The application focuses on treating advanced extrapulmonary neuroendocrine carcinoma (EP-NEC), a highly aggressive and immunologically cold cancer for which no standard therapies currently exist. The registrational clinical study, led by Professor Shen Lin of Peking University Cancer Hospital, enrolled 96 patients across 34 sites, providing the foundation for the regulatory submission. The CDE granted the drug Priority Review status in July 2026, signaling the agency's recognition of the urgent need for new treatment options in this space.
Nanjing Leads Biolabs Pushes Toward First Global 4-1BB Cancer Therapy
China's National Medical Products Administration has accepted the New Drug Application for Opamtistomig, a bispecific antibody targeting PD-L1 and 4-1BB. Developed by Nanjing Leads Biolabs, the drug is positioned to become the world's first approved therapy of its kind, potentially establishing a new benchmark in immuno-oncology for aggressive tumors.
Beyond EP-NEC, Leads Biolabs is exploring the drug's efficacy across a range of high-burden indications, including non-small cell lung cancer, hepatocellular carcinoma, and ovarian cancer. By simultaneously blocking PD-L1 immune suppression and activating the 4-1BB pathway, the drug aims to reactivate exhausted T cells in tumors that have historically proven resistant to standard checkpoint inhibitors. If successful, this approval would mark 4-1BB as the fourth major immuno-oncology target globally, following the established success of PD-1/PD-L1, CTLA-4, and LAG-3.
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