Core Viewpoint - The company, Valiant Biopharma-B (09887), has seen a stock price increase of 3.52% to HKD 55.90 following the announcement of its drug, LBL-024, receiving Fast Track designation from the FDA for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC) [1] Group 1: Drug Development and Regulatory Approvals - LBL-024, a dual-specific antibody targeting PD-L1 and 4-1BB, has now received three regulatory recognitions, including Fast Track designation from the FDA [1] - The drug 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] - The Chief Medical Officer of the company, Dr. Cai Shengli, emphasized that this milestone reflects the drug's significant clinical potential and market prospects, which will accelerate its global development and market entry [1]
维立志博-B早盘涨近4% PD-L1/4-1BB双抗获FDA快速通道资格