速递｜替尔泊肽拟纳入突破性疗法通道，GLP-1赛道首次逼近脂肪性肝病核心战场

Core Viewpoint - The article discusses the advancement of GLP-1 class drugs, particularly the dual receptor agonist Tirzepatide, which is being recognized for its significant clinical potential in treating metabolic-associated fatty liver disease (MAFLD) in China, following its inclusion in the breakthrough therapy program by the National Medical Products Administration [6][9]. Group 1: Breakthrough Therapy Application - Tirzepatide has been proposed for inclusion in the breakthrough therapy program for treating MAFLD, indicating its recognized clinical potential [6]. - The application is based on the II phase SYNERGY-NASH study, which included 190 patients diagnosed with MAFLD, highlighting the drug's efficacy in a high-risk patient population [6][9]. - The study results showed that after 52 weeks of treatment, 51.85%, 62.8%, and 73.3% of patients in the 5mg, 10mg, and 15mg dose groups achieved complete resolution of MAFLD, compared to only 13.2% in the placebo group [7][8]. Group 2: Clinical and Regulatory Implications - The drug demonstrated systemic advantages in secondary endpoints, with 59.1%, 53.3%, and 54.2% of patients in the respective dose groups showing improvement in liver fibrosis stages, while the placebo group had only 32.8% [8]. - Tirzepatide also showed significant improvements in various metabolic and liver-related indicators, including weight loss and reductions in liver injury biomarkers [8]. - Inclusion in the breakthrough therapy program allows for more frequent communication with regulatory authorities and prioritization during the review process, which is crucial for the historically challenging MAFLD drug development landscape [8][9]. Group 3: Market Position and Future Prospects - In the Chinese market, Tirzepatide has already been approved for four indications, including type 2 diabetes and weight loss, establishing a solid clinical and commercial foundation [9]. - The drug's potential breakthrough in MAFLD could position it as a comprehensive metabolic intervention tool, addressing multiple metabolic conditions simultaneously [9]. - The regulatory shift and robust histological evidence are prompting a reevaluation of the therapeutic potential of GLP-1 class drugs in the treatment of MAFLD, a field that has long lacked effective medications [9].