JAK inhibitors being the most effective in clinical treatment, yet the highest clinical remission rate is only 30-40%, highlighting the urgent need for new IBD treatments. CMS-D001, by specifically inhibiting the activation of TYK2, can target key pathogenic factors of IBD more precisely and reduce the impact on other JAK kinase-mediated signaling pathways, making it safer than other JAK inhibitors. Therefore, TYK2 inhibitors have become a new target for IBD, and may develop into new oral drugs for IBD treatment. If approved for marketing, CMS-D001 can synergize with the group's existing products such as Salford (mesalazine, used for UC and CD) and the exclusive drug Yihuo (Bifidobacterium breve powder, used to treat diarrhea in adults and children), to strengthen comprehensive management of intestinal diseases throughout the patient care continuum, enhancing the group's strength in the field of digestive therapy, and creating a synergistic effect in terms of team, expert network, and market resources to improve the group's competitiveness and market position in this field. CMS-D001 was independently developed by the group's subsidiary, Demag Pharmaceuticals, and has been approved to conduct drug clinical trials for indications of psoriasis and atopic dermatitis on January 18, 2024, and July 11, 2025 respectively. Currently, the phase I study of CMS-D001 in healthy subjects has been completed, with phase II clinical trials for psoriasis and atopic dermatitis in progress, with the first subject already enrolled. This product can synergize with Demag Pharmaceuticals' skincare products (such as the investigational long-acting anti-IL-4R monoclonal antibody MG-K10 and the marketed innovator phosphine lotions, as well as the dermatological skincare product Holishu soothing product) to form a pipeline synergy. Demag Pharmaceuticals has exclusively licensed the relevant rights regarding IBD to the group (excluding Demag Pharmaceuticals). CMS-D001 is also planned for further development for the treatment of systemic lupus erythematosus and other autoimmune diseases. The group is actively preparing to conduct related clinical trials and striving for the product to be marketed as soon as possible.