Core Viewpoint - The company announced that its PD-L1/4-1BB bispecific antibody, Velesin™ (Oparizumab, LBL-024), received orphan drug designation from the European Commission for the treatment of pulmonary neuroendocrine carcinoma, marking a significant milestone in its global development process after previously receiving similar recognition from the FDA [1]. Group 1 - The European Commission's orphan drug designation is granted to drugs 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]. - The orphan drug designation provides several key incentives, including scientific advice from the European Medicines Agency (EMA) on research design related to drug quality, benefits, and risks [2]. - The designation grants a 10-year market exclusivity period in the EU from the date of marketing authorization, during which no similar drugs for the same indication can be approved [2]. Group 2 - Additional incentives include fee reductions for regulatory guidance, marketing authorization applications, and post-marketing changes, as well as access to funding from the EC, Horizon Europe, and other sources [2]. - There are also extra incentives for micro, small, and medium-sized enterprises, including regulatory, administrative, and procedural assistance, along with fee reductions [2].
维立志博-B(09887.HK)：维利信™(PD-L1/4-1BB双特异性抗体奥帕替苏米单抗，LBL-024)用于治疗肺外神经内分泌癌获欧盟委员会授予孤...