SIMCERE PHARMA (02096): SIM0725 (CD122) Receives Drug Clinical Trial Approval Notice Issued by the National Medical Products Administration

SIMCERE PHARMA (02096) announced that SIM0725, an antibody targeting CD122 independently developed by the group, has received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration of China, and is intended 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 can block signaling mediated by interleukin-2 (IL-2) and interleukin-15 (IL-15), thereby inhibiting the responses of related effector T cells and memory T cells, and is expected to influence autoimmune responses associated with disease persistence and relapse by intervening in the survival and maintenance of IL-15-dependent pathogenic tissue-resident memory T cells. Preclinical studies showed that in a humanized mouse efficacy model, the pharmacologic activity of SIM0725 was stronger than that of the tested comparator molecules of the same class, with less impact on the number and proliferation of regulatory T cells, suggesting its differentiated immunomodulatory potential; meanwhile, SIM0725 demonstrated significantly prolonged pharmacokinetic and pharmacodynamic effects in cynomolgus monkeys, supporting its potential to achieve a lower dosing frequency in clinical settings. SIM0725 has broad application prospects in autoimmune diseases such as vitiligo, alopecia areata, celiac disease, and eosinophilic esophagitis, and has the development potential of "single molecule, multiple indications."