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Leads Biolabs Reports NMPA NDA Acceptance for Opamtistomig in Previously Treated Advanced EP-NEC

Shots: Chinese NMPA CDE has accepted the NDA for opamtistomig (LBL-024) as monotx. for previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) The NDA is supported by a registrational study led by Professor Shen Lin of Peking University Cancer Hospital, conducted across 34 sites; the study enrolled 96 pts with EP-NEC and completed enrollment in Aug 2025,…
5 hours ago

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Leads Biolabs Reports NMPA IND Clearnce to Initiate P-Ib/II Trial for Opamtistomig Combination Therapy in mCRC

Shots: The NMPA has approved IND application to initiate P-Ib/II trial of opamtistomig (LBL-024) in combination therapy for metastatic colorectal cancer (mCRC) Trial will evaluate the safety & efficacy of opamtistomig combination regimens in pts with mCRC & explore potential predictive biomarkers. Opamtistomig mechanism was already validated across EP-NEC, NSCLC, SCLC, & biliary tract cancer…
August 3, 2026

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Nanjing Leads Biolabs Receives NMPA Priority Review for Opamtistomig to Treat EP-NEC

Shots: The Chinese NMPA has accepted the BLA & granted priority review to Opamtistomig (LBL-024) as a monotx. for the treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) BLA was supported by the registrational trial data, designed to assess the efficacy & safety of Opamtistomig in pts with advanced EP-NEC whose disease had progressed following ≥2…
July 10, 2026

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