Core Viewpoint - The announcement by Vili Zhibo-B (09887) regarding the orphan drug designation for LBL-024 (Opalizumab) for the treatment of pulmonary neuroendocrine carcinoma marks a significant milestone in its global development process, following a similar designation from the FDA [1] Group 1 - The European Commission (EC) granted orphan drug designation for LBL-024 on January 9, 2026, which is the second such designation after receiving FDA recognition [1] - Orphan drugs are defined by the EC as those intended for the diagnosis, prevention, or treatment of life-threatening or chronically debilitating conditions with a prevalence of less than 5 in 10,000 in the EU [2] Group 2 - The orphan drug designation provides several key incentives, including scientific advice from the European Medicines Agency (EMA) on various aspects of research design [2] - It grants a 10-year market exclusivity period in the EU from the date of marketing authorization, preventing other companies from approving similar drugs for the same indication during this time [2] - Additional benefits include fee reductions for regulatory processes and potential funding from the EC and Horizon Europe, as well as extra incentives for micro, small, and medium-sized enterprises [2]
维立志博-B：维利信 用于治疗肺外神经内分泌癌获欧盟委员会授予孤儿药认定（ODD）