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 not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2024) — Sources

Pivotal Clinical Evidence

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

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