CASI Pharmaceuticals Inc. announced that it has received regulatory approval from the China National Medical Products Administration (NMPA) for a Phase 1/2 clinical trial application $(CTA)$ to study CID-103 for the treatment of renal allograft antibody-mediated rejection $(AMR)$. Additionally, the U.S. Food and Drug Administration (FDA) has previously approved an Investigational New Drug $(IND)$ application for a Phase 1 study of CID-103 in adults with chronic active renal allograft AMR. These approvals allow CASI Pharmaceuticals to proceed with clinical studies of CID-103, a potential anti-CD38 monoclonal antibody, in both China and the United States.
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