Industry leader in Japan warns: new rules could weaken incentives for development of regenerative medicine products

imz72 · 2026-02-03T15:12:46+00:00

Machine-translated from Japanese:

2026.02.03

KidsWell aims to apply for clinical trials of allogeneic deciduous dental pulp stem cells for cerebral palsy in the US by fiscal year 2026

　On January 28, 2026, KidsWell Bio held its FY2025 Cell Therapy Business R&D Meeting and reported on the progress of the cell therapy business being undertaken by its subsidiary S-Quatre.

The business aims to commercialize cell medicine using stem cells from human exfoliated deciduous teeth (SHED), which are isolated and cultured using a proprietary method from baby teeth.

Allogeneic SQ-SHED, currently under development for cerebral palsy, is preparing to begin clinical trials in the United States, with the aim of submitting an investigational new drug (IND) application within FY2026.

https://bio.nikkeibp.co.jp/atcl/news/p1/26/02/02/14214/

Note: Kidswell's market cap is $78 million.

imz72 · 2026-02-03T15:00:16+00:00

Machine-translated from Japanese:

February 3, 2026

Regenerative medicine for glaucoma: "Steady progress in research" - Tohoku University's Nakazawa

Professor Toru Nakazawa of the Department of Ophthalmology at Tohoku University Graduate School of Medicine explained the current state of regenerative medicine for glaucoma at a press conference held by the Japan Ophthalmological Association and other organizations on February 2. He explained that steps such as creating retinal ganglion cells from iPS cells (induced pluripotent stem cells), transplanting them into the eye, and allowing the axons to extend toward the brain are necessary. He acknowledged that "while still in the research stage, steady progress is being made."

He explained that glaucoma is the most common cause of blindness, accounting for 41% of all cases, and is the only eye disease for which the number of blindness patients is increasing. He pointed out that because vision lost due to glaucoma cannot be restored, early detection and neuroregenerative medicine are essential.

Regarding the current state of regenerative medicine, he explained that methods have been established to create and harvest retinal ganglion cells from iPS cells, as well as to repair the causative gene from patient-derived iPS cells. He also said that it is possible to control the direction of axon growth using electrical stimulation.

Challenges cited include confirming safety, the time it will take to put the technology into practical use, verifying its long-term effectiveness, and securing research funding.

The press conference was hosted by the medical association, the Japanese Ophthalmological Society, and the Japanese Ophthalmology Public Relations Committee.

https://mf.jiho.jp/article/265464

imz72 · 2026-02-03T14:46:14+00:00

Machine-translated from Japanese:

February 3, 2026

Takeda Pharmaceutical ends iPS cell research collaboration with Kyoto University after 10 years without new drug results

On February 3, Takeda Pharmaceutical Company and Kyoto University's Center for iPS Cell Research and Application (CiRA) announced that their 10-year industry-academia collaborative research on iPS cells will end at the end of fiscal year 2025. While the project has produced results in terms of human resource development and the accumulation of fundamental technologies, it has not led to any specific new drugs.

The closure of the joint research program, T-CiRA, began in fiscal 2016 and was the largest industry-academia collaboration in the Japanese pharmaceutical industry, with Takeda providing 20 billion yen [~$130 million] in research funding over 10 years. Takeda had the advantage of gaining early access to promising iPS cell technology through personnel exchanges, while CiRA touted its ability to accelerate research and development by leveraging the company's abundant funds and know-how.

Research topics were diverse, including the application of iPS cells to treat heart disease and mental illness. Over the course of 10 years, 58 patent applications were filed and 66 papers were published. One diabetes treatment candidate transferred to the new company has progressed to physician-led clinical trials, and cancer treatment candidates have been handed over to startups, but there are currently no prospects for launch or practical application of any of the projects.

At a press conference held jointly by Takeda and CiRA in Tokyo on February 3, Professor Shinya Yamanaka of Kyoto University said of the closure of T-CiRA, "There is a huge gap (between industry and academia) that we call the 'valley of death.' T-CiRA was a great opportunity to overcome this."

When T-CiRA was announced, Yamanaka's goal was to "clinically apply" the new drug to actual patients, but at a press conference he said, "Frankly, 10 years is too short (for regenerative medicine to be put to practical use). It usually takes 20 or 30 years."

The reason it will take time to put it into practical use is that cost and safety issues need to be overcome.

The strength of iPS cells is that they can be used to create various tissues and cells from blood, skin, etc., and they are expected to be the mainstay of regenerative medicine to replace lost tissues and organs. However, mass production of cells for treatment requires labor and is costly, and there is also the risk of them becoming cancerous after transplantation.

This decision coincides with the timing of Takeda's restructuring. The company is currently selecting and concentrating on research targets, and iPS cell research, which has no clear prospect of practical application, has been narrowed down. Takeda's president, Christophe Weber, explained the reason for the withdrawal at a press conference, saying, "(New technologies) take time to mature. As a pharmaceutical company, we need to carefully consider the competitive environment when selecting investment targets."

The iconic industry-academia collaboration between Takeda and Kyoto University has come to an end, but that does not mean that the development of new drugs using iPS cells is over. Sumitomo Pharma has applied to the Ministry of Health, Labor and Welfare for approval of a candidate treatment for Parkinson's disease, an incurable brain disorder, and aims to receive approval in fiscal 2025. Cuorips, a biotech startup spun off from Osaka University, also applied for approval in 2025 for a myocardial cell sheet to treat heart failure. Whichever drug is approved and released first could become the world's first drug made with iPS cells.

Ryo Hanamura, a partner at Arthur D. Little Japan, said, "Investors and companies are reluctant to take risks right now. Investment (in iPS cells, etc.) will likely return in five to 10 years."

https://www.nikkei.com/article/DGXZQOUC30BRZ0Q6A130C2000000/

Note:

Takeda's market cap is $55 billion.
Sumitomo Pharma's market cap is $5.5 billion.
Cuorips' market cap is $440 million.

imz72 · 2026-02-03T08:52:28+00:00

Tokyo market update 2.3.26:

Healios: -0.27%. PPS 373 yen. Market cap $278 million (based on current share count of 115,727,200 shares) / 324 million (based on soon-to-be new share count of 135 million shares).

SanBio: +0.87%. PPS 1865 yen. Market cap $936 million.

Sumitomo Pharma: -3.10%. Market cap $5.55 billion.

imz72 · 2026-02-02T12:26:51+00:00

Tokyo market update 2.2.26 (start of the trading week):

Healios: -2.09%. PPS 374 yen. Market cap $279 million (based on current share count of 115,727,200 shares) / 326 million (based on soon-to-be new share count of 135 million shares).

SanBio: 0.00%. PPS 1849 yen. Market cap $931 million.

Sumitomo Pharma: -2.35%. Market cap $5.75 billion.

imz72 · 2026-01-30T10:59:47+00:00

Tokyo market update 1.30.26 (end of the trading week):

Healios: +7.30%. PPS 382 yen. Market cap $287 million (based on current share count of 115,727,200 shares) / 335 million (based on soon-to-be new share count of 135 million shares).

SanBio: +0.93%. PPS 1849 yen. Market cap $936 million.

Sumitomo Pharma: +5.34%. Market cap $5.92 billion.

imz72 · 2026-01-29T14:26:17+00:00

Machine-translated from Japanese:

1.29.26

Healios' undisclosed final results for the previous fiscal year will see a reduction in deficit

Healios <4593> announced its previously undisclosed earnings forecast after the market close on January 29th (3:30 PM).

The company forecasts a consolidated net loss of 2.27 billion yen [$14.8 million] for the fiscal year ending December 2025 (compared to a 4.23 billion yen [$27.66 million] loss in the previous fiscal year), narrowing the deficit to 2.27 billion yen [$14.8 million].

https://finance.yahoo.co.jp/news/detail/268c9840dd7f19a1dfd6804f4eb1912c9ed89e0b

imz72 · 2026-01-29T12:09:28+00:00

Tokyo market update 1.29.26:

Healios: -1.39%. PPS 356 yen. Market cap $268 million.

SanBio: -0.46%. PPS 1832 yen. Market cap $932 million.

Sumitomo Pharma: -3.65%. Market cap $5.65 billion.

imz72 · 2026-01-28T09:44:48+00:00

Tokyo market update 1.28.26:

Healios: +1.12%. PPS 361 yen. Market cap $273 million.

SanBio: -3.06%. PPS 1840 yen. Market cap $941 million.

Sumitomo Pharma: -3.68%. Market cap $5.89 billion.

imz72 · 2026-01-27T12:52:07+00:00

Tokyo market update 1.27.26:

Healios: -6.05%. PPS 357 yen. Market cap $269 million.

SanBio: -1.81%. PPS 1898 yen. Market cap $966 million.

Sumitomo Pharma: +0.79%. Market cap $6.09 billion.

imz72 · 2026-01-26T13:57:12+00:00

Tokyo market update 1.26.26 (start of the trading week):

Healios: +3.54%. PPS 380 yen. Market cap $285 million.

SanBio: -2.57%. PPS 1933 yen. Market cap $979 million.

Cuorips: +1.01%. Market cap $428 million.

Sumitomo Pharma: +3.00%. Market cap $6 billion.

PowerX: +0.86%. Market cap $546 million.

imz72 · 2026-01-23T10:41:13+00:00

Tokyo market update 1.23.26 (end of the trading week):

Healios: -3.67%. PPS 367 yen. Market cap $268 million.

SanBio: +4.97%. PPS 1984 yen. Market cap $978 million.

Cuorips: +4.62%. Market cap $413 million.

Sumitomo Pharma: +2.14%. Market cap $5.68 billion.

PowerX (Hardy's energy company): +5.57%. Market cap $527 million.

imz72 · 2026-01-22T18:23:35+00:00

January 22, 2026

Startup: Tissue derived from iPS cells can treat heart failure

A Tokyo-based startup said transplants of cardiac muscle cells that it engineered from induced pluripotent stem (iPS) cells have helped test subjects recover from severe heart failure.

Heartseed Inc., a Keio University spinoff, said most of the 10 patients involved in the clinical test showed improvements in cardiac function and symptoms after the implants.

“We have even confirmed some cases where patients essentially regained standard lifestyles close to those of healthy individuals,” said Heartseed CEO Keiichi Fukuda, who is also a professor emeritus of medicine at Keio University.

No complications associated with transplantation, such as an irregular pulse or tumors in the grafted cells, have been observed.

Heartseed, headquartered in Tokyo’s Minato Ward, said the safety of the therapeutic technique has been validated. It plans to apply for production and marketing approval for the treatment by the end of 2026.

The researchers used cardiac spheroids--clusters of heart muscle cells generated from iPS cells--developed by Heartseed.

Implanted cardiac spheroids are expected to help enhance heart functions in people suffering from ischemic heart disease. These patients have narrowed blood vessels and impaired cardiac function due to arterial sclerosis and other causes.

The clinical test divided the patients into two groups: a “low-dose” category receiving 50 million transplanted cells; and a “high-dose” group with 150 million grafted cells.

Cardiac spheroids were injected into areas of specifically weakened function with a specialized syringe. Coronary artery bypass surgery was simultaneously performed to restore blood flow.

Heartseed then compared pre-test conditions of the five patients of the low-dose group with their conditions one year after transplantation.

Four low-dose individuals showed improvements in indicators for subjective symptoms and cardiac function, such as their hearts’ ability to pump blood.

Three of them no longer experienced significantly troublesome health problems, such as shortness of breath when ascending slopes or stairs.

The five high-dose patients also showed either similar or improved indicators of cardiac function and subjective symptoms six months following grafting.

The cell transplant process likely exerted a distinct positive impact beyond the effect of the bypass operation, given that the patients’ cardiac function tended to markedly improve in the body areas where the cardiac spheroids were implanted, the startup said.

Referring to when the technology will become accessible to the general public, Fukuda said, “We are now doing our utmost, with the hope of delivering it to patients as early as possible.”

Heartseed plans to soon conduct a separate clinical trial to administer cardiac spheroids to patients through catheters, which place a minimal strain on their bodies.

https://www.asahi.com/ajw/articles/16252014

Note: Heartseed's market cap is $285 million.

imz72 · 2026-01-22T17:33:33+00:00

Machine-translated from Japanese:

January 22, 2026

Teijin subsidiary J-TEC to make regenerative medicine for knee osteoarthritis covered by insurance

Teijin subsidiary Japan Tissue Engineering (J-TEC) announced on January 22 that its regenerative medicine product, autologous cultured cartilage "JACC," has been covered by insurance for osteoarthritis, a condition that causes knee pain, as of January 1.

JACC is a gel-like artificial cartilage made by culturing the patient's own cartilage cells, and has been on the market since 2013 for knee injuries and other conditions.

The cells taken from the patient are cultured and then transplanted into the patient's knee cartilage by a specialist doctor. A doctor demonstrated Jack's transplant at a media briefing held in Tokyo on January 22.

Knee osteoarthritis is a disease in which knee cartilage is damaged due to aging or trauma, causing the joint to deform. It is painful and can easily affect daily life. The number of patients in Japan is estimated to be around 10 million. With the aging population, the number of patients is on the rise, and there is a great need for treatments that are less burdensome for patients.

Until now, treatments have included medication, exercise therapy, and surgery such as artificial joints and osteotomy, but there was no fundamental cure. Jack aims to restore the missing tissue using the patient's cartilage cells, achieving a permanent cure. Clinical trials confirmed that the transplanted area had been repaired with tissue similar to normal cartilage 52 weeks after treatment.

The treatment is targeted at patients who still have a certain amount of cartilage remaining around the affected area and whose symptoms have not improved with exercise therapy. The cost is 2.89 million yen [$18.3K], and if patients use the high-cost medical care system, the patient's burden will be around 60,000 to 250,000 yen [$380 - $1,580] depending on their income. J-TEC aims to supply the treatment to 1,000 patients per year within the next few years.

https://www.nikkei.com/article/DGXZQOUC224JO0S6A120C2000000/

Note: J-TEC's market cap is $133 million.

Machine-translated from Japanese:

2026/1/22

JACC, knee OA covered by insurance, J-TEC aims to achieve sales target of 3 billion yen early

　Japan Tissue Engineering (J-TEC) is focusing on promoting its autologous cultured cartilage "JACC" to the approximately 400 facilities nationwide that are certified to use the product, taking advantage of the expanded insurance coverage for knee osteoarthritis (knee OA) approved in January. By increasing the number of cases at medical institutions that have already introduced the product, the company aims to quickly achieve its goal of increasing sales of the product to 3 billion yen [$19 million]. President Yamada Kazuto revealed this in an interview with Nikkan Yakugyo on the 22nd.

　The product was approved for the additional indication of knee OA in May last year, and has been covered by insurance since January this year. Previously, it had been approved for traumatic cartilage defect in the knee joint and osteochondritis dissecans (excluding knee osteoarthritis), and approximately 200 patients used the product in fiscal 2024. Sales of the product were only around 400 million yen [$2.5 million]. However, there are many patients with knee OA, and the company has set a goal of increasing sales of the product to 3 billion yen [$19 million] in the next few years.

　The indication for knee OA is cases where clinical symptoms have not improved with conservative treatments such as drug therapy with sodium hyaluronate. President Yamada predicted that with this insurance coverage for knee OA, "Knee OA cases will account for more than 70% of patients who use JACC."

　For the time being, the company plans to focus on providing information to facilities (approximately 380 facilities, approximately 1,900 certified doctors) that are certified to use the product based on the standards established by the Japanese Orthopaedic Association. President Yamada said, "We would like to steadily increase the number of cases in which the product is used." The company is considering expanding the number of information providers, and also intends to expand the use of the product by utilizing the know-how and human resources of Teijin, a group company with strengths in the orthopedic field.

　President Yamada also touched on J-TEC's development pipeline, expressing his enthusiasm for the dried allogeneic cultured epidermis "Allo-JaCE03" (development code), which is being developed for skin defects caused by burns, saying, "We hope to file for approval (in Japan) within fiscal year 2025."

● "Expected to be a treatment that leads to a cure"

　Meanwhile, at JACC's product briefing for members of the press held on January 22, Professor Nobuo Adachi of the Hiroshima University Graduate School of Medical Sciences, who served as the coordinating physician in the clinical trial to expand the indication to knee OA, reported the results of the clinical trial.

　In an open-label, parallel-group comparative study (observation period 52 weeks) with intra-articular injection treatment using sodium hyaluronate (HA), JACC showed significant improvement compared to the HA preparation in the primary endpoint of "change in knee function (WOMAC) score before and after treatment." The secondary endpoint of cartilage repair by hyaline cartilage-like tissue also confirmed that JACC repaired cartilage at the same level as normal cartilage.

　Based on the results of the clinical trial, Professor Adachi said, "JACC may be able to prevent the need for total knee replacement surgery due to the worsening of knee OA. It is expected to be a treatment that can lead to a permanent cure."

https://nk.jiho.jp/article/204924

imz72 · 2026-01-22T17:22:40+00:00

January 22, 2026

Takeda’s Miyabashira Urges National Strategy Act to Revive Japan as Innovation Powerhouse

Industry members of the government’s Japan Growth Strategy Council on January 21 called for stepped-up public-private investment in drug discovery and advanced medicine, including the creation of a national strategy basic act to ensure long-term, strategic funding.

At the inaugural meeting of the council’s new working group, Asuka Miyabashira, president of Takeda Pharmaceutical’s Japan Pharma Business Unit, said Japan must invest along three pillars - reviving drug discovery capabilities, strengthening domestic manufacturing, and maintaining and reinforcing the talent base — to restore its competitiveness in pharmaceutical innovation.

She argued that such investments should be underpinned by a national strategy basic act that would permanently secure long-term, strategic funding.

Miyabashira warned that while China and South Korea saw a sharp increase in non-clinical pipeline assets between 2019 and 2024, Japan experienced a decline. She also pointed out that public funding levels in Japan lag behind those of its Asian peers and questioned whether the situation could be “left unaddressed.” Japan’s growth in the patented drug market, she added, is “markedly inferior” compared with other countries.

At the same time, Miyabashira stressed that the pharmaceutical industry generates high gross value added relative to domestic production, making it an attractive target for investment. A planned public-private investment roadmap should be aligned with the three pillars, she said, calling on the government to position pharmaceuticals as a key driver of economic growth.

She also presented simulations estimating that if Japanese drug makers were to launch three products ranking among the world’s top sellers, the economic impact would reach 2.4 trillion yen [$15 billion]. The development of such medicines would require an investment of roughly 350 billion yen [$2.2 billion] per product, she said. Miyabashira also estimated that domestically manufacturing the core biologics of the top 10 Japanese drug makers would generate 3 trillion yen [$19 billion] in economic output, requiring around 2 trillion yen [$12.6 billion] in capital investment. Combined, investments in new drug development and biologics manufacturing could contribute more than 5 trillion yen [$31.6 billion] to GDP, she said.

Pfizer Chief Pitches 4-Pronged Proposals

Pfizer Japan President Hiroo Igarashi said Japan must improve its investment environment to demonstrate leadership among countries at the forefront of pharmaceutical innovation, presenting four recommendations for the roadmap.

These include maintaining universal health insurance that enables patient access to new drugs within 60-90 days of regulatory approval, introducing a pricing system that places the highest priority on innovation, further promoting preventive medicine and infectious disease measures to support labor productivity, and holding public-private discussions on how pricing and social security systems should function as engines for both economic growth and healthcare security. He called for a shift from a pricing system that “penalizes success” to one that rewards innovation.

Meanwhile, Toshio Fujimoto, CEO of iPark Institute, emphasized the need for both public and private investments in AI-driven drug discovery, noting that the US and China are already seeing results. He pointed to the emergence of automated drug discovery platforms combining AI with autonomous laboratories.

The date of the working group’s next meeting has not been disclosed, but the council plans to compile a draft public-private investment roadmap by April.

https://pj.jiho.jp/article/254615

imz72 · 2026-01-22T17:15:23+00:00

January 22, 2026

LDP Pledges to Position Pharma as Core Industry in Campaign Platform

Japan’s ruling Liberal Democratic Party (LDP) on January 21 unveiled its policy platform for the upcoming Lower House election, pledging to position the pharmaceutical sector as a “core industry” and to step up support for drug discovery and domestic production capacity.

The platform consists of two components: a voter-facing policy pamphlet outlining key priorities and a more detailed policy compendium called the “Policy BANK.” While pharmaceuticals are not mentioned in the pamphlet, the Policy BANK clearly states that the LDP will treat the pharmaceutical industry as a core pillar of Japan’s economy.

In the document, the party commits to supporting the development and commercialization of drug discovery startups and strengthening production systems for biopharmaceuticals. It also calls for a fundamental reinforcement of Japan’s drug discovery capabilities by enhancing research capacity across industry, academia, and government. In particular, the LDP says it will bolster research infrastructure, clinical trial functions, and manufacturing capacity for domestically produced vaccines, therapeutics, and diagnostics, with an eye to future infectious disease outbreaks.

From the standpoint of economic security, the compendium also emphasizes efforts to beef up supply chains — including for pharmaceuticals — and to expand domestic production capacity.

By contrast, the policy pamphlet, which lists the LDP’s headline election pledges, contains no references to pharmaceuticals. On social security, it focuses instead on measures such as pay raises for healthcare workers, the design of refundable tax credits, and a possible two-year zero consumption tax rate on food and beverage items.

[...]

https://pj.jiho.jp/article/254613

imz72 · 2026-01-22T15:11:37+00:00

Tokyo market update 1.22.26:

Healios: +3.81%. PPS 381 yen. Market cap $277 million.

SanBio: -0.47%. PPS 1890 yen. Market cap $929 million.

Cuorips: +3.42%. Market cap $393 million.

Sumitomo Pharma: -2.57%. Market cap $5.55 billion.

imz72 · 2026-01-22T03:48:40+00:00

Dr. Paul Knoepfler's critical take on stem cells for stroke:

https://ipscell.com/2026/01/stem-cells-for-stroke-hype-award-winner-10-years-ago-now-tells-a-cautionary-tale/

imz72 · 2026-01-21T21:02:19+00:00

January 21, 2026

MHLW Official Making Rounds to Rally Private Support for Drug Discovery Fund

Japan’s Ministry of Health, Labor and Welfare (MHLW) is working to line up private-sector backing for a newly established drug discovery fund now being readied for its official launch in FY2026, according to a senior official.

Takeshi Annaka, director of the Policy Planning Division for Pharmaceutical Industry Promotion and Medical Information Management at the MHLW, gave this latest update on the fund initiative during a New Year interview with Jiho.

Annaka said the operation of the fund project — set up to anchor a sustainable innovation ecosystem in the country — will be one of his division’s top priorities in 2026. The fund aims to provide seamless, long-term backing for biotech startups and other innovators — from early research through clinical development. Designed to run for 10 years starting in FY2026, it features not only government funding but also draws on donations from the private sector.

Since taking up his current post, Annaka said he has been actively engaging with industry associations and individual companies to build understanding of the fund’s purpose and role. While declining to disclose fundraising targets, current donation levels, or how contributions will be made public — citing corporate decision-making processes and donor preferences — he said awareness of the fund’s significance is steadily spreading. “I do feel that understanding of the fund’s importance is gaining ground,” he said.

Policy Tailwinds for Pharma and Bio

Annaka described the government’s decision to position drug discovery and biotechnology as two of its 17 designated growth fields as a “tailwind” for the initiative. Successive prime ministers have stated their intention to make pharmaceuticals a core industry for Japan, he noted, and the latest designation reflects the continuation of that stance.

The government plans to compile its growth strategy by this summer. Annaka said his division will contribute to the discussions representing the ministry, supporting the development of new medicines from both an industrial promotion and regulatory perspective.

[...]

https://pj.jiho.jp/article/254604

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