Gumokimab marks the eighth drug successfully developed by Akeso, six of which are already on the market. It also represents the third innovative therapeutic outside oncology to reach the commercialization phase, following ebronucimab and ebdarokimab.
The drug has undergone evaluation in four clinical trials for patients with moderate to severe plaque psoriasis, including one pivotal Phase III study (AK111-301) and three additional supportive trials.
Efficacy results indicate rapid action for gumokimab, with substantial therapeutic improvements observed within just two weeks of treatment.
Short-term Efficacy: By week 12, the PASI 75 response rate was nearly 96%, with an sPGA 0/1 response rate approaching 90%. The PASI 90 response rate was around 80%, while the PASI 100 response rate exceeded 40%, all significantly outperforming the placebo group. Over 80% of participants achieved a PASI 90 response, and around 50% experienced complete PASI 100 response.
Long-term Efficacy: Monotherapy with gumokimab showed sustained efficacy throughout 52 weeks, with continuous improvements and maintained efficacy. By week 52, the PASI 75 response rate nearly reached 100%, with stable sPGA 0/1 response rates. Furthermore, PASI 90 and PASI 100 responses improved to almost 90% and 65%, respectively.
Safety: The incidence of adverse events during both the placebo-controlled and overall treatment phases was similar between the gumokimab and placebo groups, with slightly lower metrics observed in the gumokimab group.
Professor Xu Jinhua, principal investigator of the pivotal gumokimab study and professor at Huashan Hospital, Fudan University, commented: “There is a growing need for treatments that provide rapid onset, short-term efficacy, long-lasting stability, and good tolerability. Gumokimab, an IL-17A IgG1 monoclonal antibody, specifically targets the IL-17RA pathway, a crucial factor in psoriasis, leading to quicker and more effective outcomes. Data from four studies highlight its capability to better satisfy patient needs, especially in achieving near-clearance of lesions while maintaining disease stability. Not only that, the occurrence of adverse events for gumokimab aligns closely with the placebo, indicating strong safety and tolerability. We are eager for gumokimab to be available soon as an efficient treatment option for psoriasis patients in
Dr. Yu Xia, Founder, Chairwoman, and CEO of Akeso, stated: “We are thrilled with the impressive results of gumokimab in clinical trials and the successful submission of its new drug application for market approval. I would like to extend my heartfelt thanks to all participants involved in this project and the patients who participated in clinical trials for their dedication and trust.
Psoriasis patients urgently need better treatment options, which Akeso aims to fulfill with ebdarokimab and gumokimab, both targeting different disease pathways and mutually enhancing treatment options to cover a broad range of patient requirements.
With the successful market launch of products such as ebronucimab (PCSK9), ebdarokimab (IL-12/IL-23), and gumokimab (IL-17), along with the effective progression of innovative non-oncology drugs for various indications—including manfidokimab (IL-4R), the bispecific antibody targeting IL-4R/ST2, and therapies for neurodegenerative diseases—our product portfolio’s vitality and synergy are increasingly robust. This advancement significantly boosts Akeso’s competitive edge in the non-oncology segment globally. Simultaneously, as we develop and refine a more systematic and efficient commercialization team, we have established a comprehensive and scientific strategy for marketing our non-oncology products. This strategy aims to accelerate market penetration, establishing our non-oncology sector as a key component of the company’s high-quality growth.”
About gumokimab
Gumokimab is a groundbreaking, humanized IL-17 (interleukin-17) monoclonal antibody developed by Akeso to treat autoimmune conditions like psoriasis and ankylosing spondylitis. IL-17 is a pro-inflammatory cytokine predominantly produced by activated Th17 cells; it attaches to its receptor (IL-17R) on cell surfaces, triggering immune-inflammatory responses and playing a vital role in the development of psoriasis and ankylosing spondylitis. Gumokimab specifically targets IL-17, blocking the IL-17/IL-17R signaling pathway to prevent the onset and advancement of related immune-inflammatory responses. The NDA for gumokimab targeting moderate-to-severe plaque psoriasis has been accepted by the NMPA, and a Phase III trial for ankylosing spondylitis is underway.
About Akeso
Akeso (HKEX: 9926.HK) is a prominent biopharmaceutical firm dedicated to researching, developing, manufacturing, and commercializing innovative biological therapies that are either first-in-class or best-in-class. Established in 2012, Akeso has developed a unique integrated R&D innovation system, highlighted by a comprehensive end-to-end drug development platform (ACE Platform) and cutting-edge technology for bispecific antibody development (Tetrabody). Coupled with a GMP-compliant manufacturing system and an advanced commercialization framework, the company has evolved into a globally competitive biopharmaceutical entity focused on delivering innovative solutions. With a fully integrated multifunctional platform, Akeso is independently managing a robust pipeline of over 50 innovative assets across various fields, including cancer, autoimmune diseases, inflammation, metabolic conditions, and other significant illnesses. Among these, 22 candidates are currently in clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Furthermore, five new drugs are currently available in the market, while an additional five are undergoing regulatory review across seven indications. Through effective and groundbreaking R&D innovation, Akeso consistently integrates superior global resources, advances both first-in-class and best-in-class drug discoveries, and offers affordable therapeutic antibodies to patients worldwide, continuously generating substantial commercial and social value in its quest to become a leading global biopharmaceutical powerhouse.
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