"The development of the stem cell and iPSC therapy industries in China presents three major trends: First, indications are expanding from immunomodulation to more specialized and challenging areas; second, drug development is shifting from autologous to generic (allogeneic) approaches; third, domestic innovative pharmaceutical companies are benchmarking against international high standards and actively stepping onto the international stage." On March 15th, during the live broadcast program 'Health Strategies for the Two Sessions' hosted by People's Daily Health Client, Wei Jun, co-founder and CEO of Ruijian Medicine, pointed out that currently, there will be a higher level of attention in the field of cell therapy, and the industry will make breakthroughs in larger and more challenging indications. We also have reason to believe that the market prospects will become increasingly broad, which also calls for further coordination of the industrial chain, capital, and policies.
"Cell therapy is divided into two main categories: immune cell therapy (such as CAR-T) which was launched earlier and has a relatively mature market; stem cell therapy (including iPSC) was approved later, with most products currently in clinical development stages. There is a gap in development time between the two," introduced Mao Hua, Senior Partner and Managing Director of Frost & Sullivan Greater China. The overall development time of the cell therapy industry in China is relatively short, leading to issues such as an immature industrial chain, insufficient diversified R&D resources, and a need to improve internationalization levels. However, with time and corporate development, these issues will gradually be resolved.
Speaking about the industry's development, Liu Wei, co-founder and CEO of Huakan Biotechnology, said, "Currently, the cell therapy field has formed an industrial chain that collaborates closely at the upstream (storage), midstream (research and development, transformation, manufacturing), and downstream (clinical treatment) stages; cooperation in the cell therapy field is shifting from simple 'buying and selling relationships' to deep strategic cooperation and joint development; related industries are also transitioning from a product output model that provides tools to a 'product + one-stop solution' service model, providing customers with full-process services from process development, quality system establishment to drug application. At this critical juncture, the industry needs to establish a unified quality and standard system from research and development to regulation to promote healthy industry development."
Against this backdrop, Mr. Wei called for 'more breakthrough therapies' to be covered by regulatory policies for regenerative medicine, and he also looked forward to the establishment of an innovative payment system that includes not only commercial medical insurance support but also the involvement of innovative payment products such as commercial insurance in the early stages of drug development to enhance corporate confidence in commercialization. For our own company, we also hope to strengthen horizontal cooperation with university research achievements to jointly develop new drugs for difficult-to-treat diseases.'
"The application of cells should expand from 'just making medicine' to broader fields such as exosomes and organoids, serving the wider needs of regenerative medicine and tissue engineering." Liu Wei hopes that in the future, related industries can shift from 'going it alone' to an industry-wide approach of 'open competition and win-win cooperation, learning from each other's strengths,' to jointly grow the industry pie; and from 'empirical' production that relies on human experience to 'data-driven' precision production based on AI and big data.
Mao Hua summarized, 'Cell therapy covers a wide spectrum of diseases ranging from cancer, infections to chronic diseases, with enormous market potential. It is estimated that over the next decade, the market size for immune cell therapy in China will exceed 60 billion RMB, and that for stem cell therapy will exceed 50 billion RMB, with growth potential that can be dozens or even hundreds of times greater. This requires the entire industry to keep up with changes in the disease spectrum, targeting huge markets such as degenerative diseases and immune deficiency-related diseases brought about by aging; and to persist in differentiated innovation at an international level, leaving room for future overseas expansion and payments.'
About Ruijian Medicine's iRegene
Ruijian Yilian Medicine Technology (Chengdu) Co., Ltd. (iRegene Therapeutics) is a new generation cell therapy company with a global perspective, dedicated to developing generic cell therapy products for major unmet clinical needs such as neurodegenerative diseases and ophthalmic diseases, relying on its self-built 'AI+chemoinhibition' platform. Unlike traditional development models that rely on gene editing, single experience-based screening, or isolated project advancement, Ruijian integrates AI-assisted omics discovery, deep learning virtual screening, compound validation, and cell engineering systems into a unified R&D platform, forming systematic advantages in cell fate regulation, functional induction, process stability, development efficiency, and industrialization adaptability. This platform not only helps improve the efficiency and repeatability of candidate product development but also enables the company to extend across indications and continuously output new pipelines.
Based on this platform, Ruijian has established a product pipeline covering Parkinson's disease, Multiple System Atrophy (MSA-P), and ophthalmic diseases, and continues to advance clinical development under the dual regulatory system of China and the US. The company's core product NouvNeu001 has completed enrollment and dosing of all patients in Phase II clinical trials in China, and has entered Phase IIa in the US. It completed dosing of the first patient in February 2026, demonstrating its leading pace in the global Parkinson's cell therapy field. As a dopamine-producing neural precursor cell therapy product derived from iPSC, NouvNeu001 is not only focused on symptom improvement but also attempts to explore disease modification and even functional reconstruction through neural cell replacement and neuro loop repair. The product has obtained FDA Fast Track designation (FTD) and Regenerative Medicine Advanced Therapy designation (RMAT), further enhancing its competitiveness in international clinical development and regulatory communication.
More importantly, Ruijian's value is breaking through from single projects to platform-driven continuous innovation. NouvNeu004, developed based on the same 'AI + chemical induction' underlying system, has been approved for clinical trials in both China and the US for MSA-P, a highly difficult neurodegenerative disease, and has completed enrollment of the first patient in a randomized clinical trial in China. This means that Ruijian's platform is no longer serving only a Parkinson's disease project but has initially completed replication verification in a second neurological indication. At the same time, the advancement of the company's ophthalmology pipeline NouvSight001 further demonstrates the platform's potential to expand from central nervous system to a wider range of disease areas. For the cell therapy industry, the real competitive barrier lies not only in owning a leading product but also in whether a set of reproducible, scalable, and cross-indication transferable underlying methodologies and industrialization frameworks can be established.
Ruijian is leveraging the 'AI+Chemical Induction' platform to build a systematic capability that spans from scientific discovery, candidate molecule screening, functional cell engineering to clinical translation and future industrialization expansion. The advantages brought about by platformization are not only reflected in the more efficient generation of new pipelines but also in stronger clinical development organization capabilities and global advancement capabilities when facing complex neurological diseases. With the continuous advancement of NouvNeu001, NouvNeu004, and more subsequent pipelines, Ruijian is transforming from an innovative company with leading projects into a globally competitive and long-term scalable cell therapy platform enterprise.
About Huakan Biology
Beijing Huankan Biotechnology Co., Ltd. was established in 2018, originating from the transformation of scientific and technological achievements from Tsinghua University. It was led by the research team of Professor Du Yanan from the School of Biomedical Engineering at Tsinghua University, with Tsinghua University participating in its joint establishment. The company has now developed into a national high-tech enterprise, a national specialized and refined new “little giant” enterprise, and a potential unicorn enterprise, and has received support from multiple key research and development projects from ministries such as the Ministry of Science and Technology and the Ministry of Industry and Information Technology.
As a high-quality cell manufacturing expert, Huakan Biotech has developed an original 3D cell manufacturing platform that provides customized, one-stop overall solutions based on 3D microcarriers. It enables the large-scale, automated, intelligent, and enclosed production preparation process pipelines for cell drugs and their derivatives in the hundreds of billions. Currently, Huakan Biotech's products and services are widely used in the upstream process development of cell and gene therapy, extracellular vesicles, vaccines, and protein products. At the same time, it also has broad application prospects in fields such as regenerative medicine, organ-on-a-chip technology, and food science (cell-cultured meat, etc.).
Huakan Biotechnology has assisted multiple clients in completing the IND application for new stem cell drugs and successfully obtaining approval. In 2025, it helped China's first stem cell drug be approved for market launch by leveraging its independently developed large-scale preparation technology. In the same year, Huakan Biotechnology established an overseas headquarters in Singapore to accelerate the expansion of the international market and is committed to promoting global inclusive development of the cell industry through disruptive innovation and large-scale intelligent manufacturing technology.
Upholding the vision of 'leading the new era of cell industrialization development', Huanqian Biotechnology actively participates in the establishment of industry standards, including contributing to the formulation of the 'Quality Management Specification for Raw Materials Used in the Production of Cell Therapy Products' group standard, and as a major drafting unit, organizing the compilation of the 'Extracellular Preparation and Inspection Specification for Human Mesenchymal Stem Cells'.
Huakan Biotechnology has accumulated R&D investment exceeding 100 million yuan, obtained more than a hundred intellectual property rights, including over a dozen international patents, and published more than 30 research results in international journals. The company's core product, the 3D microcarrier, has obtained two qualifications for pharmaceutical excipients from the Chinese Center for Drug Evaluation (registration numbers: F20200000496, F20210000003) and three qualifications for active pharmaceutical ingredients and pharmaceutical excipients from the US Food and Drug Administration (file numbers: MF29721; DMF037798, 035481).
To support continuous innovation and industrial development, Huakan Biotechnology has built a nearly 7,000 square meter R&D and transformation platform, including over 1,000 square meters of 3D FloTrix.® The Cell Technology Platform focuses on the development of cell manufacturing and micro-tissue regeneration medical treatment products, providing one-stop services from pre-research and development to market filing. Meanwhile, the GMP production platform has been expanded to 6,000 square meters, offering a solid and reliable supply chain guarantee for global customers.
