Department of Oncology, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China; Department of Bio-Therapeutic, the First Medical Centre, Chinese People's Liberation Army General Hospital, Beijing, China.
Department of Oncology, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.
Lancet Haematol. 2022 Dec;9(12):e942-e954. doi: 10.1016/S2352-3026(22)00331-3.
Chimeric antigen receptor (CAR) T-cell therapy is an example of gene engineering-based cellular therapy, which combines immunotherapy, gene therapy, and cellular therapy. Historically, the second clinical trial of gene therapy for patients with haemophilia B was conducted by Chinese scientists in 1991, and China became the first country to approve a commercial gene therapy product in 2003. However, China almost lost its lead in this field, partly due to an early scarcity of clear and cohesive policies regarding cellular therapy. Cellular therapy is not only a novel medical practice but also a medicinal product. The increasing commercialisation of globally approved cell therapy products made the Chinese Government issue a series of relevant policies to promote the canonical development of cell therapy and its standardisation in China. Encouraged by flexible regulatory frameworks that have facilitated the development of cellular therapy since 2017, remarkable progress has been achieved, thereby putting China back at the forefront of the field worldwide. Some policies on cellular therapy launched by the Chinese government in 2019 have contributed to the growth of cellular therapy in China; however, the regulation, governance, and management of commercialised products remain challenging. This Series paper aims to provide an overview of the current regulatory reforms on clinical cellular therapy in China with a historical perspective. We also highlight several important contributors that could promote innovation and industrialisation of cellular therapy in China. Further efforts are needed to establish a legislative system with clear and cohesive policies for the increasing use of cellular therapy in China, enabling a more prescriptive, diligent, and informed process.
嵌合抗原受体 (CAR) T 细胞疗法是基因工程细胞疗法的一个范例，它结合了免疫疗法、基因疗法和细胞疗法。历史上，中国科学家于 1991 年进行了血友病 B 患者基因治疗的第二次临床试验，中国成为 2003 年第一个批准商业基因治疗产品的国家。然而，由于细胞治疗早期缺乏明确和连贯的政策，中国在这一领域几乎失去了领先地位。细胞治疗不仅是一种新的医疗实践，也是一种药品。全球批准的细胞治疗产品的商业化程度不断提高，促使中国政府发布了一系列相关政策，以促进中国细胞治疗的规范发展及其标准化。自 2017 年以来，灵活的监管框架促进了细胞治疗的发展，中国取得了显著进展，从而使中国重回全球细胞治疗领域的前沿。中国政府在 2019 年推出的一些细胞治疗政策促进了中国细胞治疗的发展；然而，商业化产品的监管、治理和管理仍然具有挑战性。本综述文章旨在从历史角度概述中国临床细胞治疗的当前监管改革，并强调几个可能促进中国细胞治疗创新和产业化的重要因素。需要进一步努力，为中国日益增加的细胞治疗使用建立一个具有明确和连贯政策的立法体系，以实现更具规定性、勤奋和明智的进程。
