Akeso, Inc. (HK:9926) announced an update on their ongoing clinical study.
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Akeso, Inc. (HK:9926) has launched a phase 3 trial titled “A Randomized, Open-label, Controlled, Multicenter Phase 3 Clinical Trial of AK104 for Neoadjuvant/Adjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer.” The study aims to test if AK104 can improve outcomes versus standard chemotherapy in early-stage high-risk colon cancer, a niche with rising medical and commercial interest.
The main treatment under review is Cadonilimab, also called AK104, an immune-based drug designed to help the body attack cancer cells more effectively. It is being positioned as a surgery-linked treatment, given both before and after surgery, and compared with common chemotherapy options such as oxaliplatin and capecitabine used only after surgery.
The trial is interventional and randomized, meaning patients are assigned by chance to either AK104 or usual chemotherapy care. It is open-label, so doctors and patients know which treatment is given, and the primary goal is to see which approach better treats resectable colon cancer with this specific genetic profile.
The study was first submitted on February 9, 2026, signaling the formal launch of the program in regulatory databases. The latest update was filed on February 25, 2026, and the trial is listed as “not yet recruiting,” meaning site setup and approvals are still in progress before patient enrollment begins.
For investors, this update reinforces Akeso’s push into late-stage development with AK104 in an earlier line of colon cancer, which can support a higher potential market if results are positive. While near-term revenue impact is limited, the move should support sentiment around the company’s pipeline strength and may influence how investors compare Akeso with other immunotherapy players in colorectal cancer.
As of the latest posting, the phase 3 study of AK104 in resectable MSI-H/dMMR colon cancer remains in the setup stage, and further details and future updates are available on the ClinicalTrials.gov portal under the listed registration number.
To learn more about HK:9926’s potential, visit the Akeso, Inc. drug pipeline page.