LEADS BIOLABS-B (09887.HK): NDA for Virexin as Treatment for Extrapulmonary Neuroendocrine Carcinoma Accepted by NMPA

NewTimeSpace News: On 21 August 2026, Nanjing Leads Biolabs Co., Ltd. (stock code: 09887) announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has formally accepted the new drug application (NDA) for Virexin (Opaltsumab, a PD-L1/4-1BB bispecific antibody, LBL-024), the Company's self-developed investigational drug, as monotherapy for advanced pretreated extrapulmonary neuroendocrine carcinoma (EP-NEC). Virexin is the world's first PD-L1/4-1BB bispecific antibody to be submitted for marketing approval, and the application has been granted priority review eligibility; if approved, it would become the world's first antibody drug directly targeting 4-1BB, making 4-1BB the fourth druggable immunotherapy target globally after PD-1/PD-L1, CTLA-4 and LAG-3.

The NDA is based on a pivotal registration clinical study led by Professor Shen Lin of Peking University Cancer Hospital and involving 34 hospitals, which completed enrolment of all 96 EP-NEC patients in August 2025. 

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