Dose modifications were common in the iza-bren arm (about 63%), though discontinuations due to adverse events were low (1.9% vs 0.5%).

Iza-bren achieved a higher objective response rate of 51.7% (with 3.9% complete responses) and a disease control rate of 83.1% versus chemotherapy’s 20.5% ORR and 59.0% disease control, with median duration of response of 8.3 months compared with 4.0 months.

In the TNBC cohort (PANKU-Breast02), iza-bren reduced the hazard of death (OS HR 0.60) and extended median OS to 15.9 months from 12.5 months, while improving median PFS to 8.5 months vs 3.1 months, with ORR of 51.7% versus 20.5%.

Disclosure notes indicate Jiong Wu served as a consultant/advisor to Lilly.

Regulatory status includes a priority review by China’s NMPA for the ESCC indication, with global rights held by BMS outside China.

The release includes standard regulatory forward-looking statements and contact information for media and investors.

Trials were sponsored by Sichuan Biokin Pharmaceutical in Mainland China, with outside-China development conducted in collaboration with SystImmune and BMS.

Interim analyses with follow-up around 11 months suggest results mostly from Chinese trial populations; generalizability to Western populations and timelines remain uncertain, and there were higher treatment-related adverse events in ESCC requiring careful benefit-risk assessment.

First-phase results in nasopharyngeal cancer and prior ESMO data support ongoing global development and collaboration between Biokin, SystImmune, and BMS, with regulatory interactions ongoing in China and beyond.

China’s NMPA has accepted a New Drug Application for iza-bren in recurrent/metastatic ESCC and placed it in priority review.

Iza-bren, a bispecific EGFRxHER3 antibody-drug conjugate, showed statistically significant and clinically meaningful improvements in overall survival and progression-free survival in two Phase 3 trials presented at ASCO 2026, including PANKU-Breast02 for triple-negative breast cancer and PANKU-Esophagus01 for esophageal squamous cell carcinoma.

Dr. Yi Zhu, Biokin’s CEO, emphasized iza-bren’s potential first-in-class status and dual mechanism as a foundation for its clinical benefits and broader development.