We are pleased to announce that we have successfully completed the first shipment of our drug Steboronine® for BNCT (Boron Neutron Capture Therapy) to Le Cheng International Medical Tourism Pilot Zone, Boao City, Hainan Province in the People’s Republic of China. This is another great step towards the expansion of the BNCT market.
1.Overview
Sales from this transaction are expected to be approximately 600 million yen (excluding tax). We, Stella Pharma, would like to deliver our product, that is approved in Japan, also to the European and US market to contribute to patient’s needs, and this international development to China is one first important step.
２.Overview of Le Cheng International Medical Tourism Pilot Zone, Hainan Island.
Our world-wide first approved BNCT drug Steboronine® together with the BNCT Treatment System “NeuCure®” and Dose Calculation Program “NeuCure® Dose Engine” by Sumitomo Heavy Industries, Ltd. (SHI) is being implemented in Le Cheng International Medical Tourism Pilot Zone, Hainan Island, China.
The Le Cheng International Medical Tourism Pilot Zone is a deregulated special zone for the purpose of promoting medical tourism and provides preferential treatment for the import of medical equipment and pharmaceuticals. In China, as in Japan, when medical devices and pharmaceuticals are used, they must be approved by the regulatory authorities after clinical trials have been conducted. But if there is no approved drug or device yet in China, such drugs or devices can be introduced to Hainan Island after approval of the local authority, as long as they are approved in another country and for urgent clinical use at designated medical institutions. Real-world clinical treatment is therefore possible without previous clinical trials.
The target indication is “unresectable locally advanced or locally recurrent head and neck cancer” but with the ongoing development of other target indications these can be treated also in Hainan after approval in Japan.
We continue our efforts to bring BNCT, a new treatment option, to patients who need the treatment as soon as possible.
3.Start of Treatment in Hainan Island
After the flood damage in October 2024, our Chinese partner and SHI are working in collaboration to enable the early start of treatment. The start of treatment is expected to be delayed from the previously announced start date of June 2025 by SHI to the second half of FY2025. We will also do our best to achieve the early launch of the BNCT center in the special medical zone.
