LEADS BIOLABS-B (09887) announced that on January 22, 2026, the European Commission (EC) issued an executive decision dated January 9, 2026, granting Orphan Drug Designation (ODD) to the PD-L1/4-1BB bispecific antibody Vilisin™ (Opatisumab, LBL-024) for the treatment of extrapulmonary neuroendocrine carcinoma. This marks the second ODD for Vilisin™, following its designation by the US Food and Drug Administration (FDA), representing another significant milestone in its global development progress. According to the EC's definition, an orphan drug is intended for the diagnosis, prevention, or treatment of life-threatening or chronically debilitating conditions with a prevalence of fewer than 5 in 10,000 people in the EU. The granting of ODD provides several key incentives, including, but not limited to: protocol assistance, whereby the European Medicines Agency (EMA) offers scientific advice on study design covering aspects such as quality, benefit, and risk; ten years of market exclusivity in the EU, granting a ten-year period of market protection from the date of marketing authorization approval, during which regulatory authorities in the EU and its member states cannot approve similar drugs from other companies for the same indication—this exclusivity operates independently of patent protection and remains effective even in the absence of any patents; regulatory fee reductions, including reductions for protocol assistance, marketing authorization applications and inspections, post-authorization changes, and annual fees; access to funding, as ODD grants eligibility for funding from the EC, Horizon Europe, and other sources; and additional incentives for micro, small, and medium-sized enterprises, including regulatory, administrative, and procedural assistance along with further fee reductions.
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