Akeso's Ebdarokimab ( IL - 12/IL - 23 Dual - Targeted Monoclonal Antibody) Approved in China for Moderate - to - Severe Plaque Psoriasis

HONG KONG, April 18, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that ebdarokimab, an investigational monoclonal antibody developed by the company, has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of moderate-to-severe plaque psoriasis in adult patients.

Ebdarokimab is the company's first Class 1 new drug approved for autoimmune diseases and the second non-oncology new drug to receive marketing approval, following ebronucimab (PCSK9). This approval expands Akeso's commercial portfolio outside of oncology.

Ebdarokimab was evaluated in five clinical studies involving Chinese patients with moderate-to-severe plaque psoriasis. Two pivotal Phase III studies demonstrated ebdarokimab's efficacy and safety at both 16 weeks and 52 weeks in these patients.

Positive Short-Term Efficacy: Patients receiving ebdarokimab injection 135mg with two doses at weeks 0 and 4 showed a significantly positive efficacy, with a PASI 75 response rate of 79.4% at week 16.

Sustained Long-Term Efficacy: Patients receiving ebdarokimab injection 135mg every 12 weeks (Q12W) for maintenance therapy achieved long-term durable efficacy, with a PASI 75 response rate of 77.9% at week 52.

Significant Improvement in Quality of Life: Long-term maintenance treatment with ebdarokimab significantly improved patients' quality of life, alongside the improvement of skin lesions. After 16 weeks of treatment, the impact of skin disease on patients' quality of life decreased by more than 55%, further decreasing to over 65% by week 52.

Good Safety Profile: The incidence of adverse events was low and numerically lower than that of the placebo group.

Convenience of Administration: Ebdarokimab, administered as four subcutaneous injections annually, provides treatment convenience and provides long-term, stable improvements in treatment efficacy and patients' quality of life.

The clinical data for ebdarokimab was previously reported at the European Academy of Dermatology and Venereology (EADV) congress in 2023 and 2024.

Professor Jianzhong Zhang, lead investigator of the pivotal trials and Director of Peking University People's Hospital Dermatology Department, commented: "Clinical data consistently demonstrate ebdarokimab's rapid onset, durable efficacy, and excellent safety profile. With only four doses per year, it offers enhanced treatment adherence, enabling long-term disease control and improved quality of life. As clinicians, we believe ebdarokimab will provide a more accessible, effective, and convenient therapeutic option for patients."

Dr. Yu Xia, Founder, Chairwoman, President and CEO of Akeso, stated: "In addition to our oncology focus, Akeso has built a forward-looking, innovative pipeline targeting high-prevalence, high-potential disease areas, including metabolic, autoimmune, inflammatory, and neurodegenerative diseases. Our products are steadily entering the commercialization phase. With the successful launches of ebronucimab and ebdarokimab, along with the late-stage clinical development of competitive pipelines like gumokimab (IL-17 monoclonal antibody) and mandokimab (IL-4R monoclonal antibody), as well as the progress of new mechanism drugs, such as the first IL-4R/ST2 bispecific antibody in autoimmune diseases and therapies for neurodegenerative conditions, Akeso's global portfolio and competitive edge in non-oncology fields are strengthening. We eagerly anticipate the early approval of more of Akeso's independently developed non-oncology drugs, offering improved treatment outcomes for patients worldwide."

About Ebdarokimab (IL - 12/IL - 23 Monoclonal Antibody)

Ebdarokimab is a novel humanized monoclonal antibody targeting IL-12/IL-23, developed by Akeso. Ebdarokimab is indicated for the treatment of psoriasis, ulcerative colitis, and other autoimmune disorders. By inhibiting the biological activity of cytokines IL-12 and IL-23, it provides therapeutic benefits in autoimmune diseases. Psoriasis pathogenesis is associated with dysregulated immune responses, where IL-12 and IL-23, cytokines sharing a common p40 subunit, play pivotal roles in inflammation and immune modulation. IL-12 induces the activation and proliferation of Th1 cells (T helper cells 1), which secrete interferon-γ and TNF-α (tumor necrosis factor α), while IL-23 is involved in the differentiation of Th17 cells (T helper cells 17), leading to the release of IL-17 (interleukin-17). These cytokines are key mediators in inflammatory processes. Ebdarokimab binds to the p40 subunit of IL-12 and IL-23, preventing their interaction with cell surface receptors, thereby attenuating the release of cytokines such as interferon-γ, TNF-α, and IL-17 from T cells. This inhibition of cytokine-driven immune responses effectively modulates the aberrant immune activity in psoriasis.

About Akeso Inc.

Akeso,Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of innovative antibody drugs that are affordable to patients worldwide. Since the Company's inception, the Company has established an end-to-end comprehensive drug development platform (ACE Platform), encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology) that can overcome three CMC challenges in the development and manufacturing of bi-specific antibodies: 1.low expression levels, 2. process development hurdles, and 3. antibody stability and druggability.

The Company currently has a portfolio of over 50 innovative programs covering the therapeutic areas of oncology, autoimmune and metabolic diseases. Among these programs are 6 approved products independently developed by the Company and 2 products under NDA review by the NMPA. We are conducting Phase III clinical trials of 12 products, and Phase I/II clinical trials of other 12 products. 15 of the products are potential global first-in-class (FIC) or best-in-class (BIC) bi-specific antibodies/polyclonal antibodies/bi-specific ADCs. The Company's vision is to become a leading global biopharmaceutical company through focused innovation in R&D, the establishment of world class manufacturing, and continued expansion commercial network.

SOURCE Akeso, Inc.