Akeso, Inc. announced that the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) has granted priority review of the supplemental New Drug Application (sNDA) to 依达方® (ivonescimab), a first-in-class PD-1/VEGF bi-specific antibody developed by Akeso, as  monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).

This marks the second indication for which ivonescimab has been granted priority review following the treatment of EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy, highlighting its significant clinical value.

This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study. At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent radiology review committee (BICR) compared to pembrolizumab, and the hazard ratio (HR) was significantly better than expected. There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

In May 2024, ivonescimab combination therapy for EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy was approved through priority review, making it the world's first approved bispecific antibody that combines "tumor immunotherapy" and "anti-angiogenesis" mechanisms.