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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 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) of China's National Medical Products Administration (NMPA) to initiate a pivotal Phase III clinical trial for the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). This approval marks the successful advancement of Opamtis
About this update from Nanjing Leads Biolabs Co., Ltd. Class H
[{"type":"text","content":"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) of China's National Medical Products Administration (NMPA) to initiate a pivotal Phase III clinical trial for the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). This approval marks the successful advancement of Opamtistomig's clinical development in EP-NEC from late-line monotherapy to first-line combination therapy — Opamtistomig had previously received CDE approval for a pivotal single-arm registration trial in 3L+ EP-NEC patients; this Phase III approval further expands Opamtistomig's addressable patient population in EP-NEC, potentially reshaping the treatment landscape for this malignancy.","length":960,"tagName":"p"},{"type":"text","content":"This randomized, double-blind, multicenter Phase III study is led by Professor Lin Shen of Peking University Cancer Hospital. The approval was based on the promising efficacy and favorable safety profile demonstrated by Opamtistomig in a successfully completed Phase Ib/II proof-of-concept study. Detailed results are planned to be presented at the 2026 ESMO Congress.","length":368,"tagName":"p"},{"type":"text","content":"As an integral part of the overall EP-NEC development strategy, Leads Biolabs plans to submit a Biologics License Application (BLA) in the third quarter of 2026 for Opamtistomig as a single agent for the treatment of advanced EP-NEC in the third-line or later setting. In parallel, Leads Biolabs is advancing multiple proof-of-concept studies and preparing to initiate at least two additional Phase III clinical trials for Opamtistomig, exploring its application across 13 solid tumor indications, including first-line NSCLC, first-line BTC, small cell lung cancer, and ovarian cancer, thereby building a comprehensive, multi-tumor, multi-stage development layout. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC) and extrapulmonary neuroend...