CMS (00867): Innovative Drug Highly Selective TYK2 Inhibitor CMS-D001 Receives Drug Clinical Trial Approval Notice for Systemic Lupus Erythematosus Indication

CMS (00867) announced that on September 11, 2026, the innovative drug CMS-D001 tablets received a Drug Clinical Trial Approval Notice issued by China's National Medical Products Administration (NMPA), and the Drug Clinical Trial Approval Notice was received on September 14, 2026. The NMPA agreed for the Group to conduct clinical trials to evaluate the efficacy and safety of CMS-D001 in treating the systemic lupus erythematosus indication. CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor. TYK2 is one of the members of the JAK kinase family, and the JAK kinase family is an important link in immune cell signal transduction. CMS-D001, by specifically inhibiting the activation of TYK2, blocks the cellular signaling pathways of inflammatory cytokines such as IL-23, IL-12, and type I interferons, thereby suppressing the pathological process of autoimmune diseases. CMS-D001 can reduce effects on other JAK family kinases, maintaining efficacy while reducing toxic side effects. As a highly selective TYK2 inhibitor, compared with pan-JAK inhibitors, CMS-D001 has less impact on other JAK family kinases, and can maintain efficacy and reduce related safety risks in long-term disease control. Compared with marketed injectable biologics, oral CMS-D001 has advantages such as good compliance and no anti-drug antibodies. If approved for marketing, CMS-D001 will bring new medication options for Chinese SLE patients, and will efficiently synergize with the Group's existing expert network and market resources in the rheumatology and autoimmune field alongside marketed products such as the innovative drug Maitaitong (methotrexate injection), jointly enhancing the Group's competitiveness and market position in this field.