China NMPA Approves Iza-bren for Nasopharyngeal Carcinoma, Marking First Global Bispecific ADC Approval

China's National Medical Products Administration (NMPA) granted approval for iza-bren on June 22, 2026, making it the first bispecific ADC to receive regulatory approval anywhere in the world.¹ Yi Zhu, MD, Chairman and CEO of Biokin (SystImmune's parent company), underscored the milestone: "This is the first bispecific ADC approval of any kind globally. This approval validates our innovative EGFR×HER3 bispecific ADC design."¹

What is iza-bren, and how does its bispecific ADC design work?

Iza-bren is a bispecific antibody-drug conjugate (ADC) developed by SystImmune (licensed to Bristol Myers Squibb for global development outside China) that simultaneously targets epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). The molecule couples this bispecific antibody with a topoisomerase I inhibitor payload delivered via a cleavable linker.

HER3 is overexpressed across multiple epithelial malignancies and has emerged as a clinically validated ADC target. HER3 also contributes to tumor survival signaling through interactions with members of the EGFR family, providing a rationale for dual-receptor targeting strategies.² By binding both EGFR and HER3 simultaneously, iza-bren is designed to broaden tumor cell internalization and increase payload delivery relative to monospecific ADCs.

What did the pivotal data show in nasopharyngeal carcinoma?

The approval was supported by phase 3 data published in The Lancet in 2025, which demonstrated statistically significant improvements in progression-free survival and overall response rate in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who had progressed on prior platinum-based therapy.³ NPC carries a high burden of EGFR and HER3 co-expression, making it a biologically appropriate indication for the dual-targeting design.

The trial enrolled patients across sites in China, where NPC incidence is substantially higher than in Western populations due to Epstein-Barr virus prevalence and genetic risk factors, giving the NMPA pathway both clinical and epidemiological relevance.

What is the regulatory significance of this approval?

BioPharm International previously reported on iza-bren's phase 3 results in triple-negative breast cancer and esophageal squamous cell carcinoma, where the molecule has also shown activity — indications that remain under active regulatory evaluation.⁴ The NPC approval establishes a regulatory proof of concept for the bispecific ADC platform and may accelerate review timelines in those additional settings.

How does this approval advance the bispecific ADC field?

Bispecific ADCs represent one of the most technically demanding constructs in oncology drug development, requiring simultaneous optimization of antibody bispecificity, linker stability, and payload potency. The expanding pipeline of bispecific ADCs across solid tumors reflects growing interest in dual-targeting strategies as a potential approach to overcoming resistance associated with single-antigen therapies.

The iza-bren NMPA approval is the first demonstration that this class can clear the full regulatory bar — a milestone that is likely to accelerate investment and IND filings across the bispecific ADC pipeline globally.

References

1. NMPA Approves Izalontamab Brengitecan (Iza-bren) for Nasopharyngeal Carcinoma. (2026 Jun 22). SystImmune. https://www.prnewswire.com/news-releases/systimmune-announces-first-approval-of-iza-bren-for-the-treatment-of-recurrent-or-metastatic-nasopharyngeal-carcinoma-in-china-302806766.html
2. Gandullo-Sánchez L, Ocaña A, Pandiella A. (2022 Oct 21). HER3 in cancer: from the bench to the bedside. J Exp Clin Cancer Res. https://link.springer.com/article/10.1186/s13046-022-02515-x?utm_source=chatgpt.com
3. Yang Y, Zhou H, Tang L et al. (2025 Nov 8). Izalontamab brengitecan, an EGFR and HER3 bispecific antibody–drug conjugate, versus chemotherapy in heavily pretreated recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 study in China. The Lancet. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01954-3/abstract?rss=yes
4. Mirasol, F. (2026 Jun 2). Izalontamab Brengitecan Meets Dual Survival Endpoints in Phase 3 TNBC and Esophageal Cancer Trials. BioPharm International. https://www.biopharminternational.com/view/izalontamab-brengitecan-dual-survival-endpoints-phase-3-tnbc-esophageal-cancer-trials