生物大分子药物包括蛋白多肽、抗体、核酸与疫苗等，在重大疾病治疗中发挥极其重要的作用。如何最大程度保留生物大分子药物的生物活性并高效递送至靶部位、靶细胞及特定细胞器，提高生物利用度，是生物大分子药物发挥药效的关键。本项目拟围绕生物大分子药物结构稳定化和高效递释这一关键科学问题，以我国生物大分子药物递释系统（Biomacromolecular drug delivery systems, BDDS）多年的研究积累为基础，从药物、载体、机体三者间的相互作用关系入手，深入研究生物大分子药物结构稳定性规律和稳定化技术，高效递释机制和技术；设计并构建不同种类的生物大分子药物的高效递释系统；开展代表性生物大分子药物的递释系统临床前转化研究。为推进我国BDDS的研发，大幅提升我国生物大分子创新药物研发水平奠定基础。

Biomacromolecular drugs including protein, peptide, antibody, nucleic acid and vaccine are being increasingly used in the treatment of major diseases. However, a lack of efficient delivery systems greatly affects the therapeutic efficacy of biomacromolecules in vivo. To achieve their therapeutic efficacy, how to maximally retain the biological activity of biomacromolecules, how to achieve site-specific delivery to target sites, cells and organelles, and to improve the bioavailability of biomacromolecular drugs remain critical questions to be carefully addressed. The current project aims to provide solutions to critical scientific questions, i.e., structure stabilization, efficient delivery and release of biomacromolecules. With decades of research experience and a solid foundation in biomacromolecular drug delivery systems (BDDS), starting from the interrelationships between drug, carrier, and human body, our goal is to interpret the patterns of biomacromolecule structural stabilization while seeking approaches to ensure their stability/activity during formulation, and to achieve highly-efficient delivery; next, to design and construct BDDSs to accommodate the needs of various biomacromolecular therapeutics; and more importantly, to promote the translational study of selective BDDSs. The implementation of the BDDS project could significantly contribute to the research and development of biomacromolecular therapeutics in China, and lay the foundation for new biomacromolecular drug discovery and development.