October 05, 2026
Company Name: J-Pharma Co., Ltd.
Name of Representative: President and CEO Masuhiro Yoshitake
Securities Code: 520A Tokyo Stock Exchange Growth Market
Contact: Director and CFO Yutaka Fujimoto
Telephone: +81-3-6432-4270
— Global Phase III Trial of Nanvuranlat Selected for Grant Support of Up to JPY 1.5 Billion —
J-Pharma Co., Ltd. (Head Office: Minato-ku, Tokyo; President and CEO: Masuhiro Yoshitake; hereinafter “J-Pharma” or the “Company”) today announced that its Beacon-BTC trial has been selected for grant support of up to JPY 1.5 billion under a fiscal year 2026 program administered by the Japan Agency for Medical Research and Development (AMED). Beacon-BTC is a global Phase III clinical trial evaluating the LAT1 inhibitor nanvuranlat (JPH203) as a second-line treatment for biliary tract cancer.
The selection was made under AMED’s Global Research and Development Support Project for the Treatment of Intractable/Rare Diseases (“GRiT”), the global track of its program promoting innovative medical technology R&D through industry-government-academia collaboration.
This selection represents an important milestone for J-Pharma, both financially and in the development of nanvuranlat. The grant would provide up to JPY 1.5 billion in non-dilutive funding and, once formally awarded, is expected to strengthen the financial foundation for completing Part A of Beacon-BTC.
The evaluation criteria for the program include scientific and technical significance and advantages, the appropriateness of the development plan, commercial viability, and the implementation framework. J-Pharma believes the selection reflects AMED’s assessment of the development program as a whole, including not only the scientific and technical value of nanvuranlat but also the development plan and implementation framework.
The Company’s project was selected for grant support covering the multinational clinical trial itself, without funding for a feasibility study (FS)*. As a result, the project is expected to receive grant support for the multinational clinical trial without undergoing the post-FS stage-gate evaluation required for projects that include an FS within the scope of funding.
* A feasibility study (FS) is a preliminary assessment conducted to determine whether a clinical trial can be carried out, including assessments of potential patient numbers outside Japan and preliminary consultations with regulatory authorities.
Part A of Beacon-BTC, which is designed to determine the optimal dosing regimen, is already underway in the United States. The Company has established the necessary development infrastructure, including a trial design developed through discussions with the U.S. Food and Drug Administration (FDA), investigational drug supplies, and a clinical trial implementation framework, and patient enrollment in the United States is progressing. Following this selection, the Company plans to expand Part A into a multinational clinical trial that includes Japan. Further details of the updated Beacon-BTC implementation plan will be announced when they can be disclosed.
A total of 25 proposals were submitted in response to this call, of which 8 were selected.
■ Significance for J-Pharma’s Business
- Non-dilutive funding support of up to JPY 1.5 billion
If the full JPY 1.5 billion requested is awarded, J-Pharma expects that the grant, together with its existing funds, would provide sufficient funding to complete Part A without additional financing, based on its current development and funding plans. - Important third-party assessment through a competitive review process
AMED evaluates proposals based on criteria including scientific and technical significance and advantages, the appropriateness of the development plan, commercial viability, and the implementation framework. J-Pharma believes its selection reflects AMED’s evaluation of the overall development program against these criteria, including the scientific and technical value of nanvuranlat as well as the development plan and implementation framework.
■ Selected Research and Development Project
Project title
Global Phase III Clinical Trial of the LAT1 Inhibitor Nanvuranlat as a Second-Line Treatment for Biliary Tract Cancer
Lead research and development institution
J-Pharma Co., Ltd.
Research and development period (as proposed in the application)
October 2026 (planned) to December 2028 (planned)
AMED grant amount requested
JPY 1.5 billion
Grant coverage
50% of eligible expenses for the multinational clinical trial.
The actual grant amount will be finalized following the formal grant award decision and other prescribed procedures.
Scope of the application
Multinational clinical trial only; no feasibility study (FS) included in the scope of funding.
The Company applied for a grant of up to JPY 1.5 billion to cover multinational clinical trial costs, excluding an FS, and the project was selected.
■ Background to the Selection
AMED’s GRiT program aims to promote the development of drug candidates and other therapeutic innovations for intractable/rare diseases into practical treatments. The program also aims to strengthen Japan’s clinical development capabilities by supporting multinational clinical trials led by Japanese companies and encouraging the involvement of Japanese contract research organizations (CROs).
Nanvuranlat is a small-molecule compound discovered in Japan with a novel mechanism of action that selectively inhibits L-type amino acid transporter 1 (LAT1), which is highly expressed in cancer cells. Biliary tract cancer, the target indication of the ongoing global Phase III Beacon-BTC trial, is a rare cancer with a poor prognosis. In the second-line setting in particular, treatment options remain limited for many patients whose tumors lack specific molecular alterations.
Based on data from the Phase II trial conducted in Japan and discussions with the FDA, J-Pharma initiated Beacon-BTC to evaluate nanvuranlat as a second-line treatment for biliary tract cancer. Part A, which is evaluating the optimal dose and dosing regimen, is currently underway in the United States.
■ Next Steps
Following this selection, the Company will proceed with the formal grant application process. Once the grant award decision has been made, the Company intends to use the awarded funding to steadily advance the global development of nanvuranlat while reducing the costs to be funded by the Company itself.
J-Pharma considers this selection and the anticipated grant support to be an important milestone that will help reduce financial risk in the development of nanvuranlat and enhance the value of the Company’s business.
The Company is currently assessing the impact of the selection on its development budget and earnings forecasts and will promptly announce any matters requiring disclosure as they arise.
■ Comment from Masuhiro Yoshitake, President and CEO
“We regard the selection of our global Phase III clinical trial of nanvuranlat for AMED’s support program as a highly significant milestone.
“Our goal has always been to bring nanvuranlat, a drug candidate discovered in Japan, to patients around the world. We began its clinical development in Japan and have continued to expand the program globally through discussions with the FDA and the initiation of the Phase III trial in the United States.
“Following this selection, we will proceed with the necessary steps toward conducting a multinational Phase III trial that includes Japan. Once the grant award decision has been made, we will use the support provided under this program to advance development and work to bring a new treatment option to patients with biliary tract cancer, who have limited treatment options, as soon as possible.”
Related Information
- – Global Phase III trial (Beacon-BTC) for biliary tract cancer
https://www.j-pharma.com/en/clinical_trial/biliary_tract_cancer_p3/ - – Progress of the Nanvuranlat global Phase III trial and initial patient enrollment/randomization (June 16, 2026)
https://ssl4.eir-parts.net/doc/520A/ir_material/280632/00.pdf - – Nanvuranlat and biliary tract cancer
https://www.j-pharma.com/en/pipeline/biliary_tract_cancer/
About Nanvuranlat
Nanvuranlat (development code: JPH203) is a novel LAT1-selective inhibitor originally discovered by J-Pharma and is the first small-molecule compound of its kind to be clinically developed worldwide. LAT1 (L-type amino acid transporter 1) is one of the transporters involved in cellular amino acid uptake and is known to be highly expressed in many cancer cells. If approved as a pharmaceutical product, it has the potential to become a first-in-class drug with a novel mechanism of action for its target disease.
Since 2015, J-Pharma has conducted Phase I clinical studies in multiple solid tumors and identified its potential for the treatment of advanced biliary tract cancer. A Phase II clinical study targeting advanced biliary tract cancer was conducted starting in 2018, demonstrating that nanvuranlat monotherapy provides clinically meaningful benefit.*
Nanvuranlat was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) in April 2022. Furthermore, on September 25, 2024, the Investigational New Drug (IND) application for clinical studies in cancer patients was accepted by the FDA. In addition, in May 2025, J-Pharma confirmed that the Chemistry, Manufacturing, and Controls (CMC) at the commercial manufacturing scale meet the quality standards required by the FDA. Based on these developments, the Company initiated a global Phase III clinical trial in December 2025.
* Publication on the results of the Japan Phase II clinical study of Nanvuranlat:
Furuse et al. A Phase II Placebo-Controlled Study of the Effect and Safety of Nanvuranlat in Patients with Advanced Biliary Tract Cancers Previously Treated by Systemic Chemotherapy. Clin Cancer Res. 2024;30(18):3990-3995. https://doi.org/10.1158/1078-0432.CCR-24-0461
About J-Pharma Co., Ltd.
J-Pharma Co., Ltd. aims to pursue new possibilities for SLC transporters and contribute to the hope and health of people worldwide through the development of innovative new drugs that address unmet medical needs. Under this mission, the Company has focused on LAT1 (L-type amino acid transporter 1), one of the SLC transporters discovered by the Company’s founder, and is advancing the development of LAT1 inhibitors to address the needs of patients with cancer and autoimmune diseases, where existing drugs are insufficient.
For more information, please visit: https://www.j-pharma.com/en/
Inquiries:
J-Pharma Co., Ltd.
Planning Department
TEL: +81-3-6432-4270
https://www.j-pharma.com/en/contact