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’s 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.
Forward-Looking Statement of Akeso, Inc.
This announcement by Akeso, Inc. (9926.HK, “Akeso”) contains “forward-looking statements”. These statements reflect the current beliefs and expectations of Akeso’s management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. 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. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.
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