In recent years, numerous policy initiatives in China have vigorously promoted the development of the cell therapy industry. As a derivative product of cells, exosomes have also attracted increasing attention from the industry.

In May 2022, the National Development and Reform Commission issued the “14th Five-Year Plan for Bioeconomy Development,” which included “exosome therapeutic products” in the national economic development plan for the first time. The term “exosome therapeutic products” was also mentioned again in the section on “Construction of Platforms for Key Generic Biotechnological Innovations” under the special column titled “Bioeconomy Innovation Capacity Enhancement Project.”

At this year’s Two Sessions,“First-time inclusion of ‘innovative drugs’ in the Government Work Report has further fueled the continued growth of industrial applications related to exosomes.”Exosomes, hailed as the “rising stars” of biomedicine, serve as “messengers” for intercellular material exchange and signal transduction.

With stem cell exosomesin the fields of regenerative medicine, disease treatment, and drug deliveryThe continuous deepening and expansion of the application ofBecoming the New Focus of the Life Sciences and Healthcare Industry, yet its clinical translation still faces multiple challenges, spanning technical, manufacturing, regulatory, and commercialization aspects.

However, although international standards have not yet been unified, the direction is already clear.——Exosomes should be treated as drugs, and strict regulation is the general trend.As research advances, the efficient isolation, precise characterization, and standardized quality control of exosomes have become key challenges driving their clinical translation. How can technological bottlenecks be overcome? How can the leap from laboratory to industry be achieved?

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September 12–13, 2025

2025 The 2nd China Cell and Gene Therapy (CSGCT) Conference