REDMOND, Wash., July 17, 2026
SystImmune Inc. announced that its parent company, Sichuan Biokin Pharmaceutical Co., Ltd., has received approval from China’s National Medical Products Administration (NMPA) for iza-bren (izalontamab brengitecan) to treat adult patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) whose disease has progressed following platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. The approval represents the second regulatory approval for iza-bren in China, following its recent authorization for recurrent or metastatic nasopharyngeal carcinoma (NPC). The milestone further establishes iza-bren as the world’s first EGFR × HER3 bispecific antibody-drug conjugate (ADC) approved for multiple cancer indications and reinforces its growing potential as an innovative targeted therapy for difficult-to-treat solid tumors.
Phase III Trial Demonstrates Significant Survival Benefit
The NMPA approval is supported by results from the pivotal PANKU-Esophagus01 (BL-B01D1-305) Phase III clinical trial, a randomized, multicenter study involving 497 patients across 80 clinical sites in China. The trial successfully achieved both dual primary endpoints, demonstrating statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared with investigator’s choice chemotherapy. Patients treated with iza-bren achieved a median overall survival of 9.8 months, compared with 7.2 months for chemotherapy, representing a meaningful reduction in the risk of death. Median progression-free survival reached 4.2 months, more than doubling the 2.0 months observed in the chemotherapy arm. The study also demonstrated a manageable safety profile, with only 2.0% of patients discontinuing treatment due to treatment-related adverse events and low rates of interstitial lung disease (ILD), reinforcing the therapy’s favorable benefit-risk profile. These positive results were previously presented during an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting the global scientific interest in the investigational therapy.
Bispecific ADC Expands Treatment Options for Advanced ESCC
Esophageal squamous cell carcinoma remains one of the most challenging cancers to treat, particularly after disease progression following first-line chemotherapy and immunotherapy. Patients with recurrent or metastatic ESCC often experience poor outcomes, with limited treatment options available after initial therapy failure. Iza-bren, an innovative EGFR × HER3 bispecific antibody-drug conjugate, has been specifically engineered to target two critical cancer growth pathways simultaneously while delivering a potent topoisomerase I inhibitor payload directly to tumor cells. This dual-targeting approach blocks cancer cell signaling, inhibits tumor proliferation, and promotes selective cancer cell death while minimizing damage to healthy tissue. The approval provides physicians with an important new therapeutic option capable of improving survival outcomes for patients facing advanced disease and substantial unmet medical need.
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Global Development Continues Across Multiple Solid Tumors
The latest approval further strengthens SystImmune’s rapidly expanding oncology pipeline and supports the company’s broader strategy to develop next-generation bispecific antibodies and antibody-drug conjugates for difficult-to-treat cancers. Outside China, iza-bren is being jointly developed with Bristol Myers Squibb across multiple global clinical programs targeting non-small cell lung cancer, breast cancer, urothelial cancer, and several other EGFR/HER3-expressing solid tumors. With two approved indications now secured in China and an extensive international clinical development program underway, iza-bren continues to demonstrate its potential as a first-in-class precision oncology therapy capable of addressing significant unmet medical needs across multiple tumor types. The latest regulatory success reinforces SystImmune’s position as an emerging leader in bispecific ADC innovation while advancing new treatment possibilities for patients worldwide.
Source: SystImmune press release
