World's First EGFR×HER3 Bispecific ADC Iza-Bren Prescribed at GCCC on Launch Day

Iza-Bren (Yizekang), the world's first EGFR×HER3 bispecific antibody-drug conjugate, at Guangzhou Concord Cancer Center

A new milestone has arrived in oncology. On June 22, 2026, China's National Medical Products Administration (NMPA) approved izalontamab brengitecan (Iza-Bren; trade name Yizekang), the world's first bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3.

Just eight days later, on June 30, this next-generation "bispecific ADC" became commercially available in Guangdong Province. On that same day, Guangzhou Concord Cancer Center (GCCC) wrote the first prescription and completed the first clinical infusion — making the patient one of the very first recipients of this globally pioneering therapy in China.

Source: National Medical Products Administration (NMPA) official website

First prescription for Iza-Bren (Yizekang) issued by GCCC Department of Medical Oncology on June 30, 2026

This is more than a new prescription. It is a vivid example of how a Chinese-developed innovative therapy can move from regulatory approval to patient benefit with remarkable speed.

Dual-Target Recognition Plus High-Payload Warhead

What makes Iza-Bren "globally first"? Traditional ADCs are often described as "biological missiles" — one antibody carrying one toxin to one target. As the world's first bispecific ADC, Iza-Bren's design is more sophisticated:

• Dual-target binding: The antibody simultaneously engages EGFR and HER3, two proteins highly expressed on tumor cells, blocking multiple tumor growth signaling pathways at once.
• High-potency payload: It carries a novel topoisomerase I inhibitor that kills cancer cells with precision.
• Bystander effect: The therapy can eliminate not only the targeted tumor cells but also surrounding heterogeneous tumor cells, helping overcome drug resistance.

This "dual blockade + high payload" design gives Iza-Bren promising activity across several solid tumors.

Breakthrough in Recurrent or Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma has long been called the "Canton tumor" because South China is a high-incidence region. For patients who have failed PD-1 immunotherapy and multiple lines of chemotherapy, treatment options have been extremely limited.

In the pivotal Phase III registration trial, Iza-Bren delivered striking results:

• Objective response rate (ORR): 54.6% — more than half of patients achieved significant tumor shrinkage.
• Median progression-free survival (mPFS): 8.38 months, versus 4.34 months with chemotherapy — a 56% reduction in disease progression or death risk.

BICR-assessed progression-free survival: Iza-Bren vs chemotherapy in nasopharyngeal carcinoma (Source: 2025 ESMO)

BICR-assessed objective response rate and duration of response: Iza-Bren vs chemotherapy

Based on this evidence, the regimen has been included in NCCN and CSCO guidelines as a preferred recommendation for later-line nasopharyngeal carcinoma, changing clinical practice.

Beyond NPC: PANKU-Esophagus01 Hits PFS and OS Endpoints

Iza-Bren's potential extends beyond nasopharyngeal carcinoma. In the PANKU-Esophagus01 Phase III trial for esophageal squamous cell carcinoma (ESCC), Iza-Bren became the first ADC to achieve statistically significant improvements in both median PFS and overall survival (OS) in this setting.

PANKU-Esophagus01: progression-free survival results in esophageal squamous cell carcinoma

PANKU-Esophagus01: overall survival results in esophageal squamous cell carcinoma

In the recommended-dose group, the confirmed ORR approached 40%. With no previously established standard-of-care for second-line ESCC backed by high-level evidence, Iza-Bren fills a critical unmet need. The new drug application for this indication has been accepted by NMPA and granted priority review. A filing for triple-negative breast cancer is also under review.

Selected Phase III indications in the Iza-Bren development pipeline (Source: Insight database)

GCCC Speed: From Approval to Prescription in Eight Days

As one of the first hospitals in China to clinically administer Iza-Bren, Guangzhou Concord Cancer Center moved quickly. "As clinicians, we are excited but also rational," said Dr. Liu Huixia, Director of GCCC's Department of Medical Oncology. "Bispecific ADCs deliver high efficacy, but they also require careful toxicity management — for example, oral mucositis and hematologic adverse events."

Dr. Liu emphasized that before treatment, the team rigorously assesses each patient's performance status and organ function, especially screening for interstitial lung disease and severe corneal disease, to ensure patients can both benefit from and tolerate the therapy.

Patient safety reminders during treatment:

• Regular monitoring of blood counts, liver function, and kidney function.
• Contact the care team promptly if oral pain, fever, or severe diarrhea occurs.
• The drug is given by intravenous infusion; patients remain under observation after infusion until acute reactions are ruled out.

From regulatory approval to commercial availability in just eight days, and from the first prescription to broader patient access, Guangzhou Concord Cancer Center continues to leverage its strengths in complex tumor management. By accumulating real-world clinical experience, the center aims to turn Chinese innovative therapies into tangible survival benefits for patients.

We look forward to seeing this pioneering therapy bring hope to more patients as additional clinical data mature.