Chika-san, thank you so much for letting us interview you today. I’d like to begin by discussing healthcare innovation from a broader, macro perspective. Japan’s declining population and rapid aging have transformed the country into the world’s first true “super-aged” society, with more than 30% of the population now over the age of 60.
This demographic transformation is reshaping healthcare demand. We are seeing new models emerge around preventative care, digital health, and regenerative medicine.
My question is this: since Japan is already living the demographic future that countries like the U.S. and those in Europe will soon face, how has this super-aged society influenced demand for advanced therapies such as regenerative medicine and iPS cell innovation?
Thank you. Yes, in Japan—and not only Japan, but across all advanced nations—the rapid aging of the population has become one of the defining social challenges of our time. It is not simply a medical issue; it is a societal one.
With fewer people of working age and more people requiring care, medical expenditures rise, while the pool of those contributing to the economy and to social insurance shrinks. This creates severe pressure on public finances and on the sustainability of healthcare systems.
It is not realistic to believe that medical innovation alone will solve this. The problem requires systemic reform—rethinking how we structure employment, how companies hire older workers, and how social security frameworks operate. Healthcare innovation is one crucial pillar, but it must be accompanied by broader societal change.
Now, if we focus specifically on regenerative medicine, much of the field has concentrated on rare diseases such as spinocerebellar ataxia (SCA) or amyotrophic lateral sclerosis (ALS). These are extremely important areas, but because they are relatively rare, even successful treatments will not, by themselves, dramatically reshape the social system.
What will truly transform the future of aging societies is prevention—keeping people healthy as they live longer. Imagine a 75-year-old today who could live to 85 or beyond without developing serious illness. That would be a game changer for society: it would reduce healthcare costs, extend active participation in the economy, and improve quality of life.
This is why prevention is where we would like to focus our efforts. At REPROCELL, we are investing in long-term research aimed at prevention and healthy life extension. Breakthroughs in reprogramming technology, including induced pluripotent stem (iPS) cells and partial reprogramming, are very promising in this regard. While traditional regenerative medicine repairs damage, partial reprogramming offers the potential to rejuvenate cells—to make them biologically younger.
Globally, we see figures like Elon Musk and major innovators investing in longevity research, and I believe this area will converge with regenerative technologies. For our part, we are advancing projects such as biological age testing and research into iPS-based rejuvenation therapies. These may ultimately contribute not only to longer lifespans but to healthier, more productive later years of life.
So, to summarize: regenerative medicine for rare diseases is vital, but the greatest societal impact will come from preventative and rejuvenation technologies that keep large populations healthy as they age.
Thank you, that is a fascinating perspective. Let me now ask about Japan’s regulatory environment. As mentioned earlier, Japan has often been criticized for being relatively slow in developing and approving new drugs compared to Western counterparts. However, in recent years, initiatives like the Sakigake system and the conditional approval framework under the PMD Act have been introduced.
Could you give our readers an update on the current regulatory climate? Is Japan now more conducive for innovation, or do you still see reforms necessary to make it globally competitive?
To be candid, Japan has indeed been slower compared to the United States and Europe in bringing new therapies to market. The government recognizes this, which is why initiatives like the Sakigake system and the conditional approval pathway for regenerative therapies were introduced.
However, if we look at origin technologies, many breakthroughs in regenerative medicine have not come from Japan. CAR-T therapy, for example, was developed overseas and only later imported and approved here. In terms of cutting-edge therapies, the U.S. and Europe still lead, and Japan plays catch-up.
The conditional approval system introduced in 2014 was intended to accelerate regenerative medicine, but progress over the past decade has been modest. The government recently set new guidances in 2024 to clarify and strengthen the framework, showing clear intent to push reform forward.
Still, systems alone are not enough. What Japan lacks is more fundamental, basic technology development. The U.S., for instance, advances extremely quickly because the foundation of research and the culture of entrepreneurship are so strong. Japan must invest more deeply in basic science and platform technologies if it wishes to lead globally.
So, in short: the regulatory environment is improving and not a major barrier in itself. The real challenge is strengthening Japan’s technological base so that we are not only adopting overseas innovations but originating them ourselves.
Thank you. I’d now like to turn to your company’s origins. REPROCELL was founded in 2003 as Japan’s first university-origin biotech company, spun out of Kyoto and Tokyo University research. In 2007, you pivoted to focus on iPS cells following Professor Yamanaka’s groundbreaking discovery. In 2013, you listed on JASDAQ, and are currently developing several later-stage regenerative medicine products.
What has been the defining transformation in your journey from an academic spinout to a clinical-stage regenerative medicine company?
In the beginning, REPROCELL was very much a university-origin company, with professors from Kyoto and Tokyo Universities providing the scientific foundation. My role, however, was in management from the start. At that time, I was not a scientist myself, but this turned out to be an advantage.
Many academic startups sometimes fail if professors try to manage the company directly while also pursuing their research. They are brilliant scientists, but business requires different expertise. In our case, the scientists remained fully focused on their research while I managed the company. That separation allowed each side to excel.
Another factor was neutrality. Professors often become deeply specialized in a narrow field and may resist moving beyond it. Because I was not anchored to one discipline, I could network across different research domains, connect with various professors, and integrate diverse technologies into a broader technical platform. That has been essential to our growth.
Despite this evolution, our corporate policy has remained remarkably consistent over 20 years: first, global expansion; second, continuous growth with hybrid of discovery/research business and regenerative medicine; third, open innovation. We have pursued this growth strategy step by step, always with a long-term perspective.
Microscopic view of neurons
Thank you for that background. Let’s talk about Stemchymal®. This therapy has been developed in collaboration with your Taiwanese partner, Steminent Biotherapeutics, and it targets spinocerebellar degeneration. We understand you are preparing for regulatory submission under the PMD Act. Could you tell us about that process and when you expect to secure approval?
At this stage, I cannot disclose specific timelines publicly. What I can say is that we have already completed clinical trials. Preparing for submission involves compiling a series of extensive documents covering not only clinical trial data but also product quality and manufacturing processes. We are working diligently to finalize each component so that once all are in place, we can move quickly toward submission. Our intention is to proceed as rapidly as possible.
If approved, Stemchymal® would be among the very first cell-based therapies for neurodegenerative disorders, not just in Japan but globally. What would this milestone mean for patients, and what would it mean for REPROCELL’s growth?
For patients, the impact would be profound. Currently, there are no effective therapies for conditions like spinocerebellar degeneration. These are devastating diseases: progressive, incurable, stripping away motor function and eventually leaving patients without options. When we have spoken with patients, they describe receiving their diagnosis as receiving a sentence with no hope attached. That sense of despair is something I will never forget.
If Stemchymal® is approved, it could become the first and only therapy available for the disease. For patients, it would represent not just a treatment, but the arrival of hope.
For REPROCELL, this would mark our transition into being a true regenerative medicine company with an approved therapy on the market. It would also allow us to establish the necessary sales networks, regulatory frameworks, and distribution infrastructure. Importantly, we have several additional regenerative therapies in the pipeline. Success with Stemchymal® will give us the experience and know-how to accelerate subsequent launches, making it a foundational milestone for both patients and for our company’s future growth.
You also have programs advancing iPS-derived neural progenitor cells for ALS and transverse myelitis, as well as next-generation CAR-T therapies for oncology. Could you outline the key milestones and challenges that remain in bringing these programs closer to clinical use?
We are currently pursuing three main regenerative medicine projects: iPS-derived neural glia cell therapies, CAR-T therapies, and tumor-infiltrating lymphocyte (TIL) therapies.
For CAR-T and iPS-derived cell therapies, the major technical hurdles—such as demonstrating efficacy in preclinical animal studies—have already been overcome. This is important because in most programs, this is where the largest risk lies. We have cleared that stage. What remains now is largely preparatory work to advance into clinical trials: coordinating with regulators, finalizing trial design, and ensuring manufacturing readiness.
For TIL therapy, we have already entered a clinical trial in partnership with Keio University. For CAR-T and the iPS programs, we are in active discussions with Japan’s PMDA to move into the clinical phase. So the outlook is strong—we see a clear path forward with relatively few remaining technical barriers.
Let’s turn to the concept of personalized iPS cells. REPROCELL has been promoting the idea of creating patient-specific iPS lines for precision medicine. While this model has gained traction in Japan, it still faces challenges overseas—ethical, regulatory, and infrastructural. Do you see the potential to export this concept globally and become a leader in personalized regenerative medicine?
The core advantage of iPS cells is that they can be created from an individual’s own tissue. This enables autologous therapy—treatments based on the patient’s own cells—which overcomes the issue of immune rejection. Other cell types, such as mesenchymal stem cells, cannot offer this same degree of personalization.
That said, there are practical considerations. At present, the industry is focusing primarily on allogeneic approaches, where cells are derived from donors and then transplanted into multiple patients. Allogeneic therapies are easier to scale, less costly, and quicker to implement. For these reasons, I believe allogeneic therapies will become established first.
Personalized, autologous iPS therapies will follow later as technology matures. They will be especially valuable in oncology. In fact, we already see a precedent in CAR-T therapy, which is inherently autologous: patient blood cells are collected, modified, and returned to the same patient. The success of CAR-T shows the potential for autologous approaches when immune rejection is a major concern.
Ultimately, personalized iPS therapies will be the optimal solution, but they will take more time to reach widespread application. For now, our focus remains on advancing the field within Japan. Once the technology is more mature and scalable, we will consider international expansion.
Speaking of international perspectives, REPROCELL already has a presence in Europe, India, and the United States. Most recently, you expanded in the U.S. with a new GMP bio-manufacturing facility in Beltsville, Maryland, which opened in May 2024. Could you explain the advantages of this location and strategy?
The Maryland facility is significant for several reasons. First, it is supported by the state government, which provided subsidies and investment. Their intention is to establish a thriving CDMO (Contract Development and Manufacturing Organization) hub for stem cell production in the region, and they see us as a strategic partner in that vision.
For REPROCELL, this means we now operate GMP manufacturing in both Japan and the United States, allowing us to serve global demand more effectively. As demand for regenerative therapies grows, secure and scalable GMP manufacturing capacity will be essential. Our dual presence strengthens our ability to deliver on that.
Inside the GMP Manufacturing Suite in Maryland, USA
Do you plan to replicate this model elsewhere as part of your international expansion?
At present, our international footprint covers the U.S., the U.K., and India. We are also studying opportunities in Asia and the Middle East. These regions show strong potential, particularly given the rise of medical tourism. Patients from countries such as China already travel to Japan seeking access to treatments unavailable at home. I believe similar opportunities will emerge across Asia and the Middle East, making them attractive regions for expansion.
Will partnerships play a role in this expansion? What do you look for in an international partner?
Partnerships are essential. To succeed globally, we need collaborators who bring capabilities we do not yet have—whether technological, regulatory, or geographic. For example, in Asia and the Middle East, we lack established networks, so partners with strong regional presence and credibility are invaluable. We focus on partners who complement our strengths, allowing us to enter new markets more effectively and responsibly.
Let’s move to mergers and acquisitions. REPROCELL has already completed acquisitions—BioServe in the U.S. for biobanking, Stemgent in the U.S. for stem cell technologies, and Biopta in the U.K. for contract research. What role will M&A play in your future strategy, and which areas will you prioritize?
In 2014 and 2015, we pursued several acquisitions with a clear goal: buying time. Building a new company from scratch in a foreign market takes years, but acquiring an existing company provides immediate access to technology, talent, and networks. That strategy allowed us to establish ourselves quickly across multiple regions.
Going forward, our focus will remain on growth. M&A is one tool among several. If acquiring a company accelerates our entry into a promising field or strengthens our pipeline, we will consider it. But collaboration, joint ventures, and organic growth are also important. The key is always whether the move supports our long-term business development.
Looking ahead, your 25th anniversary will arrive in 2028. Where do you see REPROCELL at that milestone?
2028, I expect Stemchymal® to be approved and on the market, and I anticipate that several of our other regenerative medicine therapies will be in clinical stages and/or in preparation for submission of approval document. That means REPROCELL will truly stand as a regenerative medicine company with products serving patients.
In oncology, our CAR-T and TIL programs target solid tumors such as pancreatic and lung cancers. If we secure approval for even one of these indications, the technology can be extended to other cancers, creating enormous potential impact.
So by our 25th anniversary, I envision a company not only with approved regenerative therapies in neurology but also with breakthrough oncology treatments in development. That combination will position REPROCELL as a leader in regenerative and cellular medicine, both in Japan and globally.
REPROCELL’s Induced Pluripotent Stem Cells (IPSC) Purified Exosome
That is an inspiring vision. We very much look forward to seeing your progress and hope to return for another interview as you approach your 25th anniversary.
Thank you. It has been my pleasure to share our story and our vision.
For more information, visit their website at: http://reprocelljp.com/