China Approves Akeso’s Gumokimab for Plaque Psoriasis

Akeso has secured regulatory approval in China for gumokimab (AK111), its internally developed anti-IL-17 monoclonal antibody, for the treatment of adults with moderate-to-severe plaque psoriasis. The approval by China’s National Medical Products Administration (NMPA) marks a significant milestone for the biotechnology company as it expands its presence in the rapidly growing immunology and inflammation market.

The approval was supported by data from one pivotal Phase III clinical trial, known as AK111-301, along with three additional supportive studies. Clinical results demonstrated that gumokimab delivered rapid, robust, and sustained efficacy while maintaining a favorable safety profile and offering a more convenient dosing schedule than many currently available therapies in the same class.

Psoriasis is a chronic autoimmune skin disease characterized by inflammation and the rapid buildup of skin cells, leading to scaling, redness, itching, and discomfort. Moderate-to-severe plaque psoriasis can significantly affect patients’ quality of life, mental health, social interactions, and work productivity. According to Akeso, approximately 6.7 million people in China are living with psoriasis, highlighting the substantial need for effective long-term treatment options.

In the pivotal study, gumokimab demonstrated rapid onset of action, with clinically meaningful improvements observed as early as two weeks after treatment initiation. By Week 12, the therapy achieved a Psoriasis Area and Severity Index (PASI) 75 response rate of 94.6%, indicating that nearly all treated patients experienced at least a 75% improvement in disease severity. Additionally, 47.7% of patients achieved complete skin clearance, measured by PASI 100, substantially exceeding response rates reported for several other therapies in the IL-17 inhibitor class.

Long-term results further reinforced the therapy’s potential. By Week 52, PASI 75 response rates approached 100%, while complete skin clearance rates reached 68.9%. These findings suggest that gumokimab may offer durable disease control and sustained skin clearance for patients requiring long-term treatment.

The drug also demonstrated a favorable safety profile during clinical development. Akeso reported that rates of treatment-emergent adverse events, serious adverse events, and infections were among the lowest observed in pivotal studies involving IL-17 inhibitors. Most safety findings were consistent with the known profile of the drug class.

Another distinguishing feature of gumokimab is its dosing convenience. The treatment requires only 17 subcutaneous injections annually, including the initial loading phase. This represents approximately half the annual injection burden associated with several competing IL-17 inhibitors, which often require more frequent maintenance dosing. Reduced injection frequency could improve patient adherence and treatment persistence over time.

Professor Xu Jinhua of Huashan Hospital, Fudan University, who served as the principal investigator of the Phase III registration study, said the approval addresses a significant unmet need in psoriasis care. He noted that patients require therapies capable of delivering deep and sustained skin clearance while maintaining good tolerability over extended treatment periods.

Akeso Founder, Chairwoman, President and CEO Dr. Xia Yu described the approval as an important achievement for the company’s growing immunology portfolio. She emphasized that gumokimab complements Akeso’s previously approved psoriasis therapy, ebdarokimab, by targeting a different disease pathway and expanding treatment options for patients.

Beyond psoriasis, Akeso is seeking to broaden gumokimab’s clinical use. The company announced that a supplemental New Drug Application for active ankylosing spondylitis has already been accepted for review by the Center for Drug Evaluation of the NMPA. Meanwhile, Akeso continues advancing additional late-stage and first-in-class immunology candidates, including manfidokimab and its IL-4R/ST2 bispecific antibody AK139.

With the approval of gumokimab, Akeso strengthens its position in China’s competitive autoimmune disease market and advances its strategy of building a diversified portfolio of innovative therapies for chronic inflammatory disorders.