Orient Europharma recently announced that it has secured the commercial rights to Rakuten Medical’s Alluminox platform-based photoimmunotherapy products in Taiwan, Singapore, Malaysia, and the Philippines. This therapy was approved by Japan’s Ministry of Health, Labour and Welfare in 2021 and has since been used in nearly 1,000 treatment sessions. Currently undergoing Phase III clinical trials in Taiwan, Orient Europharma aims to obtain regulatory approval locally by next year.

Additionally, Rakuten Medical is conducting a multinational Phase III trial involving over 400 patients across Taiwan, the United States, and Japan, with the goal of submitting a New Drug Application to the U.S. Food and Drug Administration (FDA), thereby expanding the market for this innovative therapy.

The Alluminox platform is an advanced cancer treatment technology developed by Rakuten Medical. It combines targeted drugs with light-delivery devices to selectively trigger apoptosis in cancer cells and/or immunosuppressive cells through localized light exposure, minimizing damage to surrounding healthy tissue. Preclinical studies suggest that this therapy may also activate both innate and adaptive immune responses, potentially enhancing durable anti-tumor effects.

Through its subsidiary Cyntech, Orient Europharma has acquired commercialization rights in Taiwan, Singapore, Malaysia, and the Philippines. Under the agreement, Rakuten Medical will receive an upfront payment from Cyntech and will be eligible for milestone payments and royalties based on the net sales of the product in the licensed territories.

Orient Europharma stated that six clinical centers in Taiwan are participating in the ongoing Phase III trials, with 50 patients with recurrent head and neck cancer already enrolled. The company plans to submit a drug application in Taiwan next year and will continue enrolling patients as part of the global clinical program.

Founded only 15 years ago, Rakuten Medical’s flagship candidate ASP-1929—marketed in Japan under the brand name Akalux—and its corresponding light device, marketed as BioBlade, received the world’s first approval for photoimmunotherapy targeting unresectable locally advanced or recurrent head and neck cancer in Japan in 2020. Since its launch in January 2021, the treatment has steadily expanded across all 47 prefectures in Japan, with more than 180 medical institutions and over 450 physicians administering it, totaling nearly 1,000 treatment sessions to date.

Currently, ASP-1929 is being evaluated in combination with the immune checkpoint inhibitor pembrolizumab in a global Phase III trial in Taiwan and the United States as a first-line treatment for recurrent squamous cell carcinoma of the head and neck. In earlier Phase 1b/2 trials, the median overall survival (OS) had not yet been reached.

Resource: 友華引進光免疫療法 拚明年拿台灣藥證