ReGen Therapeutics Secures Nearly RMB 100 Million in Pre-A Financing to Advance iPSC-Based Therapies for Neurological Disorders and Tumor Immunotherapy

VCBeat has learned at the earliest opportunity that Guangzhou Ruizhen Regenerative Medicine Technology Co., Ltd. (hereinafter referred to as“Ruizhen Regenerative Medicine”) announced the completion of a financing round led byKejin Holdings, Wanlian Tianze, Jincheng Investmentand originalYesShareholderJoint investment of nearly 100 million yuanPre-Series A Financing.

The proceeds from this financing round will be primarily focused on advancing the iDA-001 pipeline (an iPSC-derived cell therapy for Parkinson’s disease), with the company pursuing a dual-track strategy of filing an Investigational New Drug (IND) application and launching Investigator-Initiated Trials (IITs). For the IND submission, a specialized team will strictly adhere to regulatory requirements to expedite approval for clinical trials. Concurrently, for the IITs, the company will collaborate with senior clinical experts to conduct real-world studies, thoroughly validating the safety and efficacy of iDA-001 in complex clinical settings and systematically accumulating clinical data to accelerate its translational progress.

Meanwhile, the Company will advance process development for iNK001, its investigational natural killer (NK) cell product in the tumor immunotherapy pipeline. By optimizing key manufacturing steps such as cell culture and isolation/purification, the Company aims to enhance the stability and consistency of product production, reduce manufacturing costs, and lay the technical foundation for subsequent commercial scale-up.

Furthermore, targeting Huntington’s disease as a rare disorder, the Company will leverage research data from large-animal models in its iMSN pipeline to conduct non-clinical studies, including in vitro and in vivo pharmacodynamic evaluations, and actively prepare for orphan drug designation applications, with the aim of addressing the unmet therapeutic needs in this rare disease.

RuiZhen Regenerative Medicine, founded in 2019, is dedicated to developing induced pluripotent stem cell (iPSC)-derived, universal, off-the-shelf cell therapy products for the treatment of tumors and neurological diseases. The company has established a comprehensive platform includingiPSC reprogramming and cell banking, technologies for the preparation of immune and neural cell differentiation, and gene-editing techniques for constructing engineered iPSC lines, covering the entire workflow of iPSC-based cell therapy.Applied for nearly 20 related patents, of which 15 have been granted.

Its independently developedThe invention patent for the technology of preparing dopamine precursor cells through differentiation has been granted, making it the first enterprise in China to receive such patent authorization.. The product has completed pharmacodynamic validation studies in primate models of Parkinson's disease, demonstrating ideal therapeutic efficacy, and collaborations for Investigator-Initiated Trial (IIT) clinical research projects are currently being launched.

Furthermore, Ruizhen Regenerative Medicine focuses on the preparation of high-purity induced pluripotent stem cell (iPSC)-derived natural killer cells (iNK) and the development of multi-module NK-enhanced iPSC products, having established a high-purity iNK differentiation technology, andCompleted the First Animal Study of Engineered iNK Cells in China, ADCC-enhanced iNK cells demonstrated potent tumor clearance and recurrence suppression effects, offering a new therapeutic direction for cancer treatment.

Immunofluorescence Staining Results of Dopaminergic Neuron Precursors Derived from hiPSCs

Leveraging its proprietary core iPSC technology platform and underlying technical support, Ruizhen Regenerative Medicine provides one-stop research services to pharmaceutical companies, medical institutions, and scientific research organizations. These services encompass iPSC reprogramming and storage, production of iPSC-derived functional cells, exosomes, and organoids. With significant research value in areas such as disease mechanism studies, drug screening, and exploration of cell therapy approaches, these services systematically empower innovation across the entire biomedical industry chain.

Leveraging the aforementioned core technological advantages, Ruizhen Regenerative Medicine has repeatedly won awards in prestigious industry competitions. In 2024, the company secured First Prize in the Growth Category of the Finals of the 13th China Innovation and Entrepreneurship Competition (Guangdong·Guangzhou Division) and the Guangzhou Science and Technology Innovation and Entrepreneurship Competition; was selected for Deloitte’s “2024 Deloitte Guangzhou High-Tech High-Growth Rising Stars” list; and ranked among the “Top 10 Innovative Enterprises with Investment Value of the Year” by the BiaCon Awards.

Notably, on April 10, 2025, the U.S. FDA announced the phased elimination of animal testing requirements for monoclonal antibodies and other drugs, shifting instead to new technologies such as organoids and organ-on-a-chip systems to assess drug safety and efficacy. This policy marks the entry of drug development into the “post-animal testing era” and provides a clear direction for technological innovation for pharmaceutical companies worldwide.

On the Eve of Industry Transformation, Ruizhen Regenerative Medicine Has Taken the Lead in Completing Its Strategic Layout in the Field of Organoid Technology. It Has Established Significant Competitive Advantages Through Continuous Technological Innovation—

In terms of technological breakthroughs, in April 2024, the company successfully initiated a collaborative regulatory research project with the Greater Bay Area Branch of the National Medical Products Administration (NMPA), based on its project titled “Application of iPSC-Derived Brain Organoids in Non-Clinical Studies of Central Nervous System Drugs.” By leveraging cutting-edge organoid models to optimize the drug development process, the company has filled the technical gap in non-clinical evaluation using iPSC-derived organoid models for central nervous system drugs.

At the level of strategic synergy, Ruizhen Regenerative Medicine achieves deep alignment with FDA policy directions by leveraging organoid models in drug target prediction, response assessment, and microfluidic applications.

Looking ahead, the industrial application of organoid technology will reshape the economic model of drug development. As its technology platform continues to iterate, Ruizhen Regenerative Medicine is poised to deliver more breakthrough therapeutic solutions to patients worldwide, truly realizing a vision of pharmaceutical innovation that is safer, more efficient, and more accessible.

Zhang Yan, Chairman of Kejin HoldingsIt is indicated that with the continuous advancement of innovative technologies in biomedicine, "cell therapy," representing advanced therapies and future industries, has reached a critical stage of clinical translation and application. Over the past two years, Guangzhou Science and Technology Innovation Investment Financial Holdings Ltd. (Kejin Holdings), leveraging its innovative model of "investment + investment banking + trading" and adhering to the value philosophy of "selecting the right tracks, choosing the right teams, and making early-stage investments," has continuously facilitated the aggregation of resources and high-quality development in the cell therapy industry.Ruizhen Regenerative Medicine, a rare iPSC stem cell drug R&D enterprise in Guangzhou and the Guangdong-Hong Kong-Macao Greater Bay Area, boasts a solid foundation in basic scientific research. The company has achieved substantial progress and outstanding results in multiple areas, including drug mechanism exploration, cell process development, and preclinical animal trials. Notably, in the field of Parkinson's disease treatment, it has obtained China's first invention patent authorization for dopamine neuron differentiation technology. This breakthrough is expected to position neural cell replacement therapy as the optimal direction for next-generation Parkinson's treatments, offering patients long-term or lifelong therapeutic benefits. Furthermore, the company has successfully developed multi-gene modified, functionally enhanced iPSC-NK immune cells, targeting solid tumor therapy, which holds significant promise for future drug commercialization and market potential.The successful completion of this financing round will accelerate Ruizhen Regenerative Medicine's product pipeline R&D, including the focused implementation of Investigator-Initiated Trials (IIT) and Good Laboratory Practice (GLP) studies, thereby providing a solid foundation for obtaining clinical research data in the next phase.

Liu Haiyan, Chairman of Wanlian TianzeIt was stated that in the frontier field of iPSC cell therapy, which holds significant strategic value, Ruizhen Regenerative Medicine, as a biomedical innovation enterprise cultivated and grown in Guangzhou, has always adhered to a development philosophy grounded in pragmatism and truth-seeking. The company has continuously deepened its efforts in key areas such as technological R&D and clinical translation, accumulating profound technical expertise. Leveraging its independent intellectual property system, it has completed scientific validation of the entire chain of clinical-grade cell manufacturing processes, thereby establishing a solid industrial foundation and differentiated competitive advantages. As the strategic investor in this round of financing, Wanlian Tianze Capital Investment Co., Ltd. highly recognizes the professional competence and strategic vision demonstrated by the Ruizhen Regenerative Medicine team in cell manufacturing, quality control, and full lifecycle process management. We believe that this round of financing will inject strong momentum into the enterprise, accelerate the clinical translation of its core pipeline, deepen coordinated regional industrial development, and serve as a benchmark for local biomedical innovation, enabling more patients to benefit from more accessible cell therapy solutions.

Guangzhou Science and Technology Innovation Investment Financial Holdings Ltd. (formerly Guangzhou Science and Technology Venture Capital Co., Ltd., hereinafter referred to as “Kejin Holdings”) was established in November 1999 upon approval by the Municipal Government. As a professional equity investment management institution under Guangzhou Fund, it is one of the earliest venture capital firms established in China. With the support of the Guangzhou Municipal Committee and Municipal Government, Guangzhou City Construction Investment Group, and Guangzhou Fund, Kejin Holdings has always adhered to its core competency in hard-core high technologies, deeply cultivating local advantageous industries. It has built an equity investment business chain covering the entire corporate development lifecycle, including angel investment, venture capital (VC), private equity (PE), pre-IPO, and mergers and acquisitions (M&A), thereby fostering the growth and expansion of a large number of high-quality sci-tech innovation enterprises.

Wanlian Tianze is a wholly-owned private equity subsidiary of Wanlian Securities, under the Guangzhou Financial Holdings Group. To date, it has managed 50 fund products with a total committed capital under management reaching RMB 14.7 billion. It has established a comprehensive fund suite covering funds of funds (FOFs), industrial funds, M&A funds, venture capital funds, Pre-IPO funds, and cross-border investment funds. Wanlian Tianze serves as the manager of the Angel Direct Investment Fund entrusted by the Guangzhou Municipal Science and Technology Bureau. In 2023, it obtained dual pilot qualifications for QDLP (Qualified Domestic Limited Partner) and QFLP (Qualified Foreign Limited Partner) and successfully launched China’s first QDLP fund managed by a securities firm’s private equity subsidiary to complete closing. Wanlian Tianze has formed an investment footprint rooted in the Greater Bay Area and extending across China. It has invested in a batch of innovative and outstanding enterprises in fields such as advanced manufacturing, life and health, next-generation information technology, and new materials. Its investment portfolio includes Leit Tech (832110.BJ), Jet Biofil (688026.SH), Lifang Pharmaceutical (003020.SZ), Lushan New Materials (603051.SH), Narui Radar (688522.SH), Xishan Technology (688576.SH), CanSemi, Yunzhou Biotech, Jugang Precision, Singcard Technology, Bostongene, Vanchip, Chuangxin Biology, Hongxinyu, Aosong Electronics, Leigexun, Weidian New Energy, and Lantu Technology.