HONG KONG, July 3, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") has announced the successful enrollment of the first patient in its Phase Ia clinical trial for AK146D1, a bispecific Antibody-Drug Conjugate (ADC) targeting Trop2 and Nectin4. AK146D1 is Akeso's first bispecific ADC to enter clinical trials.

AK146D1 has recently received approval from the U.S. FDA, Australia's TGA, and China's NMPA to begin clinical trials.

Currently, Akeso's globally first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), have both been approved in China. The company has also rolled out a series of leading therapeutic strategies worldwide. Akeso is the only company globally with two approved cancer immunotherapy bispecific antibodies, positioning it with a strong global leadership advantage in the IO+ADC space.

Building on this, ADC therapeutics have become a key component of Akeso's "IO+ADC" 2.0 strategy, reshaping the global treatment landscape and setting new standards for cancer care.

Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, said:
"Leveraging our extensive experience in the development of multispecific antibody drugs, the advancement of innovative bispecific ADCs like AK146D1 enables the company to unlock the global clinical potential of its innovative product portfolio, expanding opportunities for the ongoing evolution of cancer therapies."

"Our globally first-in-class bispecific antibodies cadonilimab and ivonescimab have been successfully approved in China and have shown groundbreaking clinical value across various cancer treatments. This has established a strong global advantage for the company in the IO 2.0 space. Additionally, the efficient development of ADCs, particularly a series of innovative bispecific ADCs, will further strengthen our leadership in the ADC 2.0 field. As a result, after the evolution of IO + chemotherapy, IO + ADC, and IO 2.0 + ADC, Akeso has once again created a global competitive edge in "IO+ADC" 2.0. We are excited about the potential of these next-generation treatments to benefit patients worldwide."

Trop2 and Nectin4 are highly expressed in various tumor types but exhibit relatively low expression in normal tissues, making them ideal targets for ADC therapy. By targeting both Trop2 and Nectin4, AK146D1 aims to provide a broader therapeutic window and potentially overcome resistance seen with single-target ADCs, thus improving treatment efficacy.

While there are approved monoclonal ADCs targeting Trop2 and Nectin4, AK146D1 is the first bispecific ADC targeting both markers. Preclinical studies of AK146D1 have shown promising results, demonstrating strong anti-tumor activity and favorable safety profiles in tumors expressing Trop2 or Nectin4. The development of AK146D1 holds significant potential for improving treatment outcomes for cancer patients, and Akeso is excited about the potential benefits it could offer to clinicians and patients worldwide.