亿帆医药(002019.SZ)：2’-岩藻糖基乳糖获批

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) has received approval from the National Health Commission of the People's Republic of China for its application regarding 2'-fucosyllactose, which is recognized as a food nutrition enhancer for infant formula and other related products [1] Group 1: Regulatory Approval - The company's wholly-owned subsidiary, Hangzhou Xinfu Technology Co., Ltd., received the Administrative License Review Conclusion Notice on December 4, 2025 [1] - The approval is based on the Food Safety Law and the Management Measures for New Varieties of Food Additives [1] Group 2: Product Information - 2'-fucosyllactose is a major oligosaccharide found in human breast milk, known for its functions in regulating gut microbiota, promoting brain development, and enhancing immunity [1] - According to the National Health Commission's announcement No. 8 in 2023, 2'-fucosyllactose is approved for use as a food nutrition enhancer in infant formula, including special medical purpose infant formula [1] Group 3: International Standards - The announcement also notes that 2'-fucosyllactose is permitted for use in infant formula and other food categories by regulatory bodies such as the U.S. Food and Drug Administration, the European Commission, and the Food Standards Australia New Zealand [1]