China’s NMPA approves SystImmune’s iza-bren (BL-B01D1), the first EGFR×HER3 bispecific ADC, for previously treated recurrent or metastatic nasopharyngeal carcinoma.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Iza-bren (BL-B01D1) has become the world’s first approved EGFR×HER3 bispecific antibody-drug conjugate (ADC) after receiving regulatory approval in China for adults with recurrent or metastatic nasopharyngeal carcinoma (NPC) whose disease progressed following platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. The approval is supported by pivotal Phase III data showing significant improvements in objective response rate and progression-free survival over chemotherapy.
SystImmune Inc. announced that its parent company, Sichuan Biokin Pharmaceutical, received approval from China’s National Medical Products Administration (NMPA) for the first-in-class therapy, marking the first regulatory authorization for iza-bren anywhere in the world.
The decision introduces a new treatment option for patients with recurrent or metastatic NPC, a population with few effective therapies after disease progression, while also validating SystImmune’s proprietary EGFR×HER3 bispecific ADC platform.
First-in-Class Bispecific ADC Targets EGFR and HER3
Iza-bren is a bispecific ADC that simultaneously targets epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), two proteins frequently overexpressed in epithelial cancers and linked to tumor growth and survival.
The antibody binds both targets, disrupting EGFR and HER3 signaling while delivering a proprietary Topoisomerase I inhibitor (Topo1i) payload directly into tumor cells. Following internalization, the cytotoxic payload induces DNA damage that leads to cancer cell death.
Outside China, SystImmune is developing iza-bren in collaboration with Bristol Myers Squibb across multiple solid tumor indications.
Phase III Trial Demonstrated Superior Efficacy Over Chemotherapy
The approval was supported by results from the pivotal Phase III BL-B01D1-303 trial (NCT06118333), a randomized, open-label, multicenter study conducted in China. The trial enrolled patients with recurrent or metastatic NPC who had previously received PD-1/PD-L1 inhibitors and at least two chemotherapy regimens, including one platinum-containing regimen.
Compared with physician’s choice of chemotherapy, iza-bren produced clinically meaningful improvements across several efficacy endpoints.
Blinded independent central review (BICR) confirmed an objective response rate (ORR) of 54.6% with iza-bren versus 27.0% with chemotherapy (odds ratio 3.3; 95% CI 1.9-5.8; p<0.0001).
Median duration of response (DoR) reached 8.5 months with iza-bren compared with 4.8 months for chemotherapy (hazard ratio 0.43; 95% CI 0.22-0.83).
Median progression-free survival (PFS) also improved substantially, extending to 8.38 months versus 4.34 months with chemotherapy (hazard ratio 0.44; 95% CI 0.32-0.62). Overall survival data remain immature and will continue to be evaluated.
New Option for a High-Unmet-Need Cancer
Nasopharyngeal carcinoma originates in the nasopharynx and is relatively uncommon worldwide but remains endemic in southern China, Southeast Asia, and parts of North Africa. The disease is strongly associated with Epstein-Barr virus (EBV) infection.
Patients with recurrent or metastatic NPC who progress after chemotherapy and immunotherapy generally have poor outcomes, with reported five-year overall survival rates below 10%, highlighting the need for more effective therapies.
Company Highlights Clinical and Platform Milestone
Jonathan Cheng, MD, Chief Medical Officer of SystImmune, said the approval introduces an important treatment option for patients whose disease has progressed after platinum-based chemotherapy and immunotherapy, noting that iza-bren demonstrated meaningful improvements in tumor response and progression-free survival compared with chemotherapy.
Yi Zhu, MD, Chairman and Chief Executive Officer of Biokin, described the approval as a landmark achievement for both companies and said it validates the clinical potential of the company’s EGFR×HER3 bispecific ADC technology and proprietary brengitecan-based ADC platform.
Path Forward
The approval establishes iza-bren as the first marketed product from SystImmune’s bispecific ADC platform and may support additional regulatory submissions in other regions. Development of the therapy continues across multiple tumor types through SystImmune’s collaboration with Bristol Myers Squibb outside China, with ongoing studies expected to further define its role in EGFR- and HER3-expressing cancers.
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About the Writer
Chikkula Pavan Kumar (LinkedIn), PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.