WuXi Biologics-B (09887.HK): LBL-047 obtains NMPA's IND approval

Zhongtong Financial APP News, Valesta Bio-B (09887.HK) announced that on November 25, 2025, its application for the clinical trial (IND) of the new drug candidate LBL-047, which was independently developed, has been approved by the National Medical Products Administration (NMPA) of China. LBL-047 is the world's first dual-specific fusion protein that has achieved dual submission and dual approval in both China and the United States. It consists of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and a modified transmembrane activator and CAML interactor (TACI) ligand interaction molecule in the extracellular domain. Currently, there is no drug approved for clinical trials worldwide that targets both plasmacytoid dendritic cells (pDCs) and B cells simultaneously. With this unique mechanism of action, LBL-047 has the potential to be the first of its kind and the best in class.