Nanjing Leads Biolabs Co., Ltd. announced that the European Commission has granted Orphan Drug Designation $(ODD)$ to LBL-024 (Opamtistomig), a PD-L1/4-1BB bispecific antibody, for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). This follows a previous orphan designation for LBL-024 by the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma (NEC). The company also received approval from the National Medical Products Administration (NMPA) in China to conduct a single-arm registrational trial and was granted Breakthrough Therapy Designation (BTD) by the NMPA for LBL-024 in late-line advanced EP-NEC.

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