Neuboron has once again achieved significant milestones in the field of BNCT technology. Following the successful approval of the clinical trial application for the first domestically produced boron drug BPA earlier this year, Neuboron has made further progress with its independently developed accelerator-based BNCT treatment system, "NeuPEX Block-I". This system has successfully passed the registration inspection for Class III medical devices, laying a solid foundation for the first domestic BNCT registration clinical trial scheduled for April and further promoting the development of BNCT clinical applications.
The registration inspection of medical devices is crucial for assessing product performance and safety, and it is vital for market access. As a highly integrated large-scale medical device, the accelerator-based BNCT system comprises multiple subsystems and components. Its design and implementation complexity, as well as the challenges of clinical registration, are particularly prominent. The Beijing Institute for Medical Device Inspection (BIMDI) undertook this significant registration inspection task, leveraging its professional strengths in radiotherapy, nuclear medicine, and radiological dosimetry equipment to quickly formulate and implement a rigorous inspection plan.
On March 26, 2024, BIMDI officially issued the registration inspection report, confirming that the "NeuPEX Block-I" system fully complies with the technical requirements and relevant regulatory standards in terms of safety and performance. It has become the first accelerator-based BNCT system in China to pass the medical device registration inspection. Its neutron beam performance exceeds the recommended standards of the International Atomic Energy Agency (IAEA), marking a significant technological advancement and leading position in this field for China.
This breakthrough by Neuboron is attributed to its advanced product development strategy, strict registration and quality management system, as well as strong support and guidance from regulatory authorities at all levels. As part of the "13th Five-Year Plan" National Key Research and Development Program, the "NeuPEX Block-I" system was included in the special review procedure for innovative medical devices ("green channel"), allowing for rapid progress without compromising standards. The continuous reforms and innovative policies of the National Medical Products Administration have provided an accelerated development pathway for innovative high-end medical device enterprises with core technologies.
BNCT, as a pioneering technology for tumor precision treatment, faces complexities and challenges that require innovative regulatory approaches and close cooperation among industry, academia, research institutions, and medical professionals. Innovation in both technology and regulatory models is expected to truly break international technological monopolies, promote the rise of domestic brands, and drive the high-quality development of China's medical industry, contributing to the goal of a Healthy China.
