Heron Neutron Medical Corp. New Drug B-10 L-BPA Injection Recognized by TFDA as a Pediatric or Rare Severe Disease Drug, Accelerating DIPG Clinical Development

Heron Neutron Medical Corp. (7799) announced today that its BNCT-combined new drug, B-10 L-BPA Injection, has been designated under the Taiwan Food and Drug Administration (TFDA) “Regulatory Framework for Pediatric or Rare Severe Disease Drugs” for the indication of Diffuse Intrinsic Pontine Glioma (DIPG).

 

DIPG is a rare and fatal brain tumor that primarily affects children aged 6–8 and is located in the brainstem. Due to the lack of effective treatments, approximately 90% of patients die within two years after diagnosis, prompting global efforts to develop innovative therapeutic approaches.

 

With this regulatory designation, B-10 L-BPA Injection for the DIPG indication is eligible for several accelerated and flexible regulatory measures, including:

• No separate application required for priority review, with a shortened review timeline of 240 days
• Exemption from prior Bridging Study Evaluation (BSE) for population differences, enabling faster integration of clinical data
• Flexibility in clinical trial design, including the number of subjects and trials, based on individual case needs
• If pediatric clinical trials are conducted in Taiwan and a drug license is obtained, a priority review voucher may be granted, which can be used to expedite the review of another product within the same corporate group

To accelerate market access and address unmet domestic medical needs, Heron Neutron Medical Corp. will actively collaborate with medical centers to advance clinical trial progress, enabling patients to benefit from innovative therapies as early as possible. The company is committed to rapidly bringing treatments for urgent medical needs, specific populations, and rare severe diseases to market, safeguarding the treatment rights of cancer patients.

 

B-10 L-BPA Injection has already entered Phase II clinical trials for recurrent head and neck cancer, Phase I/II trials for recurrent meningioma, and Phase I/II trials for malignant brain tumors. Clinical research in the DIPG field is also under active planning. Heron Neutron Medical Corp. will continue expanding collaborations and advancing BNCT-related drug development to provide safe, effective, and accessible innovative cancer therapies.

 

Heron Neutron Medical Corp. is currently the only domestic company dedicated to the development of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) technology. The company has successfully developed hospital-deployable AB-BNCT solutions and products, and in June 2024, its neutron irradiation system received TFDA approval as a medical device.

 

In parallel, Heron Neutron Medical Corp. is developing the boron-containing drug B-10 L-BPA Injection for BNCT applications. This drug selectively targets cancer cells expressing the LAT1 amino acid transporter. Following intravenous administration and irradiation with epithermal neutron beams, boron-10 within the tumor undergoes a neutron capture reaction, producing high linear energy transfer (LET) α-particles and lithium ions with a tissue range of less than 10 micrometers. This mechanism confines cytotoxic effects to tumor cells while sparing surrounding normal tissue. By integrating physical neutron beam targeting with biological tumor targeting, BNCT achieves a dual-targeted precision radiotherapy that significantly enhances tumor dose concentration and minimizes damage to healthy tissues.