Akeso Reports Phase 3 Trials Show Positive Results: Gumokimab (IL-17) for Ankylosing Spondylitis and Manfidokimab (IL-4Rα) for Atopic Dermatitis Achieve Primary Endpoints

HONG KONG, Aug. 25, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) ("Akeso" or "the Company") today announced positive results from its Phase 3 clinical trial of gumokimab (AK111), a novel, fully human anti-IL-17A monoclonal antibody, for the treatment of active ankylosing spondylitis (AS). The study successfully met all primary efficacy endpoints, including ASAS20 and subgroup analyses, as well as the key secondary endpoint ASAS40. Furthermore, several pre-specified secondary endpoints demonstrated both statistically significant and clinically meaningful improvements, further supporting the potential of gumokimab as an effective treatment option for AS.

Gumokimab rapidly and effectively alleviated AS symptoms, significantly improved disease activity and enhanced physical function and quality of life in patients. This promising new treatment option may offer a much-needed solution for the approximately 4 million AS patients in China. Notably, gumokimab has already shown positive results in a Phase 3 pivotal trial for moderate-to-severe psoriasis, with the New Drug Application (NDA) for this indication accepted by the NMPA CDE in January 2025. The NDA submission for moderate-to-severe psoriasis marks gumokimab as Akeso's third non-oncology drug to enter the market approval process.

In addition, Akeso reported that its novel fully human anti-IL-4Rα monoclonal antibody, manfidokimab (AK120), has also achieved positive outcomes in its Phase 3 clinical trial for moderate-to-severe atopic dermatitis (AD). The study met all primary endpoints, key secondary endpoints, several pre-specified secondary endpoints, and demonstrated statistically significant and clinically relevant improvements in patients.

Manfidokimab notably improved skin lesions and provided excellent early relief of pruritus, offering a potentially transformative treatment for patients with moderate-to-severe AD. As a result of the strong efficacy and safety profile demonstrated in this trial, Akeso plans to file an NDA for manfidokimab in this indication, aiming to provide a more effective and domestically developed IL-4Rα-targeting biologics for AD patients in China. Manfidokimab will be Akeso's fourth non-oncology drug to enter the NDA phase and represents a significant milestone in the company's expanding autoimmune pipeline.

With the successful market launches of ebronucimab (PCSK9) and ebdarokimab (IL-12/IL-23), along with the recent positive Phase 3 studies from gumokimab (IL-17) and from manfidokimab (IL-4Rα), Akeso's non-oncology franchise is rapidly expanding and will provide a future driver for commercial growth. Akeso's expanding non-oncology product portfolio is further strengthened by a robust pipeline of innovative biologics that includes our first in class IL-4R/ST2 bispecific antibody and candidates for neurodegenerative diseases. The combination of commercial launches, Phase III successes and innovation-focused pipeline will increase Akeso's competitive position globally in non-oncology indications.

Forward-Looking Statement of Akeso, Inc.
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.

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 created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company 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, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new 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.

For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.

SOURCE Akeso, Inc.