Nanjing Leads Biolabs Co., Ltd. (9887.HK) said China’s Center for Drug Evaluation accepted its New Drug Application for Opamtistomig (LBL-024; Chinese trade name 維利信) as monotherapy for previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). The application received Priority Review on July 10, 2026. If approved, the company says Opamtistomig could become the world’s first antibody drug directly targeting 4-1BB and the first approved agonist-class antibody. The filing is supported by a 34-hospital registrational study that enrolled 96 patients by August 2025. In a separate Phase II first-line non-small cell lung cancer study, Opamtistomig combined with chemotherapy produced a 65.0% objective response rate and 95.0% disease control rate among 60 efficacy-evaluable patients, including a 77.4% response rate in squamous NSCLC; updated data are scheduled for oral presentation at the World Conference on Lung Cancer on Sept. 14, 2026.