Akeso, Inc. announced that the National Medical Products Administration (NMPA) of China has approved gumokimab (AK111), the company's internally-developed anti-IL-17 monoclonal antibody, for the treatment of adult patients with moderate-to-severe plaque psoriasis.

The approval was supported by one pivotal Phase III clinical study (AK111-301) and three supportive studies. Study results demonstrate gumokimab's rapid and robust efficacy, durable complete skin clearance, and favorable safety and dosing profile. Treatment demonstrated rapid onset of action, with clinically meaningful improvement observed as early as Week 2.

• Rapid and robust efficacy at Week 12: Gumokimab achieved a PASI 75 response rate of 94.6% and a complete skin clearance rate (PASI 100) of 47.7%, substantially higher than the 28.6% PASI 100 response rate observed with other agents in the same class.
• Durable complete clearance through Week 52: The PASI 75 response rate approached 100%, while the PASI 100 response rate reached 68.9%, markedly higher than the 39.2% reported for other drugs in the same class.
• Favorable safety profile: The incidences of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and infections/infestations were numerically among the lowest rates of TEAEs, SAEs, and infections/infestations reported in pivotal trials of IL-17-inhibitors.
• Convenient dosing regimen: Gumokimab utilizes a convenient subcutaneous dosing regimen requiring only 17 injections annually (including loading phase), approximately half the annual injection burden of other IL-17 inhibitors that require more frequent maintenance dosing. Reduced injection frequency has the potential to improve long-term adherence and persistence in moderate-to-severe plaque psoriasis.

Professor Xu Jinhua, Principal Investigator of the pivotal Phase III registration study for gumokimab at Huashan Hospital, Fudan University:

"Psoriasis is a chronic, lifelong condition that demands long-term standardized management. Beyond the physical burden of skin lesions, it significantly impairs patients' quality of life, work, social functioning, and mental well-being. Achieving deep and sustained skin clearance with good tolerability remains a major unmet need. Gumokimab, an IgG1 monoclonal antibody that precisely targets IL-17, has demonstrated rapid onset, strong short-term efficacy, durable long-term control, and a favorable safety profile in clinical studies. We are delighted by its approval, which offers patients a more effective, convenient, and reliable new treatment option."

Dr. Xia Yu, Founder, Chairwoman, President and CEO of Akeso:

"I would like to thank all the investigators, study teams, and patients who participated in the clinical development of gumokimab. Their contributions have enabled us to deliver this important new therapy to the approximately 6.7 million psoriasis patients.

To better address patients' diverse needs, Akeso has successfully developed and launched ebdarokimab and gumokimab, two therapies targeting distinct pathogenic pathways that complement each other. The autoimmune disease field remains one of the largest and fastest-growing areas in innovative drug development. With these two approvals, we have built a strong, differentiated portfolio for psoriasis. Manfidokimab is advancing in late-stage development across multiple indications, while our first-in-class IL-4R/ST2 bispecific antibody AK139 and other novel agents continue to progress rapidly. This growing immunology and inflammation platform is enhancing product synergies and strengthening Akeso's global competitiveness."

In addition to moderate-to-severe plaque psoriasis, a supplemental New Drug Application (sNDA) for gumokimab in active ankylosing spondylitis has been accepted for review by the Center for Drug Evaluation (CDE) of the NMPA.