Guosen Securities Reaffirms "Outperform Market" Rating for AKESO Following Historic Ivonescimab Breakthrough

Guosen Securities has released a research report stating that the core product of AKESO (09926), Ivonescimab, achieved statistically significant and clinically meaningful Overall Survival (OS) benefit in the HARMONi-6 clinical trial, further solidifying its foundational role in next-generation immuno-oncology (IO) therapy. Ivonescimab is set to undergo validation in global multi-center Phase 3 clinical trials within the coming year, with the potential to realize its global commercial value. AKESO possesses global R&D capabilities, and the inclusion of its product's major indications in China's national medical insurance is expected to drive rapid sales volume growth. The firm maintains its "Outperform Market" rating.

Core Analysis Points

On June 1st Beijing time, Professor Lu Shun presented the HARMONi-6 clinical results at the ASCO annual meeting's plenary session. Ivonescimab combined with chemotherapy demonstrated a significant positive OS outcome compared to Tislelizumab combined with chemotherapy in the first-line treatment of patients with squamous non-small cell lung cancer (sqNSCLC).

Guosen Securities' Pharmaceutical Sector Perspective

Firstly, HARMONi-6 represents the world's first Phase 3 clinical trial in the lung cancer field to achieve dual positive results for both Progression-Free Survival (PFS) and OS compared to a PD-1 monoclonal antibody combined with chemotherapy. The Ivonescimab plus chemotherapy regimen achieved an OS Hazard Ratio (HR) of 0.66, indicating a statistically significant and clinically meaningful OS benefit. Furthermore, all patient subgroups showed significant benefit, with consistent benefit trends across each subgroup.

Secondly, the global registrational clinical trials for Ivonescimab are progressing smoothly. Four global multi-center Phase 3 trials are currently underway. Among these, the HARMONi-3 trial's squamous carcinoma cohort is expected to undergo final PFS analysis and interim OS analysis in the second half of 2026. The non-squamous carcinoma cohort is projected to complete patient enrollment in 2026, with PFS data readout expected in the first half of 2027. The success of the HARMONi-6 trial validates that the PFS benefit from Ivonescimab combined with chemotherapy in first-line NSCLC patients translates effectively into an OS benefit, which holds indicative significance for the HARMONi-3 squamous carcinoma clinical trial.

Key Risk Factors

Potential risks include slower-than-expected clinical trial progress, clinical data falling short of expectations, commercialization challenges not meeting projections, and geopolitical risks.