LEADS BIOLABS-B(09887): The summary of the Phase II clinical study of Vilex (Opalimab, a PD-L1/4-1BB bispecific antibody, LBL-024) as a first-line treatment for NSCLC has been published on the WCLC website.

LEADS BIOLABS-B (09887) announced that the full abstract of the Phase II clinical study on its self-developed investigational drug, Velisyn (Oparatuzumab, a PD-L1/4-1BB dual-specificity antibody) in combination with chemotherapy as a first-line treatment for non-small cell lung cancer (NSCLC), has officially been published on the World Lung Cancer Conference (WCLC) website. Based on the data analysis up to March 6, 2026, Velisyn in combination with chemotherapy showed encouraging overall response rates (ORR) in the general population, with strong tumor shrinkage effects observed in both squamous and non-squamous subgroups. The data disclosed in the abstract is based on just 3.6 months of follow-up, while the latest data with follow-up times exceeding seven months will be presented at the WCLC oral report session on September 14, 2026. The abstract indicates that Velisyn in combination with chemotherapy as first-line treatment for locally advanced or metastatic NSCLC achieved an ORR of 65.0% and a disease control rate (DCR) of 95.0% among 60 evaluable patients. In the squamous subgroup, the ORR was 77.4% and the DCR was 96.8%, while the ORR in the non-squamous subgroup was 51.7% with a DCR of 93.1%. Overall safety was manageable, and no new safety signals were observed. The data disclosed in the abstract is based on a follow-up of 3.6 months at the time of the initial submission. The data from follow-up exceeding seven months that will be presented at WCLC will further validate previous findings. As the follow-up period extends, the data continues to mature, the depth of response continues to deepen, and the trends for progression-free survival (PFS) benefit continue to strengthen. These results collectively support Velisyn's unique "decelerate and accelerate" dual-target immune synergistic mechanism, which is expected to establish a new IO 2.0 treatment pathway for NSCLC. Currently, Velisyn is undergoing 11 clinical studies and has demonstrated clear and positive efficacy signals across multiple indications. The clinical data for the first seven indications exhibits a potential best-in-class (BIC) therapeutic prospect.