SIMCERE PHARMA (02096.HK): SIM0725 Cleared for Clinical Trial in Autoimmune Diseases

NewTimeSpace News: On 10 November 2026, Simcere Pharmaceutical Group Limited (stock code: 2096) published a voluntary announcement that SIM0725, a CD122-targeting antibody independently developed by the Group, has received a drug clinical trial approval notice from China's National Medical Products Administration for the treatment of autoimmune diseases.

SIM0725 is a long-acting antagonistic monoclonal antibody targeting the beta chain of the interleukin-2 receptor (CD122). It blocks signalling mediated by interleukin-2 (IL-2) and interleukin-15 (IL-15), thereby inhibiting the responses of effector and memory T cells, and may influence autoimmune responses associated with disease persistence and relapse by interfering with the survival and maintenance of IL-15-dependent pathogenic tissue-resident memory T cells.

Preclinical studies showed that, in a humanised mouse efficacy model, SIM0725 had stronger pharmacodynamic activity than the comparator molecules tested and a smaller effect on the number and proliferation of regulatory T cells. In cynomolgus monkeys, SIM0725 demonstrated significantly prolonged pharmacokinetic and pharmacodynamic effects, supporting the potential for lower dosing frequency in clinical use. The Company sees potential in vitiligo, alopecia areata, coeliac disease and eosinophilic oesophagitis, with a "single molecule, multiple indications" development approach.