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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,...

2026-09-10

Huzhou, Zhejiang Launches Phase I "Drug-Device Combination" Clinical Trial for the Province's First BNCT System

Recently, the Boron Neutron Tumor Treatment Center at Huzhou Hospital Affiliated to Zhejiang University School of Medicine has drawn attention with the introduction of the province's first Boron Neutron Capture Therapy (BNCT) system. Previously, the system had already initiated a Phase I BNCT drug-device combination clinical trial. According to the system developer, Huapeng Neutron Technology (Hangzhou) Co., Ltd., BNCT is a radiotherapy technique combining drugs and devices, with its core lying in the coordinated use of boron-containing drugs and neutron irradiation. After entering the human body, the boron-containing drug can be absorbed by tumor cells; subsequent neutron beam irradiation triggers a localized reaction to achieve targeted radiotherapy against tumor cells. Unlike conventional radiotherapy, which typically employs fractionated irradiation over a longer treatment course, BNCT emphasizes selective targeting of tumor cells, aiming to reduce damage to surrounding healthy tissues and lower radiotherapy-related side effects such as hair loss and immunosuppression.

2026-08-27

Phase I of Jinjiang Ruisi Ke Particle Therapy Equipment Production Base Fully Operational

Recently, Phase I of the Ruisi Ke Advanced Particle Therapy Equipment Production Base for tumors, located in Dongshi Town, Jinjiang, Fujian, has been fully put into operation, marking new progress in the life and health industry sector of Quanzhou South Wing National High-Tech Zone. As the first launch project in the local effort to build the "China Nuclear Medicine Valley," this project is accelerating the clustering of the nuclear medical equipment industry chain. It is understood that all four production workshops of Phase I of the Ruisi Ke production base have commenced operations, with a total floor area of nearly 30,000 square meters. Inside the workshops, relevant personnel are performing precision machining on core components of the proton therapy system. The base possesses research and development, production, and testing capabilities for proton therapy systems and boron neutron capture therapy systems, making it one of the few...

2026-08-24

China's First Qualification for Radiation Health Testing and Evaluation of BNCT Equipment Approved

Recently, the Beijing Municipal Health Commission, in accordance with the "Administrative Measures for Radiation Health Technical Service Institutions" (Guoweiban ZhiJian Fa [2026] No. 1), organized experts to conduct on-site reviews of two qualification expansion applications submitted by the National Center for Occupational Safety and Health under the National Health Commission. The projects include performance testing and evaluation of Boron Neutron Capture Therapy (BNCT) equipment and thyroid iodine-131 testing. During the review process, the expert panel conducted a comprehensive examination of the center's management system, personnel allocation, instruments and equipment, and technical capabilities related to radiation health testing and evaluation through document review, technical inquiries, on-site practical operations, and simulated demonstrations...

2026-08-12

China Bio-Pharma: Enters Cooperation Agreement with Stella Pharma on Boron Neutron Therapy Drug

China Bio-Pharma Holdings Limited announced on August 12 that the company, Pengbo (Hainan) Boron Neutron Medical Technology Co., Ltd., and Japan's Stella Pharma Corporation signed a legally binding Master Cooperation Agreement on August 11, 2026, to jointly advance the development and commercialization of Steboronine in China. Steboronine is described in the announcement as the world's first approved boron neutron therapy drug, applied in Boron Neutron Capture Therapy (BNCT). Under the agreement, the cooperation between the two parties is divided into a development phase and a commercialization phase. During the development phase, the cooperation aims to leverage real-world data, real-world evidence, and real-world studies generated by the China Bio-Pharma Group to facilitate Stella Pharma in obtaining and maintaining, as soon as possible, marketing approval from China's National Medical Products Administration (NMPA) for Steboronine for the treatment of head and neck cancer; after Stella Pharma obtains marketing and manufacturing approval from the Japanese government for Steboronine for meningioma, the relevant China filings may also be extended to the meningioma indication.

2026-08-12

Fujita Health University in Japan Advances Research on Expanding BNCT Indications for Deep-Seated Cancers, to Conduct 18F-FBPA PET Exploratory Evaluation

On August 10, Stella Pharma Corporation of Japan announced that it is collaborating with Fujita Health University and other institutions to advance research and development aimed at expanding Boron Neutron Capture Therapy (BNCT) to deep-seated cancers. As part of this project, Stella Pharma will participate in an exploratory study on 18F-FBPA uptake capacity in deep-seated cancers conducted by Fujita Health University. The study will use 18F-FBPA PET to evaluate the tumor accumulation of boron drugs used in BNCT in deep-seated cancers, and based on the findings, explore the possibility of expanding BNCT indications in the future. The study plans to collect data from 50 cases, including pancreatic cancer, hepatocellular carcinoma, and biliary tract cancer, to accumulate foundational evidence needed for the development of BNCT for deep-seated cancers. BNC...

2026-08-11

Russia's Vector Research Center Proposes Quantum Dots for Boron Delivery in Neutron Capture Therapy

Russia's Vector Research Center has proposed using quantum dots as targeted boron delivery systems in boron neutron capture therapy (BNCT) to explore more precise approaches to tumor treatment. Yuri Tumanov, the center's chief researcher, presented this research progress at a conference on engineering biology and biopharmaceuticals. Boron neutron capture therapy is a cancer treatment method that combines boron-containing drugs with neutron irradiation. The basic concept involves first allowing boron-containing drugs to accumulate in tumor cells, then subjecting the patient to neutron irradiation, which triggers a nuclear reaction that releases energy concentrated within boron-containing cancer cells, thereby destroying tumor cells. How to construct boron delivery systems that are low-toxicity, highly efficient, and capable of participating in targeted tumor destruction remains one of the key challenges in this field...

2026-08-01