Bizengri zenocutuzumab

Drug Class

HER2/HER3 bispecific antibody

Mechanism

Binds to HER2 and HER3 receptors, blocking neuregulin-1 (NRG1) binding and inhibiting the heterodimerization of HER2/HER3 and its downstream signaling pathways.

Approved Indication

NRG1 fusion-positive advanced unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma, per its FDA approval.

What This Means For Patients

Bizengri is a targeted monoclonal antibody designed for patients with advanced cancers harboring NRG1 gene fusions, specifically non-small cell lung cancer and pancreatic cancer. It targets the HER2 and HER3 pathways to help control tumor progression, and patients can access it in the Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2024) — source

Pivotal Clinical Evidence

• eNRGy — Schram et al., N Engl J Med 2025 (NCT02912949) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zenocutuzumab-zbco-nrg1-positive-nsclc-and-pancreatic-cancer
• https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761405