日本語 
LOTTE HOLDINGS, CO., LTD. announces a strategic investment into Rakuten Medical, Inc., a global biotechnology company developing and commercializing photoimmunotherapy-based anticancer therapies through its proprietary Alluminox® platform.
Founded in 2010 and headquartered in San Diego, CA, Rakuten Medical is currently advancing ASP-1929, its first photoimmunotherapy drug, through a global Phase 3 clinical trial evaluating the therapy in combination with pembrolizumab as a first-line treatment for recurrent head and neck cancer. With the goal of generating pivotal data to support a planned Biologics License Application (BLA) submission to the U.S. FDA in 2028, Rakuten Medical is enrolling patients across the United States, Japan, Taiwan, and Ukraine, with clinical sites in Poland expected to be activated soon.
Beyond head and neck cancer, Rakuten Medical is also broadening its development pipeline through internal programs and investigator-initiated trials. Planned efforts include a Phase 1 clinical study of RM-0256 photoimmunotherapy for solid tumors in Japan, expected to begin in the second quarter of 2026 with grant support from the Japanese government, as well as ongoing investigator-initiated trials in esophageal and gynecologic cancers. Alongside this, the company continues to grow the commercial presence in Japan, where the ASP-1929 photoimmunotherapy products have received regulatory approvals for head and neck cancer, reinforcing its operational base and helping to support global expansion activities.
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This investment was made by LOTTE HOLDINGS Healthcare & Biopharmaceutical Corporate Venture Capital (HB‑CVC), an investment arm of LOTTE HOLDINGS, and will further strengthen Rakuten Medical’s operational capabilities across these key clinical and commercial initiatives.
In parallel with LOTTE HOLDINGS’ investment, LOTTE BIOLOGICS and Rakuten Medical executed a Master Service Agreement during the 2026 J.P. Morgan Healthcare Conference. This agreement provides for GMP‑compliant manufacturing of Rakuten Medical’s products at LOTTE BIOLOGICS’ Syracuse facility in New York and supports Rakuten Medical’s global clinical and future commercial supply strategy. The collaboration further aligns the LOTTE Group’s biopharmaceutical capabilities with Rakuten Medical’s global efforts to accelerate patient access to its novel oncology therapeutics.
SOURCE: PressreleaseJapan
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