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World’s First Approved Bispecific ADC Izalontamab Brengitecan Launches Clinical Use at Jiahui International Cancer Center

Writer: Elva Chen
Elva Chen
Aug 3
2 min read

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


On July 16, 2026, NMPA granted Iza-Bren a new indication for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) progressing after 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 where 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.

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

Unique Dual-Target ADC Design & Mechanism

Iza-Bren comprises three core components:

  1. Humanized EGFR×HER3 bispecific antibody: anti-EGFR IgG1 linked to anti-HER3 scFv via a GS linker;

  2. Cleavable Ac-GGFG linker;

  3. Topoisomerase I inhibitor payload Ed-04, with ~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. Dual simultaneous 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% vs chemotherapy 27.0% (double response rate)

  • Median DoR: 8.5 months vs 4.8 months

  • Median PFS: 8.38 months vs 4.34 months

    It has been listed as a preferred regimen by both NCCN and CSCO guidelines based on doubled survival benefits.


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

  • Median PFS: 4.17 months vs chemotherapy 1.97 months

  • Median OS: 9.79 months vs 7.20 months, 36% reduction in death risk (HR=0.64)

  • ORR: 35.3%, nearly triple chemotherapy’s 13.1%

  • DCR: 74.3% vs 45.5%

Iza-Bren demonstrates controllable safety and favorable tolerability: only 2.0% of patients discontinued treatment due to TRAEs (vs 3.3% chemotherapy), with 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 CDE under NMPA.


Comprehensive Pharmacy & Patient Services at Jiahui International Cancer Center

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

1. Drug Supply & 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 participate in MDT rounds to optimize regimens for complex cases;

  • Therapeutic Drug Monitoring (TDM) for personalized dosage adjustment of anti-infective and anti-tumor drugs;

  • 24-hour pre-prescription manual & digital review to standardize medication and reduce risks.

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.



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