Akeso Inc.  announced positive results from its Phase 3 clinical trial of gumokimab (AK111), a novel, fully human anti-IL-17A monoclonal antibody, for the treatment of active ankylosing spondylitis (AS). The study successfully met all primary efficacy endpoints, including ASAS20 and subgroup analyses, as well as the key secondary endpoint ASAS40. Furthermore, several pre-specified secondary endpoints demonstrated both statistically significant and clinically meaningful improvements, further supporting the potential of gumokimab as an effective treatment option for AS.

Gumokimab rapidly and effectively alleviated AS symptoms, significantly improved disease activity and enhanced physical function and quality of life in patients. This promising new treatment option may offer a much-needed solution for the approximately 4 million AS patients in China. Notably, gumokimab has already shown positive results in a Phase 3 pivotal trial for moderate-to-severe psoriasis, with the New Drug Application (NDA) for this indication accepted by the NMPA CDE in January 2025. The NDA submission for moderate-to-severe psoriasis marks gumokimab as Akeso's third non-oncology drug to enter the market approval process.

In addition, Akeso reported that its novel fully human anti-IL-4Rα monoclonal antibody, manfidokimab (AK120), has also achieved positive outcomes in its Phase 3 clinical trial for moderate-to-severe atopic dermatitis (AD). The study met all primary endpoints, key secondary endpoints, several pre-specified secondary endpoints, and demonstrated statistically significant and clinically relevant improvements in patients.

Manfidokimab notably improved skin lesions and provided excellent early relief of pruritus, offering a potentially transformative treatment for patients with moderate-to-severe AD. As a result of the strong efficacy and safety profile demonstrated in this trial, Akeso plans to file an NDA for manfidokimab in this indication, aiming to provide a more effective and domestically developed IL-4Rα-targeting biologics for AD patients in China. Manfidokimab will be Akeso's fourth non-oncology drug to enter the NDA phase and represents a significant milestone in the company's expanding autoimmune pipeline.

With the successful market launches of ebronucimab (PCSK9) and ebdarokimab (IL-12/IL-23), along with the recent positive Phase 3 studies from gumokimab (IL-17) and from manfidokimab (IL-4Rα), Akeso's non-oncology franchise is rapidly expanding and will provide a future driver for commercial growth. Akeso's expanding non-oncology product portfolio is further strengthened by a robust pipeline of innovative biologics that includes our first in class IL-4R/ST2 bispecific antibody and candidates for neurodegenerative diseases. The combination of commercial launches, Phase III successes and innovation-focused pipeline will increase Akeso's competitive position globally in non-oncology indications.

Forward-Looking Statement of Akeso, Inc.