KOUSAI Bio Co Ltd, based in Shanghai's Lin-gang Special Area, has completed the first patient reinfusion in the clinical development of its self-developed KSD-101 autologous dendritic cell (DC) vaccine.

KSD-101 is the world's first broad-spectrum DC vaccine targeting the Epstein-Barr virus and China's first homegrown DC vaccine to receive clearance from the US Food and Drug Administration for investigational new drug status. Its successful clinical application marks a major breakthrough for China in immunotherapy for EBV-associated cancers.

KOUSAI Bio is a high-tech enterprise specializing in DC vaccines. [Photo/Invest Lin-gang]

Founded in 2018, KOUSAI Bio established operations at Lin-gang's Life Science Blue Bay in 2021 and has since scaled rapidly. In 2023, it signed an agreement for the second phase of its R&D and manufacturing project, and in 2025 completed construction of a comprehensive R&D and production base, marking a major milestone in its transition from laboratory research to commercialization.

The vibrant innovation ecosystem in Lin-gang has underpinned its continued expansion. The comprehensive local talent policies, from housing to children's education, help attract and retain top researchers. 

Meanwhile, Life Science Blue Bay provides access to a well-established network of upstream and downstream biopharmaceutical companies. It offers compliance guidance and technical consulting to support R&D and regulatory approval processes.