Nanjing Leads Biolabs Co., Ltd. (9887.HK) said China’s Center for Drug Evaluation under the National Medical Products Administration accepted its New Drug Application for Opamtistomig (LBL-024; Chinese trade name 維利信), a PD-L1/4-1BB bispecific antibody, as monotherapy for previously treated advanced extrapulmonary neuroendocrine carcinoma. The application received Priority Review on July 10, 2026. If approved, Opamtistomig could become the world’s first antibody drug directly targeting 4-1BB and the first approved agonist-class antibody. The filing is backed by a 34-hospital registrational study that completed enrollment of 96 patients in August 2025, with detailed data planned for a leading international conference. Leads Biolabs also said the drug has been studied in 13 solid-tumor indications in China. In a separate Phase 2 first-line non-small cell lung cancer study, 60 efficacy-evaluable patients had an objective response rate of 65.0% and a disease control rate of 95.0%; the squamous subgroup recorded a 77.4% objective response rate. Updated results are scheduled for oral presentation at the World Conference on Lung Cancer on Sept. 14, 2026. Extrapulmonary neuroendocrine carcinoma is an aggressive, immunologically cold cancer with no specifically approved treatment worldwide. Platinum-based first-line chemotherapy produces an objective response rate of about 30% to 50% and median overall survival of roughly one year, while second-line options produce response rates of about 10% to 25% and median overall survival of around eight months.