NMPA Approves Iza-bren for ESCC in China
NMPA approves iza-bren ESCC for adults with recurrent or metastatic esophageal squamous cell carcinoma after platinum chemotherapy and PD-1/PD-L1 therapy. SystImmune said on July 17, 2026 that parent company Biokin won the China nod on Phase 3 PANKU-Esophagus01 survival data—the ADC's second China indication after nasopharyngeal carcinoma.
Contents10 sections
Key Takeaways
- NMPA approved iza-bren (izalontamab brengitecan) for post–platinum/PD-(L)1 recurrent or metastatic ESCC in China.
- PANKU-Esophagus01 (NCT06304974; 497 patients) met dual primary PFS and OS endpoints versus investigator-choice chemotherapy.
- Median OS 9.8 vs 7.2 months (HR 0.64); median BICR PFS 4.2 vs 2.0 months (HR 0.50).
- Grade ≥3 ILD was 0.8% with iza-bren; treatment discontinuation for TRAEs was 2.0%.
Iza-bren ESCC at a glance
| Field | Detail |
|---|---|
| Drug | Iza-bren (izalontamab brengitecan; BL-B01D1) |
| Companies | Sichuan Biokin / SystImmune (BMS partner outside China) |
| Regulator | China NMPA |
| Action | Approval announced July 17, 2026 (second China indication) |
| Indication | Adult recurrent/metastatic ESCC after platinum + PD-1/PD-L1 therapy |
| Class | EGFR × HER3 bispecific antibody-drug conjugate |
| Pivotal trial | PANKU-Esophagus01 / BL-B01D1-305 (NCT06304974) |
What did the NMPA approve?
SystImmune said Biokin received NMPA approval for iza-bren in adults with recurrent or metastatic ESCC whose disease progressed after platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. The company called it the second China approval after nasopharyngeal carcinoma and described iza-bren as a first-in-class EGFR × HER3 bispecific ADC.
Source: SystImmune's July 17 PR Newswire ESCC approval release.
What did PANKU-Esophagus01 show?
The randomized, open-label, multicenter Phase 3 trial compared iza-bren with investigator's choice chemotherapy across 80 China centers (n=497). Dual primary endpoints were PFS and OS; both were met at a pre-specified interim analysis and presented orally at ASCO 2026.
- Median OS: 9.8 vs 7.2 months (HR 0.64, 95% CI 0.49–0.83; p=0.0004)
- Median BICR PFS: 4.2 vs 2.0 months (HR 0.50, 95% CI 0.40–0.63; p<0.0001)
- TRAE discontinuations: 2.0%; all-grade / grade ≥3 ILD: 1.6% / 0.8% with iza-bren
Trial registration: ClinicalTrials.gov NCT06304974 (PANKU-Esophagus01).
Why ESCC remains a high unmet need in China
ESCC accounts for about 90% of esophageal cancers in China. SystImmune noted that after first-line platinum plus PD-1/PD-L1 therapy, most patients progress and historically faced limited second-line options with median OS under one year.
China oncology trial velocity context is covered in China trial speed and oncology go-East plans.
What is next for iza-bren globally?
SystImmune said global studies continue in NSCLC, breast cancer, urothelial cancer, and other EGFR/HER3-expressing tumors, with BMS collaboration outside China. Additional solid-tumor labels will depend on those registrational readouts, not the ESCC China approval alone.
What remains uncertain?
Full OS/PFS Kaplan–Meier curves, subgroup analyses, and detailed AE tables live in the ASCO dataset and China label. Cross-trial comparisons with other second-line ESCC options were not provided. Global filings outside China were not announced in this release.
Related NovaPharma coverage
- ASCO 2026: Asian Oncology Innovation
- Big Pharma's China Oncology Trials
- Hansoh HS-10541 NMPA trial nod for KRAS G12C
Frequently Asked Questions
What ESCC indication did NMPA approve for iza-bren?
On July 17, 2026, SystImmune said Biokin received NMPA approval for iza-bren (izalontamab brengitecan) in adults with recurrent or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. It is the drug's second China indication after nasopharyngeal carcinoma.
What did PANKU-Esophagus01 show?
In the Phase 3 PANKU-Esophagus01 study (NCT06304974; n=497), median OS was 9.8 months with iza-bren versus 7.2 months with chemotherapy (HR 0.64; p=0.0004). Median BICR PFS was 4.2 versus 2.0 months (HR 0.50; p less than 0.0001).
What kind of drug is iza-bren?
Iza-bren is an EGFR × HER3 bispecific antibody-drug conjugate (BL-B01D1). SystImmune is developing it with BMS outside China and is running global studies in NSCLC, breast, urothelial, and other EGFR/HER3-expressing cancers.
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