A new breakthrough in cancer treatment is on the horizon. Orient EuroPharma (OEP) Group has announced that it has secured the commercial rights to Rakuten Medical’s photoimmunotherapy platform in Taiwan, Singapore, Malaysia, and the Philippines. This marks Rakuten Medical’s first licensing agreement with a Taiwanese pharmaceutical company. The therapy is currently undergoing Phase III clinical trials in Taiwan, with the goal of obtaining local regulatory approval next year. Rakuten Medical also plans to consolidate clinical data from Taiwan, the U.S., and Japan to pursue FDA approval in the U.S., further expanding the reach of this innovative treatment.

Founded 15 years ago, Rakuten Medical developed the Alluminox photoimmunotherapy platform based on technology originally licensed from the United States. The therapy has already been used in nearly a thousand real-world clinical cases in Japan and has received approval from Japan’s Ministry of Health, Labour and Welfare.

Through its subsidiary Cyntech, Orient EuroPharma has acquired the commercial rights to the Alluminox platform in Taiwan and the Southeast Asian markets mentioned above. Currently, six clinical centers in Taiwan are participating in a Phase III trial, and 50 patients with recurrent head and neck cancers have already been enrolled. Regulatory approval is targeted for next year in Taiwan, which will continue contributing patients to the global clinical trial.

Dr. Yi-Hsing Lü, President of the Taiwan Head and Neck Society, emphasized that head and neck cancer ranks among the top causes of cancer incidence and mortality in Taiwanese men. Around 40% of cases are diagnosed at an advanced stage, with high recurrence rates. Existing treatment options, such as radiotherapy, often lead to complications like osteonecrosis or tissue damage. Additionally, recurrence in previously treated areas limits retreatment options, underscoring the need for new therapeutic tools.

Dr. Kuan-Chou Lin, former President of the Taiwan Association of Oral and Maxillofacial Surgery, explained that the current clinical trial focuses on patients with recurrent head and neck cancers who have failed first-line treatment. As long as the tumor site is reachable by light, the therapy can be applied, is repeatable, and causes no damage to surrounding tissues. Notably, the therapy uses targeted light activation to direct the drug precisely to tumor cells, triggering tumor destruction while simultaneously stimulating the immune system to attack remaining cancer cells in the surrounding area.

Rakuten Medical plans to enroll more than 400 patients across Japan, Taiwan, and the U.S., with the aim of submitting a New Drug Application to the U.S. FDA.

Resource: 引進抗癌光免疫療法，友華攜手日本樂天醫藥