COMPANY PROFILE / iPS CELLS & REGENERATIVE MEDICINE
Sumitomo Pharma
The approval holder for Amchepry, an iPS cell-derived neural cell product, with research and manufacturing placed in joint ventures with Sumitomo Chemical
Sumitomo Pharma is the pharmaceutical company that received conditional and time-limited marketing approval in Japan on 6 March 2026 for Amchepry, dopaminergic neural progenitor cells made from the iPS cells of a healthy donor. The product was listed on the national drug price list and went on sale on 20 May. The company describes it as the world's first iPS cell-derived regenerative/cell medicine product, and the Ministry of Health, Labour and Welfare's review materials state that, as of March 2026, it was not approved in any country or region. However, iPS cell research and development sits in the joint venture RACTHERA and manufacturing in the joint venture S-RACMO; Sumitomo Pharma holds 33.4% of each and plays the role of approval holder and seller. The approval rests on an investigator-initiated trial of seven patients, and for the time being Amchepry will be supplied only to medical institutions taking part in the post-marketing clinical trial. This profile sets out what the company has invested, who it works with, what has been confirmed and what remains open, using primary sources only.
- Sumitomo Pharma in 30 seconds, and where it stands in iPS cells and regenerative medicine
- The logo and how the name is written
- Where the company sits in iPS cells and regenerative medicine
- Scale of the company (kept brief, as a large pharma)
- Resources committed to iPS cells and regenerative medicine
- Track record so far
- Plans ahead
- What the company is aiming for in iPS cells and regenerative medicine
- Partnership map
- Technologies, products and services
- The risks this company carries
- Glossary, references and claim-to-source audit
1. Sumitomo Pharma in 30 seconds, and where it stands in iPS cells and regenerative medicine
Co., Ltd.Renamed in April 2022 from Dainippon Sumitomo Pharma
(dual head offices)Also has a head office in Tokyo. Parent company is Sumitomo Chemical (51.81% owned)
iPS cell & cell therapy (secondary)The iPS cell business is run through joint ventures
S-RACMOSumitomo Pharma 33.4%, Sumitomo Chemical 66.6%
In terms of the three types of company in this field, Sumitomo Pharma is a large pharma. It split its iPS cell business off into a joint venture by corporate demerger in February 2025, and it now plays the part of the company that holds the approval and sells the product Sourced. In other words, it is less an "iPS cell company" than the party that puts an iPS cell product onto a sales network. The approval is also conditional and time-limited, based on a small trial, and runs for seven years. Within that period the company plans to run a 35-patient post-marketing clinical trial, verify efficacy in patients aged 65 or under, and then apply for full approval. In its launch notice the company writes that, even after approval, it intends for the time being to supply only the medical institutions taking part in that trial Sourced. This article does not judge the product's merits or whether a treatment is appropriate; it sets out the current state of the company and its product from primary sources.
2. The logo and how the name is written
A note on names: the company is Sumitomo Pharma Co., Ltd. It changed its name from Dainippon Sumitomo Pharma in April 2022. RACTHERA and S-RACMO are joint ventures with Sumitomo Chemical. They are not consolidated subsidiaries of Sumitomo Pharma but affiliates accounted for by the equity method. The parent, Sumitomo Chemical Co., Ltd., is a separate legal entity, and this article keeps the two apart. The product's brand name is Amchepry; its generic name is raguneprocel, and its development codes are CT1-DAP001 (non-frozen) and DSP-1083 (frozen).
Official site: https://www.sumitomo-pharma.co.jp/3. Where the company sits in iPS cells and regenerative medicine
In terms of how it treats patients, Sumitomo Pharma's core work is transplanting iPS cell-derived nerve-system cells, as allogeneic cells (cells from a donor rather than the patient), into the brain or the eye. Its approved product, Amchepry, is made of the precursors of the dopamine-producing neurons that are lost in Parkinson's disease (dopaminergic neural progenitor cells), and is transplanted by surgery into the putamen on both sides of the brain Sourced. The company is also developing retinal cells (retinal pigment epithelial cells and a retinal sheet), and in the United States it sells Rethymic, a cultured human thymus tissue product. For an explanation of iPS cells themselves, see our explainer on iPS cells in this series; for how neurons relate to Parkinson's disease, see our explainer on iPS-derived neurons and Parkinson's disease.
4. Scale of the company
As a large pharma, the whole company gets just one table. Most of these figures come from medicines unrelated to iPS cells Sourced (amounts in Japanese yen, under IFRS; the fiscal year runs from April to March).
| Metric (consolidated, ¥ millions) | FY ended Mar 2024 | FY ended Mar 2025 | FY ended Mar 2026 |
|---|---|---|---|
| Revenue | 314,558 | 398,832 | 453,294 |
| Profit (loss) before tax | −323,114 | 17,611 | 100,344 |
| Profit (loss) attributable to owners of the parent | −314,969 | 23,634 | 106,865 |
| Cash flow from operating activities | −241,893 | 16,500 | 71,715 |
| Employees (people) | 4,980 | 3,832 | 3,123 |
In the year ended March 2026, total R&D expense was ¥44.0 billion (down 11.8% year on year) and core operating profit was ¥105.9 billion. Sales in North America of ORGOVYX (advanced prostate cancer) and GEMTESA (overactive bladder) made up 55% of consolidated revenue. The company recorded a large loss in the year ended March 2024 and returned to profit after restructuring its businesses.
The figures above are for the whole company and do not show the scale of iPS cells and regenerative medicine. R&D expense is managed globally and is not allocated, or disclosed, by segment or by product. In addition, RACTHERA and S-RACMO are equity-method companies, so their revenue, profit and headcount are not included in the consolidated figures. The cumulative R&D spending on iPS cells and regenerative medicine could not be confirmed in the primary sources Not yet confirmed.
5. Resources committed to iPS cells and regenerative medicine
Much of the money and many of the people have moved into the joint ventures, so they cannot be traced from Sumitomo Pharma's own disclosures alone. We separate what could be confirmed from what could not.
| Type of resource | Details | Category |
|---|---|---|
| People (headcount) | 3,123 consolidated employees and 1,747 on a non-consolidated basis (31 March 2026). The number dedicated to regenerative and cell medicine is not disclosed. Secondees to RACTHERA and S-RACMO are mentioned, but their number is unknown. The two ventures' own staff are not included in the consolidated figure | Could not be confirmed (dedicated headcount) |
| People (sites) | Research and development is at RACTHERA (Chuo-ku, Tokyo); manufacturing is at S-RACMO's commercial manufacturing facility "SMaRT" (Suita, Osaka; completed 2018). The company describes it as the world's first commercial manufacturing facility dedicated to regenerative and cell medicines derived from allogeneic iPS cells | Sourced |
| Money (R&D expense) | Total R&D expense was ¥44.0 billion (worldwide) in the year ended March 2026. The share for iPS cells and regenerative medicine is not disclosed | Could not be confirmed (breakdown) |
| Money (fundraising and use of proceeds) | Of estimated net proceeds of ¥96,956 million from the public offering in April 2026, ¥10,000 million is earmarked as investment and loan funds aimed at growing the regenerative and cell medicine business by the end of March 2029 (the rest: ¥30,000 million for oncology R&D, ¥10,000 million for neurodegenerative and infectious disease R&D, ¥10,000 million for capital and strategic investment, and the balance for repaying interest-bearing debt) | Sourced |
| Investment in, and carve-out to, outside parties | In February 2025 the regenerative and cell medicine business was demerged into RACTHERA, and 66.6% of its shares was transferred to Sumitomo Chemical. Sumitomo Pharma holds 33.4% of both RACTHERA and S-RACMO. As consideration it had received ¥1,998 million by the end of March 2026; development milestones can reach ¥3,996 million (the filing states that ¥666 million is due in June 2026 on Amchepry's approval) and sales milestones up to ¥154,512 million (the ceiling if every condition is met) | Sourced |
| Technology and materials brought in | The iPS cell stock comes from the Kyoto University iPS Cell Research Foundation, the differentiation and manufacturing technology from Kyoto University and others, and part of the cell purification technology from Eisai. Payment terms are not stated in the primary sources | Sourced |
| Universities, research institutes and public funding | Kyoto University (Center for iPS Cell Research and Application (CiRA) and Kyoto University Hospital), the University of California San Diego, Massachusetts Eye and Ear, the University of Minnesota, and RIKEN (the retinal sheet manufacturing method). The company states that Amchepry has received continuing national research support, including from the Japan Agency for Medical Research and Development (AMED) | Sourced |
| Investment in start-ups | The Annual Securities Report states no investments in start-ups in iPS cells or regenerative medicine | Could not be confirmed |
6. Track record so far
| When | What happened | What it means |
|---|---|---|
| 2012 | Decided to enter regenerative and cell medicine in earnest (from the timeline in the company's press-conference materials) | The same year Shinya Yamanaka won the Nobel Prize |
| February 2017 | Parkinson's disease product designated under the SAKIGAKE designation system for regenerative medicine products (a Japanese scheme giving priority review) | Became a priority target for review |
| 2018 | The SMaRT manufacturing facility was completed. In August the investigator-initiated trial began at Kyoto University Hospital | Manufacturing site and clinical trial both got under way |
| February 2025 | Regenerative and cell medicine business demerged into RACTHERA, and 66.6% of the shares transferred to Sumitomo Chemical | Leadership of the business moved to the Sumitomo Chemical group |
| April 2025 | Results of the Kyoto University investigator-initiated trial were published in Nature | The data underlying the approval application |
| 5 August 2025 | Applied for marketing approval | - |
| 12 December 2025 | Designated as an orphan regenerative medicine product | Also a basis for a premium on the drug price |
| 6 March 2026 | Amchepry received conditional and time-limited marketing approval | Approved in Japan as an iPS cell-derived regenerative/cell medicine product |
| March 2026 | The retinal sheet (DSP-3077) received orphan drug designation from the US FDA for retinitis pigmentosa | A boost to development in the United States |
| April 2026 | Public offering of shares (¥97.8 billion paid in). Of the net proceeds, ¥10 billion is planned for investment and loans in the regenerative and cell medicine business | Use of funds stated explicitly |
| 13 and 20 May 2026 | The Central Social Insurance Medical Council (Chuikyo) endorsed the proposed drug price on the 13th. On the 20th the product was listed on the national drug price list and launched (calculated price ¥55,306,737) | Usable under insurance coverage, but supply is planned only to trial-participating hospitals |
| July 2026 | The post-marketing clinical trial (Phase 4) was registered in the jRCT on the 24th and recruitment of participants began. The contract with Kyoto University Hospital is also listed among disclosures for the period 14 May to 31 July | Start of the trial that leads to full approval |
| 13 August 2026 | First patient transplanted in the US Phase 1/2 trial of the retinal sheet (DSP-3077) | Cells made at SMaRT were used in a US trial |
The trial behind the approval (within what the primary sources say)
The approval is based on an investigator-initiated trial at Kyoto University Hospital (jRCT2090220384, study code IACT16049-01). The comparison is not with another treatment or a placebo but with each patient's own condition before transplant, and the time points of assessment differ from one measure to another. The results do not guarantee any treatment effect or safety, and are not medical advice.
| Item | Details | Category |
|---|---|---|
| Trial | Investigator-initiated trial (Phase I/II) of human iPS cell-derived dopaminergic neural progenitor cells for Parkinson's disease. Single-centre, open-label, uncontrolled. The principal investigator was Ryosuke Takahashi of Kyoto University Hospital. Results were published in Nature (Sawamoto et al., 2025) | Sourced |
| Who was enrolled and how many | Patients aged 50 to under 70 with disease duration of at least five years, whose symptoms were difficult to control with drug therapy alone but who still responded to levodopa. Seven were transplanted (six analysed for effect). Low dose in patients 2 and 3 (4.8×106 cells in total, both sides); high dose in patients 4 to 7 (8.4 to 10.8×106 cells in total, both sides) | Sourced |
| Primary aim | In the paper the primary assessment was safety and adverse events; change in motor symptoms and dopamine production were secondary assessments at 24 months | Sourced |
| Motor symptoms (24 months) | The off-medication motor score (MDS-UPDRS Part III) improved in 4 of the 6 patients analysed, by 9.5 points (20.4%) on average across the six. In the on-medication state, five improved, by 4.3 points (35.7%) on average. Hoehn-Yahr stage improved in four. Each patient was compared with his or her own pre-transplant state | Sourced |
| Imaging | On an imaging test of uptake in the brain (18F-DOPA PET), the uptake rate constant in the putamen rose by 44.7% on average (more in the high-dose group). The review materials judged that the cells had engrafted in the putamen in all six | Sourced |
| Safety | No serious adverse events; 73 mild to moderate adverse events. No excessive growth of the graft on MRI. The paper states that dyskinesia increased as a result of adjusting anti-Parkinson's drugs as therapeutically needed. The immunosuppressant (tacrolimus) was taken for 52 weeks from the day of transplant and then tapered over 12 weeks | Sourced |
| The reviewers' view | The MHLW's materials note that this was a small exploratory study not intended for statistical verification, and judged efficacy to be presumable because, among other things, several patients improved in ways hard to explain by the natural course (an average worsening of 5.2 points over 24 months in an observational study). The comparison is a reference comparison with a separate population, not a direct one | Sourced |
7. Plans ahead
(30 aged 65 or under + 5 over 65)About seven sites planned. Follow-up for 96 weeks after transplant
7 years of approvalUntil then, transplants will centre on trial participants
under wayTwo tracks: a university investigator-initiated trial and a company-sponsored trial
| Planned or in-development item | Where it stands (company's account) | Category |
|---|---|---|
| Amchepry (Japan) | The main aim of the post-marketing clinical trial (Phase 4, jRCT2053260117) is to verify efficacy when the cells are transplanted into the putamen of patients aged 65 or under. The primary endpoint is the change from baseline in the total off-medication MDS-UPDRS Part III score at 96 weeks after transplant. From 2026 to about 2029, transplants will be given only to participants in this trial; the range of hospitals and patients will be widened after it is completed | Not yet confirmed |
| Amchepry (change in manufacturing) | When applying for full approval, the company plans to file a partial-change application to move manufacturing from one lot per patient to one lot for several patients (press-conference materials). The timing is not disclosed | Not yet confirmed |
| Raguneprocel (United States, Parkinson's disease) | Advancing two trials: an investigator-initiated trial at the University of California San Diego (non-frozen cells, NCT06482268, Phase 1, estimated 7 patients) and a company-sponsored trial by Sumitomo Pharma's US subsidiary (frozen cells DSP-1083, NCT06753331, Phase 1/2, estimated 25 patients) | Not yet confirmed |
| Retinal sheet (DSP-3077, United States) | A Phase 1/2 trial (NCT06891885) in retinitis pigmentosa is under way. A single dose is given under the retina of one eye; dose-escalating, single-arm and unmasked, with three cohorts of four patients each, 12 in total. The first patient was transplanted on 13 August 2026 | Not yet confirmed |
| Retinal pigment epithelial cells (HLCR011, Japan) | Advancing a Phase 1/2 trial in retinal pigment epithelium tear. Partners are Healios, Kyushu University and others | Not yet confirmed |
| Other iPS cell-derived products | Spinal cord injury (neural progenitor cells) and renal failure (nephron progenitor cells, three-dimensional organ) are at the preclinical stage (the pipeline list in the May 2026 results briefing) | Not yet confirmed |
None of the following appears in the primary sources, or the company has not disclosed it Not yet confirmed.
The specific timing of the application for and receipt of full approval (beyond "within 7 years") / SMaRT's annual manufacturing capacity / when a US approval application will be filed / revenue, profit and headcount of RACTHERA and S-RACMO / when the move to one lot for several patients will happen / cumulative R&D spending on regenerative and cell medicine. The MHLW's drug-price calculation materials do give, as the applicant's (Sumitomo Pharma's) market forecast, a projected 133 patients treated and projected sales of ¥7.4 billion at peak (year 10). These are projections made for price calculation and not the company's earnings guidance, so we give them only for reference and do not mix them with other numbers.
8. What the company is aiming for in iPS cells and regenerative medicine
This section includes things the company does not say directly. We set them out as inferences within what the primary sources support, with the evidence for each.
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| Leadership of the iPS cell business lies with the Sumitomo Chemical group, and Sumitomo Pharma has been narrowed to the role of approval holder and seller | 66.6% of RACTHERA was transferred to Sumitomo Chemical, and Sumitomo Pharma holds 33.4% of both RACTHERA and S-RACMO. The approval announcement states that Sumitomo Pharma sells and S-RACMO manufactures, and describes RACTHERA as the core of research and development in the Sumitomo Chemical group's regenerative and cell medicine business | Inference |
| Amchepry is likely not to bring significant revenue until around 2029 | The plan is to transplant only trial participants until about 2029, and the planned transplants are 1 to 2 in FY2026, about 10 in FY2027 and 10 to 20 in FY2028 | Inference |
| Part of Sumitomo Pharma's return is designed to arrive as milestones and equity-method profit | The contingent consideration for the RACTHERA share transfer provides development milestones of up to ¥3,996 million and sales milestones of up to ¥154,512 million | Inference |
| The company's overall priority is oncology first, with regenerative and cell medicine advanced through outside funds and joint ventures | The Annual Securities Report says resources are concentrated on two cancer drugs (enzomenib and nuvisertib). Of the use of proceeds from the public offering, ¥30,000 million goes to oncology R&D and ¥10,000 million to investment and loans in the regenerative and cell medicine business | Sourced |
| The next challenge in manufacturing is moving from one lot per patient to a mass-production model | The press-conference materials list a partial-change application from one lot per patient to one lot for several patients, and the review materials say that supply is limited because manufacturing starts from the differentiation stage for each patient | Inference |
The reading that revenue will stay small for a while follows straightforwardly from the company's own transplant plan. Multiplying the drug price of ¥55,306,737 by the planned transplants of about 10 in FY2027 and 10 to 20 in FY2028 gives an annual scale of roughly ¥550 million to ¥1.1 billion Our calculation. Actual revenue will not match the drug price exactly, and transplants may not go ahead as planned. By contrast, the projections in the pricing document (133 patients and ¥7.4 billion in year 10) can be read as assuming the picture after full approval, once the range of hospitals and patients has been widened. In other words, although Amchepry has been approved and launched, it is at a stage of "collecting data towards full approval" rather than "building revenue" Not yet confirmed. This inference says nothing about the merits of the product or whether it will be widely adopted.
9. Partnership map
How to read the figure: Sumitomo Pharma divides the work by leaving research and development (RACTHERA) and manufacturing (S-RACMO) to the joint ventures, while it obtains the approval and sells. The raw material, iPS cells, comes from the stock of the Kyoto University iPS Cell Research Foundation, and the differentiation technology comes from Kyoto University and others; part of the manufacturing process uses cell purification technology held by Eisai Sourced. The parent, Sumitomo Chemical, owns 51.81% of the voting rights in Sumitomo Pharma and also 66.6% of both joint ventures, so the relationship is a double one.
10. Technologies, products and services
| Item | Details (from the Annual Securities Report and public materials) |
|---|---|
| Amchepry | A cell-processed product containing dopaminergic neural progenitor cells differentiated from iPS cells made from peripheral blood mononuclear cells of a healthy adult. It is non-frozen, with 1×106 cells per container (1 mL) in physiological saline. The target is 5.4×106 cells per side, delivered by stereotactic brain surgery into the putamen on both sides (a set of 18 vials). The immunosuppressant (tacrolimus) is taken before and after transplant and tapered over 12 weeks to stop, about a year after transplant. Its shelf life is 31 hours, and it is manufactured for each operation |
| Manufacturing facility SMaRT | Suita, Osaka. Completed in 2018. The company describes it as the world's first commercial manufacturing facility dedicated to regenerative and cell medicines derived from allogeneic iPS cells. Manufacturing is carried out by S-RACMO |
| Frozen cells DSP-1083 | Frozen dopaminergic neural progenitor cells used in the company-sponsored US trial. The product approved in Japan is non-frozen |
| Retinal cells | The retinal sheet (DSP-3077) is a retinal tissue rich in photoreceptor precursor cells, based on a self-organising culture method for making three-dimensional retina from pluripotent stem cells (the SFEBq method discovered by the group of Yoshiki Sasai at RIKEN). Retinal pigment epithelial cells (HLCR011) are also in development |
| Rethymic | A cultured human thymus tissue for paediatric congenital athymia. Sold in the United States; revenue was ¥6,322 million in the year ended March 2026 (¥6,803 million the year before). The company states that it is preparing to set up its own manufacturing facility in the United States |
In this company's product, what matters for materials and processes is when and how far ahead cells can be made Sourced. Amchepry is made from an allogeneic iPS cell stock, so in principle it is designed so that many patients' doses can be made at once. The review materials, however, state that the product is non-frozen, has a shelf life of 31 hours and is made for each operation, and that because manufacturing starts from the differentiation stage for each patient, supply has a limit. That is why the company lists moving from one lot per patient to one lot for several patients as a future task. The fact that frozen cells (DSP-1083) are being tested separately in the United States also shows that cryopreservation media, the freezing and thawing steps, and transport containers are likely to hold the key to mass production Not yet confirmed.
The other point is purification of the cells. Because there is a concern about tumour formation if undifferentiated iPS cells are mixed in, undifferentiated cells are removed during manufacturing and the contamination rate is controlled in the release criteria. Hospitals, too, have to centrifuge and concentrate the preparation before administration and fill it into the delivery device. Which materials and equipment are used has not been disclosed. See also our explainers in this series on cell manufacturing and cell banks, autologous versus allogeneic cells, and GMP.
11. The risks this company carries
| Risk | Details | Category |
|---|---|---|
| Approval is conditional and time-limited | The period is 7 years. The company must run the post-marketing clinical trial (35 patients) and a use-results survey, then apply again within the period and obtain full approval. The conditions of approval require a post-marketing survey of all cases and that the product be used by physicians with ample experience in diagnosing and treating Parkinson's disease and in stereotactic brain surgery | Sourced |
| The underlying trial is small | Single-centre, open-label and uncontrolled, with seven patients transplanted (six analysed). The review materials explain that a control group was difficult because of the ethics of sham surgery and the burden of assessment during drug withdrawal. The post-approval trial is also open-label, uncontrolled and multicentre in a single arm, designed to confirm reproducibility | Sourced |
| Differences in effect by age | The review materials note that one patient who did not respond markedly on the primary assessment was older, and consider that the cells are likely not to work well in patients whose symptoms are dominated by degeneration of non-dopamine neurons; the main cohort is therefore limited to patients aged 65 or under | Sourced |
| Long-term use of immunosuppressants | Because the cells are allogeneic, the immunosuppressant (tacrolimus) is taken for about a year from the day of transplant and then tapered. Provisions are to be made for switching to another immunosuppressant if side effects prevent its use | Sourced |
| Manufacturing and supply constraints | Non-frozen, with a 31-hour shelf life, and made for each operation. Supply is limited because manufacturing starts from differentiation for each patient. The review materials assume use in about 35 patients over 7 years | Sourced |
| Dependence on joint ventures and thin information | Both research and development and manufacturing are carried out by equity-method joint ventures, so Sumitomo Pharma's consolidated figures do not show their earnings or headcount. The sales milestones are ceilings, and the amount that will actually be received is not fixed | Inference |
| Earnings structure of the whole company | Two products in North America, ORGOVYX and GEMTESA, account for 55% of consolidated revenue. The company itself states that a fall in sales, for example from competing products or generics, would have a material effect on its results. Funding for the iPS cell business also depends on this revenue | Sourced |
| Drug pricing system and insurance calculation | The Annual Securities Report notes that measures to contain drug costs, such as annual price revisions, continue in Japan. The pricing document states that Amchepry is designated as an orphan product and is covered by the drug price maintenance scheme for innovative new drugs | Sourced |
12. Glossary
- iPS cell
- Induced pluripotent stem cell. A cell made by introducing factors into a body cell, which can then be turned into many types of cell.
- Allogeneic
- Using cells from another person (a donor) rather than from the patient. Drugs to suppress rejection are needed.
- Dopaminergic neural progenitor cells
- Cells one step before becoming dopamine-producing neurons. In Parkinson's disease, the loss of these neurons causes motor symptoms.
- Conditional and time-limited approval
- A Japanese system that lets a regenerative medicine product go on the market early, with conditions and a time limit, when a small trial has confirmed safety and some efficacy can be expected. Efficacy is then confirmed after launch.
- MDS-UPDRS Part III
- A score by which a physician rates the motor symptoms of Parkinson's disease at examination. The lower the score, the milder the symptoms.
- Off and on states
- The time when the effect of medication is weak, and the time when it is working well.
- Stereotactic surgery
- Surgery in which the head is fixed and a needle is advanced to a specific site in the brain, positioned by coordinates.
- Putamen
- A structure deep in the brain involved in controlling movement. The site where Amchepry is transplanted.
- Equity-method company
- A company over which the investor has influence, for example through holding 20% or more of the voting rights. A share of its profit or loss is taken in, but its revenue and headcount are not consolidated.
- CDMO
- Contract development and manufacturing organisation. A company that develops and manufactures drugs or cells on commission.
- IFRS
- International Financial Reporting Standards. Sumitomo Pharma reports its consolidated results under these standards.
- Orphan drug designation
- A US preferential designation for drugs for diseases with few patients.
13. References
- Sumitomo Pharma Annual Securities Report, 206th fiscal year (year ended March 2026, published 23 June 2026) (in Japanese). Affiliated companies, state of business, R&D activities, risks, employees, consolidated financial statements, contingent consideration agreements, and subsequent events (public offering and use of proceeds). https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf
- Sumitomo Pharma and RACTHERA "Notice of receipt of marketing approval in Japan for Amchepry, allogeneic iPS cell-derived dopaminergic neural progenitor cells" (6 March 2026) (in Japanese). https://www.sumitomo-pharma.co.jp/news/20260306.html
- Sumitomo Pharma Amchepry conditional and time-limited approval: press-conference briefing materials (6 March 2026) (in Japanese). https://www.sumitomo-pharma.co.jp/news/assets/pdf/pr20260306.pdf
- Sumitomo Pharma FY2025 (year ended March 2026) results briefing materials (13 May 2026) (in Japanese). Plan for the post-marketing clinical trial and the list of development items. https://www.sumitomo-pharma.co.jp/news/assets/pdf/ir20260513.pdf
- Sumitomo Pharma FY2026 first-quarter results briefing materials (31 July 2026) (in Japanese). Schedule of the Phase 4 trial. https://www.sumitomo-pharma.co.jp/news/assets/pdf/ir20260731.pdf
- Sumitomo Pharma FY2026 first-quarter results (IFRS) supplementary materials (31 July 2026) (in Japanese). Partners in regenerative and cell medicine. https://www.sumitomo-pharma.co.jp/news/assets/pdf/br20260731_2.pdf
- Sumitomo Pharma "Notice of transplantation of the first patient in the US Phase 1/2 trial of allogeneic iPS cell-derived retinal sheet (three-dimensional retina) for retinitis pigmentosa" (13 August 2026) (in Japanese). https://www.sumitomo-pharma.co.jp/news/20260813-1.html
- Sumitomo Pharma "Notice of marketing approval and listing on the drug price list" (Amchepry, 26 June 2026) (in Japanese). https://sumitomo-pharma.jp/hubfs/product/package_notification/2026/amchepry_info_20260626.pdf
- Ministry of Health, Labour and Welfare (MHLW) Central Social Insurance Medical Council (Chuikyo), General Assembly Document 11, Reference 2, "Conditional and time-limited approval of three regenerative medicine products" (8 April 2026) (in Japanese). Summary of the approval review for Amchepry (pages 20 to 39). https://www.mhlw.go.jp/content/10808000/001687611.pdf
- Ministry of Health, Labour and Welfare (MHLW) Central Social Insurance Medical Council (Chuikyo), General Assembly Document 5, "List of new regenerative medicine products (scheduled for listing on 20 May 2026)" and others (13 May 2026) (in Japanese). Calculated price, calculation method and market size forecast. https://www.mhlw.go.jp/content/10808000/001699508.pdf
- Sawamoto N. et al. Phase I/II trial of iPS-cell-derived dopaminergic cells for Parkinson's disease. Nature 641, 971–977 (2025). https://doi.org/10.1038/s41586-025-08700-0
- Ministry of Health, Labour and Welfare (MHLW) Japan Registry of Clinical Trials (jRCT), jRCT2090220384, "Investigator-initiated trial (Phase I/II) of cell transplantation of human iPS cell-derived dopaminergic neural progenitor cells for Parkinson's disease to examine safety and efficacy" (in Japanese). https://jrct.mhlw.go.jp/latest-detail/jRCT2090220384
- Ministry of Health, Labour and Welfare (MHLW) jRCT2053260117, "Confirmatory study of allogeneic iPS cell-derived dopaminergic neural progenitor cells (raguneprocel) in patients with Parkinson's disease (post-marketing clinical trial)" (in Japanese). https://jrct.mhlw.go.jp/latest-detail/jRCT2053260117
- U.S. National Library of Medicine ClinicalTrials.gov NCT06753331 (US multicentre trial of DSP-1083). https://clinicaltrials.gov/study/NCT06753331
- U.S. National Library of Medicine ClinicalTrials.gov NCT06482268 (investigator-initiated trial at the University of California San Diego). https://clinicaltrials.gov/study/NCT06482268
- U.S. National Library of Medicine ClinicalTrials.gov NCT06891885 (Phase 1/2 trial of the retinal sheet DSP-3077). https://clinicaltrials.gov/study/NCT06891885
- Sumitomo Pharma Official website (source of the logo). https://www.sumitomo-pharma.co.jp/
14. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Legal name, former name (Dainippon Sumitomo Pharma), head office, TSE Prime 4506, reporting under IFRS | Sourced | References 1 and 17 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf https://www.sumitomo-pharma.co.jp/ |
| The parent is Sumitomo Chemical (51.81% owned) | Sourced | Reference 1 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf |
| Revenue, profit, cash flow and employees (years ended March 2024 to March 2026) | Sourced | Reference 1 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf |
| R&D expense of ¥44.0 billion, and two North American products accounting for 55% of revenue | Sourced | Reference 1 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf |
| Demerger of the regenerative and cell medicine business into RACTHERA, and the transfer of 66.6% of its shares to Sumitomo Chemical | Sourced | References 1 and 2 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf https://www.sumitomo-pharma.co.jp/news/20260306.html |
| 33.4% stakes in RACTHERA and S-RACMO (equity-method affiliates) | Sourced | Reference 1 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf |
| Contingent consideration (¥1,998 million received, development milestones up to ¥3,996 million, sales milestones up to ¥154,512 million) | Sourced | Reference 1 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf |
| Estimated net proceeds of ¥96,956 million from the public offering and their use (¥10,000 million of investment and loans in regenerative and cell medicine, and others) | Sourced | Reference 1 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf |
| Conditional and time-limited approval of Amchepry (6 March 2026), indications, 7-year period | Sourced | References 2 and 9 https://www.sumitomo-pharma.co.jp/news/20260306.html https://www.mhlw.go.jp/content/10808000/001687611.pdf |
| SAKIGAKE designation (2017), orphan regenerative medicine product designation (December 2025), approval application (5 August 2025) | Sourced | References 2 and 3 https://www.sumitomo-pharma.co.jp/news/20260306.html https://www.sumitomo-pharma.co.jp/news/assets/pdf/pr20260306.pdf |
| Price of ¥55,306,737 (set of 18 vials), cost-accounting method, marketability premium and SAKIGAKE premium | Sourced | Reference 10 https://www.mhlw.go.jp/content/10808000/001699508.pdf |
| Listing on the drug price list and launch on 20 May 2026, and the plan to supply only trial-participating institutions for the time being | Sourced | Reference 8 https://sumitomo-pharma.jp/hubfs/product/package_notification/2026/amchepry_info_20260626.pdf |
| Non-frozen product, 31-hour shelf life, manufacture for each operation, and use of the immunosuppressant | Sourced | References 9 and 10 https://www.mhlw.go.jp/content/10808000/001687611.pdf https://www.mhlw.go.jp/content/10808000/001699508.pdf |
| The company's description of SMaRT as the world's first commercial facility dedicated to allogeneic iPS cell-derived products | Sourced | Reference 2 https://www.sumitomo-pharma.co.jp/news/20260306.html |
| Use of the iPS cell stock, differentiation technology and Eisai's cell purification technology | Sourced | References 2 and 3 https://www.sumitomo-pharma.co.jp/news/20260306.html https://www.sumitomo-pharma.co.jp/news/assets/pdf/pr20260306.pdf |
| Design, numbers and doses of the Kyoto University investigator-initiated trial, and its efficacy and safety results (published in Nature) | Sourced | References 9, 11 and 12 https://www.mhlw.go.jp/content/10808000/001687611.pdf https://doi.org/10.1038/s41586-025-08700-0 https://jrct.mhlw.go.jp/latest-detail/jRCT2090220384 |
| The regulator's judgement (reference comparison with the natural course; why a control group was difficult) | Sourced | Reference 9 https://www.mhlw.go.jp/content/10808000/001687611.pdf |
| Design, number of patients, primary endpoint and registration (jRCT) of the post-marketing clinical trial (Phase 4) | Sourced | References 3, 9 and 13 https://www.sumitomo-pharma.co.jp/news/assets/pdf/pr20260306.pdf https://www.mhlw.go.jp/content/10808000/001687611.pdf https://jrct.mhlw.go.jp/latest-detail/jRCT2053260117 |
| Planned transplants (first patient in autumn 2026, about 10 in FY2027, 10 to 20 in FY2028) | Not yet confirmed | Reference 5 https://www.sumitomo-pharma.co.jp/news/assets/pdf/ir20260731.pdf |
| Timing of the application for full approval, SMaRT's manufacturing capacity, timing of a US approval application and similar | Not yet confirmed | No outlook has been published. This article does not estimate them either |
| US trials related to Amchepry (NCT06482268, NCT06753331) | Not yet confirmed | References 1, 14 and 15 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf https://clinicaltrials.gov/study/NCT06753331 https://clinicaltrials.gov/study/NCT06482268 |
| Phase 1/2 trial of the retinal sheet DSP-3077 and transplant of the first patient (13 August 2026) | Sourced | References 7 and 16 https://www.sumitomo-pharma.co.jp/news/20260813-1.html https://clinicaltrials.gov/study/NCT06891885 |
| Partners for the retinal pigment epithelial cells HLCR011 (Healios, Kyushu University and others); preclinical work on spinal cord injury and renal failure | Sourced | References 4 and 6 https://www.sumitomo-pharma.co.jp/news/assets/pdf/ir20260513.pdf https://www.sumitomo-pharma.co.jp/news/assets/pdf/br20260731_2.pdf |
| Rethymic sales in the United States (¥6,322 million in the year ended March 2026) | Sourced | Reference 1 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf |
| Projections in the drug-price calculation materials (133 patients and ¥7.4 billion in year 10) | Not yet confirmed | Reference 10 https://www.mhlw.go.jp/content/10808000/001699508.pdf |
| Revenue, profit and headcount of RACTHERA and S-RACMO; breakdown of R&D expense for regenerative and cell medicine | Not yet confirmed | Reference 1 https://www.sumitomo-pharma.co.jp/ir/library/securities_report/assets/pdf/securities_report_20260623.pdf Not stated in reference 1. This article does not estimate them either |
| The three-type classification (large pharma / genome editing / iPS cell and cell therapy) | Our calculation | This article's own grouping. Company names are examples from this series |
| Annual scale of about ¥550 million to ¥1.1 billion (price × planned transplants) | Our calculation | Our own calculation (¥55,306,737 × 10 to 20 patients) |
| The reading that leadership of the iPS cell business lies with the Sumitomo Chemical group and Sumitomo Pharma is narrowed to approval holder and seller | Inference | This article's interpretation of the share transfer of RACTHERA and the stated division of sales, manufacturing and R&D |
| The reading that Amchepry is likely not to bring significant revenue until around 2029 | Inference | This article's interpretation of the plan to transplant only Phase 4 trial participants and the planned number of transplants |
| The reading that part of the return is designed to arrive as milestones and equity-method profit | Inference | This article's interpretation of the contingent consideration agreement |
| The reading that the next challenge in manufacturing is moving from one lot per patient to a mass-production model | Inference | This article's interpretation of the press-conference materials and the review materials |
| The risk that dependence on joint ventures makes the true picture hard to see in consolidated figures | Inference | This article's interpretation of the description of affiliated companies |
Last updated 1 October 2026 / Troy Technical
The figures in this article are based on Sumitomo Pharma's Annual Securities Report, results materials and announcements, public materials from the Ministry of Health, Labour and Welfare, a paper published in Nature, and the jRCT and ClinicalTrials.gov registries. No research-firm estimates or press-based figures have been used. Passages marked "Inference" are this article's interpretation of the primary sources, not statements made by the company. This article does not recommend any treatment or product and is not medical advice.