CASI Pharmaceuticals shares surge 27.45% premarket after China NMPA approves Phase 1/2 trial for CID-103 in renal allograft AMR.

CASI Pharmaceuticals surged 27.45% 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 is the first to receive regulatory approval for this indication in China, complementing a previously approved U.S. Phase 1 Investigational New Drug (IND) application. The company emphasized the unmet medical need in AMR, where no approved therapies exist, and highlighted the dual regulatory milestones as critical steps toward developing a treatment for this high-risk patient population. CEO David Cory underscored the significance of these approvals in advancing CID-103’s development, reinforcing investor optimism about the drug’s potential to address a major gap in transplant medicine.