Core Insights - The approval of Xinmei Yue (Pikangqibai Injection) by the National Medical Products Administration (NMPA) marks a significant advancement in the treatment of moderate to severe plaque psoriasis in adults, being the first domestically developed IL-23p19 monoclonal antibody in China [1][2] - Psoriasis is a chronic, relapsing inflammatory disease affecting over 7 million patients in China, with a significant portion suffering from moderate to severe forms, highlighting the need for effective and personalized treatment options [1] - The CLEAR-1 study demonstrated that Xinmei Yue achieved a PASI90 response rate of 80.3% at week 16, making it the first IL-23p19 antibody to surpass this threshold in a registered phase III clinical trial [2] Company Developments - Xinmei Yue is the 17th product launched by Innovent Biologics and is a key product in the company's autoimmune portfolio, which is becoming a vital growth driver for the company [2] - The innovative engineering of the antibody structure allows Xinmei Yue to have the longest maintenance dosing interval among similar biologics, requiring only four doses per year, which enhances patient convenience [2] - The company plans to further research Xinmei Yue for additional psoriasis subtypes, psoriatic arthritis, and pediatric psoriasis to expand its therapeutic value and meet clinical needs [2]
信达生物银屑病新药匹康奇拜单抗注射液获批