Akes’ New Gumokimab Monoclonal Antibody (IL-17) Drug Application for Treatment of Moderate to Severe Psoriasis Accepted by NMPA Investing.com

HONG KONG, January 26, 2025 /PRNewswire/ — Akeso, Inc. (9926.HK) (“Akeso” or “the Company”) is pleased to announce that the New Drug Application (NDA) of its internally developed IL-17-targeting monoclonal antibody gumokimab (AK111) has been accepted by Drug Evaluation Center (CDE) of National Medical (TASE:) Product Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. The strategic combination of drugs such as gumokimab and ebronucimab (PCSK9) to address the differentiated treatment needs of psoriasis further enhanced the overall synergy of the company’s products in the autoimmune disease space.

Gumokimab is the eighth successfully approved drug that they independently developed Akeso (with six already approved for the market), and it is also the third non-oncology innovative drug, after ebronucimab (PCSK9) and ebdarokimab (IL-12/IL-23), which has progressed to the commercialization stage.

Gumokimab was evaluated in four clinical studies involving patients with moderate to severe plaque psoriasis, including one pivotal phase III clinical trial (AK111-301) and three supportive trials.

Efficacy data show that gumokimab acts rapidly, with significant therapeutic improvement observed after only 2 weeks of treatment.

WITHshort term effectiveness: At week 12, the PASI 75 response rate approached 96%, with the sPGA 0/1 response rate close to 90%. The PASI 90 response rate was close to 80%, and the PASI 100 response rate exceeded 40%, all measures of efficacy significantly superior to the placebo group. More than 80% of patients achieved a PASI 90 response and approximately 50% achieved a PASI 100 response.

Long-term effectiveness: Gumokimab monotherapy demonstrated sustained efficacy over 52 weeks, with continued improvement and long-term maintenance. By week 52, the PASI 75 response rate approached 100%, with stable sPGA 0/1 response rates. PASI 90 and PASI 100 response rates further improved to nearly 90% and 65%, respectively.

Security: During the placebo-controlled phase and the overall treatment phase, the incidence of adverse events was comparable between the gumokimab and placebo groups, with the gumokimab group showing slightly lower values ​​in all metrics.

Professor Xu Jinhuachief investigator of the key registration study of gumokimab, prof Huashan Hospital, Fudan Universitystated, “There is a growing demand for drugs that offer rapid onset, short-term efficacy, long-term stability and good tolerability. Gumokimab, an IL-17A IgG1 monoclonal antibody, directly targets the IL-17RA pathway, a key driver of psoriasis, providing faster and more effective results Data from four studies show its potential to better meet patient needs, especially in achieving Moreover, the incidence of side effects with gumokimab is comparable to placebo, indicating good safety and We look forward to the early availability of Gumokimab as a more effective treatment option for patients with psoriasis China.”

dr. Yu Xiafounder, president and executive director Akesohe stated: “We are excited about the excellent results of gumokimab in clinical trials and the successful submission of its new drug application for market approval. I would like to express my sincere gratitude to all project participants and all patients who participated in clinical trials for their efforts and trust.

Psoriasis patients urgently need better treatment options and Akeso addresses this with ebdarokimab and gumokimab, which target different disease pathways and are complementary in treatment, allowing us to meet a wide range of patient needs.

With the successful launch of products such as ebronucimab (PCSK9), edarokimab (IL-12/IL-23) and gumokimab (IL-17), as well as the effective progress of innovative non-oncology drugs targeting multiple indications, including manfidokimab (IL-4R) , IL-4R/ST2 bispecific antibody, and therapies for neurodegenerative diseases, the vitality and synergy of our product portfolio is getting stronger. This progress significantly improves Akesov global competitiveness in the neo-oncology business segment. At the same time, with the development and optimization of a more systematic, refined and efficient commercialization team, we have formulated a comprehensive and scientific commercialization strategy for our non-oncology products. This strategy is designed to accelerate market expansion, positioning our non-oncology business as a strong driver of high-quality growth for the company.”

About gumokimab

Gumokimab is an innovative, humanized IL-17 (interleukin-17) monoclonal antibody developed by Akeso for the treatment of autoimmune diseases such as psoriasis and ankylosing spondylitis. IL-17 is a pro-inflammatory cytokine primarily secreted by activated Th17 cells, which binds to its receptor (IL-17R) on the cell surface, mediating immune inflammatory responses and playing a key role in the pathogenesis of psoriasis and ankylosing spondylitis. Gumokimab specifically targets IL-17, blocking the IL-17/IL-17R signaling pathway to inhibit the initiation and progression of associated immune-inflammatory responses. Currently, an NDA for gumokimab in moderate to severe plaque psoriasis has been accepted by the NMPA, and a phase III clinical trial for ankylosing spondylitis is ongoing.

About Akeso

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company dedicated to the research, development, production and commercialization of first or best-in-class innovative biological medicines in the world. Founded in 2012, the company has created a unique integrated R&D innovation system with a comprehensive end-to-end drug development platform (ACE platform) and bi-specific antibody drug development technology (Tetrabody) as the core, production system compliant with GMP and a commercialization system with an advanced way of working and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With a fully integrated multipurpose platform, Akeso internally, it is working on a strong pipeline of over 50 innovative agents in the areas of cancer, autoimmune diseases, inflammation, metabolic diseases and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). In addition, 5 new drugs are commercially available and 5 new drugs for 7 indications are currently under regulatory review for approval. Through effective and revolutionary research and development innovation, Akeso always integrates superior global resources, develops first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social value to become a leading global biopharmaceutical company.

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