Core Viewpoint - The company Valiant Pharmaceuticals-B (09887) has received FDA approval for its new drug clinical trial application for LBL-047, indicating significant progress in its drug development pipeline [1] Group 1: Drug Development - LBL-047 is a bispecific fusion protein composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and a modified transmembrane activator and calcium-modulating cyclophilin ligand (TACI) extracellular domain [1] - The approval from the FDA is set for September 19, 2025, marking a critical milestone for the company [1] - There are currently no other bispecific fusion proteins targeting both BDCA2 and TACI approved or in clinical stages globally, highlighting LBL-047's first-in-class potential [1]
维立志博-B:LBL-047取得美国FDA的IND批准