Rakuten Medical, Inc. and LOTTE Biologics announced that they have signed a biopharmaceutical contract manufacturing agreement during the J.P. Morgan Healthcare Conference in San Francisco to strengthen Rakuten Medical's production capabilities for its innovative oncology therapy, Alluminox^® platform-based photoimmunotherapy.

Under the agreement, LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates, supporting Rakuten Medical's global clinical development and future commercialization.

Rakuten Medical's proprietary photoimmunotherapy technology is designed to selectively target cells in solid tumors, by combining cell-targeting moieties, such as antibodies, with light-activatable agents, enabling focal and selective destruction of solid tumor cells upon light exposure.

In Japan, the therapy is approved for recurrent head and neck cancer, and its footprint has expanded steadily, through broader site adoption and sustained year–over–year growth in treatment numbers. In parallel, a global Phase 3 clinical trial is underway in the United States, Taiwan region and Japan, with plans to start treatment in Ukraine and Poland soon.

Rakuten Medical also plans to initiate a Phase 1 clinical trial in Japan for other solid tumors beyond head and neck cancer this year. These clinical and commercial dynamics are driving increased demand for Rakuten Medical's bioconjugates.

LOTTE Biologics has been expanding its capabilities as a global contract development and manufacturing organization (CDMO), particularly in the field of monoclonal and multispecific antibodies, antibody-drug conjugates (ADCs), and advanced bioconjugation services. LOTTE Biologics will support the production of monoclonal antibody intermediates and their conjugates for Rakuten Medical's programs, through its specialized ADC manufacturing facility at the Syracuse Bio Campus in New York. The facility is equipped with dedicated ADC production capabilities and advanced bioconjugation technologies, enabling the company to deliver high-quality manufacturing services while meeting global regulatory requirements and ensuring stable supply for customers worldwide.