Akeso has 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 China’s 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,” the company said.

 

This marks the second indication for which gumokimab has gained NDA review acceptance. Its application for moderate-to-severe psoriasis was previously accepted by the CDE in January 2025.

 

Gumokimab is Akeso’s third non-oncology drug candidate to enter regulatory review, following ebronucimab (a PCSK9 monoclonal antibody) and ebdarokimab (an IL-12/IL-23 monoclonal antibody). The company highlighted recent milestones in its non-oncology portfolio, including the market launch and NRDL inclusion of ebronucimab and ebdarokimab, as well as the steady progression of gumokimab and manfidokimab (IL-4R monoclonal antibody) toward 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 company noted.

 

The NDA submission is supported by positive Phase III results from the AK111-303 trial in active AS patients. Gumokimab “offers effective and swift alleviation of AS symptoms, significantly improves patients’ activity, physical function, and quality of life,” Akeso reported. 

 

The study met all pre-specified efficacy endpoints, including the primary ASAS20 response rate and key secondary ASAS40 response rate, with statistically significant and clinically meaningful outcomes across all subgroups.

 

Akeso emphasized that the announcement contains forward-looking statements, cautioning that “there can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success.” The company also outlined potential risks including industry competition, regulatory changes, manufacturing delays, and patent litigation.