Akeso's Gumokimab (AK111, Anti-IL-17) Approved by NMPA for Moderate-to-Severe Plaque Psoriasis, Bolstering Its Autoimmune Disease Portfolio

Akeso's Gumokimab (AK111, Anti-IL-17) Approved by NMPA for Moderate-to-Severe Plaque Psoriasis, Bolstering Its Autoimmune Disease Portfolio

HONG KONG, June 11, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) today 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.

About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has established a robust R&D innovation ecosystem centered on its Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs), 8 innovative drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

Forward-Looking Statements
This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

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SOURCE Akeso, Inc.