HONG KONG, June 11, 2026
Akeso, Inc. announced that China’s National Medical Products Administration (NMPA) has approved gumokimab (AK111, brand name: 奇佑康®), the company’s internally developed anti-IL-17 monoclonal antibody, for the treatment of adults with moderate-to-severe plaque psoriasis. The approval marks a significant milestone for Akeso’s expanding immunology and inflammation franchise and further strengthens its position in the rapidly growing autoimmune disease market. Supported by one pivotal Phase III clinical trial and three additional studies, gumokimab demonstrated rapid onset of action, deep and durable skin clearance, favorable safety outcomes, and a convenient dosing schedule, offering a promising new therapeutic option for millions of psoriasis patients in China. The regulatory approval also reinforces Akeso’s commitment to advancing innovative biologics that address major unmet medical needs in autoimmune diseases.
Phase III Data Show Strong Efficacy and Durable Disease Control
The approval of gumokimab was supported by results from the pivotal Phase III AK111-301 study, which delivered compelling efficacy outcomes in patients with moderate-to-severe plaque psoriasis. Clinical findings demonstrated a PASI 75 response rate of 94.6% and a PASI 100 complete skin clearance rate of 47.7% at Week 12, significantly exceeding results reported for several therapies within the same drug class. Long-term follow-up further highlighted the durability of treatment, with the PASI 75 response rate approaching 100% and the PASI 100 response rate reaching 68.9% at Week 52, indicating sustained disease control over one year of treatment. Patients also experienced meaningful clinical improvements as early as Week 2, demonstrating the therapy’s rapid onset of action. These results position gumokimab among the most competitive IL-17-targeted therapies currently available for plaque psoriasis treatment.
Safety Profile and Reduced Injection Burden Support Patient Adherence
Beyond efficacy, gumokimab demonstrated a highly favorable safety profile across clinical studies. Reported rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and infections were numerically among the lowest observed in pivotal trials involving IL-17 inhibitors. Another key differentiator is the therapy’s convenient administration schedule. Gumokimab requires only 17 injections per year, including the loading phase, representing approximately half the annual injection burden associated with many competing IL-17 therapies.
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Reduced dosing frequency has the potential to improve long-term treatment adherence and persistence, which remain critical challenges in managing chronic autoimmune diseases such as psoriasis. The combination of robust efficacy, durable skin clearance, strong safety performance, and patient-friendly dosing may help establish gumokimab as a preferred treatment option in the highly competitive biologics market.
Expanding Akeso’s Autoimmune Disease Portfolio
The approval significantly enhances Akeso’s growing presence in autoimmune and inflammatory diseases. According to company leadership, the addition of gumokimab complements ebdarokimab, creating a differentiated psoriasis portfolio targeting distinct disease pathways. Akeso is also advancing several next-generation immunology assets, including manfidokimab, which is currently in late-stage development across multiple indications, and AK139, a first-in-class IL-4R/ST2 bispecific antibody. Furthermore, a supplemental New Drug Application for gumokimab in active ankylosing spondylitis has already been accepted for review by the Center for Drug Evaluation of the NMPA, potentially expanding the therapy’s commercial reach.
With more than 50 innovative drug candidates in development and eight products already commercialized, Akeso continues to strengthen its position as a leading global biopharmaceutical innovator. The approval of gumokimab not only expands treatment options for approximately 6.7 million psoriasis patients but also highlights the company’s growing capabilities in developing best-in-class biologics for autoimmune diseases.
Source: Akeso press release
