外泌体成美妆研发新风口，但还有两大难关要过

Core Viewpoint - The recent regulatory movement in the pharmaceutical sector, particularly the classification of exosomes as advanced therapy medicinal products (ATMP), has significant implications for the beauty industry, especially in the development of skincare products utilizing exosomes [3][5][31]. Regulatory Developments - In July 2023, the National Medical Products Administration (NMPA) released guidelines that clarify the classification of cell therapy products, officially categorizing exosomes as drugs [3][5]. - This regulatory clarity resolves previous ambiguities regarding the status of stem cells and exosomes, which are now recognized as pharmaceutical products [5][31]. Industry Trends - Over 17 beauty-related companies, including major players like L'Oréal and Estée Lauder, are actively exploring the potential of exosomes in skincare, indicating a growing trend towards innovative beauty solutions [5][17]. - Exosomes are gaining attention for their unique properties, such as promoting skin rejuvenation and anti-aging effects, which are increasingly being recognized in the beauty industry [9][13]. Scientific Background - Exosomes are small vesicles secreted by cells, containing proteins and nucleic acids, and are involved in intercellular communication [7][8]. - The scientific foundation for exosome research has been bolstered by Nobel Prize-winning discoveries related to cell communication and gene regulation [8][9]. Market Potential - The market for exosome-related skincare products is expanding, with significant sales growth observed on platforms like Douyin, where sales reached 1.646 billion yuan in the first half of 2025, marking a year-on-year increase of 359.8% [25][27]. - The average price of exosome-related skincare products on Douyin was 371.46 yuan, indicating a premium positioning in the market [25]. Challenges Ahead - Despite the promising potential, the beauty industry faces challenges related to regulatory compliance, as current regulations in China do not recognize exosomes as valid cosmetic ingredients [29][30]. - There is also a need for clearer technical standards and clinical evidence to support the efficacy and safety of exosome-based products [32][33].