On June 22, 2026, China’s NMPA granted conditional approval to izalontamab brengitecan (iza-bren, Yizekang, BL-B01D1), the world’s first approved bispecific antibody-drug conjugate , for heavily pretreated recurrent or metastatic nasopharyngeal carcinoma. In a phase 3 trial it achieved a 54.6% response rate and cut the risk of progression by 56%.
Source: National Medical Products Administration website, as reported by Xinhua
How It Works: A Guided Missile With Two Targeting Heads
An antibody-drug conjugate, or ADC, works like a guided missile. The antibody is the guidance system, recognizing a specific marker on cancer cells; a linker attaches a highly potent chemotherapy payload; once the cancer cell pulls the ADC inside, the payload is released to kill the cell. This is more precise than conventional systemic chemotherapy.
Izalontamab brengitecan, developed by China’s Biokin Pharmaceutical (Sichuan Baili Pharmaceutical), goes further: one antibody binds both EGFR and HER3 on nasopharyngeal cancer cells. After EGFR-targeted treatment, tumors often escape by ramping up the HER3 pathway, yet a HER3 antibody alone is barely effective because HER3 has little kinase activity. Blocking both markers at once improves binding while closing that escape route.
Each antibody carries about eight payload molecules (DAR about 8) of a topoisomerase I inhibitor, giving strong per-molecule potency. The released toxin can also cross cell membranes and kill nearby antigen-negative cancer cells—a bystander effect that helps with tumor heterogeneity.
Iza-bren binds EGFR and HER3, is internalized, and releases a DNA-damaging payload (schematic, not to scale)
How Treatment Is Given
1 Confirm eligibility
Pathology-confirmed recurrent or metastatic nasopharyngeal carcinoma that progressed after at least two lines of systemic chemotherapy (including a platinum regimen) and a PD-1/PD-L1 inhibitor; a specialist reviews organ function and fitness.
2 Intravenous infusion
In the phase 3 regimen, 2.5 mg/kg by IV infusion on days 1 and 8 of each 3-week cycle.
3 Regular blood monitoring
Complete blood counts are checked closely for anemia and reduced platelets, white cells, and neutrophils, with supportive care as needed.
4 Imaging assessment
Scans at scheduled intervals measure tumor shrinkage and progression-free survival. This is a later-line treatment, not first-line therapy for every stage.
Clinical Results: The First Phase 3 Trial in Later-Line NPC
Approval was based on PANKU-NPC 01 (BL-B01D1-303, NCT06118333), led by Professor Li Zhang at Sun Yat-sen University Cancer Center across 55 Chinese centers—the world’s first confirmatory phase 3 trial in later-line nasopharyngeal carcinoma. It enrolled 386 patients randomized 1:1 to iza-bren or the investigator’s choice of gemcitabine, capecitabine, or docetaxel. Results were a late-breaking abstract at ESMO 2025 and published in The Lancet (2025;406:2235–2243).
By blinded independent review, the confirmed objective response rate was 54.6% (95% CI 45.2–63.8) with iza-bren versus 27.0% with chemotherapy; median duration of response was 8.51 versus 4.76 months, and median progression-free survival was 8.38 versus 4.34 months (HR 0.44, 95% CI 0.32–0.62), a 56% reduction in the risk of progression or death. Overall survival data were not yet mature.
For context, older single-agent chemotherapy produced response rates around 30% and median progression-free survival of roughly 1.5 to 5.3 months, mostly from small studies. The drug is now a preferred later-line option in the NCCN Guidelines for NPC, China Edition (2026), and the 2026 CSCO guidelines (level I recommendation, the only category 1A evidence).
Safety: Strong Efficacy, Real Blood Toxicity
According to The Lancet, grade 3 or higher treatment-related adverse events occurred in 80% of the iza-bren group versus 62% with chemotherapy, dominated by hematologic toxicity: anemia 50% (vs 10%), thrombocytopenia 43% (vs 7%), leukopenia 43% (vs 44%), and neutropenia 38% (vs 41%). Serious treatment-related events were 43% versus 27%, and four treatment-related deaths (2%) were reported. Most non-hematologic events were grade 1–2.
Some participating centers and media reports cite a treatment-discontinuation rate of about 2.6% due to adverse events, with blood counts recovering quickly; that figure may use a different definition than the Lancet analysis, so the journal data should be treated as the primary reference.
Access and suitability This is a conditional approval, and long-term overall survival still needs follow-up. It is limited to a specific later-line population, requires IV infusion and close blood monitoring, and is not approved outside China (including the United States) as of September 2026; international patients currently access it through Chinese hospitals.
Why the World’s NPC Expertise Lives in China
Nasopharyngeal carcinoma is strikingly concentrated in southern China, Southeast Asia, and parts of Africa, and it is closely linked to Epstein-Barr virus infection. Cases are rare in Western countries, so companies there can neither recruit large trials nor build disease-specific experience. China’s large patient population and dedicated centers such as Sun Yat-sen University Cancer Center have driven the global standard of care.
In the wider ADC field, single-target agents such as Enhertu and Trodelvy are approved for several tumors, but the bispecific ADC category was opened by China. In December 2023 Biokin licensed global rights to Bristol Myers Squibb in a deal with an US$800 million upfront payment and up to US$8.4 billion total, then a record for an ADC out-licensing. Beyond NPC, the drug was approved in China for esophageal squamous cell carcinoma in 2026; its triple-negative breast cancer application has been accepted, with studies in lung, ovarian, and urothelial cancers ongoing.
For patients abroad, coming to China means earlier access to a first-in-class medicine and entry into the world’s deepest NPC practice—from pathology and radiotherapy planning to later-line systemic therapy, a concentration of case experience that is difficult to replicate elsewhere.
Izalontamab brengitecan (bispecific ADC) vs conventional later-line chemotherapy
Conditions It Can Treat
• Recurrent/metastatic nasopharyngeal carcinoma (approved, later line)
• Esophageal squamous cell carcinoma (approved in China, 2026)
• Triple-negative breast cancer (application accepted)
• EGFR-mutant non-small cell lung cancer (trials)
• HR+/HER2- breast cancer (phase 3 endpoint met)
• Ovarian cancer (trials)
• Urothelial carcinoma (trials)
• Cholangiocarcinoma (trials)
Want to know if this technology is right for you? Joyful Medical can help organize your medical records, connect you with the Chinese hospitals and specialist teams using this technology, and assess a treatment plan in China. After you submit your case, our coordinator will contact you. Free Case Evaluation