关键词: 长三角区域, 生物医药, 创新, 服务, 高质量发展

Abstract:

The integrated development of the Yangtze River Delta represents a major regional strategy established and actively advanced at the national level. The region is one of China's most concentrated areas for biopharmaceutical industry factors， relatively complete industrial chains， and richest innovation resources. In recent years， driven by the improvement of people's living standards and the pursuit of healthy lifestyles， coupled with the challenges of an aging population， high incidence of chronic and infectious diseases， the global biopharmaceutical industry landscape is undergoing rapid transformation. Emerging fields and technologies—including gene editing， synthetic biology， regenerative medicine， artificial intelligence（AI）， and 3D drug printing have continuously emerged. Within the region， drug internationalization is accelerating， and localized production and registration of originator drugs are showing a trend of aggregation. At the same time， the industry still faces challenges such as relatively weak original innovation capacity， inefficient translation of scientific and technological achievements， and insufficient regulatory resources. This article reviews the current status of innovative development， industrial characteristics， as well as existing situations and challenges of the biopharmaceutical industry in the Yangtze River Delta region. Based on practical experience in drug evaluation and inspection within the region， it proposes several concrete measures to promote high-quality development of the biopharmaceutical industry and facilitate the effective implementation of drug review and approval system reforms in the Yangtze River Delta.

Key words:  ,  , Yangtze river delta region； , Biomedical industry； , Innovation； , service； , High-quality development