On January 4, 2024, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced on its official website that Neuboron's self-developed Class 2 new drug, "Borofalan(10B) for Injection" (BPA), has been approved for clinical trial applications, becoming the first domestic (and the second globally) BNCT boron drug to enter the registered clinical stage.
Neuboron's self-developed domestic BPA is a broad-spectrum boron-containing drug transported via the L-amino acid transport system (LAT-1), intended for the treatment of recurrent malignant head and neck tumors. Compared with similar products already on the market in Japan, Neuboron's BPA has optimized the prescription and process, and adopted a lyophilized dosage form, which is more convenient for individualized clinical use, thereby enhancing the clinical usability and accessibility.
In 2019, Neuboron had already completed the production of multiple batches of high-boron-abundance bulk drugs and multiple batches of pilot-scale formulations. The drugs were prepared in workshops that comply with the "Good Manufacturing Practice" (GMP) for pharmaceuticals and strictly followed the GMP requirements.
Non-clinical research further demonstrated that the domestic BPA, in combination with neutron irradiation, exhibited a tumor inhibition rate of over 85%, indicating that BNCT has good efficacy in both head and neck cancer and glioma models, and showcasing the strong therapeutic potential of domestic BNCT technology in gliomas and head and neck tumors.
The approval of the domestic BPA for clinical trials marks a milestone in China's progress in the clinical application and development of BNCT. It is believed that with the in-depth advancement of clinical development, BNCT will come closer to us, and the day of defeating cancer may no longer be far away.
