CASI Pharmaceuticals Announces Approval of Clinical Trial Application by China NMPA for Phase 1 / 2 Study of CID-103 for Renal Allograft Antibody-Mediated Rejection (AMR)
CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody; binds to unique CD38 epitope AMR is a leading cause of kidney transplant loss with no approved treatments U.S. IND previously approved by FDA for Phase 1 AMR study SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / January 15, 2026 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company developing CID-103, a potentially best-in-class, anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced that China National Medical Products Administration (NMPA) has approved a Clinical Trial Application (CTA) to conduct a Phase 1 /2 clinical trial for CID-103 in adults with chronic active renal allograft antibody-mediated rejection (AMR). The Phase 1 / 2 clinical trial is a dose-ranging and safety study evaluating the tolerability and efficacy of CID-103 in patients with renal allograft AMR.
