Ruijian Medicine Secures Over RMB 200 Million in Series B+ Financing to Advance Global Leading iPSC-Derived Cell Therapies

Apr 11, 2025 14:31 CST Updated 14:31

iRegene Therapeutics

Cell Therapy Product Developer

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In recent years, induced pluripotent stem cells (iPSC) have demonstrated tremendous potential in medical research and clinical treatment, with market attention continuously increasing. In 2024 alone, the total global financing for iPSC-related companies has exceeded $8 billion, marking a nearly 60% increase from the previous year, with financing amounts rising against the trend amidst a "capital winter."

On April 11, iRegene, which focuses on the iPSC chemical induction platform, announced the completion of a nearly 100-million-yuan B+ round of financing. This round of financing was led by Fengchuan Capital, with participation from Hetang Ventures.Easy CapitalActing as the exclusive financial advisor. Combined with the company's over RMB 100 million Series B financing completed in October last year, iRegene has cumulatively raised more than RMB 200 million in less than half a year, setting a new high for financing in China's iPSC field.

"iRegene has gradually grown into a global leading enterprise in the iPSC field through solid technical research and development as well as clinical advancement," said the lead investor of this round of financing.Fengchuan CapitalFounder Xiang Duan stated that iRegene, with its globally leading small-molecule chemical transcription regulation iPSC technology platform, is developing a new generation of chemically induced universal cell therapies. The company’s pipeline focuses on unmet clinical needs, demonstrating impressive safety and efficacy potential, with broad commercial prospects. We look forward to iRegene further accelerating the industrialization and commercialization of its various pipelines through this round of financing, bringing revolutionary changes to the global healthcare field.

Holding the world's first clinical-stage drug in the field

RootAccording to the latest report by BCC Research, the global iPSC therapy market size is expected to reach $5.2 billion by 2028, with the Asia-Pacific region leading at a compound annual growth rate of 10.4%.Behind the continuous expansion of the market scale lies the enormous therapeutic potential demonstrated by iPSC cell drugs.

Taking iRegene's self-developed NouvNeu001 as an example, as a therapeutic drug for Parkinson's disease—an irreversible condition—NouvNeu001 achieves high-purity neuronal subtype differentiation through compound modulation. It forms connections with the body's original neurons and enhances cellular secretion functions, further strengthening the improvement of the original lesion by the transplanted cells to achieve comprehensive therapeutic effects. This truly "reverses" the progression of Parkinson’s disease and has the potential to revolutionize existing clinical treatments.

As early as August 2023, NouvNeu001 was approved by the National Medical Products Administration (NMPA) to carry out combined Phase I-II clinical research, becomingParkinson's FieldThe world's first chemically induced universal cell drug to enter clinical stage.

In November 2024, the Phase I clinical trial of NouvNeu001 for mid-to-late stage Parkinson's disease has completed enrollment of all subjects. Clinical results show that the subjects have good safety and generally exhibit significant improvements in motor function and quality of life. Particularly in the low-dose group, the longest follow-up time for a subject has exceeded 60 weeks, and the behavioral improvement effects in patients are still steadily continuing.

"Some patients who were in an extremely severe condition and required family care at the time of enrollment could move independently after four weeks of treatment, and their walking ability became very stable after six months of treatment, greatly improving their quality of life." Dr. Wei Jun, founder and CEO of iRegene, pointed out that this might indicate the high feasibility of universal cell transplantation for treating Parkinson's disease, and the transplanted cells can function effectively in patients over the long term.

Guo Kai, Managing Director of Hetang Ventures, pointed out that the current drug strategy of transplanting dopamine precursor cells for the treatment of Parkinson's disease already has a clear biological mechanism and has recently received preliminary clinical efficacy data support. It is expected to become the first therapy capable of significantly delaying disease progression. The core product of iRegene, NouvNeu001, is the world's first iPSC-derived dopamine precursor cell therapy product to enter the clinical stage, demonstrating significant advantages in terms of clinical progress, clinical efficacy, and production costs.

It is reported that the Phase II clinical trial of NouvNeu001 is also about to officially commence in the near future. Overseas, in June 2024, the U.S. Food and Drug Administration (FDA) formally approved the IND application for NouvNeu001, achieving "dual filing and dual approval" of IND in both China and the United States. The related Phase I clinical trial in the U.S. is also planned to begin in the first half of this year. The overall clinical progress in both China and the U.S. is significantly ahead of global competitors.

Seizing the Frontier of iPSC Cell Drug Therapy

Disruptive products and cutting-edge clinical advancements are just one of the reasons why iRegene has continuously secured substantial financing. At the core of this capital favor lies the broader potential demonstrated by iRegene's chemically induced iPSC cell therapy.

Similarly, in the field of Parkinson's disease, as the onset of such diseases is becoming increasingly younger, iRegene has launched its self-developed product NouvNeu003 for early-onset Parkinson's disease, achieving full lifecycle and full treatment cycle coverage for two major patient populations: "elderly and early-onset" Parkinson's patients.

As early as December 2023, NouvNeu003 had received NMPA approval to officially enter Phase I clinical trials, adding another "first" for iRegene — the world's first iPSC-derived off-the-shelf cell therapy product to enter the registrational clinical stage for early-onset Parkinson's disease.

Currently, NouvNeu003 has also completed the enrollment of all subjects in its Phase I clinical trial, maintaining the same pace as the clinical progress of NouvNeu001. The clinical trial has also indicated good tolerability of NouvNeu003 among subjects and preliminarily revealed specific cellular treatment patterns for early-onset Parkinson's disease, laying the foundation for subsequent confirmatory clinical studies.

In addition, in other potential fields of iPSC cell therapy, iRegene's breakthrough ophthalmology product NouvSight001 was granted Orphan Drug Designation (ODD) by the U.S. FDA in March 2024. This product is aimed at treating "a series of retinitis pigmentosa indications" and represents the first off-the-shelf ophthalmic cell therapy product derived from induced pluripotent stem cells (iPSC) developed by iRegene.

According to Dr. Wei Jun, the recently completed B+ round of financing will be used to accelerate the clinical trials in China and the U.S. for the company's core product pipeline, as well as the development of multiple innovative pipelines and the establishment of clinical capabilities.

Overall, iRegene has become the leading company in the international pluripotent stem cell field with the most regulatory approvals, the fastest pipeline progress, and the largest number of treated patients. Its unique "chemical induction" cell function remodeling platform has further demonstrated its distinct advantages in the clinical stage.

Fang Yang, Executive Director of Easy Capital, the exclusive financial advisor for this round of financing, stated that iRegene is currently the only company in China to have completed the formal registration of the Phase I clinical trial for iPSC cell drugs. At the same time, the company plans to initiate a Phase I clinical trial with the FDA this year. In terms of overall clinical progress, iRegene has significantly outpaced its competitors in the industry and is expected to become the first cell therapy company in China approved in the field of Parkinson's disease. We look forward to iRegene further accelerating the industrialization and commercialization of its pipeline through this round of financing, continuing to drive innovation in biopharmaceuticals, and bringing revolutionary changes to the global healthcare sector.

Dr. Wei Jun stated that iRegene has always adhered to the principle of "starting from the needs of patients and addressing genuine clinical demands," using "original innovation" to develop entirely new therapies that can truly reverse disease progression for patients. "This round of financing will further solidify the foundation for iRegene to accelerate clinical progress, and the team will undoubtedly redouble its efforts to bring new therapies to a wide range of patients. In addition, the completion of this financing will also provide support for iRegene to further expand into the international market."

Source: iRegeneTechnology