Core Viewpoint - The article discusses the establishment of a regulatory framework for advanced therapy medicinal products (ATMPs) in China, aiming to enhance the quality of the industry and align with international standards [1][2][4]. Group 1: Definition and Classification - The draft document defines "advanced therapy medicinal products" as those developed, produced, and regulated according to pharmaceutical regulations, including cell and gene therapies [2][4]. - ATMPs in China are categorized into three main types: cell therapy medicinal products (CTMPs), gene therapy medicinal products (GTMPs), and others based on their material basis and active ingredients [2][6]. Group 2: Industry Development and Global Position - The advanced therapy sector is identified as a core area of life sciences, crucial for fostering future industries and promoting high-quality development in the bio-economy [3][4]. - As of 2024, China has made significant progress in CGT drug development, with 4 out of 17 global CGT therapies approved, and 6 out of over ten CAR-T products approved worldwide [3][4]. Group 3: Regulatory Challenges and International Coordination - The current lack of regulatory definitions and industry consensus in China poses challenges for the development, technical review, and regulation of advanced therapies [4][6]. - The draft aims to unify the naming, scope, and classification of advanced therapy products, facilitating faster reviews and approvals while enhancing international regulatory coordination [1][4]. Group 4: Specific Regulatory Provisions - The draft specifies that certain products, such as blood components and reproductive cells, are excluded from the definition of ATMPs [6]. - CAR-T therapies are classified as "ex vivo gene-modified cell products," differing from classifications by other global regulatory bodies, reflecting a focus on the material basis and characteristics of the products [6][7]. Group 5: Future Prospects and Inclusivity - The classification framework is designed to be forward-looking and inclusive, allowing for the integration of new technologies and products as they develop [7]. - The draft has incorporated feedback from over 70 industry experts and representatives, indicating a collaborative approach to regulatory development [7].

Investment Rating - The report indicates a positive investment outlook for the cell and gene therapy (CGT) industry, highlighting its potential as a trillion-dollar blue ocean market driven by technological breakthroughs and accelerated commercialization [5]. Core Insights - The CGT industry encompasses a wide range of applications, including cell therapy and gene therapy, aimed at curing various diseases. The industry faces high technical barriers and stringent quality control, but the rich pipeline of research and development (R&D) is leading to stable market growth [5][11]. - China has emerged as a major region for clinical trials of immune cell therapies, with significant advancements in CGT drug development. The market is expected to grow further with more product approvals and exploration of new targets [5][21]. - Despite a tightening funding environment, cell therapy drug development targeting solid tumors remains a hot area of investment [5][35]. Summary by Sections Industry Overview - The CGT industry is characterized by high technical barriers, a rich pipeline of drugs in development, and a wide range of applications targeting genetic diseases, cancers, infectious diseases, and chronic conditions [11][20]. Market Size and Growth - The market size of the CGT industry in China grew from 0.26 billion RMB in 2019 to 32.72 billion RMB in 2023, with a compound annual growth rate (CAGR) of 233.71%. It is projected to reach 526.50 billion RMB by 2028, with a CAGR of 58.04% [33][34]. R&D Pipeline - The report notes that as of 2023, there are over 647 CGT projects in development in China, with 8 products already approved for market. The focus is on targets such as CD19, BCMA, and CD22, primarily for treating non-Hodgkin lymphoma and multiple myeloma [47]. Competitive Landscape - The CGT industry features a tiered competitive landscape, with leading companies like WuXi AppTec and Eternal Biotech at the forefront. The report highlights the trend of CGT companies transitioning to Contract Development and Manufacturing Organizations (CDMO) to enhance competitiveness [43][46]. Regulatory Environment - The report outlines various supportive policies aimed at promoting CGT development, including guidelines for clinical research and product evaluation, which are expected to facilitate innovation and market entry [41]. Investment Trends - In 2023, the CGT funding landscape saw a decline in investment events and amounts compared to 2022, but cell therapy targeting solid tumors continues to attract significant attention from investors [35].