[Heroic] Company Files IND Application with Taiwan TFDA for B10 L-BPA Injection for Pre-operative Adjuvant Therapy in Locally Advanced Oral Cancer
Heroic has submitted an Investigational New Drug (IND) application to Taiwan's TFDA for its B10 L-BPA injection, aimed at pre-operative adjuvant therapy for locally advanced oral cancer. This study will evaluate Boron Neutron Capture Therapy (BNCT) as a novel treatment strategy.
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- 📰 Published: May 11, 2026 at 09:00
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## Press Release Information
Title: [Heroic] Company Files IND Application with Taiwan TFDA for B10 L-BPA Injection for Pre-operative Adjuvant Therapy in Locally Advanced Oral Cancer
Subtitle:
Company Name:
Industry:
Body (First 8000 characters): 1. Date of Fact Occurrence: 115/05/11
2. Investigational Drug Name or Code: B10 L-BPA Injection
3. Purpose: To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) as pre-operative adjuvant therapy for locally advanced oral cancer.
4. All Planned R&D Stages: Phase 1 and Phase 2 clinical trials.
5. Current R&D Stage (Please state if the current stage is application submission/approval/disapproval. If disapproved, please explain the company's risks and countermeasures; also explain future business direction and cumulative R&D expenses invested):
(1) Application submission/approval/disapproval/results of human clinical trials (including interim analysis)/other significant events affecting new drug R&D: Submitted an Investigational New Drug (IND) application for academic research use, Phase 1 and Phase 2 human clinical trials to the Taiwan Food and Drug Administration (TFDA).
(2) If not approved by the competent authority, or if interim analysis results of human clinical trials do not reach statistical significance, or other significant events affecting new drug R&D occur, company risks and countermeasures:
Not applicable.
(3) If approved by the competent authority, or if interim analysis results of human clinical trials reach statistical significance, or other significant events affecting new drug R&D occur, future business direction: Not applicable.
(4) Cumulative R&D expenses invested: Due to future marketing strategies and licensing information, and to protect the rights and interests of the company and investors, this information will not be disclosed at this time.
6. Next R&D Stage (Please state the estimated completion time and estimated obligations):
(1) Estimated Completion Time: The actual schedule will depend on the review progress of the Taiwan Food and Drug Administration (TFDA).
(2) Estimated Obligations: Not applicable.
7. Market Status: In the field of head and neck cancer treatment, for patients with locally advanced (Locally Advanced) resectable tumors, achieving effective tumor volume reduction, increasing surgical resection rates, and preserving organ function through pre-operative adjuvant therapy (Neoadjuvant Therapy) has always been a major clinical challenge. Traditional pre-operative adjuvant therapies, including induction chemotherapy or concurrent chemoradiotherapy, often have systemic toxic side effects and potential damage to surrounding healthy tissues, which may increase post-operative complications or affect wound healing, facing certain limitations in clinical application. Currently, most clinical trials of Boron Neutron Capture Therapy (BNCT) focus on recurrent, unresectable, or refractory tumors. There are no clinical trials yet that use BNCT for pre-operative adjuvant therapy to effectively reduce tumor volume before surgery.
According to existing clinical research data, Boron Neutron Capture Therapy (BNCT) has the potential for cellular-level precision killing. Oral cancer is a type of head and neck cancer, offering a potential therapeutic option for such patients. In terms of market size, head and neck cancer has 1.7 million new diagnoses globally each year, with about 30%-40% of patients being locally advanced, making them the target group for pre-operative adjuvant therapy. This clinical application can supplement the treatment stages and types of oral cancer, offering a broader potential market. This study will further evaluate whether BNCT, as one of the Neoadjuvant Therapy strategies, can assist patients with tumors in more challenging locations or sizes, establishing a new clinical application direction through the integration of tumor control and subsequent surgery.
8. Other Matters to be Noted (If the entity of the event or resolution is a publicly issued company, this material information also complies with Article 7, Paragraph 8 of the Enforcement Rules of the Securities Transaction Act, which has a significant impact on shareholder equity or stock price):
Academic clinical trials are primarily for scientific or medical research purposes, led by medical institutions, academic units, or researchers. The company often acts as a sponsor, providing resources to support research by academic and research institutions. The clinical outcomes are mainly for academic publication, revision of clinical guidelines, and improvement of medical quality.
9. New drug development involves long timelines, high costs, and no guarantee of success. These factors may pose investment risks; investors should carefully judge and invest cautiously.
Keywords: Material Information
Title: [Heroic] Company Files IND Application with Taiwan TFDA for B10 L-BPA Injection for Pre-operative Adjuvant Therapy in Locally Advanced Oral Cancer
Subtitle:
Company Name:
Industry:
Body (First 8000 characters): 1. Date of Fact Occurrence: 115/05/11
2. Investigational Drug Name or Code: B10 L-BPA Injection
3. Purpose: To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) as pre-operative adjuvant therapy for locally advanced oral cancer.
4. All Planned R&D Stages: Phase 1 and Phase 2 clinical trials.
5. Current R&D Stage (Please state if the current stage is application submission/approval/disapproval. If disapproved, please explain the company's risks and countermeasures; also explain future business direction and cumulative R&D expenses invested):
(1) Application submission/approval/disapproval/results of human clinical trials (including interim analysis)/other significant events affecting new drug R&D: Submitted an Investigational New Drug (IND) application for academic research use, Phase 1 and Phase 2 human clinical trials to the Taiwan Food and Drug Administration (TFDA).
(2) If not approved by the competent authority, or if interim analysis results of human clinical trials do not reach statistical significance, or other significant events affecting new drug R&D occur, company risks and countermeasures:
Not applicable.
(3) If approved by the competent authority, or if interim analysis results of human clinical trials reach statistical significance, or other significant events affecting new drug R&D occur, future business direction: Not applicable.
(4) Cumulative R&D expenses invested: Due to future marketing strategies and licensing information, and to protect the rights and interests of the company and investors, this information will not be disclosed at this time.
6. Next R&D Stage (Please state the estimated completion time and estimated obligations):
(1) Estimated Completion Time: The actual schedule will depend on the review progress of the Taiwan Food and Drug Administration (TFDA).
(2) Estimated Obligations: Not applicable.
7. Market Status: In the field of head and neck cancer treatment, for patients with locally advanced (Locally Advanced) resectable tumors, achieving effective tumor volume reduction, increasing surgical resection rates, and preserving organ function through pre-operative adjuvant therapy (Neoadjuvant Therapy) has always been a major clinical challenge. Traditional pre-operative adjuvant therapies, including induction chemotherapy or concurrent chemoradiotherapy, often have systemic toxic side effects and potential damage to surrounding healthy tissues, which may increase post-operative complications or affect wound healing, facing certain limitations in clinical application. Currently, most clinical trials of Boron Neutron Capture Therapy (BNCT) focus on recurrent, unresectable, or refractory tumors. There are no clinical trials yet that use BNCT for pre-operative adjuvant therapy to effectively reduce tumor volume before surgery.
According to existing clinical research data, Boron Neutron Capture Therapy (BNCT) has the potential for cellular-level precision killing. Oral cancer is a type of head and neck cancer, offering a potential therapeutic option for such patients. In terms of market size, head and neck cancer has 1.7 million new diagnoses globally each year, with about 30%-40% of patients being locally advanced, making them the target group for pre-operative adjuvant therapy. This clinical application can supplement the treatment stages and types of oral cancer, offering a broader potential market. This study will further evaluate whether BNCT, as one of the Neoadjuvant Therapy strategies, can assist patients with tumors in more challenging locations or sizes, establishing a new clinical application direction through the integration of tumor control and subsequent surgery.
8. Other Matters to be Noted (If the entity of the event or resolution is a publicly issued company, this material information also complies with Article 7, Paragraph 8 of the Enforcement Rules of the Securities Transaction Act, which has a significant impact on shareholder equity or stock price):
Academic clinical trials are primarily for scientific or medical research purposes, led by medical institutions, academic units, or researchers. The company often acts as a sponsor, providing resources to support research by academic and research institutions. The clinical outcomes are mainly for academic publication, revision of clinical guidelines, and improvement of medical quality.
9. New drug development involves long timelines, high costs, and no guarantee of success. These factors may pose investment risks; investors should carefully judge and invest cautiously.
Keywords: Material Information