LEADS BIOLABS-B(09887): Vitrakvi has been granted orphan drug designation (ODD) by the European Commission for the treatment of pulmonary neuroendocrine tumors.

LEADS BIOLABS-B(09887) announced that on January 22, 2026, the European Commission (EC) issued a commission decision granting orphan drug designation to Velifin (Opatimabutuzumab, LBL-024), a PD-L1/4-1BB bispecific antibody, for the treatment of extrapulmonary neuroendocrine cancer, with the decision executed on January 9, 2026. This is the second orphan drug designation obtained by Velifin after being recognized by the Food and Drug Administration (FDA) in the United States, marking another important milestone in Velifin's global development process. According to the EC's definition, orphan drugs are intended for the diagnosis, prevention, or treatment of life-threatening or chronically debilitating diseases with a prevalence of less than five in ten thousand in the European Union. The grant of orphan drug designation provides several key incentives, including but not limited to: protocol assistance, under which the European Medicines Agency (EMA) provides scientific advice covering different aspects such as drug quality, benefits, and risks; a ten-year market exclusivity in the EU, during which regulatory authorities in the EU and its member states cannot approve similar drugs for the same indication for ten years from the date of market approval, even in the absence of any patents; fee reductions for regulatory activities, including protocol assistance, marketing authorization applications and inspections, post-authorization changes, and annual maintenance costs; access to funding from the EC, Horizon Europe, and other sources after obtaining orphan drug designation; and additional incentives for micro, small, and medium-sized enterprises, including regulatory, administrative, and procedural assistance as well as fee reductions.