Nanvuranlat

Strategic partnership enables direct progression to Phase 3, bypassing additional Phase 2 study, as first patients are randomized in global trial TOKYO, Japan and DUBLIN, Ireland — [June 17, 2026] J ‑ Pharma Co., Ltd., a clinical-stage biotechnology company focused on novel therapies targeting amino acid transporters, and Uniphar, a leading international healthcare services company, today jointly announced progress in the development of JPH203 (nanvuranlat), a novel LAT1 inhibitor for the treatment of second-line biliary tract cancer. Following alignment with the U.S. Food and Drug Administration (FDA), the program has advanced into Phase 3 clinical development and initial patients are now enrolled in the global study. Development History J‑Pharma’s nanvuranlat program is rooted in pioneering work on LAT1, a transporter now widely recognized for its role in cancer biology. This scientific foundation traces back to Dr. Hitoshi Endou, founder of J‑Pharma and Professor Emeritus of Kyorin University, who originally identified LAT1 as a therapeutic target. Building on Dr. Endou’s discovery, J-Pharma translated LAT1 biology into a therapeutic approach and discovered nanvuranlat, a first-in-class LAT1 inhibitor targeting amino acid transport mechanisms involved in tumor growth. In Phase 1 and Phase 2 studies conducted in Japan, J‑Pharma demonstrated encouraging efficacy and safety signals in biliary tract cancer, supporting FDA agreement to advance to a global Phase 3 study. Through this progression, J‑Pharma has advanced a discovery rooted in Japanese academic science into a global late-stage development program. Regulatory Strategy Enabling Phase 3 Central to this milestone is the strategic partnership between J‑Pharma and Uniphar Development, Uniphar’s regulatory and clinical development division, enabling FDA agreement on a Phase 3 study through a targeted regulatory engagement strategy, bypassing the need for an additional Phase 2 study. "Reaching Phase 3 with FDA alignment is a defining milestone for J‑Pharma and, more importantly, for the patients with biliary tract cancer who urgently need new options," says Max Yoshitake, President & CEO of J‑Pharma. "Biliary tract cancer remains an area of significant unmet medical need worldwide, and we believe that bringing a new therapy to patients as quickly as possible carries major social significance. We are grateful for the close collaboration with Uniphar Development, which helped us translate our clinical data package into a clear regulatory strategy and global development path. We remain committed to working with Uniphar on the rigorous execution of the Phase 3 study and to exploring the potential of nanvuranlat for patients who may benefit from it." First Patients Enrolled in Global Study Building on the regulatory foundation established through the partnership, J‑Pharma has initiated its global Phase 3 study, with the first patients now successfully randomized. J‑Pharma and Uniphar Development are jointly managing the Phase 3 study, with Uniphar Development also serving as J‑Pharma’s U.S. agent with FDA. The program’s advancement into Phase 3 is helping to underpin investor confidence, contributing to J‑Pharma’s successful completion of its initial public offering (IPO) in Japan in March 2026. "We are proud to stand alongside J‑Pharma in announcing these achievements," says Chuck Finn, PhD, Chief Scientific and Development Officer at Uniphar Development. "This collaboration demonstrates the power of an integrated regulatory and development approach. Uniphar’s extensive regulatory, oncology, and development expertise combined with J‑Pharma’s scientific vision and development discipline, plus CEO Max Yoshitake’s global development experience, have been important factors in moving the program from data reassessment and FDA engagement to active Phase 3 enrollment. We are proud to continue supporting J‑Pharma’s efforts to address unmet treatment needs for biliary tract cancer and bring meaningful new options to patients." Uniphar Development continues to serve as J‑Pharma’s U.S. regulatory and development partner, providing ongoing strategic support as the Phase 3 trial progresses.