Drug intelligence / Profile preview

IAH0968

Development stage
Phase 3
Lead developer
SUNHO BioPharmaceutical
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

IAH0968 is an afucosylated anti-HER2 (human epidermal growth factor receptor 2) monoclonal antibody designed to enhance antibody-dependent cellular cytotoxicity (ADCC) by improving binding affinity to FcγRIIIa receptors on immune effector cells. It is produced using a FUT8-deficient CHO cell line, resulting in complete fucose removal from the Fc region, which significantly increases its ADCC activity compared to conventional anti-HER2 antibodies like trastuzumab. Preclinical and early clinical studies have shown that IAH0968 has similar HER2 binding properties as trastuzumab but with superior anti-tumor efficacy and a favorable safety profile. The drug is being developed primarily for HER2-positive cancers, including breast cancer, gastric cancer, colorectal cancer, bile duct neoplasms, and other advanced solid tumors—especially in patients who are resistant or refractory to prior anti-HER2 therapies[1][5][6][7].

Other names
IAH-0968IAH0968IAH 0968
02

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)

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