On April 28, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that ivonescimab, the company’s first-in-class PD-1/VEGF bispecific antibody, has secured multiple authoritative updates and upgrades across first-line and later-line settings in the officially updated 2026 Chinese Society of Clinical Oncology (CSCO) Guideline for the Diagnosis and Treatment of Non-Small Cell Lung Cancer (NSCLC). These strong recommendations further solidify ivonescimab’s breakthrough clinical value and its position as a new standard of care (SOC), highlighting its leadership as a next-generation immunotherapy driving the IO 2.0 era.
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Key Highlights
In the Phase III HARMONi-2 study, ivonescimab monotherapy demonstrated superior progression-free survival compared with pembrolizumab in first-line PD-L1-positive (TPS ≥1%) NSCLC. Based on these results, ivonescimab has been upgraded to a Class I recommendation for first-line treatment of both squamous and non-squamous NSCLC with PD-L1 TPS ≥1%. This indication was previously approved in China and included in the National Reimbursement Drug List (NRDL). The upgrade strengthens its position as a preferred first-line option for PD-L1-positive advanced NSCLC.
In the Phase III HARMONi-6 study, ivonescimab plus chemotherapy showed positive results versus PD-1 inhibitor plus chemotherapy in first-line squamous NSCLC. This combination has received a new Class II recommendation for first-line treatment of squamous NSCLC. The supplemental application for this indication is currently under regulatory review.
Latest CSCO Guideline Recommendations for Ivonescimab
Post-resistance treatment in EGFR-mutant NSCLC: Ivonescimab plus chemotherapy maintains a Class I recommendation.
First-line treatment for advanced driver gene-negative squamous NSCLC with PD-L1 TPS ≥1%: Ivonescimab monotherapy upgraded to Class I recommendation.
First-line treatment for advanced driver gene-negative non-squamous NSCLC with PD-L1 TPS ≥1%: Ivonescimab monotherapy upgraded to Class I recommendation.
First-line treatment for advanced driver gene-negative squamous NSCLC: Ivonescimab plus chemotherapy newly added as Class II recommendation.
To date, the breakthrough clinical value of ivonescimab has been demonstrated in dozens of clinical trials and real-world experience involving more than 70,000 patients. It has gained wide acceptance among oncologists and patients, contributing to the ongoing advancement of immuno-oncology treatment paradigms globally.
(Press release, Akeso Biopharma, APR 28, 2026, View Source [SID1234664871])