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匹康奇拜单抗注射液(信美悦)
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信达生物银屑病新药获批上市
Xin Lang Cai Jing· 2025-11-28 10:21
Core Viewpoint - Innovent Biologics (1801.HK) has received approval from the National Medical Products Administration (NMPA) for its monoclonal antibody injection, Pikanqibai (brand name: Xinmeiyue), for the treatment of moderate to severe plaque psoriasis in adult patients, marking it as the first domestically developed IL-23p19 targeted monoclonal antibody in China [1] Company Summary - The newly approved drug is based on the Phase III CLEAR-1 study conducted in China, demonstrating that over 80% of patients achieved a clearance of more than 90% of skin lesions after four months of treatment [1] - Pikanqibai offers a maintenance treatment regimen with a dosing frequency of once every 12 weeks, which is the longest maintenance dosing interval among similar biologics, requiring only four doses per year [1] - The company plans to continue research on Pikanqibai for other psoriasis subtypes, psoriatic arthritis, and pediatric psoriasis [1] Industry Summary - Psoriasis is a chronic, relapsing, inflammatory, and systemic disease influenced by the interaction between individual and environmental factors, characterized by recurrent episodes and lifelong management [1] - It is estimated that there are over 7 million psoriasis patients in China, with plaque psoriasis being the most common type, and approximately 30% of these patients classified as moderate to severe [1]