Two Decades of Expertise in Cell Banking & Stem Cell Therapeutics: YouSai Life Sciences Charts Course for Industrial Leadership
At the invitation of the Airport Economic Area of Tianjin Port Free Trade Zone, VCBeat recently conducted an interview withDr. Chen Xiaobo, heFounder of UCAR Life, who entered the cell industry in 2008.。
Dr. Chen XiaoboDr. Chen Xiaobo graduated in 1998 from the seven-year Clinical Medicine program at Nankai University School of Medicine, and subsequently remained at the university for three years to engage in clinical treatment, teaching, and research with a focus on cardiovascular diseases. In 2001, he was awarded a government-sponsored scholarship to study at Heidelberg University in Germany, where he earned his Ph.D. in Cardiology in just two years. He then continued his work in Germany for another six years, conducting basic scientific research and clinical practice in areas including angiogenesis, cardiomyocyte migration, myocardial ischemia, and myocardial infarction.
In late 2008, after returning to China, Dr. Chen Xiaobo recognized the promising prospects for the development of the cell therapy industry, andJoined Vcanbio, the first cell industry company listed on the Main Board in China., responsible for the company's R&D, production, and quality management systems in cell technology. Nine years later, he served as CTO and General Manager at a publicly listed cell therapy company in Hong Kong.
Subsequently, against the backdrop of the gradual development of China’s cell therapy industry and increasingly favorable policy support, Chen Xiaobo led his team to independently establish UCell Life—Dedicated to Building a Standardized Platform for the Cell Industry。
Drawing on decades of experience in basic research, clinical research, translational science, enterprise incubation, and corporate management, Chen Xiaobo observed that, judging from the overall development trends of the biopharmaceutical industry, it is inevitable to transition and shift from traditional chemical drugs to small-molecule drugs, biologics, and cell therapies.“Cell therapy is the pearl in the crown,” Chen Xiaobo stated in an interview., to establish a company in the cell therapy industry—the sector with the greatest potential—one must not only possess scientific research capabilities but also take into account the enterprise’s survival and development.
Scientific research may proceed without regard to cost or return, but as a business, one must establish a stable business model of its own. Therefore,While engaged in the R&D of cell-based therapeutics and cellular applications, YouSai Life has also strategically prioritized its cell storage business.。
Yousai Life has currently mastered mature preservation technologies for all cell products, including adipose-derived stem cells, immune cells, and dental pulp stem cells.ParticularlyAdipose-Derived Stem Cell Storage Project: Leading Success Rates and Professionalism in China. In the field of cellular application technologies, YouSai Life has developed numerousStem Cell and Immune Cell Therapeutic Products, covering customersHealth Management、Chronic Disease Management AdjustmentandAdjunctive Clinical Therapyall requirements, while simultaneously advancing the regulatory filing for related cell-based therapies. Currently, its drug indications are primarily focused on repairLiver Injuryas the main focus.
The most critical issues in cell storage are the safety and viability of the samples.All liquid nitrogen tanks used by Yousai Life for cell storage feature large, absolute-vacuum vessels that effectively minimize liquid nitrogen evaporation, ensuring sample safety and eliminating the risk of cross-contamination. Cell samples enter a dormant state in liquid nitrogen tanks at an ultra-low temperature of -196°C, allowing for preservation over decades, potentially even exceeding the human lifespan. Currently, the Yousai Biological Resource Storage CenterOver 2,000 stored samples. In addition to safety, Ucell Life's storage technology can ensure that after the cell samples are revivedActivity reaches over 95%, exceeding 80% of the industry's general standards.
In addition to its cell storage business, Yousai Life is also committed toUmbilical Cord-Derived Stem Cell Therapeuticsof the application process. In terms of scientific achievements and product commercialization, stem cell therapies have reached a relatively mature stage, with broad applications and favorable therapeutic outcomes. Meanwhile, allogeneic cells are more amenable to large-scale production, thereby facilitating better cost control.Yousai's stem cell drug is expected to enter the IND stage in one and a half years.
Yousai Life possesses strong professional specializationQuality Management System, including aspects such as environment, product, and process, and withChinese Academy of Sciences、Tianjin Medical Universityto carry out multi-faceted technical cooperation. In addition toTianjinIn addition, YouSai Life will also be in this yearFujian Province、Hebei ProvinceEstablishing a base has received strong support from the local government and gained favor from relevant industrial investment funds. In the future, autologous cell therapies, regenerative medicine materials, and other areas will become its new directions for development.The company's related financing plans are also about to be launched.。
As a veteran who began his career as a clinician and has been focusing on the cell therapy industry since 2008,Chen Xiaobo believes that to run a successful cell therapy company, technology, R&D capabilities, quality control, and integrity are all indispensable.。
Cellular products are directly linked to human life and health; therefore, technology constitutes the core lifeline of cell therapy companies, determining their ability to establish a market presence. R&D capability serves as the driving force behind corporate growth, influencing the potential for sustainable development.
Quality management is intrinsically linked to production technology and processes. Given the short shelf life of cell-based products and the insufficient time available for standardized testing, comprehensive monitoring throughout the entire production process is essential to ensure product quality. Furthermore, integrity is the key factor enabling enterprises to achieve long-term sustainability in the life and health industry, where regulatory policies are still being refined.
“The cell therapy industry is still in its early stages of development; in addition to the proactive efforts of enterprises themselves, the improvement and standardization of policies are also crucial.”In Chen Xiaobo's view,For specialized pharmaceuticals such as cell-based therapies, tiered management is the most ideal approach.. Adhering to the principle of minimal intervention, drugs are graded based on factors such as cell type, process requirements, and risk level, and differentiated management plans are formulated for each grade to mitigate the impact of heterogeneity among cell-based therapies.
Currently, domestic policies in China are primarily based on a drug-based management model, which is relatively suitable for CAR-T therapies, butFor cell-based therapies with established safety profiles and confirmed efficacy, technical-level regulation is more appropriate.It is advisable to initiate pilot programs in Free Trade Zones and High-Tech Industrial Development Zones, gradually liberalizing regulations while accumulating experience through continuous experimentation, so as to adapt to the increasingly diverse new technologies, new products, and new disease areas emerging in the cell therapy industry.
Generally speaking, the stricter the policies, the higher the drug costs; the “principle of minimal intervention” helps formulate moderately regulated policy frameworks. On the other hand, there is significant potential for domestic substitution in supporting equipment, reagents, and consumables within the cell therapy industry, which represents one viable approach to cost reduction.Simultaneously leveraging policy support and domestic substitution to reduce the cost of cell-based products is the pathway to achieving widespread accessibility of cell therapies in the future.
Cell-based therapies have vast potential for development, and when combined with other treatment modalities such as gene therapy, they hold promise for providing solutions to the majority of known diseases.With a clear understanding of the cell industry and thorough consideration of its future development, YouSai Life is poised to align its growth with industry trends, upholding the principles of solidity, advancement, integrity, and innovation.