集中监管体系下通过分散治理实现区域赋能促进中国细胞治疗发展

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.