Press Center

• OEP/Cyntec to bring Rakuten Medical’s innovative cancer therapies to new markets
• Rakuten Medical to receive upfront payment and potential milestones and royalties based on future sales

San Diego, CA, and Taipei, Taiwan – June 25, 2025 – Rakuten Medical, Inc. (“RMI”) and Orient EuroPharma Co., Ltd. (“OEP”) today announced the signing of an exclusive licensing agreement (“Agreement”) between RMI and Cyntec Co., Ltd. (“Cyntec”), an affiliate of OEP, to co-develop and commercialize photoimmunotherapy products based on RMI’s proprietary Alluminox™ platform in Taiwan, Malaysia, Singapore, and the Philippines (collectively, the “Territory”).

The Alluminox™ platform-based photoimmunotherapy is RMI’s innovative cancer treatment modality, which combines a drug with devices for localized light illumination. This novel therapeutic approach has been observed in pre-clinical studies to induce rapid and selective depletion of cancer and/or immunosuppressive cells with minimal impact on surrounding healthy tissue. This precision targeting may help preserve critical functions and quality of life for patients. Moreover, pre-clinical observations have shown that photoimmunotherapy may also stimulate both innate and adaptive anti-tumor immune responses, suggesting the possibility of sustained anti-tumor effects. These features may position Alluminox™ platform-based photoimmunotherapy as a novel form of precision, immune-activating surgery.

Under the Agreement, Cyntec will lead the co-development, regulatory filings, and commercialization of Alluminox™ platform-based products – both drugs and devices – in the Territory. RMI will support Cyntec throughout these activities by providing scientific, clinical and commercial expertise.

RMI will receive an upfront payment in consideration for the Agreement from Cyntec. RMI is also eligible to receive milestones and royalties tied to future net sales of Alluminox™ platform-based products in the Territory.

Commenting on the signing of the Agreement, Mickey Mikitani, CEO of Rakuten Medical stated, “This agreement significantly expands our opportunity to contribute to healthcare across a broader region of Asia through our innovative Alluminox™ platform. We have a strong team across the globe—including Taiwan, the United States and Japan—where everyone is working closely to strengthen the scientific foundation of the platform while advancing our therapy through real-world clinical experience both in global clinical trials and commercial use in Japan. We are excited to collaborate with OEP and Cyntec to accelerate the availability of our treatment to patients in Taiwan, Malaysia, Singapore, and the Philippines, and to take another key step toward fulfilling our mission.”

“This partnership is not only a strategic business opportunity but also a reflection of OEP’s long-term commitment to patient care,” said Peter Tsai, Chairman of OEP. “We are committed to driving the localization and adoption of Alluminox™ platform-based photoimmunotherapy, expediting its path to market, and expanding its clinical and commercial value across the Territory.”

Partnership Ceremony (From left)

• Minami Maeda, President of Rakuten Medical, Inc.
• Dr. Yi-Shing Leu, Chairman of the Taiwan Head and Neck Cancer Society
• Louise Chang, Managing Director, Rakuten Medical Taiwan, Inc.
• Dr. Kuan-Chou Lin, Former President of the Chinese Society of Oral and Maxillofacial Surgery
• Calvin Tsai, Chief Executive Officer of OEP

Rakuten Medical’s lead drug ASP-1929 (marketed in Japan as Akalux®) and device system (marketed in Japan as BioBlade®) received the world’s first regulatory approval in Japan in 2020 for unresectable locally advanced or recurrent head and neck cancer, under the Sakigake Designation System and the Conditional Early Approval System. Since its commercial launch in January 2021, the therapy’s presence has grown steadily. Today, ASP-1929 photoimmunotherapy is available in all 47 Japanese prefectures, with nearly 1,000 treatments delivered across more than 180 medical facilities by over 450 physicians.

Disclaimer: Rakuten Medical’s Alluminox™ platform-based photoimmunotherapy is investigational outside Japan.

Real-world data from Japan has shown a manageable safety profile and encouraging efficacy, including an Overall Response Rate (ORR) exceeding 68% and a Complete Response (CR) rate of over 30 % in head and neck cancer¹ as well as a CR rate of over 73% in nasopharyngeal cancer².

ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently being investigated in a global Phase 3 trial in Taiwan and the United States as a first-line treatment for recurrent head and neck cancer. (Protocol number: ASP-1929-381 / Acronym: ECLIPSE / ClinicalTrials.gov Identifier: NCT06699212). A prior Phase 1b/2 study showed promising interim evaluation results, including a 24-month survival rate of 52.4% and a median overall survival (OS) not yet reached ³.

1. Akalux IV Infusion 250 mg Post-Marketing Surveillance (all-case survey) Interim Analysis (Data Cutoff Date: 2024/9/24)
2. Takeshi Shinozaki, et al. Photoimmunotherapy in nasopharyngeal carcinoma recurrence. Poster presented at: 2024 ASCO Annual Meeting.
3. David M. Cognetti, et al. Recent safety and efficacy findings from a phase 1b/2 open-label combination study of ASP-1929 photoimmunotherapy with anti-PD-1 therapy in EGFR-expressing advanced head and neck squamous cell carcinoma (HNSCC). Poster presented at: 2024 ASCO Annual Meeting.

About Rakuten Medical, Inc. 

Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical’s photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.

About Alluminox™ platform  

The Alluminox™ platform is Rakuten Medical’s investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye® 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical’s pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical’s Alluminox platform-based photoimmunotherapy is investigational.

About Orient EuroPharma Co., Ltd.
Orient EuroPharma Co., Ltd. (OEP), established in 1982, has grown into a leading multinational pharmaceutical company headquartered in Taiwan. Listed on the Taipei Exchange (TPEx) since 2003. (4120.TW), OEP has built a strong presence across Southeast Asia, with extensive sales network in the region. OEP’s diversified portfolio spans prescription pharmaceuticals, oncology treatments, cosmeceuticals, and infant-to-adult nutrition and health products. The company also operates a dedicated subsidiary for innovative drug development and manufacturing. With integrated capabilities in pharmaceutical R&D, clinical trials, manufacturing, and regional marketing, OEP continues to advance healthcare solutions throughout Taiwan and the broader Asia-Pacific region.