iRegene completes RMB 210 million Series C1 financing to accelerate development of a global platform-type cell therapy Biotech

Recently, iRegene officially announced the completion of its RMB 210 million series C1 financing round. This round was jointly led by Luminous Ventures and Apricot Capital. The proceeds will be fully allocated to the global advancement of the company's core clinical pipelines, continuous iteration and upgrade of its "AI plus chemical induction" technology platform, development of large-scale industrial production systems, international multicenter clinical development, and the establishment and implementation of global commercial partnerships.

The successful completion of this financing not only represents strong recognition from the capital market of iRegene's capabilities in building an AI-driven cell therapy platform, rapid delivery of core clinical pipelines, forward-looking development in aging-related diseases, global clinical execution, and industrial implementation potential, but also marks iRegene's accelerated transformation from a pipeline-driven innovative biotechnology company into a platform-type cell therapy enterprise with sustained multi-pipeline output capacity, full industry chain closed-loop advantages, and global core competitiveness. In the high-barrier innovative field of neurodegenerative diseases, iRegene continues to lead the global induced pluripotent stem cell-derived off-the-shelf cell therapy industry.

As global population aging continues to accelerate, the disease spectrum is undergoing profound transformation. Aging-related diseases, represented by Parkinson's disease, multiple system atrophy, Alzheimer's disease, retinal degenerative diseases, and irreversible visual function impairment, have become core challenges facing global healthcare systems. These diseases are characterized by irreversible progression, unmet clinical needs, lack of treatment options, and sharply declining quality of life for patients.

iRegene's pipeline development has consistently aligned with global aging trends, taking neurodegenerative diseases as its core starting point. The company has built a product matrix covering major unmet needs in areas such as central nervous system disorders and ophthalmic rare diseases, completely breaking the limitations of single-indication development and ensuring strong long-term growth certainty.

Leveraging its proprietary core technology platform, iRegene has established multiple globally leading clinical-stage pipelines, forming a differentiated and significant platform advantage:

1) NouvNeu001, the flagship product, is the only cell therapy product in the global induced pluripotent stem cell field to have received both the U.S. Food and Drug Administration Fast Track designation and Regenerative Medicine Advanced Therapy designation. Precisely targeting Parkinson's disease, it has now advanced to phase II clinical trials simultaneously in China and the United States. The first patient dosing in the U.S. phase II clinical trial has been initiated at Weill Cornell Medicine. The China phase II clinical trial is being fully conducted across five top-tier research centers: Beijing Hospital, the First Affiliated Hospital of the University of Science and Technology of China, Union Hospital Tongji Medical College Huazhong University of Science and Technology, West China Hospital of Sichuan University, and Zhongnan Hospital of Wuhan University. The research and development progress ranks among the top tier of similar pipelines globally.

2) NouvNeu004, targeting multiple system atrophy with parkinsonian features, has achieved a major breakthrough with clinical trial approvals in both China and the United States. In October 2025, it received a full-cycle phase I-III clinical trial approval from the National Medical Products Administration. In November of the same year, it received approval from the U.S. Food and Drug Administration to conduct an international phase I clinical trial, becoming the world's first induced pluripotent stem cell-derived cell therapy product for multiple system atrophy to enter clinical development, bringing new therapeutic hope to patients with this previously untreatable disease.

3) NouvSight001, the core product in the ophthalmology field, has received orphan drug designation from the U.S. Food and Drug Administration. Focused on retinitis pigmentosa and related indications, it further expands the application boundaries of the platform in degenerative eye diseases.

From a single leading program to simultaneous breakthroughs across multiple pipelines, iRegene has completed a critical transition from a "program-driven innovation company" to a "platform-type cell therapy enterprise." The continuous advancement of multiple clinical pipelines not only validates the replicability and scalability of the company's technology platform but also solidifies iRegene's first-mover advantage in the field of aging-related diseases. This allows the company's commercial value to no longer be limited to the success of a single product, but rather to continuously capture long-term healthcare demand driven by the aging trend through its platform capabilities, and grow into a globally competitive innovative pharmaceutical company.

iRegene's continued leadership in the high-barrier cell therapy field stems from its proprietary "AI plus chemical induction" platform, which possesses global intellectual property rights. This unique technological system completely reconfigures the paradigm of cell fate discovery and chemical induction development using artificial intelligence, breaking through core bottlenecks in traditional cell therapy research and development, and serving as the core engine for the company's continuous output of innovative pipelines.

Unlike conventional cell therapy technology pathways, iRegene deeply integrates AI-driven omics analysis with precise functional control of cells through chemical induction, forming a standardized, replicable, and industrially scalable research and development methodology that addresses common industry challenges at the foundational level.

The core operational logic of this platform consists of three key steps: first, utilizing a unique computational biology platform to identify core driver genes for cell reprogramming; second, employing AI-powered high-throughput screening to precisely identify small molecule compound combinations that induce directional cell differentiation; and third, achieving precise remodeling of cell fate and function through pure chemical induction. This approach eliminates the need for gene editing, relying solely on simple combinations of small molecule compounds and basal media to achieve efficient, low-cost, large-scale production of functional enhanced off-the-shelf cell therapeutics from induced pluripotent stem cells.

iRegene's "AI plus chemical induction" platform can optimize small molecule combinations through algorithms to achieve direct directional induction of specific dopaminergic neuron subtypes. During the induction process, it simultaneously performs functional enhancement of the cells, while also enabling the development of a more controllable and standardized chemical system that effectively reduces batch-to-batch variability associated with biological factors. This creates core advantages in precision, functionality, and consistency. Therefore, iRegene's proprietary "AI plus chemical induction" platform makes it easier to build a stable and reliable chemistry, manufacturing, and controls system, supporting both large-scale production of off-the-shelf cell therapeutics and significantly reducing the cost and supply chain pressures associated with individualized customization.

The value of the "AI plus chemical induction" platform has long evolved from a basic tool supporting individual programs into a platform engine that continuously generates globally leading cell therapy assets. Beyond the core product NouvNeu001, multiple pipelines including NouvNeu004 and NouvSight001 have been rapidly advanced to clinical stages using this platform, fully validating its extensibility across indications and disease areas. In Parkinson's disease treatment, the platform enabled the efficient preparation of functional enhanced dopaminergic neural precursor cells for NouvNeu001, which, after transplantation, can survive long-term, stably differentiate, and form functional integration within the patient's brain. In multiple system atrophy treatment, the platform supports NouvNeu004 in achieving a dual-mechanism of action combining "neurotrophic support plus neural reconstruction," capable of both secreting neurotrophic factors to protect endangered neurons and differentiating into functional neural cells for systemic repair. In the ophthalmic disease area, the company has established the NouvSight pipeline series targeting irreversible visual function impairment, advancing NouvSight001 to precisely target retinitis pigmentosa as a breakthrough therapy for rare eye diseases, while also opening up possibilities for further expanding the application boundaries in the ophthalmology field.

The core intellectual property of this unique technology platform has been granted patent protection in multiple countries, including China, the United States, and Japan, forming a strong global technology barrier. It has not only significantly improved the research and development efficiency and success rate of cell therapy products but has also fundamentally transformed the industry's research and development paradigm, making the industrialization, globalization, and commercialization of induced pluripotent stem cell-derived off-the-shelf cell therapy a reality, thereby establishing a unique core barrier for iRegene.

Global competition in cutting-edge innovative drugs is fundamentally a multi-dimensional contest of technology, clinical development, regulatory affairs, industrialization, and team execution. iRegene's ability to stand out in the global neural cell therapy field is not only attributable to its unique technology platform and forward-looking pipeline strategy, but also relies on the team's international vision, innovative courage, and exceptional execution capabilities. This is precisely the core reason why leading healthcare and technology investors such as Luminous Ventures and Apricot Capital continue to increase their investments with strong conviction.

At the clinical development level, the iRegene team has demonstrated a precise understanding of global regulatory frameworks and clinical development timelines, achieving simultaneous clinical trial approvals in both China and the United States for its core products with coordinated global advancement. This showcases the team's mature and robust international clinical operations capabilities. NouvNeu001 is the world's first induced pluripotent stem cell-derived cell therapy product to receive both Fast Track designation and Regenerative Medicine Advanced Therapy designation, and is also the world's first chemically induced off-the-shelf cell therapy product in the neurological disease field to receive Regenerative Medicine Advanced Therapy designation. From obtaining a special exemption from the U.S. Food and Drug Administration to directly enter phase II clinical trials in the United States, to completing the first U.S. phase II patient dosing at Weill Cornell Medicine, and to rapidly advancing patient enrollment in the China phase II trial, every milestone reflects the team's precise control over clinical pathways. NouvNeu004 obtaining consecutive clinical trial approvals from both the National Medical Products Administration and the U.S. Food and Drug Administration within just one month, becoming the world's first cell therapy product for multiple system atrophy to enter clinical development, is a direct testament to the team's execution capabilities.

At the globalization level, iRegene has established a comprehensive international operations system. The company has set up an innovation center in Denmark, officially launched its clinical center in Australia, established a joint innovation center with Danaher to advance technology research and clinical translation, and built a global logistics and supply chain covering China, the United States, and Australia. This ensures end-to-end independent control over drug production, transportation, and supply, laying a solid foundation for global multi-center clinical trials and future commercialization. This full-chain strategy — from fundamental innovation to global clinical development, and from technology research to industrial implementation — fully demonstrates the team's international vision and strategic foresight.

Leveraging its unique platform technology, robust clinical advancement capabilities, and global strategy, iRegene has earned strong recognition and strategic support from investment institutions.

At a new starting point of development, iRegene is leveraging technological innovation and a global vision to break new ground, continuously leading the global regenerative medicine field. By reshaping disease treatment paradigms through cell therapy, the company aims to bring truly breakthrough therapeutic options to patients with aging-related diseases around the world.