Advanced radiotherapeutic innovator Heron Medical (禾榮科技) announced on May 25, 2026, that it has formally submitted an Investigational New Drug (IND) application to the Taiwan FDA (TFDA) for its proprietary B10 L-BPA Injection formulation. The company is partnering with premium clinical trial sites, including Linkou Chang Gung Memorial Hospital, to initiate a clinical trial evaluating the safety, tolerability, and initial efficacy profiles of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) in patients presenting with recurrent locally advanced or metastatic Triple-Negative Breast Cancer (TNBC). This marks Heron Medical's formal clinical translation of BNCT beyond head and neck cancers into aggressive solid tumors.

• The TNBC Therapeutic Challenge: TNBC lacks estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor 2 (HER2) amplification, leaving conventional endocrine therapies and HER2-targeted biologics ineffective. Clinically, late-stage TNBC patients face high recurrence rates, rapid disease progression, and limited survival-extending options.
• The BNCT Biophysical Mechanism: BNCT works by selectively accumulating boron-10 carriers within neoplastic tissues. When exposed to an external epithermal neutron beam, a localized nuclear fission reaction occurs, generating alpha particles and lithium-7 nuclei. These high linear energy transfer (LET) particles travel a distance equivalent to a single cell diameter ($approx 5text{--}9 mutext{m}$), precisely destroying tumor cells while leaving adjacent healthy parenchyma unharmed.
• Strategic Roadmap: Shen Hsiao-lien, General Manager of Heron Medical, emphasized that the corporate objective is to advance the deployment of its BNCT platform across a wider range of solid tumors. This strategy aims to solidify the company's position as an integrated leader combining proprietary AB-BNCT hardware systems, novel boron-containing compounds, and an international clinical translation platform.

Resource: 禾榮科拓展BNCT新適應症 瞄準三陰性乳癌高未滿足需求