Akeso Doses First Patient in Phase II Study of Novel TROP2/Nectin-4 Bispecific ADC (AK146D1) in Combination with Ivonescimab for Advanced NSCLC

HONG KONG, July 20, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that the first patient has been dosed in a Phase II clinical study (AK146D1-201) evaluating its internally developed TROP2/Nectin-4 bispecific antibody-drug conjugate (ADC), AK146D1, in combination with ivonescimab (the Company's PD-1/VEGF bispecific antibody) in patients with advanced non-small cell lung cancer (NSCLC). The study will explore the therapeutic potential of this combination, with a particular emphasis on the first-line treatment setting.

The advancement of ADC 2.0 candidates AK146D1 and AK138D1 into Phase II trials marks a critical milestone for Akeso's "IO2.0 + ADC2.0" strategy. Built upon our proprietary bispecific and multispecific antibody technology alongside our innovative IO2.0 portfolio, this progress underscores our commitment to elevating the standard of care for major global diseases like lung cancer. Furthermore, it reinforces our cancer therapy matrix, positioning Akeso with distinct, cross-generational competitive advantages in the global market.

In the immuno-oncology (IO) arena, Akeso stands as the only company globally with two approved bispecific antibodies for cancer immunotherapy. The Company is actively evaluating ivonescimab and cadonilimab in combination with its pipeline of proprietary next-generation ADC2.0 agents. Increasingly, global partners recognize both ivonescimab and cadonilimab as preferred agents for combination regimens and breakthrough therapy explorations across a wide spectrum of tumor types.

Within the ADC landscape, Akeso has established a pipeline of breakthrough next-generation candidates, with AK146D1, AK138D1, AK157D1, and AK158D1 (a bispecific ADC) already in clinical development. These novel agents are designed to overcome the narrow therapeutic window and safety limitations frequently observed in conventional ADCs, effectively ushering ADC therapy into a new 2.0 era.

Ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, has demonstrated clinically transformative benefits compared to PD-1 inhibitor-based therapies across multiple Phase III studies, supported by a robust body of clinical evidence. AK146D1 is an ADC2.0 agent that exhibits potent antitumor activity and a favorable safety profile. The combination of AK146D1 and ivonescimab holds the potential to significantly enhance clinical efficacy, reduce treatment-related toxicity, and broaden the range of eligible patients. By addressing the multifaceted clinical limitations of conventional immunotherapy and current ADC therapies, this regimen aims to emerge as a next-generation solution that offers superior efficacy and safety for patients with cancer.

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, Akeso has built a comprehensive R&D innovation ecosystem anchored by its proprietary 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.

Backed by world-class GMP manufacturing facilities and a highly efficient, integrated commercialization system, Akeso has developed into a globally competitive biopharmaceutical enterprise. Leveraging its fully integrated, multi-functional platform, the company maintains a robust pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Of these, 27 candidates have advanced into clinical trials—including 15 bispecific or multispecific antibodies and bispecific ADCs—and 8 innovative drugs have reached commercial stage.

Through efficient and groundbreaking R&D, Akeso integrates premier global resources to develop transformative medicines, deliver high-quality, affordable therapeutic antibodies to patients worldwide, and generate sustained commercial and societal value as it strives to become a global leader in biopharmaceutical innovation.

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.

SOURCE Akeso, Inc.