Core Viewpoint - The National Medical Products Administration (NMPA) has released a draft for public consultation regarding the scope, classification, and definition of "Advanced Therapy Medicinal Products" (ATMPs), aiming to establish a regulatory framework for innovative therapies in China [1][2]. Group 1: Definition and Classification - The draft focuses on gene therapy, cell therapy, and other innovative technologies, excluding traditional vaccines, antibiotics, and blood products [1][3]. - ATMPs are categorized into three main types: cell therapy products, gene therapy products, and others, with specific subcategories for each [4][7]. Group 2: Regulatory Impact - The establishment of a regulatory framework for ATMPs is expected to increase compliance costs for companies in the short term but will promote innovation and attract investment in the long term [2][8]. - The clarity in classification and regulation is anticipated to facilitate the transition of innovative products from laboratories to clinical applications, thereby enhancing market opportunities [9][11]. Group 3: Market Potential - The market for stem cell therapy in China is projected to exceed 20 billion yuan, with expectations to reach 26.5 billion yuan by 2024 [8]. - The gene therapy market in China is expected to reach $2.59 billion by 2025, with a potential growth to 50 billion yuan from 2025 to 2027 [9]. Group 4: Industry Development - The new regulatory framework is likely to enhance industry concentration and accelerate specialization, leading to resource aggregation towards leading companies [9][11]. - The framework will also promote the development of the entire industry chain, including upstream raw materials and downstream logistics systems, thereby fostering a more mature ecosystem [9][11].