Yoshie Tsurumaki

Regulatory insights on adeno-associated virus-based gene therapies, cell- and tissue-based products, and CAR-T cell therapies: report from the 8th Asia Partnership Conference of Regenerative Medicine, April 24, 2025

Shunsuke Tominaga, Yoshie Tsurumaki, Yusuke Kagawa, Aki Kito et autres

The 8th Asia Partnership Conference of Regenerative Medicine (APACRM) was held in a hybrid format—both in person and online—on April 24, 2025, to advance regulatory harmonization for regenerative medicine products across Asia. Understanding the domestic regulatory guidelines and their underlying rationales within …

jp, us (code pays fourni par la source)

Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024

Yoshie Tsurumaki, Yusuke Kagawa, Hirokuni Mizoguchi, Masaaki Miyano et autres

The 7th Asia Partnership Conference of Regenerative Medicine (APACRM) was held both in person and online on April 25, 2024, to promote the regulatory harmonization of regenerative medicine products across Asia. Recognizing domestic regulatory guidelines and their underlying rationales within each country …

jp, us, cn (code pays fourni par la source)

Pursuing cell therapy approvals in APAC: your guide to navigating regulations in Japan, South Korea, and Singapore

Eddie Han Pin Tan, Vorapin Chinchalongporn, Fajar Dumadi, Yoshie Tsurumaki et autres

sg, ca, jp, kr, au (code pays fourni par la source)

Optimizing the commercial manufacturing of tisagenlecleucel for patients in Japan: A 4-year experiential journey

Fumiko Iwamoto, David Fong, Margarida Rodrigues, Yoshie Tsurumaki

Background: Tisagenlecleucel, an autologous CD19-directed chimeric antigen receptor T-cell therapy, was approved in Japan, in March 2019 for patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukamia and r/r diffuse large B-cell lymphoma, and in August 2022 for patients with r/r follicular lymphoma. …

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Regulatory insights on advanced CAR-T cell products, AAV-based Gene therapies, and medical care/practice in cell and Gene therapies: Report from the 6th Asia partnership conference of regenerative medicine- April 20, 2023

Hiroshi Karasawa, Hirokuni Mizoguchi, Bryan Choi, Chia‐Ling Hsieh et autres

The 6th Asia Partnership Conference of Regenerative Medicine (APACRM) was held in person with online on April 20, 2023, to promote the regulatory harmonization of regenerative medicine products throughout Asia. Recognizing domestic regulatory guidelines within each country and region and the underlying …

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Non-clinical, quality and environmental impact assessments of cell and gene therapy products: Report on the 5th Asia Partnership Conference of Regenerative Medicine - April 7, 2022

Toshimitsu Tanaka, Hiroshi Karasawa, Masahiko Yasumoto, Byung Hyune Choi et autres

The 5th Asia Partnership Conference of Regenerative Medicine (APACRM) was held online on April 7, 2022 to promote regulatory harmonization of regenerative medicine products throughout Asia. The recognition of domestic regulatory guidelines within each country and region and the underpinning rationales are …

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Nonclinical and quality assessment of cell therapy products: Report on the 4th Asia Partnership Conference of Regenerative Medicine, April 15, 2021

Tomohiro Yoneda, Toshimitsu Tanaka, Kiyoko Bando, Byung Hyune Choi et autres

The 4th Asia Partnership Conference of Regenerative Medicine (APACRM) was held online on April 15, 2021, to promote regulatory harmonization of regenerative medicine products throughout Asia. Recognizing domestic regulatory guidelines within each country and region, and their underpinning rationales, is an important …

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The Past, Present, and Future of Clinically Applied Chimeric Antigen Receptor-T-Cell Therapy

Yuki Fujiwara, Toshiki Kato, Futoshi Hasegawa, Muha Sunahara et autres

Immunotherapy represents the fourth pillar of cancer therapy after surgery, chemotherapy, and radiation. Chimeric antigen receptor (CAR)-T-cell therapy is an artificial immune cell therapy applied in clinical practice and is currently indicated for hematological malignancies, with cluster of differentiation 19 (CD19) as …

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Non-clinical assessment of cell therapy products: the perspective from five Asian countries/regions based on regulatory guidelines and the underpinning rationales

Tomohiro Yoneda, Byung Hyune Choi, Pawan Kumar Gupta, Chih‐Yuan Ho et autres

BACKGROUND AIMS: Cell-based regenerative medicine is an innovative field that can potentially alter the overall survival and quality of life of patients with devastating diseases. Several cell therapy products (CTPs) have been approved within the last two decades, and more are under …

ch, jp, kr, in, cn, tw (code pays fourni par la source)

Introduction of Chimeric Antigen Receptor T-cell therapy, Tisagenlecleucel in Japan

Yuki Fujiwara, Jihyun Park, Takeo Dochi, Yoshie Tsurumaki

2019年3月、日本で初めて免疫細胞療法であるキメラ抗原受容体T細胞療法（chimeric antigen receptor-T cell therapy：CAR-T細胞療法）、チサゲンレクルユーセル（製品名；キムリア®点滴静注、ノバルティス）が承認された。チサゲンレクルユーセルの適応は、再発または難治性のCD19陽性のB細胞性急性リンパ芽球性白血病（B-cell acute lymphoblastic leukemia：B-ALL）および、再発または難治性のCD19陽性びまん性大細胞型B細胞リンパ腫（diffuse large B-cell lymphoma：DLBCL）である。チサゲンレクルユーセルは、患者自身のT細胞を原材料とする再生医療等製品であり、白血球アフェレーシスにより採取したT細胞にレンチウイルスベクターを用いてキメラ抗原受容体（chimeric antigen receptor： CAR）遺伝子を導入して製造される。今回の承認は、再発または難治性のCD19陽性のB-ALLとDLBCLを対象とした国際多施設共同第II相試験（ELIANA試験、JULIET試験）の結果に基づいている。このCAR-T細胞療法は、高度な細胞製造技術はもちろん、複雑な製造工程を厳格に管理する体制が求められている。

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