Akeso's Gumokimab (AK111), an Anti-IL-17 Monoclonal Antibody, Approved by China's NMPA for Moderate-to-Severe Plaque Psoriasis
核心洞察
China's NMPA has approved Akeso (搜索)'s gumokimab (AK111), an anti-IL-17 (搜索) monoclonal antibody, for adult patients with moderate-to-severe plaque psoriasis (搜索).
In the pivotal Phase III trial, gumokimab achieved a PASI 75 response rate of 94.6% and a PASI 100 complete clearance rate of 47.7% at Week 12, with durable efficacy through Week 52.
The drug offers a convenient dosing regimen requiring only 17 injections annually, approximately half the injection burden of other IL-17 (搜索) inhibitors.
Akeso (搜索), Inc. (9926.HK) announced that China's National Medical Products Administration (NMPA) has approved gumokimab (AK111), the company's internally-developed anti-IL-17 (搜索) monoclonal antibody, for the treatment of adult patients with moderate-to-severe plaque psoriasis (搜索). The approval, dated June 11, 2026, marks a significant expansion of Akeso's autoimmune disease portfolio and introduces a new therapeutic option for the approximately 6.7 million psoriasis patients in China.
The regulatory decision was supported by one pivotal Phase III clinical study (AK111-301) and three supportive studies. Gumokimab is an IgG1 monoclonal antibody that precisely targets IL-17 (搜索), a key cytokine in the pathogenesis of plaque psoriasis and other inflammatory conditions.
Robust and Rapid Efficacy
Gumokimab demonstrated clinically meaningful improvement as early as Week 2, underscoring its rapid onset of action. At the primary analysis point of Week 12, the agent achieved a PASI 75 response rate of 94.6% and a complete skin clearance rate (PASI 100) of 47.7%. Akeso (搜索) noted that this PASI 100 response rate was substantially higher than the 28.6% reported with other agents in the same class.
Durable responses were observed through Week 52, where the PASI 75 response rate approached 100% and the PASI 100 response rate reached 68.9% — markedly higher than the 39.2% reported for other drugs in the IL-17 (搜索) inhibitor class.
Favorable Safety and Dosing Profile
The safety profile of gumokimab was notable, with incidences of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and infections/infestations that were numerically among the lowest rates reported in pivotal trials of IL-17 (搜索) inhibitors.
Gumokimab also offers a differentiated dosing regimen requiring only 17 subcutaneous injections annually, including the loading phase. This represents approximately half the annual injection burden of other IL-17 (搜索) inhibitors that require more frequent maintenance dosing. Reduced injection frequency has the potential to improve long-term adherence and persistence in patients with moderate-to-severe plaque psoriasis (搜索).
Expert Perspectives
Professor Xu Jinhua, Principal Investigator of the pivotal Phase III registration study at Huashan Hospital, Fudan University, emphasized the clinical need addressed by this approval: "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."
Professor Xu added that gumokimab "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 (搜索), thanked the investigators, study teams, and patients who participated in the clinical development, noting their contributions have "enabled us to deliver this important new therapy to the approximately 6.7 million psoriasis patients."
Strategic Portfolio Expansion
With the approval of gumokimab, Akeso (搜索) now has two approved therapies targeting distinct pathogenic pathways in psoriasis — gumokimab and ebdarokimab — which the company describes as complementary. Dr. Xia Yu highlighted that the autoimmune disease field "remains one of the largest and fastest-growing areas in innovative drug development" and that Akeso has "built a strong, differentiated portfolio for psoriasis."
Beyond plaque psoriasis, a supplemental New Drug Application (sNDA) for gumokimab in active ankylosing spondylitis (搜索) has been accepted for review by the Center for Drug Evaluation (CDE) of the NMPA. Phase III clinical trials for the registration of gumokimab in both moderate-to-severe plaque psoriasis (搜索) and ankylosing spondylitis have met all efficacy endpoints.
Akeso (搜索)'s broader immunology and inflammation pipeline includes manfidokimab in late-stage development across multiple indications, the first-in-class IL-4R/ST2 bispecific antibody AK139, and other novel agents. The company's R&D infrastructure is built on its Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, and several other technology platforms, supporting a pipeline of over 50 innovative assets across cancer, autoimmune disease, inflammation, and metabolic disease.