By Yuan-Hao Liu
To the Members of International Society for Neutron Capture Therapy (ISNCT),
We are delighted to share significant advancements achieved by Neuboron Medical Group in the realm of Boron Neutron Capture Therapy (BNCT). These developments mark substantial progress within the BNCT domain in China and reflect our unwavering dedication to scientific innovation and the advancement of therapeutic options.
Medical Device Testing Success: On March 26, the Beijing Institute of Medical Device Testing (BIMT) conferred Medical Device Testing Reports on our NeuPEX Block-I, an accelerator-based BNCT (AB-BNCT) system. This certification affirms the system’s adherence to rigorous safety and efficacy standards, showcasing its potential as an integral component in BNCT applications.
IND Approval for BPA: Previously, in January 2024, the Center of Drug Examination of the National Medical Product Administration, China, has approved the Investigational New Drug (IND) application for our boronophenylalanine (NBB-001, also known as BPA). This pivotal approval sets the stage for the initiation of Phase-I clinical trials to assess the safety and initial efficacy of BPA in treating patients with recurrent head-and-neck cancer.
Commencement of Phase-I Trial: Scheduled to begin in April 2024 at the Xiamen Humanity Hospital, this approved Phase-I trial signifies a critical juncture in BNCT clinical research. It embodies our sustained commitment to exploring and broadening the therapeutic potential of BNCT for complex oncological conditions.
Since its establishment in 2014, Neuboron Medical Group has been at the forefront of BNCT research and development. Our integrated approach has culminated in the creation of a comprehensive BNCT solution, including the NeuPEX AB-BNCT System, the NeuMANTA Treatment Planning System, the therapeutic agent NBB-001 (BPA), and the diagnostic agent NBB-002 (18F-BPA). This unified strategy demonstrates our commitment to enhancing the precision, accessibility, and efficacy of BNCT.
The recent authorizations and the inauguration of the Phase-I trial underscore the dedication of the Chinese BNCT community to advancing this technology for the betterment of global healthcare. As we advance, we remain devoted to disseminating our research findings and collaborating with the scientific community to foster an environment that enriches our collective understanding and application of BNCT. Neuboron is committed to making BNCT technology accessible, affordable, and advanced for all patients in need.
For more detailed information on our research and developments, we warmly invite interested parties to contact us via email at contact@neuboron.com.
With sincere regards,
Yuan-Hao Liu
On Behalf of Neuboron Medical Group