Portfolio News

HONG KONG, Jan. 19, 2026 --Akeso, Inc. (9926.HK) announced that its supplemental New Drug Application (sNDA) for gumokimab (AK111), a novel humanized anti-IL-17A monoclonal antibody for the treatment of active ankylosing spondylitis (AS), has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). There are approximately 4 million AS patients in China, and gumokimab represents a potentially promising new therapeutic option for this disease.

 

Active ankylosing spondylitis (AS) is the second indication for which gumokimab has gained acceptance for NDA review. The application for its use in treating moderate-to-severe psoriasis was previously accepted by the CDE in January 2025.

 

Gumokimab is Akeso’s third non-oncology drug candidate to enter the regulatory review phase, following ebronucimab (PCSK9 monoclonal antibody) and ebdarokimab (IL-12/lL-23 monoclonal antibody). Recent notable progress from Akeso’s non-oncology franchise includes the market launch and NRDL inclusion of both ebronucimab and ebdarokimab, and the steady advancement of gumokimab and manfidokimab (IL-4R monoclonal antibody) towards commercialization.  These commercial and late stage developments are coupled with world-class innovation highlighted by the entry into clinical studies by AK139, Akeso’s first-in-class IL-4Rα/ST2 bispecific antibody for immunological indications, and by AK152, Akeso’s potential best-in-class bispecific candidate for neurodegeneration.

 

The NDA acceptance for gumokimab is based on the positive results from its pivotal Phase III clinical trial in the treatment of AS, AK111-303. This study demonstrated that gumokimab offers effective and swift alleviation of AS symptoms, significantly improves patients’  activity, physical function, and quality of life. In the study, gumokimab successfully met all pre-specified efficacy endpoints in individuals with active ankylosing spondylitis. The primary endpoint (ASAS20 response rate) showed consistent improvements across all subgroup analyses. The key secondary endpoint (ASAS40 response rate), and several other predefined secondary endpoints all reflected statistically significant and clinically meaningful outcomes.