The biologics license application for LEADS BIOLABS-B's (ASX: 09887) investigational drug, VELIXIN™ (the PD-L1/4-1BB bispecific antibody oplitelimab, LBL-024), as a monotherapy for advanced extrapulmonary neuroendocrine carcinoma has been accepted into the priority review and approval pathway by China's National Medical Products Administration Center for Drug Evaluation.

This BLA submission is supported by positive results from a pivotal registration clinical study led by Professor Lin Shen from Beijing Cancer Hospital, which evaluated the efficacy and safety of VELIXIN™ in patients with advanced EP-NEC who had progressed after at least two prior lines of systemic therapy.

Under relevant Chinese regulations, the review timeline for a BLA accepted into the priority pathway is 130 working days, compared to 200 working days for the standard review procedure.

The inclusion of VELIXIN™ in the priority review program represents a significant milestone on its path to commercialization, providing clear guidance and certainty regarding its anticipated approval timeline.

The company is actively advancing pre-commercialization preparations related to the product's potential launch.