Akeso has announced that the Centre for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its supplemental New Drug Application (sNDA) for gumokimab for the treatment of active Ankylosing Spondylitis (AS).

Gumokimab is a novel humanised monoclonal antibody targeting interleukin-17A and is being developed as a potential new treatment option for AS, a chronic inflammatory disease affecting an estimated four million patients in China.

This marks the second indication for which gumokimab has entered regulatory review, following the CDE’s acceptance of its NDA for the treatment of moderate-to-severe psoriasis in January 2025.

Gumokimab is Akeso’s third non-oncology drug candidate to advance into the regulatory review stage, after ebronucimab, a PCSK9 monoclonal antibody, and ebdarokimab, an IL-12/IL-23 monoclonal antibody. Both ebronucimab and ebdarokimab have been commercially launched and included in China’s National Reimbursement Drug List (NRDL), highlighting the company’s expanding non-oncology portfolio.

The acceptance of the sNDA is supported by positive results from the pivotal Phase III AK111-303 clinical trial in patients with active ankylosing spondylitis. The study demonstrated that gumokimab provided rapid and effective symptom relief, significantly improving disease activity, physical function and quality of life.

Gumokimab met all pre-specified primary and secondary efficacy endpoints in the trial. The primary endpoint, ASAS20 response rate, showed consistent improvements across all patient subgroups, while the key secondary endpoint, ASAS40 response rate and other secondary measures demonstrated statistically significant and clinically meaningful benefits.