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.

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.

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 neuroendocrine carcinoma (EP-NEC).

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The Phase Ib/II data for Opamtistomig in first-line treatment of EP-NEC are encouraging. In our communications with the CDE, we have seen the regulatory agency's strong focus on unmet clinical needs and its recognition of Opamtistomig's clinical value. Based on the clear regulatory feedback, we are rapidly implementing the pivotal Phase III study protocol, and we look forward to validating its potential to extend patient survival through a high-quality trial, bringing this innovative therapy to EP-NEC patients as soon as possible."