In the first half of 2025, a major piece of news emerged in China's regenerative medicine field: the total financing amount of iPSC (induced pluripotent stem cells, iPS cells) therapy companies surpassed that of T-cell therapy companies for the first time.

As of June 30, a total of 9 iPSC therapy companies had received financing, with a total fundraising amount of approximately 72 million US dollars, while the total financing amount of T-cell therapy companies during the same period was approximately 41 million US dollars. This milestone event marks that iPSC therapy is entering a golden period of rapid development in China.

The prospects of iPS cell therapy

The iPSC technology was first developed by Shinya Yamanaka and Kazutoshi Takahashi of Kyoto University in Japan in 2006. As a result, Shinya Yamanaka shared the 2012 Nobel Prize with Sir John Gordon.

Cell therapy based on iPSC technology is becoming a cutting-edge direction in regenerative medicine. Compared with primary cell therapies such as T cells, NK cells and mesenchymal stem cells, iPSC technology has significant advantages.

Primary cell therapy has many limitations. For instance, some cell types, such as neurons, cannot be directly collected for transplantation, and the quality of primary cells may be affected by diseases or germline mutations, showing heterogeneity. Ipscs can be genetically engineered, cloned and expanded, and can differentiate into many somatic cell types. Compared with embryonic stem cells, they have fewer ethical restrictions.

Xenotransplantation experiments have also demonstrated that iPSC technology can be used to obtain hard-to-obtain cell types, improve tissue dysfunction related to diseases, and restore homeostasis in the body. At present, at least 155 clinical trials of iPSC therapy are underway worldwide.

In addition, the iPSC field has great potential. Compared with CAR-T therapy, iPSC has the advantages of low cost, large-scale production, ready-to-use, and wide range of diseases to be treated. At present, the development progress of allogeneic iPSC products is significantly ahead of that of autologous therapy.

Financing in the field of iPSC therapy in China will be active in 2025

In 2025, the financing in the iPSC therapy field in China will be active, with many enterprises receiving significant financial support. Shize Biomedical completed a new round of market-oriented financing in May 2025, with investors including C&D Emerging Investment and other institutions. This is part of the 300 to 400 million yuan pure market-oriented financing the company completed between 2022 and 2025. The funds will be used for clinical research on the pipeline of neurological disease treatment.

During the same period, Zhongsheng Suyuan Biotechnology raised a total of 235 million yuan in its Series B financing, which will be used to advance the development of its first approved clinical drug derived from iPSC mesenchymal cells and natural killer cells in China.

Representative cases also include: Ruizhen Regenerative Medicine completed a Pre-A round of financing of nearly 100 million yuan in May, focusing on promoting the pipeline of iPSC treatment for Parkinson's disease. Ruijian Yilian Medicine completed a B+ round of financing of nearly 100 million yuan in April, supporting the development of its first chemical-induced universal cell drug to enter the clinical stage globally. Qiselian Biotech has received an angel round of financing exclusively invested by BioVinda, focusing on the development of personalized iPSC treatment and anti-aging products.

In addition, Xingsai Ruizhen Biotech completed a nearly 100 million yuan angel + round of financing in March, jointly participated by Rehabilitation Capital and Chuangrui Investment. The company has built an iPSC rapid reprogramming and gene editing platform. Elp Regenerative Medicine completed its Series C financing in June, advancing the clinical trial of its IPSC-derived cardiomyocytes for the treatment of heart failure. Beijing Saiao Biology received strategic investment at the beginning of the year and has been focusing on the application development of iPSC in the field of anti-aging.

These cases jointly demonstrate the development characteristics of the iPSC therapy field in China in 2025: First, the financing round has moved forward, with the proportion of angel round and Series A projects increasing; Second, the application fields have diversified, expanding from neurological diseases to heart failure, anti-aging and other areas. Thirdly, technology platform enterprises are more favored by capital, and companies with independent iPSC reprogramming and differentiation technologies have higher valuations. With the advancement of clinical progress, it is expected that more large-scale financing cases will be witnessed in this field in the future.

These financing cases demonstrate that in 2025, Chinese iPSC therapy enterprises are accelerating their clinical transformation, and the capital market is maintaining a high level of attention to this field.

Clinical Research Progress of iPSC Therapy in China in 2025

In the first half of 2025, China made significant clinical progress in the field of iPSC therapy, covering multiple treatment areas such as neurological diseases, diabetes, tumors and cardiovascular diseases.

In terms of neurological diseases, Shanghai East Hospital has used autologous IPscs to differentiate dopaminergic neural precursor cells to treat Parkinson's disease. The motor function of patients has improved significantly, and the MDS-UPDRS III score has improved by up to 52.9%.

The allogeneic universal iPSC product (XS411 Injection) developed by Shize Biotech has been approved by the drug regulatory authorities of China and the United States for the treatment of Parkinson's disease. It has completed the treatment of multiple patients and has shown good safety. In terms of the treatment of ALS, Shize Biotech's XS228 injection has been approved for clinical trials in both China and the United States. Preliminary results show that it can delay the progression of the disease.

In the field of spinal cord injury, the world's first allogeneic universal IPSC-derived neural cell new drug has been approved in China and the United States, and clinical trials are jointly conducted by Dalian Medical University and the Affiliated Hospital of Sun Yat-sen University.

What we need to emphasize is that the "Allogeneic Human Regenerative Islet Injection" developed by Shanghai Changzheng Hospital has been approved for clinical trials, becoming the second universal regenerative islet therapy in the world and the first in China.

The iPSC-CAR-NK therapy has demonstrated unique advantages. The team led by Xu Huji from Naval Medical University successfully treated severe systemic sclderma using IPSC-derived dual-target CAR-NK cells (QN-139b), achieving serum immunological reconstruction and reversal of tissue fibrosis. The results were published in the journal Cell.

In the field of cardiovascular diseases, the iPSC cardiomyocyte treatment for heart failure project of Elp Regenerative Medicine has entered the joint development stage, providing potential solutions for approximately 13.7 million heart failure patients in China.

The Phase I clinical trial of Hode Bio's hNPC01 injection for the treatment of hemiplegia after ischemic stroke has been completed, demonstrating good safety and efficacy.

In 2025, the iPSC therapy in China will present three major characteristics: First, the clinical transformation will accelerate, with multiple products obtaining regulatory approvals in both China and the United States; Second, the application fields have diversified, expanding from the nervous system to diseases such as diabetes and heart failure. Third, technology platform enterprises are favored by capital. With policy support and capital investment, China's iPSC therapy is expected to play a more significant role in the global cell therapy field and provide innovative solutions for the treatment of major diseases.

iPSC has greater potential and wider applications

The dawn of commercialization for iPSC therapy has already emerged. Stem cell products have recently achieved commercial breakthroughs in both China and the United States. At the end of last year, Mesoblast's mesenchymal stromal cell (MSC) therapy Ryoncil was approved by the US FDA, becoming the first stem cell therapy approved by the agency.

In January this year, the National Medical Products Administration of China conditionally approved the MSC therapy Emmetaxel injection of Platinumide. This drug became the first stem cell therapy approved for marketing in China. Both drugs are used for the treatment of acute graft-versus-host disease.

Compared with the more mature MSC technology, iPSC has greater potential and wider application. For instance, mesenchymal stem cells derived from iPS cells have the advantages of being more homogeneous, stable and infinitely expandable compared to those derived from umbilical cords. iPS cells can be delivered infinitely. Mesenchymal stem cells induced from single cells or clones are theoretically more homogeneous, with controllable product quality, making them suitable for personalized treatment. Although umbilical cord-derived mesenchymal stem cells have strong proliferation ability and low immunogenicity, there are differences among donors, and the quantity obtained is limited. Mesenchymal stem cells derived from iPS cells provide a more stable and reliable cell source for the treatment of complex diseases.

In addition, the advantages of CAR-T and CAR-NK cell therapies derived from iPS cells lie in their standardized production, reduced risk of immune rejection, convenient genetic engineering modification, large-scale expansion, high consistency and homogeneity between batches, as well as broad-spectrum anti-tumor activity and superior safety.

In the future, iPSC therapy can be used to treat a variety of diseases at a relatively low cost, especially chronic diseases such as cancer, diabetes, neurodegenerative diseases, ophthalmology, and various immune inflammatory diseases.

In recent years, the state and local governments have introduced a number of supportive measures in the field of stem cell technology. In February last year, the newly revised "Catalogue for the Guidance of Industrial Structure Adjustment" included cell therapy drugs and cell culture in the list of encouraged industries. In May, the Beijing Drug Administration issued the country's first "Drug Production License" for stem cells. In December, the "Regulations on Promoting New Biomedical Technologies in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port" was officially released. This is currently the most substantive regulation on cell therapy in China. Subsequently, Hainan successively released two batches of implementation directories for the transformation and application of new biomedical technologies, which included multiple stem cell treatments. On June 10th of this year, the National Medical Products Administration (CDE) of China released the "Scope, Classification and Interpretation of Advanced Therapeutic Drugs (Draft for Comment)", which for the first time clearly defined that "advanced therapeutic drugs (ATMP)" in China are divided into cell therapy drugs (CTMP), gene therapy drugs (GTMPs) and other categories. Establishing a clear classification framework for the registration application and market access of stem cell drugs, iPSC is very likely to become the next trend for the application of stem cell technology.

Looking ahead, the iPSC therapy has a promising future. With the continuous advancement of technology, the gradual improvement of regulatory policies, and the sustained attention of the capital market, iPSC therapy is expected to break through the bottlenecks in research and development and production, achieve large-scale commercial application, bring new treatment hope to many patients, and open a new chapter in regenerative medicine.