#Japan #Tokyo #CAR-T #Gilead #Kite

Gilead and Kite's New Facility in Japan

Gilead Sciences, Inc. (referred to as "Gilead"), headquartered in Chiyoda, Tokyo, along with Kite Pharma, Inc. ("Kite"), based in California, is excited to announce the opening of a new domestic facility aimed at providing CAR T cell therapy products efficiently and reliably to patients. This facility is part of their ongoing commitment to enhance the availability of their flagship CAR T therapy, Yescarta (generic name: axicabtagene ciloleucel).

Since Gilead assumed manufacturing and marketing approval for Yescarta in Japan in June 2023, the number of certified treatment centers has soared from 6 to 70, as of October 1, 2025. As demand for CAR T cell therapies is expected to rise significantly, this new facility allows for more streamlined and stable delivery of CAR T cell products to certified healthcare providers across the nation.

Kenneth B. Blais, the President and CEO of Gilead's Japan operations, emphasizes the strategic importance of CAR T cell therapy in the company's mission to advance cancer treatment. He stated, "Our obligation is to deliver therapies to patients with hematologic cancers, where timely treatment is crucial. This new facility will enhance the efficiency and stability of what is inherently a complex treatment process, unlocking the potential for curative options."

Laura Alquist, Senior Vice President of Technical Operations at Kite, added, "Kite boasts one of the world's largest manufacturing networks for cell therapies. To meet the growing demand for CAR T cell therapy and respond to the needs of patients and healthcare professionals, we are continuously optimizing our network. The establishment of this new Japanese facility is a testament to Kite’s commitment to providing timely and sustainable CAR T cell products to patients across the country who urgently need these therapies."

Facility Overview

• - Name: Gilead Sciences, Inc. Haneda Depot
• - Location: Tokyo, Japan
• - Approval Date: September 2025

About Yescarta (Axicabtagene Ciloleucel)

Yescarta (axicabtagene ciloleucel) is a CAR T cell therapy that targets CD19, a protein found on the surface of certain cancer cells. This therapy harnesses the patient’s own immune system to fight cancer. By extracting the patient's T cells, modifying them to express a chimeric antigen receptor, and reintroducing them into the patient’s body, Yescarta empowers these cells to recognize and destroy cancer cells. Each infusion is specifically manufactured for individuals, requiring only one treatment.

In Japan, Yescarta was designated as a regenerative medicine product for rare diseases by the Ministry of Health, Labor and Welfare in 2018. It was approved as a treatment for large B-cell lymphoma—the type of non-Hodgkin lymphoma—first in January 2021, and received additional indications for second-line therapy in December 2022.

Indications in Japan

Yescarta is approved for use in patients with relapsed or refractory large B-cell lymphoma, including:

• - Diffuse large B-cell lymphoma
• - Primary mediastinal large B-cell lymphoma
• - Transformed follicular lymphoma
• - High-grade B-cell lymphoma

However, it is only available to patients who have not previously undergone treatment with CD19-targeted CAR T cell infusion therapy.

About Kite

Kite, a Gilead company based in Santa Monica, California, is a biopharmaceutical enterprise dedicated to the pursuit of innovative cell therapies for cancer treatment. As a global leader, Kite has successfully provided CAR-T cell therapy to numerous patients and possesses one of the largest domestically-owned networks of cell therapy manufacturing—from process development to vector production, spanning clinical trials and commercial manufacturing.
For further information, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences has been pursuing medical innovation for over 35 years, aiming to create a healthier world for everyone. The company is dedicated to developing innovative therapeutics for life-threatening diseases such as HIV, viral hepatitis, COVID-19, and cancer. With headquarters in Foster City, California, Gilead operates in more than 35 countries worldwide.