China Approves Akeso's Ebdarokimab for Moderate-to-Severe Plaque Psoriasis

HONG KONG, April 18, 2025 - Akeso, Inc. has announced that its investigational monoclonal antibody, ebdarokimab, has been approved by the National Medical Products Administration (NMPA) for treating moderate-to-severe plaque psoriasis in adults. This approval marks a significant milestone for Akeso, as it is their first Class 1 new drug for autoimmune diseases and their second non-oncology drug to receive marketing approval, following ebronucimab (PCSK9). The company is expanding its pharmaceutical offerings beyond oncology with this development.

Ebdarokimab underwent evaluation through five clinical studies targeting Chinese patients with moderate-to-severe plaque psoriasis. Two pivotal Phase III studies were crucial in establishing the drug's efficacy and safety over short-term (16 weeks) and long-term (52 weeks) periods.

In the short term, patients receiving ebdarokimab injections of 135mg at weeks 0 and 4 showed a notable efficacy, achieving a PASI 75 response rate of 79.4% by the 16th week. The long-term analysis revealed that maintenance therapy with the same dosage every 12 weeks resulted in a durable response, with a PASI 75 response rate of 77.9% at week 52.

Beyond treating skin lesions, the drug had a substantial impact on patients' quality of life. By week 16, patients reported over a 55% decrease in the skin disease's impact on their lives, and this improvement further increased to over 65% by week 52.

Ebdarokimab has been well-received for its safety profile, as the occurrence of adverse events was low and numerically lower than the placebo group. The drug's administration requires only four subcutaneous injections per year, offering convenience and stable, long-term improvements in both treatment efficacy and patients' quality of life. This data was previously presented at the European Academy of Dermatology and Venereology (EADV) congresses in 2023 and 2024.

Professor Jianzhong Zhang, the lead investigator of the pivotal trials and Director of Dermatology at Peking University People's Hospital, pointed out the consistent demonstration of ebdarokimab's rapid onset, long-lasting efficacy, and excellent safety. He emphasized that the drug's dosing schedule enhances treatment adherence and supports long-term disease control, improving patients' quality of life.

Dr. Yu Xia, Founder and CEO of Akeso, highlighted the company's expanding focus beyond oncology, with a pipeline targeting prevalent and high-potential areas such as metabolic, autoimmune, inflammatory, and neurodegenerative diseases. The success of ebronucimab and ebdarokimab, paired with the development of other drugs like gumokimab and mandokimab, underscores Akeso's growing influence and competitive advantage in non-oncology therapeutic fields. The company anticipates further approvals for its innovative non-oncology drugs, promising better treatment options for patients globally.

Ebdarokimab, a humanized monoclonal antibody targeting IL-12/IL-23, is designed for treating psoriasis, ulcerative colitis, and other autoimmune disorders. By inhibiting IL-12 and IL-23 cytokines, which are crucial in inflammatory processes and immune modulation, the drug offers therapeutic benefits in managing psoriasis. These cytokines share a common p40 subunit that ebdarokimab binds to, preventing interaction with cell receptors and reducing cytokine-driven immune responses, which effectively modulates the immune activity associated with psoriasis.

Akeso, Inc., a biopharmaceutical company, focuses on creating innovative and affordable antibody drugs. Their comprehensive drug development platform, ACE, integrates discovery and development processes, while their Tetrabody technology addresses challenges in bi-specific antibody development. With over 50 programs in various therapeutic areas, Akeso aims to become a leading global biopharmaceutical company through focused innovation and global expansion.