CASI Pharmaceuticals shares surge 10.77% premarket after China NMPA approves Phase 1/2 trial for CID-103 in renal allograft antibody-mediated rejection.

CASI Pharmaceuticals surged 10.77% in premarket trading following the announcement that China’s National Medical Products Administration (NMPA) approved its Clinical Trial Application for a Phase 1/2 study of CID-103 in treating renal allograft antibody-mediated rejection (AMR). CID-103, a potential best-in-class anti-CD38 monoclonal antibody, targets a unique epitope and addresses a significant unmet need, as no approved therapies exist for AMR, a leading cause of kidney transplant loss. The approval builds on prior U.S. FDA clearance for a Phase 1 AMR study, marking regulatory progress in both key markets. The CEO highlighted the milestone as critical to developing an approved therapy for AMR, underscoring the drug’s potential to address a high-impact therapeutic area with limited treatment options.