LEADS BIOLABS-B(09887): Vilxin (opamtisumab, PD-L1/41BB bispecific antibody) monotherapy for advanced EP-NEC pivotal registrational Phase IIB study selected as LBA, and three studies granted preferred oral presentation eligibility

LEADS BIOLABS-B(09887) announced that at the European Society for Medical Oncology Annual Congress 2026 (2026 ESMO), the pivotal registrational Phase IIB clinical study of the Company's self-developed investigational drug Vilxin (opamtisumab, PD-L1/41BB bispecific antibody) as monotherapy for advanced extrapulmonary neuroendocrine carcinoma ("EP-NEC") has been selected as a Late-Breaking Abstract (LBA) and granted preferred oral presentation eligibility, marking that the study possesses breakthrough innovative nature and significant clinical value, and its results are expected to change existing clinical practice and reshape the standard treatment landscape for advanced EP-NEC. Notably, at 2026 ESMO, three studies of the Company have been granted preferred oral presentation eligibility, ranking among the top among Chinese pharmaceutical companies in terms of the number of selections. The detailed information of the study selected as LBA is set out below. Study title: Opamtisumab (LBL-024) monotherapy in previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC): results from a pivotal registrational Phase IIb study of a novel PD-L1x41BB bispecific antibody Presentation format: Preferred oral presentation; Principal investigator: Professor Shen Lin, Peking University Cancer Hospital; Speaker: Director Lu Ming, Peking University Cancer Hospital; Presentation time: October 26, 10:1510:25 a.m. local time. The selection of the pivotal Phase IIb study as an LBA at ESMO is intended to evaluate the efficacy and safety of Vilxin monotherapy in patients with advanced EP-NEC who have previously received at least second-line or later systemic therapy, and the study data provide core support for the Company's New Drug Application (NDA) submission to relevant regulatory authorities. At 2026 ESMO, the Company has obtained three preferred oral presentation eligibilities, including: (i) the pivotal registrational Phase IIb study of Vilxin monotherapy for advanced EP-NEC (selected as LBA); (ii) the Phase Ib/II study of Vilxin combined with chemotherapy as first-line treatment for EP-NEC; and (iii) the Phase I study of LBL-034 for relapsed or refractory multiple myeloma (RRMM). Preferred oral presentation is one of ESMO's highest-tier oral presentation categories, granted only to original research data of outstanding quality, representing recognition by the international oncology community of the study's innovativeness, data quality, and clinical value. The Company having three studies simultaneously selected for preferred oral presentation at 2026 ESMO is not only a breakthrough of a single study, but also a comprehensive affirmation of the Company's innovation capability, clinical development system, and multi-tumor layout, fully demonstrating the Company's strength in continuously producing high-quality clinical research and participating in international academic competition. In addition, four other high-quality studies of the Company have been successfully selected for poster presentations at the congress, covering clinical research of Vilxin in biliary tract cancer (BTC), mechanistic research in microsatellite-stable colorectal cancer, and multiple meta-analyses, etc., presenting the Company's refined and diversified R&D layout in an all-round and multi-angle manner, from solid tumor clinical exploration to systematic review of research data.