On July 17, 2025 NKGen Biotech, Inc. (OTC: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, and HekaBio K.K., headquartered in Chuo-ku, Tokyo ("HekaBio"), reported a strategic partnership to accelerate the regulatory, manufacturing and commercial development of NKGen’s autologous NK cell therapy, troculeucel, in Japan following HekaBio’s recently announced investment in common equity of NKGen (Press release, NKGEN Biotech, JUL 17, 2025, View Source [SID1234654424]).
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HekaBio will lead all clinical trials in Japan and oversee all regulatory activities with Japan’s Pharmaceuticals and Medical Devices Agency for pre-market approval of troculeucel in several neurodegenerative disease indications, including Alzheimer’s and Parkinson’s Diseases.
As troculeucel is an autologous, non-genetically modified cell therapy, there is allowance under regenerative medicine regulations in Japan to offer this therapy to patients on an accelerated path, much faster than in other major markets. HekaBio will fully leverage the regulation and its domestic strategic partner network, aiming for first dosing in Japanese patients over the next 12 months. Beyond intractable disease, troculeucel has the potential to also support Japan’s aging population in the longevity/wellness space.
"Japan has always had an advanced progressive health care system where great attention has been placed on the use of novel autologous cell therapies for prevention, longevity, and wellness as well as for the treatment of more chronic illnesses," said Paul Y. Song, MD, Chairman and Chief Executive Officer ("CEO") of NKGen. "I am convinced that HekaBio’s clinical, regulatory, and commercial expertise will guide us to satisfy all regulatory requirements, find the best local manufacturing partner to make our therapy readily available, and ultimately develop the best commercial strategy for Japan. We are very excited to partner with HekaBio."
"Dementia, particularly Alzheimer’s Disease, and other neurodegenerative diseases together present significant health and social challenges in Japan due to the country’s aging population. We are very excited about our partnership with NKGen and look forward to advancing troculeucel for the benefit of patients and society," said Rob Claar, CEO of HekaBio.