Xiansheng Pharmaceutical (02096): SIM0725 (CD122) was issued a drug clinical trial approval notice by the State Drug Administration

Zhitong Finance App News, Xiansheng Pharmaceutical (02096) announced that SIM0725, an antibody targeting CD122 developed independently by the Group, has obtained a drug clinical trial approval notice issued by the China National Drug Administration and is intended to be used to treat autoimmune diseases.

Sim0725 is a long-acting antagonistic monoclonal antibody targeting the interleukin-2 receptor beta chain (CD122). It blocks interleukin-2 (IL-2) and interleukin-15 (IL-15) -mediated signaling, thereby inhibiting the responses of related effector T cells and memory T cells, and is expected to influence the survival and maintenance of IL-15-dependent pathogenic tissue-resident memory T cells. Preclinical studies have shown that in humanized mouse pharmacodynamics models, SIM0725 is more active than similar control molecules tested, and has less effect on the number and proliferation of regulatory T cells, indicating that it has differentiated immunomodulatory potential; at the same time, SIM0725 showed significantly prolonged pharmacokinetic and pharmacodynamic effects in crab-eating monkeys, supporting its potential to achieve lower clinical administration frequencies. SIM0725 has broad application prospects in autoimmune diseases such as vitiligo, alopecia areata, celiac disease, and eosinophilic esophagitis, and has the potential for “single molecule, multiple indications”.