According to the Zhitong Finance APP, Zelgen Pharmaceuticals (688266.SH) announced that its clinical trial application for the injectable ZGGS34 has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced solid tumors.

ZGGS34 is a trispecific antibody drug developed by the company and its subsidiary Gensun Biopharma Inc. through its bispecific/multispecific antibody research and development platform, belonging to the class of trispecific T cell engagers (TriTE). ZGGS34 (MUC17/CD3/CD28) is a trispecific antibody targeting CD3 and CD28 on T cells, as well as the tumor-associated antigen (TAA) MUC17.

Preclinical research results show that ZGGS34 has significant tumor suppression effects in various tumor models, leading to tumor regression, indicating that ZGGS34 has a strong tumor-killing effect. Completed toxicology studies of ZGGS34 in non-human primates demonstrate its controllable toxic side effects and good safety profile