J-Pharma and Uniphar Announce Strategic Partnership Milestone: Global Phase 3 Trial Initiation for JPH203 (nanvuranlat)

June 16, 2026

Company Name: J-Pharma Co., Ltd.

Representative: President and CEO, Masahiro Yoshitake

(Code Number: 520A)

Contact: Planning Department

(Tel: 03-6432-4270)

Tokyo, Japan, and Dublin, Ireland – June 16, 2026 – J-Pharma Co., Ltd. (hereinafter “J-Pharma”), a clinical-stage biotechnology company focused on developing novel therapeutics targeting amino acid transporters, and Uniphar, a leading global healthcare services company, today jointly announced development progress on JPH203 (nanvuranlat, Nanvuranlat), a novel LAT1 inhibitor for second-line treatment of biliary tract cancer. Following agreement with the U.S. Food and Drug Administration (FDA), the program has transitioned into Phase 3 clinical development, with first patient enrollment and randomization now underway in the global trial.

Development Background

J-Pharma’s nanvuranlat development program is based on pioneering research into LAT1 (L-type amino acid transporter 1), an amino acid transporter widely recognized for its importance in cancer biology. This scientific foundation originated with Dr. Hitoshi Endo, founder of J-Pharma and Professor Emeritus at Kinki University, who first identified LAT1 as a therapeutic target.

Building on Dr. Endo’s discovery, J-Pharma translated the biological insights on LAT1 into a therapeutic approach, creating nanvuranlat, a first-in-class LAT1 inhibitor that targets amino acid transport mechanisms involved in tumor proliferation.

Promising efficacy and safety signals were observed in Phase 1 and Phase 2 trials conducted in Japan, and these results formed the basis for agreement with the FDA to proceed directly to a global Phase 3 trial.

This advancement enables J-Pharma to evolve its Japan-originated academic science into a global late-stage clinical development program.

Regulatory Strategy Enabling Phase 3

At the core of this milestone is the strategic partnership between J-Pharma and Uniphar Development, the regulatory and clinical development support arm of the Uniphar Group. Under this collaboration, both companies achieved agreement with the FDA on the Phase 3 trial design through a precise regulatory strategy, establishing a pathway to advance directly to Phase 3 without conducting an additional Phase 2 trial.

Masahiro Yoshitake, President and CEO of J-Pharma, stated:

"Advancing to Phase 3 following discussions with the FDA is a significant milestone for J-Pharma and, more importantly, holds great significance for biliary tract cancer patients who urgently need new treatment options. Biliary tract cancer remains a disease area with substantial unmet medical needs worldwide, and we believe there is significant social value in delivering new therapies to patients as soon as possible. We deeply appreciate the close collaboration with Uniphar Development, which enabled us to translate our clinical data package into a clear regulatory strategy and global development plan. Going forward, we will continue to work with Uniphar to rigorously execute the Phase 3 trial and pursue the potential benefits nanvuranlat may bring to patients."

First Patient Enrollment and Randomization in Global Trial

Based on the regulatory foundation established through the partnership, J-Pharma has initiated its global Phase 3 trial and completed first patient enrollment and randomization. J-Pharma and Uniphar Development are jointly managing the Phase 3 trial, with Uniphar Development also serving as J-Pharma’s U.S. agent for FDA submissions.

The program’s advancement to Phase 3 has also served as a key factor in building investor confidence, contributing to J-Pharma’s successful initial public offering (IPO) in Japan in March 2026.

Dr. Chuck Finn, Chief Scientific and Development Officer at Uniphar Development, stated:

"We are honored to announce this achievement together with J-Pharma. This partnership exemplifies the effectiveness of an integrated approach to regulatory and development strategy. The combination of Uniphar Group’s broad expertise in regulatory affairs, oncology, and development—including Uniphar Development—with J-Pharma’s scientific vision, development execution capability, and President Masahiro Yoshitake’s global development experience, has been a critical factor in advancing this program from data re-evaluation and FDA discussions to the initiation of patient enrollment in the Phase 3 trial. We are proud to continue supporting J-Pharma’s mission to address unmet medical needs in biliary tract cancer and deliver meaningful new options to patients."

Uniphar Development will continue to provide strategic support as J-Pharma’s regulatory and development partner in the United States, aligned with the progress of the Phase 3 trial.

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For inquiries regarding this announcement:

J-Pharma Co., Ltd. Planning Department

Tel: 03-6432-4270

https://www.j-pharma.com/contact/

For inquiries regarding Uniphar:

TALA

Heather Hopkin

Email: heather.hopkin@teamtala.com

Tel: +44 (0)7545 536147

Beth O’Shea

Email: beth.oshea@teamtala.com

Tel: +44 (0)7891 481003

About JPH203 (nanvuranlat, Nanvuranlat)

Nanvuranlat (development code: JPH203) is a novel, selective LAT1 inhibitor developed by J-Pharma. It is the first small-molecule compound in the world with this mechanism of action to enter clinical development. LAT1 (L-type amino acid transporter 1) is a transporter involved in amino acid uptake into cells and is known to be highly expressed in many cancer cells. If approved, nanvuranlat has the potential to become a first-in-class medicine—a drug approved for the first time with a novel mechanism of action for a given disease.

Since 2015, J-Pharma has conducted Phase 1 clinical trials in multiple solid tumors, and based on these results, identified potential for application in the treatment of advanced biliary tract cancer. Since 2018, the company has conducted a Phase 2 clinical trial in patients with advanced biliary tract cancer, confirming useful clinical efficacy as a monotherapy.

Additionally, nanvuranlat received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in April 2022, and on September 25, 2024, the Investigational New Drug (IND) application for clinical trials of nanvuranlat in cancer patients was accepted by the FDA.