Neuboron's NeuPex AB-BNCT System Approved for the "Green Channel" Special Review Process by the NMPA to Drive Commercialization for a Novel Targeted Radiotherapy Modality

News 2023.08.151810

Neuboron's Boron Neutron Capture Therapy AB-BNCT system, NeuPex, has passed the State Center for Medical Device Evaluation (CMDE) public notice and is now undergoing the "Innovative Medical Devices Special Review Process." This is China's first AB-BNCT system to receive approval through the National Medical Products Administration's (NMPA) innovation approval process, highlighting its superior quality and clinical applications.


In 2014, the National Medical Products Administration (NMPA) introduced the "Special Approval Procedures for Innovative Medical Devices (Trial)". This was later revised and officially launched as the "Special Review Procedures for Innovative Medical Devices" in 2018. The aim is to prioritize the review of medical devices that hold patents for core technology inventions in the country, are first-in-class products in terms of technical principles, are internationally leading at a technical level, and have significant clinical application value. The NMPA refers to this process as the "Green Channel." There are specific compulsory requirements for product innovation, advancement, and clinical application value that must be met as part of the review procedure.


Upon receiving approval, the NMPA's review team offers personalized guidance throughout the registration process, making it more convenient and flexible. This significantly shortens the review time, promotes the adoption of emerging technologies, and ultimately expedites the commercialization and application of NeuPex in China.


Neuboron is dedicated to serving cancer patients worldwide. They are currently working on commercializing their products in China while also collaborating with Europe, Southeast Asia, and other global markets. In recent years, Neuboron has established strong partnerships with countries such as Italy, Spain, Russia, Singapore, and Malaysia. One notable initiative is the Sino-Italian Fund for International Cooperation Project, which aims to share the expertise of Xiamen BNCT and support the INFN and the University of Campania in building the Caserta project in Italy.


Neuboron has been actively pursuing the ideals of openness and inclusivity by collaborating with global experts and scholars to enhance cooperation and knowledge exchange within the BNCT industry. They have engaged in several national-level international cooperation projects, partnering with institutions such as the Italian National Institute of Nuclear Physics (INFN), Pavia University, and the Budker Institute of Nuclear Physics (BINP). This has resulted in Neuboron's participation in a multitude of national research projects for several years, including the Sino-Italian international cooperation project in science and technology innovation, the digital diagnostic and therapeutic equipment project, and the China-Japan international cooperation project under the Ministry of Science and Technology of China (MOST) and the National Natural Science Foundation of China (NSFC).


Receiving approval to enter the "Special Review Procedure for Innovative Medical Devices" is a huge milestone in Neuboron's product registration process. The company views this as a new chapter and will make every effort towards BNCT commercialization to improve patients' quality of life.