ZIIHERA zanidatamab-hrii

Drug Class

HER2-targeted bispecific antibody

Mechanism

Binds simultaneously to two distinct non-overlapping extracellular domains of HER2, inducing receptor clustering and receptor internalization to inhibit tumor growth.

Approved Indication

FDA-approved for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC).

What This Means For Patients

ZIIHERA 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

• HERIZON-BTC-01 — Harding et al., Lancet Oncol 2023 (NCT04466891) — Sources

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs
• https://www.jazzpharma.com/media/