Core Viewpoint - The approval of Xinmei Yue (Pikangqibai Injection) by the National Medical Products Administration marks a significant advancement in the treatment of moderate to severe plaque psoriasis, being the first IL-23p19 monoclonal antibody developed by a domestic company in China [1][2]. Group 1: Drug Approval and Market Impact - Xinmei Yue has been approved for use in adult patients with moderate to severe plaque psoriasis, a chronic and recurrent inflammatory disease affecting over 7 million patients in China, with a significant portion requiring lifelong management [1]. - The drug's approval is based on the results of the Phase III CLEAR-1 study, which demonstrated that over 80% of patients achieved a clearance of more than 90% of skin lesions after four months of treatment [2]. Group 2: Clinical Efficacy and Advantages - The CLEAR-1 study indicates that IL-23p19 targeted antibodies, like Pikangqibai, show significant advantages in maintaining long-term efficacy and convenience of use compared to existing treatments [2]. - Unlike most current biologics that require monthly or bi-monthly injections, Xinmei Yue has been engineered to extend its half-life, allowing for administration once every three months while maintaining strong efficacy, providing a new solution for long-term patient management [2].

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]