Core Viewpoint - The approval of the new drug Xinmei Yue (IBI112) by the NMPA marks a significant advancement in the treatment of moderate to severe plaque psoriasis in China, being the first domestically developed IL-23p19 monoclonal antibody, which offers a longer dosing interval and potential comprehensive benefits for patients [1][2][3] Group 1: Drug Approval and Clinical Results - Xinmei Yue (IBI112) has received approval from the NMPA for the treatment of adult patients with moderate to severe plaque psoriasis [1] - The approval is based on positive results from the pivotal Phase III clinical trial CLEAR-1, where 80.3% of patients achieved PASI 90 and 93.5% achieved sPGA 0/1 at week 16, significantly higher than the placebo group [1][2] - The drug demonstrates a long maintenance dosing interval of every 12 weeks, which is the longest among similar biologics [1][3] Group 2: Patient Impact and Market Potential - There are over 7 million psoriasis patients in China, with plaque psoriasis being the most prevalent, leading to significant impacts on quality of life and mental health [2] - The treatment landscape for moderate to severe plaque psoriasis has evolved from traditional systemic therapies to precision treatments with biologics and small molecule targeted therapies [2] - The focus has shifted towards achieving higher treatment goals, such as PASI 90/100 and significant improvements in quality of life [2] Group 3: Safety Profile - The overall safety profile of Xinmei Yue is favorable, with the most common adverse event being upper respiratory infections, consistent with safety characteristics of similar drugs [2]
信达生物：信美悦 (匹康奇拜单抗注射液)获国家药监局批准用于治疗中重度斑块状银屑病