World's First Approved Bispecific ADC Izalontamab Brengitecan Enters Clinical Use at Jiahui International Cancer Center

Independently developed by Sichuan Biokin Pharmaceutical Co., Ltd., Izalontamab Brengitecan for Injection (Iza-Bren) is a first-in-class EGFR x HER3 bispecific antibody-drug conjugate (bispecific ADC). It received its first NMPA approval in June 2026 for adults with recurrent/metastatic nasopharyngeal carcinoma who failed at least two lines of systemic chemotherapy plus PD-1/PD-L1 inhibitors, and had previously obtained FDA Breakthrough Therapy Designation.

On July 16, 2026, the NMPA granted Iza-Bren a new indication for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) progressing after a PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy (Application No. CXSS2600012). The approval is backed by the Phase 3 PANKU-Esophagus01 trial — the first global ADC study delivering positive dual PFS and OS endpoints for ESCC. It is poised to become the first standard ADC therapy for ESCC.

This launch marks a milestone in which China's biotech shifts from follower to global leader in precision oncology. Iza-Bren is now clinically available at the Cancer Center of Shanghai Jiahui International Hospital.

Unique Dual-Target ADC Design and Mechanism

Iza-Bren has three core components:

• A humanized EGFR x HER3 bispecific antibody: an anti-EGFR IgG1 linked to an anti-HER3 scFv via a GS linker.
• A cleavable Ac-GGFG linker.
• A topoisomerase I inhibitor payload, Ed-04, with about 8 Brengitecan molecules conjugated per antibody unit.

The bispecific antibody binds EGFR and/or HER3 on tumor cell surfaces, enters cells via endocytosis, and releases Ed-04 after lysosomal enzymatic cleavage. The payload blocks tumor DNA synthesis to induce cancer cell death. Simultaneous dual-target inhibition delivers broad anti-tumor coverage with superior precision, potency and stability.

Groundbreaking Clinical Efficacy Data

Phase 3 PANKU-NPC01 (Nasopharyngeal Carcinoma)

• ORR: 54.6% versus 27.0% for chemotherapy (double the response rate).
• Median DoR: 8.5 months versus 4.8 months.
• Median PFS: 8.38 months versus 4.34 months.

Based on doubled survival benefits, it has been listed as a preferred regimen by both the NCCN and CSCO guidelines.

Phase 3 PANKU-Esophagus01 (ESCC, presented at the 2026 ASCO Oral Session)

• Median PFS: 4.17 months versus 1.97 months for chemotherapy.
• Median OS: 9.79 months versus 7.20 months, a 36% reduction in death risk (HR = 0.64).
• ORR: 35.3%, nearly triple chemotherapy's 13.1%.
• DCR: 74.3% versus 45.5%.

Iza-Bren shows controllable safety and favorable tolerability: only 2.0% of patients discontinued treatment due to treatment-related adverse events (versus 3.3% for chemotherapy), with an ILD incidence as low as 1.6%.

Ongoing Clinical Exploration Across Multiple Tumors

Beyond NPC and ESCC, the New Drug Application for Iza-Bren in triple-negative breast cancer has been accepted by the CDE under the NMPA.

Comprehensive Pharmacy and Patient Services at Jiahui International Cancer Center

Our Cancer Center and Pharmacy Department rapidly introduce world-leading oncology therapies to expand treatment options, with full-spectrum pharmaceutical services:

1. Drug Supply and Quality Management

Fully compliant with GSP standards for traceable procurement, storage and dispensing; supplies original international agents and high-quality generics for oncology and rare disease care.

2. Clinical Pharmacy Support

• Pharmacists join MDT rounds to optimize regimens for complex cases.
• Therapeutic drug monitoring (TDM) for personalized dosing of anti-infective and anti-tumor drugs.
• 24-hour pre-prescription manual and digital review to standardize medication and reduce risk.

3. Full-Cycle Patient Medication Education

Dedicated consultation windows and online advisory channels; one-on-one bedside counseling for discharged patients, with intensive follow-up for first-time anti-tumor therapy users to ease anxiety and boost adherence.