Core Viewpoint - The company Valiant Pharmaceuticals (维立志博-B, 09887) has seen a significant stock increase following the announcement of its core product, LBL-024, receiving orphan drug designation from the European Commission for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC) [1] Group 1: Product Development - LBL-024 has reached an important milestone in its global development process with the orphan drug designation [1] - The product is currently undergoing Phase II or registration clinical trials for three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC, showcasing first-in-class (FIC) or best-in-class (BIC) potential [1] Group 2: Regulatory Approvals - On January 14, LBL-024 received Fast Track designation from the U.S. FDA for the treatment of extra-pulmonary neuroendocrine carcinoma [1] - LBL-024 is a bispecific antibody that targets both PD-L1 and 4-1BB, making it the first targeted therapy for 4-1BB receptor in the registration clinical stage for extra-pulmonary neuroendocrine carcinoma [1]
维立志博-B再涨超6% 维利信获欧盟孤儿药资格及美国FDA快速通道资格认定