LEADS BIOLABS-B(09887): Velifexin (PD-L1/4-1BB bispecific antibody Opatezumab monoclonal antibody, LBL-024) has been included in the priority review and approval process for the treatment of advanced pulmonary extrapulmonary neuroendocrine carcinoma.

LEADS BIOLABS-B (09887) announced that the biologic product, VELISYNTM (PD-L1/4-1BB bispecific antibody Opaltrimab monoclonal antibody, LBL024) for the monotherapy of advanced extra-pulmonary neuroendocrine carcinoma has received the approval for inclusion in the priority review and approval process by the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). This BLA application is based on positive results from a key registration clinical study led by Professor Lin Shen of Beijing Cancer Hospital, aiming to evaluate the efficacy and safety of VELISYNTM in advanced EP-NEC patients who have progressed after receiving second-line or above systemic therapy. According to relevant Chinese regulations, the review time for BLAs included in the priority review and approval process is 130 working days, while the standard review process is 200 working days. The inclusion of VELISYNTM in the priority review and approval process marks an important milestone towards its commercialization, providing clear guidance and certainty for its expected approval timeline. The company is actively advancing related pre-commercialization preparations.