BNCT Technology - 90 Years of Development

The birth of BNCT relies on breakthroughs in fundamental physicsIn 1932, Chadwick discovered neutrons, and in 1935, Taylor and Goldhaber described them; The key nuclear reaction of ⁰ B (n,α) ⁷ Li lays the core support for its technical principles.

In 1936, Locke first proposed the concept of neutron capture therapy for cancer, which became the starting point of BNCT technology. Its core logic‐ — The targeted aggregation of tumor cells by boron drugs and the precise killing of cancer by neutron irradiation are still ideal treatment directions to this day.

In 1940, Kruger published the first BNCT experimental results, which preliminarily verified the feasibility of the concept and established the concept of "BNCT"; Boron drug enrichment+neutron triggered reaction; The dual precision core framework.

The clinical exploration of BNCT started very early and officially began in the 1950s1951-1953Brookhaven National Laboratory in the United States utilized graphite research reactors for the first time in the treatment of malignant glioma patients, becomingThe world's first clinical application of BNCTThis marked the beginning of clinical exploration. During the same period, researchers found that the combination of boron compounds with amino acids can significantly increase the boron concentration in tumor tissues, laying a key foundation for subsequent precision treatment and proving its feasibility for human tumor treatment.

Although the first application verified feasibility, in the late 1950s, subsequent studies in the United States fell into a 30-year hiatus due to insufficient enrichment concentration of boron drugs in tumors, unsatisfactory therapeutic effects, and significant damage to normal tissues. However, the valuable human body data accumulated during this stage provides important references for overcoming technical bottlenecks in the future.

During the period of global research stagnation, Japan became a core driving forceIn 1968, Japanese scholar Hatanaka introduced sodium borate (BSH) to restart clinical exploration of BNCT; In 1987, Mishima's team used boron phenylalanine (BPA) to treat advanced malignant melanoma and optimized the treatment plan; In 1989, the Hatanaka team announced exciting results; — The 5-year survival rate of selected malignant glioma patients after treatment reached 58%, far exceeding traditional methods. This not only validates the effectiveness of the optimized plan, but also triggers a new global wave of BNCT research.

Since the 1990s, with the iteration of boron drugs and the innovation of neutron source technology, BNCT has entered a stage of standardized and large-scale development, and its technological maturity has continued to improve. During this period, research is no longer limited to small-scale exploration, but is advancing towards expanding indications, optimizing efficacy, and verifying safety, laying a solid foundation for clinical translation.

In terms of boron drugs, second-generation compounds such as L-BPA and BSH enhance tumor enrichment efficiency and selectivity, and low toxicity can achieve; Diagnosis+Treatment; coordination; The third-generation compounds are currently undergoing preclinical research, focusing on optimizing targeting and efficacy.

The innovation of neutron source technology provides key support for large-scale applications: early reliance on nuclear reactor equipment was large and costly, making it difficult to promote; After the 1990s, breakthroughs were made in the development of accelerator neutron sources. In 2008, Kyoto University andMitsubishi Heavy IndustriesThe jointly developed accelerator BNCT system was officially applied on a large scale in 2012, marking the entry of BNCT into the industry; Accelerator Era” Promote its widespread popularization.

2020 is an important milestone in the maturity of BNCT:After decades of research and accumulation, Japan has become the first country in the world to include BNCT in medical insurance, approving its use for the treatment of unresectable, locally advanced or locally recurrent head and neck cancer. The world's first BNCT device has been approved for market simultaneously with boron drugs. This achievement is supported by over a thousand clinical data cases accumulated globally, fully demonstrating its maturity and reliability. According to official summary data on clinical applications after its launch in Japan, BNCT was used in 154 patients with locally advanced or locally recurrent head and neck cancerThe objective remission rate is 70.1%, and the complete remission rate is 46.1%(Nearly half of the patients' tumors have completely regressed)! As of now, the marketed system has treated over 500 patients, and the relevant efficacy and safety data further validate the maturity of BNCT technology.

Although the development of BNCT in China started relatively late, relying on the collaborative innovation model between medical research and enterprises, it has achieved rapid progress from technology research and development to clinical exploration. The core equipment and boron drugs have gradually been localized, and multiple clinical trials have been carried out in an orderly manner. The overall process is closely following the global forefront, accelerating the clinical landing of technology and bringing new treatment hope to refractory tumor patients in China.

Among them, the cooperation project between Fenglin Nuclear Group and Shandong University Qilu Hospital is quite representative. The two parties jointly established a neutron medicine center in 2022, and the domestically developed boron neutron capture therapy system has passed the inspection of three types of medical devices and been included in the "Special Review Procedure for Innovative Medical Devices" of the National Medical Products Administration, achieving breakthroughs in boron drug research and development simultaneously.The Phase I clinical trial in 2025 has been approved by the National Medical Products Administration and the Clinical Trial Ethics Committee of Shandong University Qilu Hospital (Qingdao)The recruitment process for patients with recurrent or unresectable head and neck malignant tumors has officially begun.