China Expedites Review for Leads Biolabs’ Cancer Therapy Opamtistomig

The Center for Drug Evaluation under the National Medical Products Administration confirmed the expedited timeline, which cuts the standard review process from 200 working days to 130. This decision follows a pivotal clinical study led by Professor Shen Lin of Peking University Cancer Hospital, which tracked the efficacy of the drug in patients who had already exhausted at least two previous lines of systemic therapy.

Extrapulmonary neuroendocrine carcinoma remains a notoriously difficult disease to treat. With no globally approved therapies specifically indicated for the condition, patients typically face a median overall survival of only three to four months after standard platinum-based chemotherapy fails. Opamtistomig, which targets both PD-L1 and the 4-1BB co-stimulatory receptor, is designed to trigger a more robust immune response in these "cold" tumors. The company is now mobilizing its commercial infrastructure to prepare for a potential market launch, viewing this milestone as validation of its decade-long focus on bispecific antibody engineering.