Domestic BNCT anti-cancer technology shows remarkable efficacy in clinical trials
Recently, China has made important progress in the cutting-edge anti-cancer technology field of boron neutron capture therapy (BNCT). The BNCT equipment independently developed by the Institute of High Energy Physics of the Chinese Academy of Sciences and Guoke Neutron Medical Technology Co., Ltd. is operating stably and has completed the Phase I clinical trial of a total of 6 patients in the first dose group. The efficacy is significant and the side effects are small. The new generation of precision anti-cancer technology is one step closer to benefiting patients.
Equipment and standards go hand in hand to lay the foundation for clinical application
As a "cell-level precision sniper", the core advantage of BNCT technology is that it can accurately destroy cancer cells while causing minimal damage to normal tissues. The domestic BNCT clinical equipment used in this clinical trial operates stably, all indicators meet international treatment standards, and has successfully passed the national medical device type inspection. Previously, the project team completed comprehensive preclinical research, including cell experiments, animal safety tests, etc., which fully verified the safety and effectiveness of the technology and laid a solid foundation for the smooth development of clinical trials.
Clinical trial data is eye-catching, patients’ symptoms significantly improved
Since the clinical trial was launched at Dongguan People's Hospital in August this year, all 6 patients in the first dose group have completed treatment, and preliminary data have shown encouraging efficacy. A nasopharyngeal cancer patient's facial pain, lip numbness and other symptoms were significantly improved; an oral cancer patient's left cheek bleeding and swelling were effectively controlled; a head giant cell tumor of bone patient achieved improved hearing in his right ear and clearer vision.
Passed the national Class III medical device registration inspection
The BNCT equipment successfully passed the national Class III medical device registration inspection on March 21, 2025, achieving the necessary qualifications and conditions for the legal and compliant conduct of clinical trials of the equipment. Currently, the project is advancing follow-up work at full speed, and plans to start enrolling patients in the second dose group immediately after the observation period of the last patient ends. According to the established timetable, the project will complete all clinical trials next year and obtain marketing approval from the National Medical Products Administration. By then, the production base located in Songshan Lake, Dongguan will be able to realize large-scale supply of this new anti-cancer equipment, bringing new treatment hope to many patients with recurrent and locally metastatic head and neck cancer.
The successful clinical practice of domestically produced BNCT technology is not only an important milestone in China's independent innovation of high-end medical equipment, but will also provide a more efficient new option for domestic cancer treatment.