Core Viewpoint - The approval of the IND application for LBL-047 marks a significant milestone for the company, as it is the first bispecific fusion protein to receive dual regulatory approval in both the US and China, indicating its potential as a first-in-class and best-in-class therapeutic option [1] Group 1: Drug Development - LBL-047 is a bispecific fusion protein targeting both plasmacytoid dendritic cells (pDC) and B cells, with no other drugs currently approved for clinical trials that simultaneously target these cells globally [1] - The clinical trial approved is a double-blind, randomized, placebo-controlled, dose-escalation Phase I study, assessing the safety, tolerability, and preliminary clinical efficacy of LBL-047 in both healthy adults and patients with systemic lupus erythematosus (SLE) [1] Group 2: Research Leadership - The trial involving healthy volunteers will be led by Professor Meng Xianmin from Shanghai Public Health Clinical Center, while the trial involving SLE patients will be conducted by Professors Ye Shuang and Chen Sheng from Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine [1]
维立志博-B(09887.HK)：LBL-047取得NMPA的IND批准