Domestically Developed "Boron Neutron Capture Therapy System" Enters the National Special Review Procedure for Innovative Medical Devices

Recently, the Medical Device Technical Review Center of the National Medical Products Administration issued a public notice on the review results of applications for the Special Review Procedure for Innovative Medical Devices (No. 14 of 2026). The “boron neutron capture therapy system” independently developed by Huapeng Neutron Technology (Hangzhou) Co., Ltd. has officially entered the National Special Review Procedure for Innovative Medical Devices after the public notice period.

Screenshot from the official website of the Medical Device Technical Review Center of the National Medical Products Administration

The Special Review Procedure for Innovative Medical Devices is a review channel established by the National Medical Products Administration to encourage medical device innovation and promote the application of new technologies, effective since December 1, 2018. According to the relevant procedures, drug regulatory authorities and technical institutions will, on the premise of not lowering standards and not reducing procedures, carry out early intervention, designate dedicated personnel, and conduct scientific review for qualifying innovative medical devices, and give them priority in processing.

Boron neutron capture therapy (BNCT) is a tumor radiotherapy technique that combines targeted boron drugs with epithermal neutrons. Its basic principle is as follows: after boron drugs carrying boron-10 enter the human body through intravenous injection or other means, they selectively accumulate in tumor cells; subsequently, the epithermal neutron beam generated by the equipment locally irradiates the tumor target area. After neutrons are captured by boron-10 within tumor cells, a cellular-level nuclear reaction occurs, releasing high-linear energy transfer heavy ions such as α particles and lithium ions, thereby killing tumor cells while minimizing damage to surrounding normal tissues.

It is understood that the boron neutron capture therapy system HyBorSys®—35kW, independently developed and produced by Huapeng Neutron, covers BNCT treatment-related equipment and system integration. The treatment planning system supporting this system is based on self-developed algorithms and can support dose calculation and target area planning; its independently developed second-generation boron drug has obtained clinical trial approval from the National Medical Products Administration, and Phase I BNCT "drug-device combination" clinical trials are currently underway.

Entering the Special Review Procedure for Innovative Medical Devices this time means that the registration review process of this domestically produced BNCT system is expected to accelerate. Huapeng Neutron stated that it will continue to advance the research and development and registration application of the BNCT treatment system, conduct clinical trials as required, and promote the clinical translation of domestically produced boron neutron capture therapy technology.