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Article History

Received: 27 July 2025

Revised: 17 December 2025

Accepted: 22 December 2025

First Online: 6 January 2026

Declarations

:

: WM reports grants from Ono Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd., and Genmab K.K., and honoraria from Chugai Pharmaceutical Co., Ltd. YO reports grants from Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., IQVIA Services Japan K.K., Janssen Pharmaceutical K.K., Abbvie Inc., Labcorp Development Japan K.K., SYNEOS HEALTH CLINICAL K.K., and PAREXEL INTERNATIONAL INC., and honoraria from Novartis Pharma K.K. MH reports grants from Nippon Shinyaku Co., Ltd., and honoraria from Nippon Shinyaku Co., Ltd. KK reports honoraria from Novartis Pharma K.K., Chugai Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., and Meiji Seika Pharma Co., Ltd. MC, DK, KT and TM are employees of Nippon Shinyaku Co., Ltd. KT reports research funding of the submitted study from Nippon Shinyaku Co., Ltd., and grants from Meiji Seika Pharma Co., Ltd., and Nippon Shinyaku Co., Ltd., and royalties or licenses from Sysmex Co., Otsuka Pharmaceutical Co., REALM IDx, Inc., and NICHIREI BIOSCIENCES INC., and consulting fees from NICHIREI BIOSCIENCES INC., Meiji Seika Pharma Co., Ltd., and Nippon Shinyaku Co., Ltd., and honoraria from Kyowa Kirin Co., Ltd., Chugai Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Co., Ltd., AstraZeneca K.K., Eisai Co., Ltd., and Janssen Pharmaceutical K.K. KI reports research funding of the submitted study from MSD Co., Ltd., AstraZeneca K.K., Abbvie Inc., Incyte Corp., Bristol-Myers-Squibb K.K., Novartis Pharma K.K., Bayer Yakuhin, Ltd., Pfizer Japan Inc., Janssen Pharmaceutical K.K., Yakult Honsha Co., Kyowa Kirin Co., Ltd., Daiichi Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd., BeiGene Co., Ltd., Genmab K.K., Loxo Oncology, Inc., Otsuka Pharmaceutical Co., Regeneron Pharmaceuticals Inc., and Gilead Sciences Inc., and consulting fees from MSD Co., Ltd., AstraZeneca K.K., Abbvie Inc., Incyte Corp., Bristol-Myers-Squibb K.K., Novartis Pharma K.K., Bayer Yakuhin, Ltd., Pfizer Japan Inc., Janssen Pharmaceutical K.K., Yakult Honsha Co., Kyowa Kirin Co., Ltd., Daiichi Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd., BeiGene Co., Ltd., Genmab K.K., Loxo Oncology, Inc., Otsuka Pharmaceutical Co., Regeneron Pharmaceuticals Inc., Gilead Sciences Inc., and Nippon Shinyaku Co., Ltd., and honoraria from MSD Co., Ltd., AstraZeneca K.K., Abbvie Inc., Bristol-Myers-Squibb K.K., Novartis Pharma K.K., Yakult Honsha Co., Kyowa Kirin Co., Ltd., Chugai Pharmaceutical Co., Ltd., BeiGene Co., Ltd., Genmab K.K., Otsuka Pharmaceutical Co., Ono Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma co., Ltd., Eisai Co., Ltd., SymBio Pharmaceuticals Co., Ltd., Takeda Pharmaceutical Co., Ltd., Zenyaku Kogyo Co., Ltd., Carna Biosciences, Inc., and Nippon Shinyaku Co., Ltd. RS reports grants from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Taiho Pharmaceutical co., Ltd., Eisai Co., Ltd., Meiji Seika Pharma Co., Ltd., Otsuka Pharmaceutical Co., and Nippon Kayaku Co., Ltd., and honoraria from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Abbvie Inc., Bristol-Myers-Squibb K.K., Eisai Co., Ltd., Otsuka Pharmaceutical Co., Nippon Shinyaku Co., Ltd., Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co., Ltd., Meiji Seika Pharma Co., Ltd., Novartis Pharma K.K., SymBio Pharmaceuticals Co., Ltd., Astellas Pharma Inc., Nihon Servier Co., Ltd. Asahi Kasei Pharma Corp., Pfizer Japan Inc., AstraZeneca K.K., Sumitomo Pharma Co., Ltd., Eli Lilly and Co., Nippon Kayaku Co., Ltd., Ono Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Gilead Sciences Inc., Sanofi K.K., and BeiGene Co., Ltd.

: All data generated or analyzed during this study are included in this published article and its supplementary information files.