Global Expansion Through U.S. and European Regulatory Approvals and Partnerships

「BNCT treatment for head and neck cancer began in March 2026 at the 鵬博(海南)BNCT Center in the Hainan Island Medical Special Zone.」

「In November 2024, the company signed a basic agreement with TAE LIFE SCIENCES US, LLC, a US biotechnology company, covering joint development and commercialization, including the conduct of clinical trials in the United States and Europe. The company also made its first shipment of Steboronin® to the Hainan Island Medical Special Zone in China in March 2025, and treatment is scheduled to begin at the BNCT center in the Hainan Island Medical Special Zone in the second half of 2025.」

「Before beginning drug supplies to the Hainan Island Medical Special Zone in the People's Republic of China, the company conducted transport validation and steadily advanced preparations for the start of drug supplies. It also received a total deposit of ¥1 billion from 鵬博（海南）硼中子医療科技有限公司, a subsidiary of 中国生物科技服務控股有限公司, and confirmed that the fulfillment of the agreements between the two companies required to begin BNCT treatment and the procedures associated with launching the business were progressing smoothly.」

「In its overseas business, the company continues discussions with contract pharmaceutical manufacturers and consulting companies to establish a system for supplying drugs to the US and European markets, while proceeding with import and export procedures, including confirmation with relevant local authorities and logistics companies, for supplying drugs to the Hainan Island Medical Special Zone, where treatment is scheduled to begin in 2025.」

「In its overseas business, the company held discussions with contract pharmaceutical manufacturers and consulting companies to establish a system for supplying drugs to the US and European markets. It also proceeded with confirmation of import and export procedures with relevant local authorities and logistics companies in preparation for supplying drugs to the Hainan Island Medical Special Zone, where treatment is scheduled to begin in 2025.」

「In its overseas business, the company held discussions with contract pharmaceutical manufacturers and consulting companies to establish a system for supplying drugs to the US and European markets. It also proceeded with confirmation of import and export procedures with relevant local authorities and logistics companies in preparation for supplying drugs to the Hainan Island Medical Special Zone, where treatment is scheduled to begin in 2025.」

「In its overseas expansion, the company is preparing to begin pharmaceutical exports to the Hainan Boao Lecheng International Medical Tourism Pilot Zone in China, where the introduction of BNCT has been decided, from fiscal 2025. In addition, on 7 December, it signed a basic agreement on pharmaceutical development and manufacturing with Bryllan LLC, a US contract pharmaceutical manufacturing company, for the purpose of outsourcing the manufacture, packaging and storage of the company's products, with the aim of establishing a stable supply system for Steboronin® in the US and European markets. By having Bryllan LLC manufacture products that comply with the regulations of each country and region, the company plans to supply the US market and export to the European market, thereby establishing a business platform for global expansion.」

「In its overseas business, the company received consideration for the introduction of BNCT to the Hainan Boao Lecheng International Medical Tourism Pilot Zone in China under the agreement concerning sales activities for accelerator introduction signed with SUMITOMO HEAVY INDUSTRIES,LTD. in June. For the Hainan Boao project, the Chinese partner 中国生物科技服務控股有限公司 held a groundbreaking ceremony on 25 September together with relevant local authorities for a BNCT boron neutron therapy center. The company also began discussions toward signing individual agreements linked to the basic agreement concerning the supply of Steboronin® with 中国生物科技服務控股有限公司 and its subsidiary 鵬博（海南）硼中子医療科技有限公司, and is taking further steps to expand overseas sales channels.」

「Against this backdrop, to promote its overseas business, the company signed a new agreement that further strengthens its existing partnership with SUMITOMO HEAVY INDUSTRIES,LTD. by clarifying the scope of marketing activities to be conducted jointly by the two companies and the fees for supporting the company's activities, enabling the companies to collaborate flexibly on sales activities for introducing BNCT treatment accelerators. The company also took steps to expand overseas sales channels, including signing a basic agreement concerning the supply of Steboronin® with 中国生物科技服務控股有限公司 and its subsidiary 鵬博（海南）硼中子医療科技有限公司, in connection with the introduction of BNCT to the Hainan Boao Lecheng International Medical Tourism Pilot Zone in China.」

「Overseas, the company aims to obtain approvals, primarily in the United States, Europe and Asia, for indications approved in Japan. It is also planning an alliance model involving collaboration with pharmaceutical companies and others familiar with the regulations in each country, and is working to select partner companies. The company positions expanding the indications for Steboronin® in overseas oncology markets, where particularly strong growth is expected, as an important growth strategy and plans to allocate management resources with a focus on this area.」

「Because the start of the planned clinical trial in Finland is expected to be later than initially scheduled, the company changed the timing of the allocation of funds.」

「Overseas, the company aims to obtain approvals, primarily in the United States and Europe, for indications approved in Japan. It is also planning an alliance model involving collaboration with pharmaceutical companies and others familiar with the regulations in each country, and is working to select partner companies.」