Core Insights - The article discusses the rapid development of cell and gene therapy (CGT) in China, highlighting its transition from a follower to a parallel and even leading position in the global market [1][2]. Industry Overview - The global CGT clinical trials have reached approximately 2000, with China accounting for over 50% of these trials and over 60% in the cell therapy sector [1]. - China has approved 14 CGT products, including 7 CAR-T products, 3 small nucleic acid products, 2 gene therapies, 1 stem cell therapy, and 1 oncolytic virus therapy, with 9 of these approved in the last three years [2]. Policy and Regulatory Environment - Recent policies, such as the CDE's draft on advanced therapy products, aim to clarify definitions and accelerate innovation, attracting investment and enhancing international competitiveness [2][4]. - The National Medical Products Administration (NMPA) has introduced a 30-day review process for innovative drug clinical trial applications, improving the efficiency of drug approvals [3]. Clinical Development and Innovation - The CGT sector is experiencing a surge in clinical trial approvals, with 765 new drug clinical trial applications reviewed by the CDE as of mid-2025 [5]. - The introduction of AI-driven platforms, such as the NanoForge by Jitai Technology, represents a significant technological advancement in CGT delivery systems [5]. Market Dynamics and Challenges - CGT products are currently expensive, with CAR-T therapies costing over one million yuan per treatment, raising concerns about accessibility for patients [6][7]. - The market is dominated by multinational companies, but Chinese firms are rapidly emerging through differentiated innovation and international collaboration [6]. Future Prospects - The potential expansion of cell therapies into solid tumors could significantly increase the patient population benefiting from these treatments, although challenges remain in addressing the complexities of tumor microenvironments [8]. - Gene therapy may see a reduction in costs and an expansion of market opportunities as it moves towards treating more common diseases, but it faces intense competition in these areas [9].