Akeso’s gumokimab (AK111) has received NMPA approval in China for moderate-to-severe plaque psoriasis after demonstrating strong PASI responses, durable efficacy through 52 weeks, favorable safety, and convenient dosing.
Written By: Fariha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
Akeso has received approval from China’s National Medical Products Administration (NMPA) for gumokimab (AK111; Qi You Kang®) to treat adults with moderate-to-severe plaque psoriasis, marking an important addition to the company’s growing autoimmune disease portfolio.
Plaque psoriasis remains a chronic immune-mediated disease that extends beyond skin manifestations, often affecting patients’ quality of life, psychological well-being, and social functioning. Despite advances in biologic therapy, clinicians continue to seek treatments capable of delivering rapid disease control, durable skin clearance, and long-term safety.
Gumokimab, a novel anti-IL-17 monoclonal antibody developed by Akeso, targets a key inflammatory pathway implicated in psoriasis pathogenesis. The approval is supported by data from the pivotal Phase III AK111-301 trial (NCT05504317) and three supportive clinical studies, which collectively demonstrated rapid onset of action, sustained efficacy, and a favorable safety profile.
Clinical Trial Demonstrates Rapid and Robust Responses
Clinical responses emerged early in treatment, with meaningful improvements observed as early as Week 2. According to Akeso, the efficacy data compared favorably with outcomes reported for other IL-17 inhibitors evaluated in plaque psoriasis.
By Week 12, 94.6% of patients achieved a Psoriasis Area and Severity Index 75 (PASI 75) response, indicating at least a 75% reduction in disease severity. Nearly half of treated patients (47.7%) achieved complete skin clearance, as measured by PASI 100. These results compared favorably with outcomes reported for other IL-17-targeted therapies and underscore gumokimab’s strong efficacy profile in plaque psoriasis.
Durable Efficacy Through One Year
The treatment benefits remained durable through one year of follow-up. At Week 52, nearly all patients maintained PASI 75 responses, while 68.9% achieved PASI 100. This level of complete skin clearance exceeded the approximately 39.2% PASI 100 response reported with comparable therapies, highlighting the durability and depth of response achieved with gumokimab.
Favorable Safety and Convenient Dosing
Safety outcomes further strengthened the therapy’s clinical profile. Rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and infections/infestations were numerically among the lowest reported across pivotal IL-17 inhibitor trials, supporting the favorable safety profile observed throughout the clinical development program.
The therapy may also offer practical advantages in routine clinical practice. Gumokimab requires only 17 subcutaneous injections annually, including the loading phase, reducing treatment burden compared with several currently available biologic therapies. Less frequent dosing may support treatment adherence and improve long-term disease management.
Expert Perspectives and Future Development
Professor Xu Jinhua of Huashan Hospital, Fudan University, and principal investigator of the clinical program, emphasized the importance of effective long-term treatment strategies for patients with psoriasis and welcomed the approval as an important addition to the therapeutic armamentarium.
Dr. Xia Yu, Founder, Chairwoman, President, and Chief Executive Officer of Akeso, acknowledged the contributions of patients, investigators, and healthcare professionals who participated in the development program. She also noted that the approval brings a new treatment option to the approximately 6.7 million people living with psoriasis and further strengthens the company’s expanding presence in autoimmune diseases.
Akeso is also advancing gumokimab beyond psoriasis. A supplemental New Drug Application (sNDA) seeking approval for the treatment of active ankylosing spondylitis has been accepted for review by the Center for Drug Evaluation (CDE) of the NMPA.
With rapid onset of action, high rates of skin clearance, durable efficacy through 52 weeks, a favorable safety profile, and a convenient dosing schedule, gumokimab enters the Chinese psoriasis market as an important new treatment option for patients with moderate-to-severe disease. The approval also supports Akeso’s strategy of expanding its immunology and inflammation portfolio through the development of novel therapies targeting autoimmune diseases.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.