Akeso, Inc. announced 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.
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.
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