Leads Biolabs Showcases Key Candidates, Four Phase III Trials

China's Leads Biolabs hosted an R&D Day, outlining plans to initiate four registrational Phase III trials between late 2026 and 2027. The trials will evaluate its lead asset, opamtistomig, in three frontline solid tumour indications – extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), and biliary tract cancer (BTC) – as well as its T-cell engager candidate, LBL-034, in relapsed/refractory multiple myeloma (r/rMM). The move signals the company's transition into a late-stage clinical development and value realisation phase.

Opamtistomig is a PD-L1×4-1BB bispecific antibody (BsAb). Key supporting data includes an objective response rate (ORR) of 72.2% in 18 evaluable patients with first-line NSCLC, and an ORR of 33.3% with a median overall survival (mOS) of 11.9 months in later-line EP-NEC. The candidate has received breakthrough therapy designation (BTD) in China and orphan drug designations in the EU and US for EP-NEC. The company expects to present larger datasets for these indications at major oncology conferences in late 2026.

According to PharmCube's NextBiopharm® database, opamtistomig is the second-furthest developed PD-L1×4-1BB BsAb worldwide. Click here to request a free trial for NextBiopharm®.

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