en.Wedoany.com Reported - Akeso (9926.HK) announced that the China National Medical Products Administration (NMPA) has approved its self-developed anti-IL-17 monoclonal antibody gumokimab (AK111) for the treatment of adult patients with moderate-to-severe plaque psoriasis.
The approval is based on a pivotal Phase III clinical study (AK111-301) and three supportive studies. The results demonstrated that gumokimab provides rapid and potent efficacy, durable complete skin clearance, and a favorable safety profile and dosing regimen. Treatment showed a rapid onset of action, with clinically meaningful improvements observed as early as Week 2.
At Week 12, gumokimab achieved a PASI 75 response rate of 94.6% and a complete skin clearance rate (PASI 100) of 47.7%, significantly higher than the 28.6% PASI 100 response rate observed with other similar drugs. By 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 similar drugs.
In terms of safety, the incidence rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and infections/infestations were among the lowest reported in pivotal trials of IL-17 inhibitors. Regarding the dosing regimen, gumokimab employs a convenient subcutaneous administration schedule requiring only 17 injections per year (including the loading phase), approximately half the annual injection burden of other IL-17 inhibitors that require more frequent maintenance dosing. Reduced injection frequency may improve long-term compliance and persistence in patients with moderate-to-severe plaque psoriasis.
Professor Xu Jinhua, principal investigator of the pivotal Phase III registration study of gumokimab at Huashan Hospital affiliated with Fudan University, stated that psoriasis is a chronic, lifelong disease requiring long-term standardized management. Beyond the physical burden of skin lesions, it significantly impairs patients' quality of life, work, social functioning, and mental health. Achieving deep and sustained skin clearance with good tolerability remains a major unmet need. Gumokimab, an IgG1 monoclonal antibody precisely targeting IL-17, has demonstrated rapid onset, strong short-term efficacy, durable long-term control, and a favorable safety profile in clinical studies.
Dr. Xia Yu, founder, chairman, president, and CEO of Akeso, said, "We thank all investigators, research teams, and patients involved in the clinical development of gumokimab. Their contributions have enabled the company to provide this new therapy to approximately 6.7 million psoriasis patients. To meet the diverse needs of patients, Akeso has successfully developed and launched ivonescimab and gumokimab, which target different pathogenic pathways and complement each other. The autoimmune disease field remains one of the largest and fastest-growing areas in innovative drug development. With these two approvals, the company has established a product portfolio for psoriasis. Manfuximab is in late-stage development for multiple indications, while the first-in-class IL-4R/ST2 bispecific antibody AK139 and other novel drugs are advancing rapidly."
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.
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