New Drug Arrives at Jiahui:
World's First Approved Bispecific ADC Izalontamab Brengitecan Begins Clinical Use

SHANGHAI — Izalontamab Brengitecan for Injection, developed by Sichuan Baili Tianheng (百利天恒), is the world's first EGFR×HER3 bispecific antibody-drug conjugate (bispecific ADC). Approved in China in June 2026 for adults with recurrent or metastatic nasopharyngeal carcinoma after failure of at least two prior systemic chemotherapy lines and anti-PD-1/PD-L1 therapy, the drug has also received Breakthrough Therapy designation from the U.S. FDA. Its approval marks both the beginning of the bispecific ADC era in precision oncology and a milestone in which Chinese biopharma has moved from follower to global leader.

Recently, Izalontamab Brengitecan has officially begun its first clinical application at Jiahui International Cancer Center in Shanghai.

Unique Dual-Target ADC Design and Mechanism

As the world's first EGFR×HER3 bispecific ADC, Izalontamab Brengitecan is a humanized antibody-drug conjugate targeting both EGFR and HER3. Its structure consists of three parts:

1. Bispecific antibody: A humanized anti-EGFR×HER3 bispecific antibody formed by connecting an anti-EGFR IgG1 antibody via a GS linker at the heavy chain C-terminus to an anti-HER3 scFv.
2. Linker: An Ac-GGFG linker containing an Ac cleavable site.
3. Payload: Topoisomerase I inhibitor Ed-04, with approximately eight Brengitecan molecules conjugated per antibody.

The antibody portion binds to EGFR and/or HER3 on tumor cell surfaces, is internalized, and releases Ed-04 in lysosomes after enzymatic cleavage. This blocks DNA synthesis in tumor cells, killing them while simultaneously inhibiting two tumor-associated targets. The design offers broad tumor coverage, greater precision, stronger efficacy, and improved stability.

Outstanding Clinical Data

In the pivotal Phase III PANKU-NPC01 study for later-line nasopharyngeal carcinoma, Izalontamab Brengitecan demonstrated substantial improvement compared with chemotherapy:

• Objective response rate (ORR): 54.6% vs. 27.0% with chemotherapy — more than doubled
• Median duration of response (DoR): 8.5 months vs. 4.8 months
• Median progression-free survival (PFS): 8.38 months vs. 4.34 months

Based on this doubling of efficacy and survival benefit, the drug has been listed as a preferred regimen by both the U.S. National Comprehensive Cancer Network (NCCN) and the Chinese Society of Clinical Oncology (CSCO).

Clinical Exploration in Multiple Cancers

Beyond nasopharyngeal carcinoma, Izalontamab Brengitecan is expanding its clinical footprint. Marketing applications for esophageal squamous cell carcinoma and triple-negative breast cancer have already been formally accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration.

Jiahui International Cancer Center and Pharmacy Services

Jiahui International Cancer Center and the Department of Pharmacy are committed to bringing globally leading oncology therapies to patients as quickly as possible. Pharmacy services include:

Drug Supply and Quality Management

• Strict adherence to Good Supply Practice (GSP) standards, ensuring full traceability from procurement to storage and dispensing.
• Introduction of international originator drugs and high-quality generics to meet special medication needs in oncology and rare diseases.

Clinical Pharmacy Services

• Pharmacists in multidisciplinary teams (MDT): Providing medication optimization recommendations for complex cases.
• Therapeutic drug monitoring (TDM): Individualized dose adjustment for anti-infective and anti-tumor agents.
• Medication safety oversight: 24-hour human-in-the-loop prescription review, supported by pre-dispensing review systems, to promote standardized prescribing and reduce medication risk.

Comprehensive Patient Medication Education

Through medication counseling windows and online consultations, all patients receive face-to-face medication instructions, bedside discharge education, and targeted follow-up for high-risk patients — such as those receiving first-line anti-tumor therapy — to reduce anxiety and improve adherence.