Kangzhe Pharmaceutical (00867): CMS-D001, an innovative drug highly selective TYK2 inhibitor, obtained a notice of approval for clinical trials of systemic lupus erythematosus indicative drugs

Zhitong Finance App News, Kangzhe Pharmaceutical (00867) announced that on September 11, 2026, the innovative drug CMS-D001 tablets obtained a drug clinical trial approval notice issued by China's National Drug Administration (NMPA), and received a drug clinical trial approval notice on September 14, 2026. NMPA agreed with the Group to conduct clinical trials to evaluate the efficacy and safety of CMS-D001 in the treatment of systemic lupus erythematosus.

CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor. TYK2 is a member of the JAK kinase family, which is an important part of immune cell signaling. By specifically inhibiting TYK2 activation, CMS-D001 blocks cellular signaling pathways of inflammatory cytokines such as IL-23, IL-12, and interferon type I, thereby inhibiting the pathological process of autoimmune diseases. CMS-D001 can reduce the effects on other JAK family kinases and reduce toxic side effects while maintaining efficacy.

As a highly selective TYK2 inhibitor, CMS-D001 has less effect on other JAK family kinases than pan-JAK inhibitors, and can maintain efficacy and reduce related safety risks in long-term disease control. Compared with commercially available injectable biologics, CMS-D001 oral administration has advantages such as good compliance and no resistant antibodies. If approved for marketing, CMS-D001 will bring new medication options to Chinese SLE patients, and efficiently collaborate with the Group's existing expert network and market resources in the field of rheumatism prevention with products currently on sale, such as the innovative drug Meitai (methotrexate injection), to jointly enhance the Group's competitiveness and market position in this field.