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Ivonescimab's Updated Label Shows Positive Dual Results in PFS and OS from HARMONi-A Study

On Jan. 6, 2026, Akeso, Inc. said China's National Medical Products Administration approved a significant label update for ivonescimab, incorporating final AK112-301/HARMONi-A study data.
As a randomized, double-blind Phase III study, the AK112-301/HARMONi-A trial was the first in EGFR-TKI-resistant locally advanced or metastatic nsq-NSCLC to show positive outcomes for co-primary endpoints, with long-term safety favorable and no new signals.
Showing robust survival benefits, the final analysis found ivonescimab plus chemotherapy reduced progression or death risk by 54% and showed a 26% lower death risk at 77% data maturity.
Following NRDL inclusion, patients in China gain widespread access to ivonescimab, supported by prior first-line approval for PD-L1-positive NSCLC offering chemotherapy-free treatment.
With a pipeline of over 50 innovative assets, Akeso, Inc. highlights 26 candidates in clinical trials and 7 new drugs commercially available but cautions about forward‑looking statements and risks.

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Ivonescimab's Updated Label Shows Positive Dual Results in PFS and OS from HARMONi-A Study

HONG KONG, Jan. 6, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced that the National Medical Products Administration has approved a significant label update in China for its internally developed, first-in-class PD-1/VEGF bispecific antibody, ivonescimab. The updated label incorporates final analysis…

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