Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) announced the successful completion of patient enrollment in the ongoing single-arm, pivotal registrational clinical trial (CTR20213023) for Opamtistomig (LBL-024), a novel PD-L1/4-1BB bispecific antibody.

This marks the world's first registrational clinical trial evaluating an immunotherapy monotherapy for extrapulmonary neuroendocrine carcinoma (EP-NEC). The study, led by Professor Shen Lin from Peking University Cancer Hospital and conducted across multiple medical centers, aims to evaluate the efficacy and safety of Opamtistomig in patients with advanced EP-NEC who failed at least two lines of chemotherapy.

EP-NEC is a highly aggressive, immunologically "cold" tumor. The current first-line standard treatment for advanced EP-NEC remains platinum-based chemotherapy, with an objective response rate (ORR) of 30%-50% and a median overall survival (mOS) of approximately 1 year. For patients with platinum-resistant, no established second-line standard of care exists, representing a pressing unmet need for new therapeutic options.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:" As the first PD-L1/4-1BB-targeted bispecific antibody globally to have reached pivotal single-arm registrational stage, Opamtistomig has demonstrated compelling antitumor activity and favorable safety in early trials. Completing enrollment months ahead of schedule accelerates clinical development timelines and reflects both strong confidence of investigators in the trial design and the urgent patient need for effective, safer therapies. We remain committed to advancing rigorous clinical development across multiple indications, including EP-NEC."

Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, added, "This achievement was made possible by the exceptional execution of our clinical team, the dedication of investigators, and the trust of patients and their families. Every data point in this study represents hope for patients facing a devastating disease. Guided by our mission-care for life, focus on innovation, and win win cooperation-we will continue to invest in R&D to accelerate Opamtistomig's global development and deliver transformative therapies worldwide."