Biopharmaceutical company Akeso Inc (HKEX: 9926.HK) announced on Monday that the National Medical Products Administration Center for Drug Evaluation has accepted its supplemental New Drug Application for gumokimab (AK111), a humanised anti-IL-17A monoclonal antibody, for the treatment of active ankylosing spondylitis in China.

Acceptance marks the second indication under regulatory review for gumokimab, following CDE acceptance of its New Drug Application for moderate-to-severe psoriasis in January 2025. Ankylosing spondylitis affects an estimated four million patients in China, positioning gumokimab as a potential new therapeutic option.

The application is supported by positive results from the pivotal Phase III AK111-303 trial, which met all pre-specified primary and secondary efficacy endpoints. Study data demonstrated rapid and effective symptom relief, with statistically significant and clinically meaningful improvements in disease activity, physical function and quality of life.

Gumokimab is Akeso's third non-oncology asset to enter regulatory review, following ebronucimab and ebdarokimab, both of which have been launched and included in China's National Reimbursement Drug List. Progress reflects continued expansion of Akeso's non-oncology pipeline alongside advancing late-stage and early-stage innovation programmes.