Japan approves world‑first iPS cell drugs for summer release
March 6, 2026
Japan has formally approved the world’s first regenerative medical products utilizing induced pluripotent stem (iPS) cells, paving the way for use in patients as early as this summer.
Health Minister Kenichiro Ueno granted approval for the two products on March 6 under a fast-track provisional certification system.
They mark the world’s first practical use of medical treatments derived from iPS cells.
The approved drugs are ReHeart, developed by the Osaka University–originated venture Cuorips Inc., for the treatment of severe heart failure, and Amchepry, a neural cell therapy, developed by Sumitomo Pharma Co., for the treatment of Parkinson’s disease.
Both products use third‑party iPS cells stocked by the CiRA Foundation, which was established by Kyoto University.
With the drugs now approved, prices will be set and will be authorized for use in treatments covered by the national health insurance system.
For regenerative medical products, drug prices are generally determined within four to five months after approval. The treatments using these drugs could be available for patients as early as this summer.
Both products were approved under the conditional and time‑limited approval system, which is designed to deliver regenerative medical products to patients as quickly as possible.
This system is a kind of provisional license, allowing safety and efficacy to be assessed using data from fewer patients than is required for clinical trials of conventional drugs.
For this reason, companies are required to study treatment outcomes during the seven‑year period following the start of sales and obtain “full approval” after reassessing efficacy and other factors.
ReHeart will be assessed under the treatment of 75 patients and Amchepry for 35 patients, including 30 who are 65 or younger. The clinical outcomes of all patients who are treated using these products will be examined.
The iPS cell was created by Shinya Yamanaka, a professor at Kyoto University, who received the Nobel Prize in Physiology or Medicine in 2012 for his groundbreaking work with iPS cells.
This year marks the 20th anniversary since Yamanaka first generated iPS cells using mice in 2006.
[Source: The Asahi Shimbun]
Health Minister Ueno Kenichiro said after a Cabinet meeting on Friday that he hopes patients in Japan and throughout the world will be helped. He added that the necessary procedures will be moved forward so the treatments can quickly reach all patients.
https://www3.nhk.or.jp/nhkworld/en/news/20260306_17/
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I see your still around. Graham
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Read 1/2 way through this article and checkout over about production facility which has athxq name all over it.
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[From the registries (machine-translated from Japanese)]:
Multipotent adult progenitor cells for use in treating intracerebral hemorrhage - Patent Application 20070122999
Abstract
[Problem] Multipotent adult progenitor cells for use in treating intracerebral hemorrhage are provided.
[Solution] Aspects of the invention described herein relate to the administration of multipotent adult progenitor cells to treat intracerebral hemorrhage.
Previously, stem cells have not been considered useful for treating ICH. As described herein, it has surprisingly been found that administering multipotent adult stem cells as described herein to treat ICH has an unexpected and surprisingly effective therapeutic benefit on ICH outcome, as shown by measures of hematoma volume, cerebral blood flow/perfusion outcome, and functional neurological assessment.
...
Inventor: Robert Mays
Current Assignee: Healios KK
https://patents.google.com/patent/JP2025181956A/ja
[Issuing Country] Japan Patent Office (JP)
[Publication type] Patent publication
[Registration date] 2026-02-20
[Issue Date] 2026-03-03
[Title of Invention] Multipotent adult progenitor cells for use in treating intracerebral hemorrhage
International Patent Classification]
...
[Number of claims] 52
Application date】2020-01-30
[Publication Date] 2022-04-25
[International Release Date] 2020-08-06
[Date of request for review] 2023-01-26
[Priority date] 2019-02-01
[Priority claiming country/region or organization] US
[Name or Company Name] Healios Co., Ltd.
...
[Claims]
[Claim 1]
A composition for treating intracerebral hemorrhage and reducing intracerebral hematoma volume in a subject, the composition comprising multipotent adult progenitor cells that express oct-4, rex-1, and rox-1, the multipotent adult progenitor cells being neither embryonic stem cells, nor embryonic germ cells, and capable of differentiating into at least one cell type of each of at least two of the endodermal, ectodermal, and mesodermal lineages, and being allogeneic or xenogeneic to the subject.
...
https://ipforce.jp/patent-jp-P_B1-07822785
My [imz72] note:
1.I don't know what this procedure means.
2.In March 2021 Athersys published this abstract:
Multipotent Adult Progenitor Cells as a Highly Promising Therapy for Treatment of Intracerebral Hemorrhage
3.In November 2021, Dr. Robert Mays, who was then Head of Neuroscience at Athersys, said in an interview:
"We have ongoing preclinical work a number of indications, we've got the most of them continued down the line, including great hemorrhagic stroke data and we hope to be submitting that paper in 2022."
However, this paper has not been published since.
4.In March 2022, BJ Lehmann, who was the Interim CEO of Athersys back then, said at a Maxim presentation:
"Ischemic stroke, as I mentioned, is our lead indication. I think we all understand the nature of the opportunity to help patients here - significant and increasing incidence as the patient population ages.
There's both ischemic stroke and hemorrhagic stroke. We've demonstrated in both varietals we can have potential effect. We've done clinical work in ischemic stroke, and just preclinical work in the hemorrhagic area, but we do believe we can impact both types of strokes in a meaningful way."
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Machine-translated from Japanese:
March 9, 2026
Sumitomo Pharma and Sumitomo Chemical provide financial and human resources support for the parent-child bond that supported iPS drug approval
Sumitomo Pharma has received approval to manufacture and sell a regenerative medicine product using iPS cells. It took more than 10 years for the company to fully launch its iPS drug discovery business, which began in 2013. Despite facing a funding shortfall after the patent expiration of its flagship drug, the company was able to secure approval thanks to the support of the entire group from its parent company, Sumitomo Chemical.
"Our focus is on small molecule drug discovery, and there were some internal doubts about whether regenerative medicine could really be achieved. With this approval, we are now confident that the entire company can work together," said Sumitomo Pharma President Toru Kimura emphatically at a press conference on March 6.
"We are the first in the world to commercialize pharmaceuticals derived from iPS cells, which can differentiate into any cell type in the body. Amchepry, a neuronal cell line for Parkinson's disease, is surgically transplanted into the brain to compensate for lost neuronal function. Our goal is to provide a fundamental cure, rather than simply suppress the progression of symptoms."
This approval is conditional and time-limited. The company aims to obtain further data on efficacy and safety during the seven-year approval period before submitting a formal application. The first patient could be transplanted as early as the end of 2026.
Professor Yamanaka joined the company the year after winning the Nobel Prize
Sumitomo Pharma established a specialized department in 2013 and entered the iPS drug discovery business. The previous year, Professor Shinya Yamanaka of Kyoto University, who developed iPS cells, had won the Nobel Prize. Sumitomo Pharma (then known as Sumitomo Dainippon Pharma) had focused on small molecule drugs for the nervous system and cancer, but saw potential for growth in this field.
In 2014, the company opened the Regenerative and Cellular Medicine Kobe Center in Kobe, and in 2018, it began operating the manufacturing plant SMaRT.
The COVID-19 pandemic, which began in earnest in 2020, cast a dark cloud over the development plan. Clinical trials that had begun in 2018 were delayed. Discussions with the Pharmaceuticals and Medical Devices Agency (PMDA), the review authority, then ran into difficulties over the interpretation of clinical trial data based on a small number of cases.
Financial difficulties also arose. In 2023, the patent for its mainstay schizophrenia drug, Latuda, expired in the United States. As business performance deteriorated significantly, research and development expenses, which had exceeded 90 billion yen in the fiscal year ending March 2024, were halved.
Nevertheless, the company continued to invest around 10 billion yen [$63 million] annually in its regenerative medicine and cellular medicine business. Sumitomo Chemical was the driving force behind this. In 2024, Sumitomo Pharma spun off its regenerative medicine and cellular medicine business and established a joint venture with Sumitomo Chemical called "Racthera." While most of the personnel responsible for development were provided by Sumitomo Pharma, Sumitomo Chemical invested approximately two-thirds of the capital. The manufacturing base was also transferred to another joint venture called "S-RACMO," creating a system in which the entire group could provide support.
It was not an easy decision for Sumitomo Chemical either. In addition to the deteriorating performance of Sumitomo Pharma, the company's petrochemical business was also struggling, resulting in a final deficit of over 300 billion yen [$1.9 billion] for the fiscal year ending March 2024. There is still talk of selling Sumitomo Pharma or partnering with another company.
The reason for the continued support is that it will enable the group to utilize its collective strength and is expected to be a driver of future growth. At a press conference on March 6, Sumitomo Chemical President Nobuaki Mito emphasized that he would like to develop iPS medicine as "one of the pillars of the group."
"Sumitomo Chemical conducted research on regenerative cells in the early 2000s, and many of the researchers involved at that time are also active in this project. We will mobilize all of our group's resources to work towards the final goal," he said. To evaluate the safety of chemicals on the human body, the company has been working on research into using embryonic stem cells (ES cells) as an alternative.
Amchepry still has a long way to go before it can become profitable. Kimura acknowledges that "there will be almost no impact on our business performance over the next few years, and in fact, research and development costs for clinical trials will increase."
The Japanese market is positioned as a place to build a track record. Th
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BTW, Saisei Ventures, which is a subsidiary of Healios, is one of the seed investors of Kenai Therapeutics, as is shown in the presentation:
https://youtu.be/mUMLUZchAJw?t=693
and on Saisei's website:
https://www.saiseiventures.com/portfolio/
Gemini says:
Saisei Ventures is listed as a participating investor in Kenai Therapeutics' $82 million Series A financing round, which was announced in early 2024 (and is a primary part of the company's total funding of approximately $89 million as of 2026). This round was co-led by the Alaska Permanent Fund Corporation, Cure Ventures, and The Column Group, with Saisei Ventures and Euclidean Capital also participating.
Regarding the exact percentage of ownership, this information is not publicly available.
As a private biotechnology company, Kenai Therapeutics is not required to disclose the specific cap table (the breakdown of who owns how much) or the individual equity stakes held by its venture capital partners. In the venture capital industry, these details are typically kept confidential between the company and its investors. ?
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Machine-translated from Japanese:
March 24, 2026
Astellas opens its Nakanoshima Cross lab to the public, showcasing automated cell culture using robots and AI
On March 24, Astellas Pharma unveiled a development base opened by its joint venture with Yaskawa Electric, Cellafa Bioscience, at Nakanoshima Cross, a cutting-edge medical hub in Osaka. The base will combine the humanoid general-purpose robot "Maholo," developed by a subsidiary of Yaskawa Electric, with artificial intelligence (AI) to advance the practical application of automated cell culture technology.
Cell therapy using iPS cells and other living cells means that variations in the manufacturing process directly impact quality. Traditionally, much of the process relied on the manual work of skilled technicians, making reproducibility and scaling up challenging. Maholo is said to automate more than 90% of the manufacturing process. Remote operation is also possible, contributing to labor savings on-site.
At the event held on the same day, Cellafa President Hidehito Yamaguchi said, "We will introduce robots from the research stage and build a foundation that allows us to run everything from development to manufacturing in one place. We want to accelerate the industrialization of regenerative medicine."
The company was established in September 2025 and will be engaged in contract work for universities and startups, developing cell manufacturing processes and manufacturing investigational drugs. The Nakanoshima Cross base will serve as a hub for incorporating cutting-edge technologies and coordinating with customers.
https://www.nikkei.com/article/DGXZQOUF241070U6A320C2000000/
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March 17, 2026
Personal iPSC Service to Launch with Production Cost in the 10-Million-Yen Range
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Fees will initially consist of the manufacturing cost — set in the 10-million-yen range — plus separate storage charges depending on the duration. The partners aim to bring prices down over time through operational efficiencies. The companies target 20 orders in FY2026 and 1,000 by FY2030, equivalent to sales of roughly 10 billion yen [$63 million].
...
The service targets individuals — both in and outside Japan — willing to invest heavily in personal health. Nakagawa said the service could gain traction particularly in multi-ethnic markets such as the US, where differences in HLA types can make matching donor-derived iPSCs more difficult.
Nakagawa noted that the new pricing marks a sharp drop from earlier estimates of around 50 million yen [$315K] for producing autologous iPSCs. Even so, Teijin Regenet President Yasushi Tanaka acknowledged the cost remains “somewhat high” for private individuals, saying the companies will work to reduce prices through automation and labor-saving manufacturing systems.
Nakagawa added that advances in manufacturing know-how, economies of scale, and automated quality-controlled processes should also help lower costs over time.
https://pj.jiho.jp/article/254973
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And 2 short videos from a Chilean TV channel, which can be viewed with English dubbing and subtitles:
March 17, 2026
Japan authorizes the first regenerative therapy for Parkinson's disease using pluripotent cells
https://youtu.be/QCyz6xFs0kA
Innovative stem cell therapy for Parkinson's disease presented
https://youtu.be/7ZXo9_SmLVc
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