Notice Regarding Registration of Investigator-Initiated Clinical Trial (jRCT) for "Nanvuranlat" in Biliary Tract Cancer

May 18, 2026

J-Pharma Co., Ltd.

J-Pharma Co., Ltd. (Headquarters: Minato-ku, Tokyo; hereinafter "the Company") announces that trial information has been registered and published on the Japan Registry of Clinical Trials (jRCT) in preparation for the start of an investigator-initiated clinical trial (JON-2404-B) for the combination of nanvuranlat and immune checkpoint inhibitors (ICI) in the first-line treatment of biliary tract cancer.

URL: https://jrct.mhlw.go.jp/latest-detail/jRCT2031260086

This trial is conducted at the initiative of physicians, and the Company will support the smooth execution of the trial based on a contract with the Cancer Institute Hospital of JFCR.

Dr. Masato Ozaka, Head of the Department of Hepatobiliary and Pancreatic Oncology at the Cancer Institute Hospital of JFCR, which is the representative facility for this trial, provided the following comment:

"Although the combination therapy of cisplatin/gemcitabine and anti-PD-1/PD-L1 antibodies is the current standard of care for biliary tract cancer, the 24-month survival rate remains below 25%, and unmet medical needs are still high. In particular, from week 25 onwards after the start of treatment, patients transition to maintenance therapy with an anti-PD-L1 antibody alone or an anti-PD-1 antibody and gemcitabine, but disease progression during the maintenance therapy period is a challenge. Many biliary tract cancer patients are elderly, and in many cases, they cannot continue aggressive drug treatment due to side effects even if it is effective, so there is a need for treatment options that allow for the continuation of standard therapy over a long period.

In this trial, by adding nanvuranlat to the current standard therapy (anti-PD-L1 + chemotherapy) as maintenance therapy from week 19 to week 25 onwards after the start of treatment, we expect further improvement in treatment efficacy without competing with the standard therapy."

Mr. Yoshitake, Representative Director and President of the Company, stated the following:

"It is known that cancer cells take in amino acids via LAT1 to acquire the nutrients necessary for proliferation. It has also been reported that the uptake of amino acids by cancer cells depletes amino acids in the tumor microenvironment, which may consequently impair the function of immune cells and suppress the immune response against cancer cells. Nanvuranlat, a LAT1 inhibitor, has the potential to affect the immune response in the tumor microenvironment in addition to its effect of suppressing the supply of amino acids to cancer cells, and non-clinical data suggesting activation of immune cells by LAT1 inhibition have been obtained through research by the Company. Furthermore, a synergistic effect between nanvuranlat and immune checkpoint inhibitors has been reported in animal models, and this may become a new therapeutic approach through both a direct effect on cancer cells and an effect on the anti-tumor immune response."

The Company will steadily advance the already initiated global Phase 3 clinical trial (Beacon-BTC) in the United States for the LAT1 inhibitor "nanvuranlat," while supporting the smooth execution of the investigator-initiated clinical trial in Japan to verify the combination therapy with ICI. The Company will continue to promote research and development with the aim of providing innovative treatment options that meet the hopes of patients worldwide.

[About Nanvuranlat]

Nanvuranlat (development code: JPH203) is a LAT1 selective inhibitor newly discovered by the Company, and is the first small molecule compound with this mechanism of action in the world to be clinically developed. LAT1 (L-type amino acid transporter 1) is one of the transporters involved in the cellular uptake of amino acids 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 (the first drug to be approved for a disease with a new mechanism of action) new drug. The Company has been conducting Phase 1 clinical trials targeting multiple solid tumors since 2015, and based on the results, found potential applicability to the treatment of advanced biliary tract cancer. Since 2018, the Company has been conducting Phase 2 clinical trials targeting advanced biliary tract cancer and has confirmed that it shows useful clinical efficacy as a single agent.

In addition, nanvuranlat received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in April 2022, and an Investigational New Drug (IND) application for clinical trials of nanvuranlat in cancer patients was accepted on September 25, 2024. Furthermore, in May 2025, it was confirmed that the CMC (Chemistry, Manufacturing, and Controls) at commercial manufacturing scale met the quality standards required by the FDA. Based on these developments, the Company in December 2025 for a global Phase I