China Medical System Holdings Limited said it obtained a Drug Clinical Trial Approval Notice from China’s National Medical Products Administration on Sep, 14 2026, allowing the company to initiate clinical studies of its highly selective TYK2 inhibitor CMS-D001 in patients with systemic lupus erythematosus (SLE).

CMS-D001 targets tyrosine kinase 2 to block inflammatory cytokine signalling (IL-23, IL-12 and Type I interferons) involved in autoimmune disorders. The company expects the oral agent to reduce off-target effects seen with pan-JAK inhibitors and to offer better adherence than injectable biologics.

Around one million people in mainland China live with SLE, with about 200,000 new cases each year, according to local epidemiological data cited by the firm. Existing therapies can leave patients vulnerable to relapse, organ damage and infection, creating continued demand for safer and more effective options.

CMS-D001, developed by subsidiary Dermavon Holdings Limited, is already in Phase II trials for psoriasis and atopic dermatitis and has clinical-trial clearance for ulcerative colitis and Crohn’s disease. Rights for SLE and inflammatory bowel disease indications are licensed exclusively to the parent company.

The group said it is preparing to launch SLE trials promptly and plans to leverage its rheumatology portfolio, which includes Metoject (methotrexate injection), to strengthen its market position once CMS-D001 is approved. It advised investors to exercise caution when dealing in its securities.