（原标题：从"追随者"到"并行者"，中国细胞与基因治疗加速突围） 21世纪经济报道记者 闫硕 近年来，随着生物科技等前沿技术的蓬勃发展，全球范围内以细胞治疗药品和基因治疗药品为代表的药 品研发、申报和批准数量持续增加，在癌症、罕见遗传疾病等疑难重症的临床治疗方面取得了突破性进 展。 数据显示，全球已有约2000个细胞与基因治疗（CGT）临床试验，其中中国占据了超50%的份额，在细 胞治疗领域更是占全球60%以上。 "自2017年传奇生物开启中国细胞与基因治疗技术的全球创新之路以来，随着工艺成本的持续降低、临 床数据的积累，以及国家药监局药审中心（CDE）对先进治疗药品定义的明确，中国正从全球CGT赛道 的追随者快速转变为并行者甚至领跑者。"君联资本执行董事戚飞向21世纪经济报道记者表示。 中国银河证券也分析指出，细胞基因治疗是目前生物医药领域最具前景的发展方向，已进入成果兑现 期。CGT是继小分子、大分子靶向疗法之后的新一代精准疗法，引领生物制药的新一轮浪潮。CGT成药 效果好临床成功率高，从根源治疗疾病，单次治疗带来长期疗效，为难治性疾病治疗提供了新选择， CAR-T、干细胞、TCR-T、TIL等多种产品近 ...

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].