Rakuten Medical Targets U.S. Market With Light-Based Cancer Therapy, Eyes 2028 FDA Filing

Rakuten Medical, the biotech unit of Japanese conglomerate Rakuten, is allocating roughly 95% of its resources to entering the U.S. market, where it is running Phase 3 trials of its photoimmunotherapy treatment and targeting a 2028 FDA submission. The San Diego-headquartered firm already markets the therapy for head and neck cancers in Japan. The treatment pairs a proprietary drug, Akalux, which binds to epidermal growth factor receptors on cancer cells and tags them with light-activated dye, with the Alluminox platform that applies red light to destroy tagged cells. CEO Minami Maeda said the company aims to treat all solid tumors, requiring significant capital for research and development. Rakuten Medical installs Alluminox at hospitals free of charge and earns most revenue from Akalux drug sales, a razors-and-blades model. Its Japan unit is profitable, though the global entity operates at a loss on high research spending. The company treated about 700 to 800 patients annually across some 200 Japanese hospitals, up from 30 in its first year. Near-term expansion targets include Taiwan, Macau, Singapore, Hong Kong and Saudi Arabia.