ZIIHERA zanidatamab-hrii
Drug Class
HER2-targeted bispecific antibodyHER2靶向双特异性单克隆抗体
Mechanism
Binds simultaneously to two distinct non-overlapping extracellular domains of HER2, inducing receptor clustering and receptor internalization to inhibit tumor growth.同时结合 HER2 受体的两个非重叠胞外结构域，诱导受体聚集并内吞，阻断生长信号并介导免疫抗肿瘤效应。
Approved Indication
FDA-approved for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC).FDA批准用于治疗既往接受过系统治疗的、不可切除或转移性 HER2 阳性（IHC 3+）胆道癌 (BTC) 患者。
What This Means For Patients
ZIIHERA is a novel bispecific antibody targeting HER2 in biliary tract cancers. Approved by the FDA under accelerated regulations, it is accessible for clinical use in Hainan Boao Lecheng.ZIIHERA 是一种靶向 HER2 的新型双特异性抗体。其已获得 FDA 加速批准用于治疗 HER2 阳性的晚期胆道癌，目前患者可在海南博鳌乐城申请临床特许使用。
Regulatory Approvals
- FDA — approved (2024) — source
Pivotal Clinical Evidence
- HERIZON-BTC-01 — Harding et al., Lancet Oncol 2023 (NCT04466891) — DOI
Sources
This page provides regulatory and mechanism-of-action information for reference only. It is not medical advice, a treatment recommendation, or a guarantee of outcome. Availability is subject to individual clinical review.