Chinese biopharmaceutical company Akeso Inc (HK:9926) announced on Friday that ebdarokimab, an investigational monoclonal antibody developed by the company, has received marketing approval from China's National Medical Products Administration (NMPA) for the treatment of moderate-to-severe plaque psoriasis in adult patients.
Ebdarokimab is Akeso'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 the company's commercial portfolio outside oncology.
Ebdarokimab was evaluated in five clinical studies involving Chinese patients with moderate-to-severe plaque psoriasis.
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."
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