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Leads Biolabs' PD-L1/4-1BB Bispecific Antibody Wins Pivotal Phase III Approval, Set to Reshape the Frontline Treatment Landscape for Advanced EP-NEC
The approval expands Opamtistomig from late-line monotherapy to first-line combination therapy for advanced EP-NEC, where no drugs are approved, the company said.
- On Monday, Nanjing Leads Biolabs Co., Ltd. announced China's National Medical Products Administration approved a pivotal Phase III clinical trial for Opamtistomig to treat advanced extrapulmonary neuroendocrine carcinoma as first-line therapy.
- EP-NEC is a highly aggressive, immunologically "cold" tumor with no globally approved drugs; standard platinum-based chemotherapy offers only a 30%-50% objective response rate and approximately 1 year median survival, creating urgent unmet need.
- Designed using Leads Biolabs' proprietary X-Body platform, Opamtistomig targets PD-L1 and the 4-1BB receptor to trigger synergistic anti-tumor immune response. The antibody has been evaluated across 13 solid tumor indications in China.
- Professor Lin Shen of Peking University Cancer Hospital will lead the randomized, double-blind, multicenter Phase III study, while Leads Biolabs plans to submit a Biologics License Application in the third quarter of 2026.
- Opamtistomig has secured Breakthrough Therapy Designation from the NMPA, along with Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and European Commission, underscoring global recognition of unmet needs.
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Leads Biolabs' PD-L1/4-1BB Bispecific Antibody Wins Pivotal Phase III Approval, Set to Reshape the Frontline Treatment Landscape for Advanced EP-NEC
NANJING, China, May 18, 2026 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced that its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), has received approval from the Center for Drug Evaluation (CDE)…
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