LEADS BIOLABS-B(09887): Viliximab (PD-L1/4-1BB bispecific antibody Opatisumab monotherapy, LBL-024) for the treatment of advanced pulmonary neuroendocrine cancer has obtained CDE approval for Phase III clinical research.

LEADS BIOLABS-B (09887) announced that the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) of the People's Republic of China has approved the initiation of a confirmatory Phase III clinical study evaluating Veliximab (PD-L1/4-1BB bispecific antibody Opatilesumab, LBL-024) in combination with platinum-based chemotherapy as first-line treatment in patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). This approval marks the successful advancement of Opatilesumab from a back-line monotherapy for EP-NEC towards first-line combination therapy. Previously, Opatilesumab had been approved by the CDE for conducting a single-arm pivotal registration clinical study for third-line and above EP-NEC patients; now, the approval for this first-line Phase III study expands the eligible population for Opatilesumab in the field of EP-NEC, fundamentally reshaping the treatment landscape for this cancer. This randomized, double-blind, multicenter Phase III clinical study is led by Professor Lin Shen of Beijing Cancer Hospital and is being conducted simultaneously in multiple hospitals across the country. The study approval is based on the breakthrough efficacy and good safety demonstrated by Opatilesumab in the phase Ib/II concept validation study. The study has successfully completed the concept validation trial, and detailed results are expected to be presented at this year's ESMO Congress. As an integral part of Opatilesumab's overall development strategy in the field of EP-NEC, the single-arm pivotal registration clinical study of Opatilesumab as a monotherapy for third-line and above advanced EP-NEC patients is scheduled to submit a BLA application in the third quarter of 2026. Meanwhile, the company is progressing with multiple concept validation studies of Opatilesumab and planning to conduct at least two additional Phase III clinical studies to explore its application in 13 solid tumor indications, including first-line non-small cell lung cancer, first-line cholangiocarcinoma, small cell lung cancer, and ovarian cancer, forming a comprehensive research layout covering multiple tumor types and stages. Opatilesumab has demonstrated first-in-class (FIC) or best-in-class (BIC) potential in registration or Phase II clinical trials in four indications: extrapulmonary neuroendocrine carcinoma, non-small cell lung cancer, small cell lung cancer, and cholangiocarcinoma.