HONG KONG — 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’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.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world’s first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.
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