As a landmark achievement in the development of China's cell therapy industry, the approval of Ruibosheng (Aimimaituo Injection) is essentially the inevitable outcome of the long-term resonance of technological accumulation, capital support, policy guidance, and clinical demand. It has fully validated a feasible pathway for successfully commercializing stem cell therapy products from early R&D to the market in China.

As early as 2013, Ruibosheng, as one of the first stem cell therapies to submit clinical trial applications via the drug regulatory pathway, took the lead amid an unclear industry regulatory framework. By 2020, its Phase II clinical trial demonstrated positive efficacy signals, preliminarily verifying the product's value. Its Phase III clinical trial was completed in 2024, with results showing that Ruibosheng achieved positive efficacy and favorable tolerability in treating steroid-refractory acute gastrointestinal graft-versus-host disease (aGVHD), with a key endpoint of 63.0% overall response rate at Day 28. This process relied on over a decade of persistent key technological breakthroughs—especially the innovative production process based on the immunomodulatory mechanism of mesenchymal stem cells (MSCs), such as the large-scale 3D microcarrier culture system, which effectively overcame bottlenecks in efficiency, cost, and quality control in traditional production.

More crucially, a series of top-level design policies encouraging the development of the bioeconomy and innovative drugs during China's 13th and 14th Five-Year Plan periods provided increasingly clear regulatory support for the clinical research, registration, and production supervision of stem cell drugs. Riding this momentum, Ruibosheng successfully obtained China's first "Drug Production License" for stem cells in 2024 and was conditionally approved for marketing via the priority review procedure in January 2025, for the treatment of steroid-refractory aGVHD—a condition with urgent clinical needs and limited effective therapies.

On the market side, Ruibosheng demonstrated strong industrial implementation capabilities, achieving dual breakthroughs in payment and pricing: on one hand, the drug was included in the special drug list of the government-guided "Beijing Inclusive Health Insurance" in 2025, with insured patients eligible for up to 65% reimbursement. This marks the first time the clinical value of stem cell therapy has been officially endorsed by a provincial inclusive insurance program, setting a replicable model for future integration into broader payment systems. More strategically significant is its disruptive pricing—domestic treatment costs approximately 19,800 RMB per dose, only 1/70 of the comparable U.S. product Ryoncil (around 1.39 million RMB per dose).

This price gap is not merely a market concession; its fundamental support lies in China's scarce full-industry-chain independent and controllable advantages: from domestic substitution of upstream core raw materials, to large-scale cost reduction in the midstream based on automated 3D microcarrier culture systems (unit cost reduced by over 60%), and to closed-loop management of production, quality control, and logistics downstream, completely avoiding high overseas CDMO outsourcing fees and supply chain risks. This complete industrial capability enables it to maintain reasonable profits while possessing tremendous price competitiveness and market penetration flexibility.

The approval of China's first stem cell drug not only signifies the formation of a complete industrial closed loop from IND application, clinical validation, and GMP production to final approval but also marks the official entry of China's cell therapy industry into the first year of integrated "R&D, production, and sales." It has established a clear and replicable "standard paradigm" for the entire industry.

Stem cells are cells capable of self-renewal and differentiation. Stem cell technology is widely applied in clinical research and trials. Hematopoietic stem cell transplantation has long been a major therapeutic approach for patients with malignant hematological tumors. Additionally, induced pluripotent stem cells (iPSCs), discovered in 2006, have been proven to repair the retina and blood vessels in mice, opening a unique niche in the cell replacement therapy market. The mechanism of action of stem cell therapy is complex and diverse, with its core lying in the homing, differentiation, and immunomodulatory capabilities of stem cells:

• Stem cells differentiate into various cell lineages to replace damaged cells and tissues;
• Stem cells regulate or secrete cytokines via their potent immunomodulatory function to suppress excessive immune responses;
• Stem cell paracrine therapy reduces inflammation and promotes cell proliferation by secreting various proteins, enzymes, and factors, exerting immunomodulatory, angiogenic, and anti-apoptotic effects;
• Through direct cell-cell interactions, stem cells modulate immunity and promote cell or tissue repair, or transfer mitochondria to damaged cells via tunneling nanotubes (TNTs).

This multi-target, systemic mode of action enables stem cell therapy to intervene in a wide range of diseases, including neurological, circulatory, skeletal, cardiovascular, and autoimmune diseases. Its core advantage is intervening in disease progression at the "root cause" level, upgrading the therapeutic strategy from traditional "external intervention" to activating the body's own "regenerative and regulatory system." For example, autologous iPSCs can be infinitely differentiated into various functional cells in vitro, providing patients with individualized, immune-rejection-free therapeutic "seeds," thus offering a promising one-time treatment option for numerous chronic, degenerative, and tissue injury diseases with limited effective therapies.

Substantial progress has been made in the commercialization of stem cell therapy. Benefiting from policy advantages, South Korea and Japan have approved multiple stem cell drugs by December 2025: South Korea has approved products for amyotrophic lateral sclerosis, knee osteoarthritis, Crohn's disease fistula, and acute myocardial infarction; Japan has approved products for autism spectrum disorder, traumatic brain injury, complex anal fistula, and spinal cord injury. In 2024, the U.S. approved RYONCIL, the first bone marrow-derived stem cell drug for pediatric steroid-refractory aGVHD. Shortly after, China's allogeneic umbilical cord-derived stem cell drug "Ruibosheng" was approved for the same indication. This not only means that major global markets have opened up complete marketing pathways for stem cell drugs but also marks that China's R&D and registration capabilities for top-tier stem cell drugs have aligned with international frontiers.

Sources: U.S. FDA, European EMA, China NMPA, Japan PMDA, South Korea MFDS, Sullivan Analysis

The core mechanism of immune cell therapy is to endow or enhance immune cells with the ability to specifically recognize and kill target cells through genetic engineering and cell expansion technologies. Its technical pathways are mainly divided into two categories: the ex vivo pathway, which involves isolating, modifying, expanding, and reinfusing cells (e.g., CAR-T, TIL, and NK cell therapies); and the in vivo pathway, which directly modifies immune cells in the body via delivery systems (e.g., in vivo CAR-T). Immune cell therapy can treat a variety of diseases including tumors, autoimmune diseases, and infectious diseases, making it a highly promising therapeutic approach.

The outstanding advantages of immune cell therapy lie in its high targeting, long-term efficacy, and customizable design. Compared with traditional radiotherapy, chemotherapy, and targeted drugs, cell therapy can break through the limitations of the immunosuppressive tumor microenvironment, achieve precise "living cell drug" delivery, and some modified immune cells (e.g., memory T cells) can survive long-term in the body, forming persistent immune surveillance and protection.

Immune cell therapy represented by CAR-T has demonstrated a commercial paradigm of "target-focused, rapid iteration." Since the global launch of the first CD19-targeted CAR-T product in 2017, therapies targeting CD19 and BCMA have reshaped the treatment standards for hematological tumors. More strategically significant is the rise of the Chinese market: following the approval of the first domestic CAR-T product in 2021, over 8 products have been launched within four years, covering CD19 and BCMA targets. This proves that China has fully mastered the complete industrialization system from process development and GMP production to quality control. On the other hand, the accelerated launch speed (with new products still entering the market in 2025) reflects a systematic improvement in local R&D efficiency and clinical advancement capabilities, marking that China has transitioned from "technology introduction" to a new stage of "original innovation and rapid productization" in this field.

Sources: U.S. FDA, European EMA, China NMPA, Sullivan Analysis

R&D in stem cell and immune cell therapy continues to accelerate, with the scope of indications rapidly expanding beyond currently approved areas to cover a broader range of diseases.

Both the regulatory breakthroughs of stem cell therapy in the Chinese and U.S. markets and the continuous increase in marketed CAR-T products constitute conclusive industrial evidence: the cell therapy field has systematically crossed the stage dominated by basic research and early clinical exploration, and successfully established a complete industrial paradigm covering target discovery, process development, rigorous clinical validation, internationally compliant registration, and large-scale commercial production. This paradigm has been jointly recognized by major global drug regulatory authorities including the U.S. FDA, China NMPA, Japan PMDA, and European EMA.

There are over 1,000 clinical-stage research projects in the global cell therapy pipeline. In terms of clinical phase distribution, Phase I projects account for as high as 52.5%, indicating that the cell therapy field remains in an active stage of rapid technological iteration and therapeutic concept validation, with numerous innovative projects transitioning from the laboratory to the clinic. Meanwhile, over 5% of projects have advanced to Phase III and Phase II/III, with expectations of approval in the near future.

From the perspective of indication layout, R&D focus in cell therapy is shifting from traditional hematological tumors to broader therapeutic areas such as solid tumors and autoimmune diseases. The R&D pipeline is highly concentrated on major, unmet clinical needs with heavy disease burdens and limited efficacy of traditional therapies, such as autoimmune diseases (e.g., systemic lupus erythematosus), respiratory diseases (e.g., chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis), and neurological diseases. These areas share complex pathological mechanisms, often involving immune system dysregulation, chronic inflammation, irreversible tissue damage, or impaired repair and regeneration, while existing treatments are mostly limited to symptom control or single-target inhibition, failing to fundamentally alter disease progression.

Cell therapy, especially stem cell and immune cell therapies, offers a novel intervention logic beyond traditional drugs by virtue of its unique living cell properties: intervening directly in the root pathophysiological processes of diseases through comprehensive mechanisms such as multi-target, systemic immunomodulation, cytotoxicity, anti-inflammation, anti-fibrosis, neurotrophic support, and even structural tissue repair.

With the continuous improvement of the global regulatory science framework and the pathway validation provided by the successful launch of the first batch of products under rigorous review, the deepening of cell therapy in these core indication areas not only foreshadows the innovation of the future therapeutic landscape but also marks the accelerated maturation of a high-value industrial ecosystem driven by solving substantive clinical problems.

After an early period of free development, China's cell therapy industry has, since around 2015, entered a new stage of "scientific liberalization" centered on clinical value with the increasingly clear and robust national regulatory framework, successfully driving a profound industrial purification and comprehensive upgrading.

The regulatory history of China's cell therapy has undergone four evolutionary stages: before 2015, it was a period of loose regulation, with cell therapy coexisting under both medical technology and drug pathways, leading to free but non-standard industry development; 2015-2016 marked a strict adjustment phase, with the state tightening supervision via the Administrative Measures for Clinical Research of Stem Cells (Trial) and special inspections, suspending unapproved clinical applications of Class III medical technologies; 2017 shifted to a standardized guidance stage, with the Guiding Principles for Research and Evaluation of Cell Therapy Products clarifying their drug attributes and establishing a research filing system; after 2020, it entered a standardized development phase, with accelerated product R&D under a "quasi-dual-track system" framework, continuous improvement of the policy system, and support from national 14th Five-Year Plan special programs and local industrial policies, ultimately forming a development path from loose exploration to strict rectification, and then to institutionalized guidance and innovation-driven growth.

A series of landmark policy documents have been successively issued, marking that China's cell therapy regulatory framework has completed a critical transition from the early exploratory stage to standardized, high-quality development.

Source: Sullivan Analysis

Among them, Document No. 818 has systematically constructed a full-chain regulatory framework, with its core content focusing on three key dimensions: clinical research filing system, translational application approval pathways, and research institution qualifications. By establishing a clear "filing-research-approval" pathway and strict qualification requirements, Document No. 818 encourages compliant innovation while systematically raising industry thresholds.

For research institutions and enterprises, the policies provide a clear translational pathway while requiring solid preclinical research and strict adherence to ethical norms, with simultaneous increases in compliance costs and requirements. The regulations' emphasis on full-process compliance has directly spawned and expanded market demand for specialized R&D outsourcing, production quality control, and third-party testing services. For medical institutions, the policies focus clinical research qualifications on high-level tertiary hospitals. For patients and subjects, the policies protect subject rights while laying an institutional foundation for patients to access safe and effective advanced therapies earlier in the future.

These policies have provided full-chain, systematic regulation from strategic guidance and production quality control to clinical translation, accelerating the industry's professional integration and standardization process. They have thus delineated a clear development track for enterprises with genuine technological strength, quality management systems, and compliant operational capabilities, driving the entire industry from early exploration to a new stage of high-quality, sustainable development.

The intensive introduction of characteristic, refined local policies across provinces and cities is becoming a key accelerator driving cell therapy from the laboratory to the market.

Institutional Innovation and Pilot Implementation: Amid the accelerated layout of the cell therapy industry, various regions are actively exploring optimal pathways for R&D and translation based on differentiated regional policies and functional positioning. Since the State Council issued Document No. 818, explicitly supporting the clinical translation of new biomedical technologies, local governments have responded positively to the national strategy, successively introducing supportive policies with local characteristics, forming a "policy relay" to promote the development of the cell and gene therapy industry. In this wave of favorable policies, Tianjin, Chongqing, Xiamen, and the three provinces and one municipality in the Yangtze River Delta (Shanghai, Jiangsu, Zhejiang, Anhui) have taken particularly notable actions.

Source: Sullivan Analysis

Within this policy layout, the Classified and Graded Standards for Clinical Research and Translational Application of New Gene and Cell Therapy Technologies (Trial) issued by the Tianjin Free Trade Zone in November 2025 is particularly breakthrough and representative. As one of the first industrial practice norms formulated by local governments following Document No. 818, this measure innovatively established a scientific regulatory system of "risk classification, access categorization." Through precise division into high, medium, and low risk levels, it created a differentiated, dynamically adjustable regulatory framework that not only builds a safety bottom line for high-risk technologies but also opens an accelerated channel for mature technologies. This "Tianjin Model" has not only injected strong impetus into local industrial development but also provided a replicable, promotable regulatory paradigm for the whole country, reflecting local governments' determination and wisdom in responding to national calls and leading industrial development through institutional innovation.

Local Legislative Empowerment: Inland regions such as Hunan, Sichuan, and Chongqing have begun local legislation, taking the lead in promoting the establishment of a cell therapy R&D system and laying the foundation for building a full industrial ecosystem for cell therapy. By clarifying rights and responsibilities and stabilizing expectations for the cell therapy industry through local legislation, they have not only initially established an R&D system but, more importantly, provided institutional guarantees and an innovative environment for building a complete industrial ecosystem.

The cell therapy industry chain has formed a basic pattern of integrated upstream and downstream sectors with accelerated midstream development: upstream core equipment and high-value consumables are still dominated by imports, with supply chain security and domestic substitution as the cornerstones of industrial autonomy; midstream R&D and production enterprises have become the core driving force of the industry, with the number of IND approvals, clinical trial scale, and capital market enthusiasm continuing to rise, demonstrating strong innovative vitality; downstream applications are highly concentrated in high-level medical institutions, whose clinical capabilities and diagnosis and treatment norms are key interfaces for product value realization. Under this development pattern, industrial value is rapidly concentrating on platform-based enterprises with both core technological autonomy and large-scale service capabilities. These enterprises are reshaping the industrial chain ecosystem through one-stop solutions and leading the industry toward a standardized, large-scale, and sustainable commercialization stage.

Figure: China's Cell Therapy Industry Chain

Source: Sullivan Analysis

Challenges Faced by Industrial Chain Segments:

• Drug Registration: As "living" therapeutic entities, cells exhibit complex, non-linear correlations between production processes and critical quality attributes (CQAs) of the final product, leading to a significant "black box" effect in process development and scale-up. Registration requires extremely detailed chemistry, manufacturing, and controls (CMC) research data to demonstrate process robustness and batch-to-batch consistency. On the other hand, regulatory authorities adopt a prudent "risk-benefit" principle for such cutting-edge therapies, setting evidence standards for safety (e.g., tumorigenicity, immunogenicity, unintended differentiation) and efficacy (requiring in vitro potency assay methods correlated with clinical endpoints) far higher than those for traditional drugs.
• Process Standardization and Large-Scale Quality Control: Variations in donor sources and process methods lead to batch-to-batch heterogeneity in product potency and phenotype. Additionally, the cell product manufacturing process involves multiple steps including cell culture, activation, transduction, purification, and enrichment, all posing challenges to process standardization and large-scale quality control.
• Stringent Quality Control Requirements: Quality control throughout production, including aseptic operation, purity, and safety of preparation outcomes, critically impacts the efficacy of final products. Its stringency far exceeds that of traditional drugs, as the efficacy and safety of "living cell" drugs are highly dependent on precise control of the entire production process—from aseptic operation of starting materials and maintenance of purity during culture to safety testing of final products (e.g., sterility, mycoplasma, endotoxin, and abnormal immunogenicity). Any minor deviation in any link may directly lead to product failure or clinical risks.

Huayu Bio is a high-tech enterprise focused on the cell therapy field. The company has established 16 cell resource centers nationwide, building a complete industrial chain from cell resource storage to drug R&D and production, driven by the dual wheels of a CDMO platform and a commercial diagnosis and treatment platform. Its full-industry-chain business model can simultaneously serve the clinical translation of "medical technologies" and the R&D and marketing of "cell drugs."

The company has laid out and constructed its core barrier—a functional seed source screening system. This system integrates multidisciplinary technologies such as multi-parameter screening, high-throughput data analysis, and in vitro/in vivo functional validation to conduct precise functional screening and optimization from the cell source, ensuring the acquisition of high-quality stem cells with clear therapeutic potential. This not only significantly improves the efficiency and stability of subsequent process development but also strengthens the therapeutic targeting and clinical translation success rate of products at the most fundamental seed source level, laying a solid foundation for value realization across the entire industrial chain.

Huayu's independently developed series of key reagents for cell processes feature chemically defined compositions and excellent, stable performance, significantly enhancing the efficiency, functionality, and safety of cell preparation, and helping customers achieve stable, efficient, and cost-controllable cell drug production.

The independently developed NK kit breaks through the limitations of traditional serum-containing formulations, adopting a chemically defined, serum-free, feeder-free culture system. Through precise regulation of cytokine ratios, it increases the in vitro activation and expansion efficiency of NK cells by over 40% compared to similar kits on the market, avoids cell function fluctuations caused by batch differences, and stably maintains NK cell cytotoxicity at over 95%.

The independently developed NK cryopreservation medium achieves a survival rate of over 90% for NK cells after cryopreservation and resuscitation under conventional -80°C freezing or liquid nitrogen cryopreservation conditions. It effectively protects the integrity of functional receptors such as CD56 and NKG2D on the NK cell surface, with a cytotoxicity retention rate of over 90% after resuscitation, solving the pain points of existing domestic products ("survivable but functionally weak") and imported products ("excellent function but high cost and unstable supply chain").

The independently developed hematopoietic stem cell cryopreservation medium, with core advantages of optimized formulations and processes, ensures high cell resuscitation rate and functional activity while significantly improving the safety and convenience of clinical application. Adopting pharmaceutical-grade, animal-derived component-free, low-toxicity formulations, it supports high-density cryopreservation and achieves a cell resuscitation viability rate of over 90%, effectively maintaining the proliferation capacity and biological characteristics of stem cells after resuscitation.

I. Ultra-High-Purity Immune Cell Preparation

Huayu's independently developed NK cell culture and cryopreservation technology can obtain high-purity, high-expansion NK cells in a short time, achieving an NK cell ratio of >95%, an expansion fold of over 5,000, and a viability rate of over 90% after cryopreservation and resuscitation—far exceeding industry levels, representing a key technological innovation in the NK cell storage field. Unlike methods using apoptotic cancer cell line K562 (feeder cells) to induce NK cells, Huayu uses recombinant growth factors for cell expansion, with all components known and high safety. This has significantly improved NK cell purity and expansion rate, while achieving near 100% in vitro tumor killing effect with strong tumor cytotoxicity and high cell therapeutic efficacy. Two invention patents have been authorized: Culture Medium Composition and Culture Method Suitable for NK Cells (ZL 202211004571.3) and Method for Cryopreserving NK Cells (ZL 202211318311.3).

II. iPSC Preparation Technology

Huayu has developed iPSC preparation processes from peripheral blood and fibroblasts, breaking through the technical limitations of traditional viral vectors and developing a non-integrating (LNP+mRNA) reprogramming system to improve reprogramming efficiency and safety. It has carried out multi-dimensional quality testing and established full-process standards covering donor screening to cryopreservation, complying with clinical-grade requirements.

III. Stem Cell Exosome Isolation and Purification

Huayu has laid out the exosome production and application transformation field, developing an efficient exosome isolation and purification method that meets exosome identification standards after verification via electron microscopy imaging, particle size distribution, and particle concentration analysis. An invention patent Method for Enriching Exosomes and Conjugates Used in the Method has been filed and is currently under substantive examination. Among them, iPSC-derived exosomes can effectively improve neurological function through multiple mechanisms such as regulating neuroinflammation, promoting angiogenesis, reducing cell apoptosis, and enhancing endogenous neurogenesis, while avoiding risks associated with living cell implantation.

Huayu's pharmaceutical-grade quality control standards and intelligent process control together form its industry-leading quality moat. As one of the industry standard setters, the company has established a rigorous quality inspection system and standards covering the entire cell life cycle (from proliferation capacity and immunomodulation to tumorigenicity testing). Its umbilical cord mesenchymal stem cell products with high immunomodulatory activity have obtained three batches of quality review reports from the National Institutes for Food and Drug Control (NIFDC), marking that its quality system meets high standards in terms of safety and efficacy. Through an independently developed intelligent control platform integrating a LIMS system, unmanned AGV operation, and full-process GPS traceability, Huayu has achieved a full-chain data closed loop and quality traceability from cell preparation to storage, implementing the concept of "quality by design" in every link. This provides solid guarantees for batch consistency of cell products, safety of clinical translation, and stability of large-scale application.

Huayu's CDMO platform has built a one-stop service system supported by six core capabilities around the full-cycle development of cell therapy products. Based on professional R&D and compliant production facilities, the platform provides customers with full-chain integrated solutions from early process development and clinical production to final registration through a standardized quality management system, proven practical registration experience, and an extensive market cooperation network.

Sources: Company Data, Sullivan Analysis

Huayu has carried out a systematic pipeline layout around major unmet clinical needs. Its stem cell therapies are being developed for multiple indications including knee osteoarthritis, renal injury, COPD, pulmonary fibrosis, GVHD, neurological diseases, and SLE; while its immune cell therapies focus on tackling solid tumors, a key therapeutic frontier, driving the systematic development and maturation of its cell therapy platform from multiple dimensions including technology, pipeline, and clinical value.

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive interstitial lung disease of unknown etiology, clinically characterized by dyspnea and continuous decline in lung function. The disease has high disability and mortality rates, with a global prevalence of approximately 35.1 per 100,000 people and an increasing incidence of approximately 11.2 per 100,000 people, leading to a growing disease burden. The core unmet clinical need for IPF is that existing drugs can only limitedly delay lung function decline, neither reversing established pulmonary fibrosis nor alleviating the heavy symptom burden on patients. Therefore, there is an urgent clinical need for novel therapies that can achieve anti-fibrosis, immunomodulation, and tissue repair at the mechanistic level.

Huayu's umbilical cord-derived mesenchymal stem cell therapy for IPF is a cutting-edge exploration addressing this major need. Relying on the multiple potentials of UC-MSCs, the therapy aims to intervene in disease progression by regulating abnormal immune responses, inhibiting fibroblast activation, and promoting alveolar microenvironment repair. The project has currently entered the clinical stage (Clinical Trial Approval Notice No.: 2025LP01967, Clinical Trial Registration No.: CTR20254455).

To improve clinical therapeutic effects, the company has screened cell batches with stronger differentiation and immunomodulatory capabilities based on its seed source screening method, with further screening via detection of relevant cytokine secretion levels. Studies have shown that umbilical cord mesenchymal stem cells alleviate bleomycin-induced pulmonary fibrosis in mice by secreting HGF to activate the PI3K-AKT-mTOR signaling pathway; and IL-10, an anti-inflammatory factor, can reduce inflammatory responses and alleviate pulmonary fibrosis. These two cytokines are selected as screening markers for pulmonary fibrosis.

Finally, two in vitro pulmonary fibrosis models were established—TGFβ1-induced epithelial-mesenchymal transition (EMT) of bronchial epithelial cells and bleomycin-induced bronchial epithelial cell injury—to functionally evaluate the optimal stem cell batches, which were then used as seed sources for animal efficacy and clinical studies. Data show that co-culture of screened stem cells with TGFβ1-induced bronchial epithelial cells significantly increases MMP-7 and CDH1 expression, reduces COL1A1 and Vimentin expression, and inhibits cell migration after EMT, indicating that stem cells exert inhibitory effects on collagen deposition and EMT processes. Meanwhile, co-culture of stem cells with bleomycin-induced bronchial epithelial cells inhibits apoptosis of damaged epithelial cells. These in vitro disease models all demonstrate the anti-fibrotic effects of stem cells.

In addition, an in vivo rat pulmonary fibrosis model was established via intratracheal nebulization of bleomycin. Results showed that different doses of stem cells (low-dose group: 1×10⁶ cells/kg, medium-dose group: 3×10⁶ cells/kg, high-dose group: 1×10⁷ cells/kg) all significantly improved lung function, survival rate, and lung tissue lesion severity, with a certain dose-dependent effect. In vivo and in vitro efficacy evaluations fully demonstrate the effectiveness of seed source-screened stem cell products.

Source: Company Data

Furthermore, Huayu has submitted investigational new drug (IND) applications for pipelines including umbilical cord mesenchymal stem cells for systemic lupus erythematosus and graft-versus-host disease, and infrapatellar fat pad stem cells for knee osteoarthritis. Systemic lupus erythematosus is a complex autoimmune disease involving multiple organs; graft-versus-host disease is a fatal complication after allogeneic hematopoietic stem cell transplantation, with its pathological core lying in the excessive attack of donor immune cells on host tissues. UC-MSCs intervene in the pathological processes of these two indications at the root by migrating to inflammatory sites, secreting bioactive factors, systemically regulating overactivated immune cells, and promoting damaged tissue repair. Knee osteoarthritis is a common chronic degenerative joint disease characterized by articular cartilage degeneration, marginal osteophyte formation, and joint inflammation. Human infrapatellar fat pad stem cells exhibit superior chondrogenic capacity compared to MSCs derived from umbilical cord, bone marrow, and subcutaneous fat. They can also regulate the local microenvironment of damaged tissues and modulate immune inflammatory responses through cell-cell communication, holding potential clinical value in the treatment of knee osteoarthritis.

The cell therapy industry has transitioned from laboratory exploration to a new stage of parallel industrialization and commercialization. Driven by the resonance of continuous technological breakthroughs, clarified regulatory pathways, and validated clinical value, it is becoming a core track for addressing major unmet clinical needs and leading biopharmaceutical innovation. With a closed-loop full-industry-chain layout covering seed source screening, independent raw and auxiliary materials, ultra-pure cell preparation, and CDMO services, Huayu Bio has built platform capabilities with both technological depth and industrial synergy, committed to becoming a key infrastructure provider and enabler supporting China's cell therapy industry from diversified exploration to large-scale commercial application.