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

NewTimeSpace News: On 14 September 2026, China Medical System Holdings Limited (stock code: 00867.HK) announced on a voluntary and business update basis that CMS-D001 tablets, an innovative drug, obtained a drug clinical trial approval notice issued by the National Medical Products Administration (NMPA) of the PRC on 11 September 2026, which the Company received on 14 September 2026, with the NMPA agreeing to the Group carrying out clinical trials to evaluate the efficacy and safety of CMS-D001 in treating the systemic lupus erythematosus (SLE) indication.

CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor. By specifically inhibiting the activation of TYK2, it blocks the cellular signalling pathways of inflammatory cytokines such as IL-23, IL-12 and type I interferon, thereby suppressing the pathological process of autoimmune diseases. Compared with pan-JAK inhibitors, it has less impact on other JAK family kinases, maintaining efficacy while reducing toxicities and side effects, and its oral administration offers advantages such as good compliance and no anti-drug antibodies. The product was independently developed by Demei Pharmaceutical Co., Ltd. (德鎂醫藥有限公司), a subsidiary of the Group, and has been approved to conduct clinical trials for the psoriasis, atopic dermatitis, ulcerative colitis and Crohn's disease indications, with Phase II clinical trials for psoriasis and atopic dermatitis underway; Demei Pharmaceutical has exclusively licensed the relevant rights in respect of SLE and inflammatory bowel disease, including but not limited to the ulcerative colitis and Crohn's disease indications, to the Group (other than Demei Pharmaceutical).

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