ReproCELL Incorporated
4978・Growth Market・Chemicals
Business
ReproCELL Incorporated is a biotechnology company with a technology platform originating from Professor Shinya Yamanaka's invention of iPS cells, operating across four locations in Japan, the US, Europe, and India. In the "Research Support Business," the company provides research reagents, human biological samples, and contract services to universities, public research institutions, and pharmaceutical companies. In the "Medical Business," it handles research and development, contract manufacturing (CDMO), and clinical testing of regenerative medicine products, including StemChymal for spinocerebellar degeneration. In FY2026 (ending March 2026), sales were ¥2,233 million, with the Research Support Business accounting for approximately 87% of sales, serving as the short-to-medium-term revenue base.
Business Model
In the Research Support Business, the company secures ongoing revenue through the manufacture and sale of research reagents and cell products, as well as contract services. In the Medical Business, the company aims for mid-to-long-term revenue through obtaining approvals for regenerative medicine products, CDMO contract manufacturing, and clinical testing. Since business revenue alone is insufficient to cover funding needs, the company supplements this with public grants and third-party allotment capital increases, securing liquidity of ¥2,603 million in cash and deposits and ¥3,904 million in securities as of the end of FY2026 (ending March 2026).
Company Strengths
The company's initial product was the culture medium used when Professor Yamanaka established iPS cells, and it holds the world's first track record of manufacturing and selling iPS cell-derived cardiomyocytes, neurons, and hepatocytes. It owns RNA reprogramming technology, genome editing technology, and differentiation induction technology in-house, and has also obtained a commercial use license from iPS Academia Japan.
The company operates four sites: Japan (Tonomachi, ReproCELL Regenerative Medicine Center), the United States (REPROCELL USA), the United Kingdom (REPROCELL Europe, which holds a GLP-compliant facility), and India (Bioserve). In October 2025, Histocell in Spain obtained GMP certification, establishing a CDMO framework across three regions—Japan, the US, and Europe. The clinical-use iPS cells are registered with an FDA DMF, supporting simplified procedures for US approval applications.
StemChymal, targeted at spinocerebellar degeneration, was designated as an orphan regenerative medical product in December 2018, making it eligible for development cost subsidies (up to 50%) and priority review. In the domestic Phase II clinical trial, safety was confirmed and a trend toward efficacy was observed. In November 2024, Steminent obtained foreign manufacturer certification, fulfilling one of the requirements for the approval application.
ENVALITH's Perspective
Performance Trend
Revenue trended as follows: ¥2,235 million in FY2022 → ¥2,953 million in FY2023 → ¥2,427 million in FY2024 → ¥2,979 million in FY2025 → ¥2,233 million in FY2026, showing a sharp decline after peaking in FY2025. In FY2026 (ending March 2026), both segments saw major revenue declines, with the Research Support Business down 19.1% year-on-year to ¥1,952 million and the Medical Business down 50.2% year-on-year to ¥281 million. The operating loss widened from ¥130 million in the previous period to ¥860 million, compounded by an increase in R&D expenses (from ¥536 million to ¥627 million) and a significant decline in gross profit (from ¥1,649 million to ¥1,015 million). As an external factor, a foreign exchange gain of ¥109 million (versus ¥17 million in the previous period) provided some support to ordinary income, but the ordinary loss still reached ¥581 million. For FY2027 (ending March 2027), the company forecasts revenue of ¥2,629 million (up 17.7% year-on-year) and an operating loss of ¥630 million, indicating only a narrowing of losses rather than a return to profitability.
Growth Strategy
Advancing dual growth drivers of expanding Research Support Business revenue and accelerating early approval and commercialization of the four Medical Business pipelines
Domestic Phase II clinical trial completed (May 2022). In November 2024, Steminent Biotherapeutics obtained foreign manufacturer accreditation, satisfying one of the approval requirements. As an orphan drug designation product eligible for priority review and development cost subsidies of up to 50%, preparation for the marketing authorization application targeting spinocerebellar degeneration patients continues.
In October 2025, Histocell (Spain) obtained AEMPS GMP certification; in January 2026, provision of "StemEdit™" commenced; and in March of the same year, MCB manufacturing services began at REPROCELL USA Inc., establishing an integrated contract manufacturing framework spanning donor selection through GMP cell banking. iPS cells supplied to Gameto have accumulated a track record of quality through the acquisition of FDA Phase III IND status.
For TIL Therapy, under the Advanced Medical Care B program at Keio University (targeting cervical cancer), the second patient was administered in November 2024, with a total of 10 patients planned by 2026. For GPC-1 CAR-T Therapy, following selection for AMED funding in December 2024, non-clinical studies and quality establishment are being advanced in collaboration with Kyoto University and the International University of Health and Welfare, aiming for early initiation of a clinical trial targeting esophageal cancer.
In April 2025, the HLA-knockout iPS cell line "StemEdit™ Human iPSC non-HLA" was launched for sale. The company is developing a comprehensive platform for pharmaceutical companies that combines value-added services such as iPS cell-based drug discovery model cells, gene editing, and three-dimensional model tissues with Cell Measurement Instruments (Agency Sales), aiming to strengthen its stable revenue base.
Last updated: July 19, 2026