Stem Cells and CAR-T Cell Therapy: Emufeng Biotechnology Pursues Hong Kong IPO to Advance Solid Tumor Treatments

Emufeng Biotechnology files for a Hong Kong IPO to advance CAR-T and stem cells-based therapies for solid tumors, including a Phase III candidate targeting gastric cancer.

Emufeng Biotechnology Files for Hong Kong IPO to Advance CAR-T and Stem Cell-Derived Cell Therapies for Solid Tumors

What does it take to translate advanced cell therapy research — including innovations that build on decades of stem cells science — into accessible, scalable cancer treatments? For Shenzhen Emufeng Biotechnology Co., Ltd., the answer may lie in accessing public capital markets. In February 2026, the company formally submitted a listing application to the Main Board of the Hong Kong Stock Exchange (HKEX), marking a significant milestone in its transition from a clinical-stage research organization to a commercial-ready entity in the global oncology landscape.

With a post-investment valuation of approximately RMB 2.075 billion (roughly USD 285 million), Emufeng Biotechnology is positioning itself as a competitive participant in the rapidly evolving field of CAR-T (Chimeric Antigen Receptor T-cell) therapy — a class of advanced cell therapies that shares conceptual foundations with broader stem cells research in immune system reprogramming. Huatai International is serving as the sole sponsor for the listing.

Company Background and Founding Mission

Emufeng Biotechnology was established in 2020 and is headquartered in Shenzhen, China. According to its prospectus filed with the HKEX, the company describes itself as an innovative cell therapy developer with a primary focus on extending the clinical utility of CAR-T therapies beyond hematologic cancers into the significantly more challenging domain of solid tumors.

The company’s founding premise addresses one of the most persistent limitations in cellular immunotherapy: while CAR-T products have achieved notable results in blood-based cancers such as leukemia and lymphoma, their effectiveness against solid tumors has historically been constrained by a complex immunosuppressive microenvironment, poor T-cell infiltration, and antigen heterogeneity. Emufeng Biotechnology’s pipeline and platform technologies are specifically designed to confront these obstacles.

The company’s broader research framework also incorporates investigational work in in vivo CAR-T delivery — a frontier area of cell therapy that draws on gene delivery principles closely related to advanced stem cells and gene therapy research. This positions Emufeng at the intersection of multiple cutting-edge disciplines within regenerative medicine and oncology.

Core Pipeline: IMC002 and IMC001

IMC002 — Anti-CLDN18.2 CAR-T Cell Therapy (Phase III)

Emufeng Biotechnology’s lead asset, IMC002, is an autologous CAR-T cell therapy candidate designed to target Claudin 18.2 (CLDN18.2), a tight junction protein that is overexpressed in gastric, gastroesophageal junction, and pancreatic cancers. CLDN18.2 has attracted considerable attention in oncology drug development as a therapeutically actionable target due to its highly restricted expression in normal tissue and its upregulation in specific solid tumor types.

IMC002 is currently enrolled in a pivotal Phase III clinical trial in China, investigating its efficacy and safety in patients with CLDN18.2-positive advanced gastric cancer (GC) and gastroesophageal junction (GEJ) adenocarcinoma. The company reports that IMC002 ranks second globally in terms of clinical advancement among CAR-T cell therapy candidates targeting solid tumors, a positioning that reflects the product’s maturity within an extremely competitive and technically demanding development space.

The company has emphasized that IMC002 offers meaningful differentiation across several dimensions: clinical efficacy data from early-stage trials, a manageable safety profile, consistent manufacturing quality, and a production cost structure that may allow for broader patient accessibility compared to first-generation CAR-T products.

IMC001 — Anti-EpCAM CAR-T Cell Therapy (Phase I/IIa)

The company’s second clinical candidate, IMC001, targets the Epithelial Cell Adhesion Molecule (EpCAM), a surface antigen widely expressed across a broad spectrum of solid epithelial tumors. EpCAM’s near-universal expression in epithelial cancers makes it a strategically valuable target for a multi-indication cell therapy program.

IMC001 is currently in a Phase I/IIa clinical trial in China for patients with EpCAM-positive solid tumors spanning multiple epithelial cancer types, including gastric cancer, pancreatic cancer, colorectal cancer, ovarian cancer, and breast cancer. A notable feature of IMC001’s design is its purported ability to target not only the primary tumor mass but also metastatic lesions and circulating tumor cells — a capability that, if validated in later-phase trials, would represent a meaningful advancement in the systemic treatment of disseminated epithelial malignancies.

The iMAGIC Platform: In Vivo CAR-T and Next-Generation Cell Engineering

Beyond its autologous, ex vivo cell therapy candidates, Emufeng Biotechnology has developed a proprietary in vivo CAR-T platform designated iMAGIC (In vivo Modification and Gene-editing for Adoptive Cell Immunotherapy, or similar nomenclature as disclosed). This platform represents a conceptual evolution from traditional CAR-T manufacturing, in which T cells are extracted from a patient, genetically modified in a laboratory setting, expanded, and reinfused — a process that is resource-intensive, time-consuming, and difficult to scale.

The iMAGIC platform instead aims to deliver gene-editing constructs directly into the patient’s bloodstream or tissues, enabling the reprogramming of endogenous T cells — and in some formulations, hematopoietic stem cells and progenitor cells that share characteristics with broader stem cells populations — without the need for ex vivo cell manipulation. This approach has the potential to reduce manufacturing complexity, lower costs, and improve the accessibility of cell-based immunotherapy.

Three investigational candidates have been incubated within the iMAGIC platform:

IMV101 is being developed for both hematologic malignancies and autoimmune diseases. The dual indication reflects growing scientific interest in the application of CAR-T and related cell therapies — originally developed for oncology — to immune-mediated conditions such as systemic lupus erythematosus and other refractory autoimmune disorders.

IMV102 targets hematologic malignancies and is positioned as a complementary in vivo asset to the company’s existing ex vivo pipeline.

IMV103 is designed for the treatment of solid tumors, extending the iMAGIC platform’s potential into the same clinical territory addressed by IMC001 and IMC002, albeit through an entirely different delivery mechanism.

According to the prospectus, some of these candidates are already participating in investigator-initiated clinical trials in China, while others are expected to enter trials in the first half of 2026.

Financial Overview

Revenue and Other Income

Emufeng Biotechnology, as a pre-commercial clinical-stage entity, does not yet generate product revenue. The company’s income to date consists primarily of government grants, subsidies, and other ancillary gains. Reported figures are as follows:

For the full fiscal year 2024, the company recorded other income and gains of approximately RMB 3.36 million. For the nine months ended September 30, 2024, the corresponding figure was approximately RMB 2.137 million. For the nine months ended September 30, 2025, other income and gains totaled approximately RMB 2.877 million.

Research and Development Expenditure

Research and development spending reflects the company’s stage of development and its investment in multiple concurrent clinical programs. For the full fiscal year 2024, R&D expenditure totaled approximately RMB 54.44 million. For the nine months ended September 30, 2024, R&D expenditure was approximately RMB 38.574 million. For the nine months ended September 30, 2025, this figure reached approximately RMB 48.694 million — indicating an accelerating rate of clinical investment as the company advances its lead programs toward later-stage trials and prepares for potential commercialization.

The substantial proportion of expenditure allocated to R&D, relative to the company’s current income base, is consistent with the financial profile of other clinical-stage biotechnology companies pursuing complex cell and gene therapy programs globally.

Market Context: Global and Regional Oncology Landscape

The Evolving Potential of CAR-T and Cell-Based Therapies

CAR-T cell therapy has undergone significant evolution since the approval of the first commercial products for hematologic cancers. Researchers and developers are now actively pursuing strategies to extend its reach into solid tumors and autoimmune diseases — domains where the unmet medical need remains substantial and where conventional treatment options often fall short.

This expansion is being enabled by several parallel advances: improvements in CAR construct design, including next-generation architectures that incorporate advanced gene editing tools; the development of in vivo delivery systems using both viral and non-viral vectors; and the integration of multi-target strategies and molecular safety switches intended to improve both efficacy and tolerability. Collectively, these innovations are reshaping what cell therapy — including therapies grounded in stem cells and T-cell biology — may be capable of achieving across a wide range of disease indications.

Gastric Cancer Incidence: A Significant Clinical Opportunity

Gastric cancer represents one of the primary target indications for Emufeng Biotechnology’s lead asset, IMC002, and its clinical importance is underscored by epidemiological data included in the company’s prospectus.

Globally, the annual incidence of gastric cancer is projected to increase from approximately 893,600 new cases in 2019 to approximately 1,017,400 in 2024, representing a compound annual growth rate (CAGR) of 2.6%. Projections indicate continued growth, reaching approximately 1,194,700 new cases annually by 2030 (CAGR of 3.2% from 2024 to 2030) and approximately 1,361,600 new cases by 2035 (CAGR of 3.1% from 2030 to 2035).

In China, which accounts for a disproportionately large share of the global gastric cancer burden, annual incidence rose from approximately 329,700 cases in 2019 to approximately 376,100 cases in 2024, reflecting a CAGR of 2.7%. The figure is projected to reach approximately 419,100 by 2030 (CAGR of 1.8% from 2024 to 2030) and approximately 456,200 by 2035 (CAGR of 1.7% from 2030 to 2035). These projections are consistent with data from major international oncology epidemiology sources and reflect an aging global population alongside regional dietary and environmental risk factors.

The scale of unmet need in gastric cancer — particularly in advanced and metastatic settings where current standard-of-care options offer limited durable response rates — underscores the clinical rationale for continued investment in targeted cell therapy approaches such as CLDN18.2-directed CAR-T.

Regulatory and Clinical Development Pathway

Emufeng Biotechnology’s clinical programs are currently operating within the regulatory framework administered by China’s National Medical Products Administration (NMPA), which oversees the conduct of clinical trials and the eventual approval pathway for cell therapy products in mainland China. The Phase III trial of IMC002 represents a pivotal study designed to generate the efficacy and safety data required to support a future marketing authorization application.

The company’s Hong Kong listing, while primarily a capital markets event, also signals alignment with the HKEX’s Chapter 18A framework for pre-revenue biotech companies, which was introduced to facilitate listings by clinical-stage life sciences companies that have not yet achieved profitability. This framework has been used by numerous cell therapy, gene therapy, and stem cells-adjacent biotechnology companies seeking access to Hong Kong’s capital markets.

Internationally, the development of autologous and allogeneic CAR-T cell therapies for solid tumors is subject to varying regulatory pathways. In the United States, such products are regulated as biological drugs by the FDA’s Center for Biologics Evaluation and Research (CBER), often via the Breakthrough Therapy designation and Biologics License Application (BLA) pathway. In the European Union, advanced therapy medicinal products (ATMPs) — including CAR-T therapies and stem cells-based therapeutics — are regulated by the European Medicines Agency (EMA) under the ATMP Regulation. The degree to which Emufeng Biotechnology may pursue international regulatory submissions beyond China will depend on data outcomes from its ongoing clinical programs.

Strategic Positioning and Capital Allocation

The HKEX listing application represents Emufeng Biotechnology’s primary mechanism for raising capital to fund the continued advancement of its clinical pipeline, scale up its proprietary manufacturing infrastructure, and support regulatory activities associated with eventual commercialization. The company has highlighted its proprietary ex vivo manufacturing process as a potential source of competitive cost advantage, which — if reproducible at commercial scale — could differentiate its products in markets where the high cost of cell therapy manufacturing has historically limited patient access.

The dual-platform strategy, combining ex vivo CAR-T (IMC001 and IMC002) with the iMAGIC in vivo platform, reflects a broader industry trend toward building diversified cell therapy portfolios capable of addressing both near-term clinical opportunities and longer-term platform value. This approach mirrors that of several international cell therapy developers who have pursued similar strategies in the United States, Europe, and Asia-Pacific markets.

Conclusion

Emufeng Biotechnology’s application to list on the Hong Kong Stock Exchange Main Board reflects the maturation of China’s cell therapy sector and its increasing integration into global biomedical research and capital markets. With a lead Phase III asset in IMC002, a multi-indication Phase I/IIa program in IMC001, and an early-stage in vivo platform in iMAGIC, the company’s portfolio spans multiple stages of clinical development and therapeutic application.

The scientific foundations underpinning these programs — encompassing CAR-T cell engineering, targeted gene delivery, and cellular immunology concepts that intersect with stem cells and hematopoietic biology — place Emufeng Biotechnology within one of the most technically sophisticated and closely scrutinized sectors in contemporary biomedical research. Whether the IPO proceeds and how the clinical data matures will be closely observed by patients, clinicians, investors, and regulatory agencies worldwide.

This article is based on publicly available information from Emufeng Biotechnology’s HKEX listing application disclosure as reported in February 2026. It is intended for informational purposes only and does not constitute financial, investment, or medical advice.