Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK)  announced that the biologics license application (BLA) for Opamtistomig (LBL-024, a PD-L1/4-1BB bispecific antibody) as monotherapy for the treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China for inclusion in the priority review and approval procedure. This BLA submission is based on the positive results from a pivotal registrational clinical study led by Professor Shen Lin of Peking University Cancer Hospital, which was designed to evaluate the efficacy and safety of Opamtistomig in patients with advanced EP-NEC whose disease had progressed following two or more prior lines of systemic therapy.

Under the relevant PRC regulations, the review timeline for a BLA included in the priority review and approval procedure is 130 working days, as compared with 200 working days under the ordinary review procedure. The inclusion of Opamtistomig in the priority review process represents a key milestone toward its commercialization, providing clarity and visibility on its expected approval timeline. The Company is actively advancing relevant pre-launch commercialization preparations.