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."
Roivant to announce Q3 2026 financial results
HUTCHMED reports positive Phase III results for sovleplenib in wAIHA
Physiomics secures follow-on UK contract for Phase 2 study support
Amgen's UPLIZNA receives US FDA approval
Physiomics secures new contract with Numab Therapeutics for preclinical antibody development
InduPro secures strategic investment and collaboration with Sanofi to advance autoimmune therapy
Innovent Biologics reports first participant dosed in Phase 1 trial of IBI3011
AstraZeneca to invest USD2bn in major Maryland manufacturing expansion
European Commission approves Celltrion's Remsima IV liquid formulation
TIRmed Pharma partners with Bachem to advance production of atopic dermatitis therapy
Fondazione Telethon reports positive opinion for Waskyra marketing authorisation in Europe
Vascarta and CUNY report positive preclinical results in glioblastoma treatment