BPA

Boron Neutron Capture Therapy (BNCT), as an emerging precision tumor therapy technology, has its efficacy highly dependent on the performance of specific boron carriers. 4-Borono-L-phenylalanine (L-BPA) is the core API of the most widely used BNCT targeted drug worldwide at present. It belongs to amino acid-based boron transporters, and is specifically enriched in tumor tissues through L-type amino acid transporter 1 (LAT1) that is overexpressed in tumor cells. Boron-10 isotopes undergo nuclear fission reaction under neutron beam irradiation, and the released short-range α particles can precisely kill tumor cells with minimal damage to surrounding normal tissues. At present, this component is mainly used for BNCT treatment of refractory solid tumors such as malignant melanoma, glioma, and head and neck squamous cell carcinoma, providing a new treatment option for advanced tumor patients who do not respond to conventional treatments.

The global BNCT market is currently in a stage of rapid expansion. In 2023, the global BNCT-related market size has exceeded 1.2 billion US dollars, with a compound annual growth rate of over 35%. Among them, L-BPA, as the only commercialized boron carrier, accounts for more than 90% of the boron API market share. The R&D of BNCT equipment and drugs in China is progressing rapidly. Two BNCT equipment have entered the clinical stage, and the corresponding market demand for L-BPA API continues to rise. At present, there are few enterprises in China that can produce high-purity L-BPA on a large scale, the competitive landscape is relatively loose, the API supply gap is large, and the market potential has not been fully released.

The original research enterprise of 4-Borono-L-phenylalanine is Stella Pharma of Japan, and the trade name of the original formulation is Borofalan. Its core compound patents in major markets such as Japan and the United States expired in 2019, and the compound patent in China also expired in 2019. The main dosage form approved by the original research is injection, with a specification of 10g/bag, which has been included in the Pharmaceutical Products List of the Ministry of Health, Labour and Welfare of Japan and the FDA Orphan Drug List. Up to now, there is no L-BPA preparation approved for marketing in China, and there is no public L-BPA registration number in A status on the CDE API registration platform for the time being, and the generic drug R&D and API registration work of multiple enterprises are underway. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for 4-Borono-L-phenylalanine, which can cover the impurity reference standard requirements throughout the whole process from API R&D to quality research and registration declaration. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can be provided with complete structure confirmation and standardization reports to help enterprises accelerate the R&D and declaration process.