Akeso, Inc. (9926.HK) (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.