HARMONi-6 Phase III Study of Ivonescimab Accepted by The Lancet and Selected for ESMO 2025 LBA Presentation

HONG KONG, Oct. 16, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) today announced that the groundbreaking results from the registrational Phase III AK112-306/HARMONi-6 study of ivonescimab have been accepted for publication in The Lancet. The study evaluated ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, combined with chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). The article of Lancet will be simultaneously published during the 2025 European Society for Medical Oncology (2025 ESMO) Congress.

The HARMONi-6 trial result has been selected as a Late-Breaking Abstract (LBA) for the 2025 ESMO Congress. Professor Lu Shun, Director of the Oncology Department at Shanghai Chest Hospital, presented the study's findings at the Presidential Symposium. The results of this study extend Akeso's leadership in immunotherapy 2.0 and promise to shape future clinical strategies.

The HARMONi-6 trial marks a significant advancement for ivonescimab following its success in the head-to-head study against pembrolizumab as first-line treatment for PD-L1-positive NSCLC. This Phase III study has now demonstrated positive outcomes in a comparison of ivonescimab plus chemotherapy versus PD-1 inhibitor plus chemotherapy for the first-line treatment of squamous NSCLC, addressing a key unmet need in the treatment for advanced squamous NSCLC using anti-angiogenic agents. These successful outcomes demonstrate that ivonescimab achieves significant clinical breakthroughs, not only in comparison to PD-1 monotherapy or PD-1 combination chemotherapy, the current standard of care for many cancers in the immuno-oncology field, but also against VEGF-targeted therapies in anti-angiogenesis.

The encouraging results from the HARMONi-6 study have led to the review of a supplemental New Drug Application (sNDA) in China for ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous NSCLC.

Forward-Looking Statement of Akeso, Inc.

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.

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 created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company 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, 24 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.

For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.

SOURCE Akeso, Inc.