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].
同靶点首款国产单抗获批，实现“每季度给药一次”最长用药间隔