Komori
Other Disclosures4593HEALIOS K.K.Pharmaceuticals

Notice of Selection for an FY2026 AMED (Japan Agency for Medical Research and Development) Call for Proposals: Project for Developing Foundational Technologies for the Industrialization of Regenerative Medicine and Gene Therapy (Project to Promote the Industrialization of Regenerative, Cellular and Gene Therapies)

The research to develop a commercial manufacturing process for eNK® cells, being conducted by ヘリオス with its development partner, has been selected as a supported research project under AMED’s FY2026 program. For AKT-01/HLCN061 for pleural mesothelioma, the project aims to establish a GMP-compliant manufacturing process using a 50 L bioreactor.

Worth reading
56In focus
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Direction
Improvement
Direction inferred from the company’s description.
Scale
79933
¥ thousand (annual maximum subsidy amount, including indirect costs)
Wording
Conditional
How definitive the wording is.

Announced details

eNK® cellsAKT-01/HLCN061 (NK cells derived from genetically modified iPS cells)
Applicable field (uses covered by this announcement)

Commercial manufacturing of regenerative medicine products for pleural mesothelioma; regenerative, cellular and gene therapies

Relationship between the counterparty and the company
HEALIOS K.K.4593
Relationship with the Company

Akatsuki Therapeutics is the Company’s development partner and leads the development of AKT-01/HLCN061. The Company and Akatsuki Therapeutics are jointly advancing development. The Company’s relationship with AMED is that the project was selected as a supported research project under this program.

CounterpartyJapan Agency for Medical Research and Development (AMED)Akatsuki Therapeutics

AMED is a National Research and Development Agency. Akatsuki Therapeutics is a biotechnology company headquartered at 8-1 Kakuda-cho, Kita-ku, Osaka, Osaka Prefecture. Its representative director is Yamazaki Junya (山﨑順也). The company develops next-generation cellular immunotherapies for cancer and other serious diseases.

Location (as indicated in this announcement)

50 L bioreactor

Impact on Business Performance

The project currently has no impact on the consolidated results for the fiscal year ending December 2026. The Company will promptly disclose any matters requiring disclosure that arise in the future.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

AMED (Japan Agency for Medical Research and Development) FY2026 open call information

Announced details
ItemDetails
Names of Products / Services CoveredeNK® cells, AKT-01/HLCN061 (NK cells derived from genetically modified iPS cells)
CounterpartyJapan Agency for Medical Research and Development (AMED), Akatsuki Therapeutics
Counterparty overviewAMED is a National Research and Development Agency. Akatsuki Therapeutics is a biotechnology company headquartered at 8-1 Kakuda-cho, Kita-ku, Osaka, Osaka Prefecture. Its representative director is Yamazaki Junya (山﨑順也). The company develops next-generation cellular immunotherapies for cancer and other serious diseases.
Relationship with the CompanyAkatsuki Therapeutics is the Company’s development partner and leads the development of AKT-01/HLCN061. The Company and Akatsuki Therapeutics are jointly advancing development. The Company’s relationship with AMED is that the project was selected as a supported research project under this program.
Applicable areaCommercial manufacturing of regenerative medicine products for pleural mesothelioma; regenerative, cellular and gene therapies
Location scale50 L bioreactor
Impact on Business PerformanceThe project currently has no impact on the consolidated results for the fiscal year ending December 2026. The Company will promptly disclose any matters requiring disclosure that arise in the future.
SourceAMED (Japan Agency for Medical Research and Development) FY2026 open call information
Items this document does not state (10)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationQuantitative EffectsUsage history

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

AMED provides funding for establishing the quality and manufacturing methods required at the preclinical stage to advance to company-sponsored clinical trials, with the aim of promoting the commercialization of regenerative medicine products and other products in the fields of regenerative, cellular and gene therapies.

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Notice of Selection for an FY2026 AMED (Japan Agency for Medical Research and Development) Call for Proposals: Project for Developing Foundational Technologies for the Industrialization of Regenerative Medicine and Gene Therapy (Project to Promote the Industrialization of Regenerative, Cellular and Gene Therapies) | HEALIOS K.K. (4593) timely disclosure | Komori