Neuboron Medical Group Advances Cancer Treatment: Introducing Next-Generation Boron Neutron Capture Therapy

2024-04-10

临床1期临床申请

NANJING, China--(BUSINESS WIRE)-- Neuboron Medical Group (Neuboron) is pleased to announce significant progress in the commercialization of its comprehensive Boron Neutron Capture Therapy (BNCT) solution, marking a new era in the treatment of refractory tumors. On March 26, the Beijing Institute of Medical Device Testing (BIMT) granted Neuboron’s NeuPEX Block-I, an electrostatic accelerator-based BNCT system, its Medical Device Testing Reports. Concurrently, the Center of Drug Examination of the National Medical Product Administration, China, approved the Investigational New Drug (IND) application for Neuboron’s boronophenylalanine (NBB-001, also known as BPA). This approval facilitates the commencement of Phase-I Clinical Trials targeting recurrent head-and-neck cancer at the Xiamen Humanity Hospital, the premier operational BNCT Center in China. Founded in 2014, Neuboron stands at the forefront of BNCT innovation, dedication, and patient care. Neuboron’s decade of research and development has established Neuboron as the only entity globally to develop a proprietary Accelerator-Based BNCT (AB-BNCT) system alongside boron drugs, offering hospitals a complete BNCT solution. This solution encompasses the NeuPEX AB-BNCT System, the NeuMANTA Treatment Planning System, treatment boron drug NBB-001 (BPA), and diagnostic NBB-002 (18F-BPA). Neuboron’s inaugural AB-BNCT System, NeuPEX Block-I, was operational by 2021, and by October 2022, it had successfully administered its first patient treatment under an Investigator Initiated Trial (IIT), marking China as the second nation to achieve a full spectrum of BNCT clinical capabilities. NeuPEX distinguishes itself by its efficiency and 'green' credentials, capable of conducting over 2,400 irradiation sessions annually, thanks to its advanced patient positioning and simulation capabilities. The NeuMANTA Treatment Planning System, with its COMPASS Monte Carlo dose engine, delivers swift and precise dose calculations, reducing processing times to approximately five minutes. A pivotal advancement has been the development of a high-yield, nucleophilic reaction process for synthesizing 18F-BPA for PET scans, enhancing availability and critical diagnostic and treatment planning capabilities. Additionally, Neuboron’s BPA formulation as a freeze-dried powder ensures ease of transport and extended shelf life, preventing Maillard reactions. Prof. Yuan-Hao Liu, Founder and CEO of Neuboron, anticipates the initiation of its first clinical trial this April, with Phase I completion expected within the year. "Our entry into the Phase-I trial represents a significant stride towards our commitment to making BNCT accessible, affordable, and advanced," Prof. Liu remarked. "Our collaboration with global academic, research, and healthcare institutions, alongside industrial partners like TAE Life Sciences, underscores our dedication to fostering an open, cooperative BNCT ecosystem." Looking forward, Neuboron, in collaboration with the Xiamen Humanity Hospital, will extend its IIT trials to explore BNCT applications across a broader range of solid tumors and refine treatment methodologies. While the IND trial is restricted to domestic patients, the IIT trials are open internationally, widening access to this innovative treatment modality. Neuboron aims for market approval by late 2025 to early 2026. Discover more about Neuboron Medical Group's revolutionary impact on cancer therapy at . New drug cooperation please contact bd@neuboron.com. BNCT system cooperation please contact sales@neuboron.com.

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