HONG KONG, April 28, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced 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.

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.

About Akeso

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has established a robust R&D innovation ecosystem centered on its Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

Forward-Looking Statements

This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

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