Izalontamab Brengitecan for Injection, a first-in-class novel EGFR×HER3 bispecific antibody-drug conjugate (bispecific ADC), has been independently developed by Sichuan Biokin Pharmaceutical in China. The therapy received its first global approval in China in June 2026 for adult patients with recurrent or metastatic nasopharyngeal carcinoma and esophageal squamous cell carcinoma who have failed at least two lines of prior systemic chemotherapy and PD-1/PD-L1 inhibitor therapy. It was previously granted Breakthrough Therapy Designation (BTD) by the U.S. FDA.
Jiahui International Cancer Center (JICC) in Shanghai, China, recently dispensed its first prescription for Izalontamab Brengitecan for Injection.
Unique Dual-Target ADC Design and Mechanism of Action
As the world’s first approved EGFR×HER3 bispecific ADC, Izalontamab Brengitecan for Injection represents a new approach to precision cancer therapy. Unlike traditional single-target treatments, it simultaneously targets two key tumor markers, helping overcome treatment resistance and improving cancer cell elimination.
By combining dual-target recognition with a highly potent anti-cancer payload, Izalontamab Brengitecan for Injection is designed to deliver treatment more precisely to tumor cells while also enhancing its ability to attack surrounding cancer cells. This approach may provide stronger anti-tumor effects compared with conventional single-target ADC therapies.
Importantly, its innovative design helps reduce unwanted effects on normal tissues, addressing a key challenge of traditional EGFR-targeted therapies such as skin-related toxicity. Overall, Izalontamab Brengitecan for Injection represents a next-generation ADC approach that aims to achieve more effective tumor control with improved treatment precision and tolerability.
Clinical Efficacy Data (Second-Line+ Treatment for Nasopharyngeal Carcinoma, Phase III PANKU-NPC01 Trial)
The objective response rate (ORR), or tumor shrinkage, reached 54.6%, nearly doubling the 27.0% observed in the chemotherapy group.
The median duration of response (DoR) was 8.5 months, compared with 4.8 months for chemotherapy.
The median progression-free survival (PFS) was 8.38 months, versus 4.34 months in the chemotherapy group.
Based on the landmark phase III results showing doubled PFS and ORR over chemotherapy, Izalontamab Brengitecan for Injection has been designated a preferred treatment regimen by authoritative guidelines including National Comprehensive Cancer Network (NCCN) and the Chinese Society of Clinical Oncology (CSCO).
Clinical Evaluation Across Multiple Cancer Types
In addition to the clinical application progress of Izalontamab Brengitecan for Injection in nasopharyngeal carcinoma and esophageal squamous cell carcinoma, the new drug applications for triple-negative breast cancer and non-small cell lung cancer have been formally accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
The launch of Izalontamab Brengitecan for Injection represents a major step forward in precision cancer treatment and shows China’s growing role as a global leader in biopharmaceutical innovation.
Jiahui International Cancer Center and its Department of Pharmacy are committed to bringing the world's leading oncology treatment solutions to cancer patients as quickly as possible, delivering hope to those in need.
