新药周观点：司美格鲁肽获批MASH，国产GLP-1出海值得关注-20250818

Investment Rating - The report maintains an investment rating of "Outperform" [4] Core Insights - Novo Nordisk's semaglutide has received FDA approval for a new indication for the treatment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASH), which is expected to increase the sales scale of GLP-1 drugs beyond diabetes and weight loss indications [21][24] - The report highlights the significant market potential for GLP-1 drugs and the deep positioning of domestic companies in this field, particularly regarding overseas licensing opportunities for domestic GLP-1 products [25] Summary by Sections Weekly New Drug Market Review - From August 11 to August 17, 2025, the top five gainers in the new drug sector were: Beihai Kangcheng (+35.6%), Basilea Pharmaceutica (+32.6%), Deqi Pharmaceuticals (+30.2%), Heyu Biotech (+30.1%), and Gilead Sciences (+29.7%). The top five losers were: Boan Biologics (-11.6%), Laika Pharmaceuticals (-3.9%), Ailis (-3.2%), Nossland (-1.2%), and CanSino Biologics (-1.1%) [16][18] Recommended Stocks - The report suggests focusing on domestic GLP-1 products for overseas licensing, including: 1. RAY1225 from Zhongsheng Pharmaceutical for GLP-1/GIP dual weekly administration 2. ASC30 from Gilead Sciences for oral GLP-1 small molecules 3. BGM0504 from Borui Pharmaceuticals and ZX2021 from Kangyuan Pharmaceuticals for multi-target GLP-1 receptor agonists 4. UBT251 from Lianfa Pharmaceuticals and HS-10535 from Hansoh Pharmaceutical for already licensed MNC products [20][25] Key Analysis of the New Drug Industry - The approval of semaglutide for MASH marks it as the first GLP-1 therapy approved for this condition, expanding treatment options for patients and potentially increasing market size [21][24] New Drug Application Approvals and Acceptances - This week, there were 6 new drug applications accepted, including semaglutide injection from Huisheng Biopharmaceutical and others [29][31] Clinical Application Approvals and Acceptances - This week, 18 new drug clinical applications were approved, and 39 new drug clinical applications were accepted [32][35]