Ruijian Medicine Secures Over RMB 200 Million in Half a Year Amid Market Downturn, Advancing Multiple Global First-in-Class iPSC-Derived Therapies

In recent years, induced pluripotent stem cells (iPSC) have demonstrated significant 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 amid a "capital winter."

On April 11, iRegene, which focuses on the iPSC chemical induction platform, announced the completion of a nearly RMB 100 million Series B+ financing round. This round was led by FUNG & CHUEN CAPITAL PTY LIMITED, with participation from TusPark Ventures, and CEC CAPITAL serving as the exclusive financial advisor. Combined with the over RMB 100 million Series B financing completed in October last year, iRegene has cumulatively raised over 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 leader in the iPSC field through solid technological research and clinical advancement," said Duan Xiang, founder of FUNG & CHUEN CAPITAL PTY LIMITED, the lead investor in this round of financing. 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.

According to the latest report from BCC Research, the global iPSC therapy market size is projected to reach $5.2 billion by 2028, with the Asia-Pacific region leading at a compound annual growth rate (CAGR) of 10.4%. Behind the expanding market size lies the immense therapeutic potential demonstrated by iPSC-based cell therapies.

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, truly "reversing" the progression of Parkinson's disease. It has the potential to revolutionize current clinical treatment methods.

As early as August 2023, NouvNeu001 was approved by the National Medical Products Administration (NMPA) to carry out combined Phase I-II clinical research, becoming the world's first chemically induced, off-the-shelf cell therapy to enter the clinical stage in the Parkinson's disease field.

In November 2024, the Phase I clinical trial of NouvNeu001 for mid-to-late stage Parkinson's disease has completed the 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 subjects has exceeded 60 weeks, and the behavioral improvement effects in patients are still stably continuing.

"Some patients who were already in a very 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 within the patient’s body over the long term.

Guo Kai, Managing Director of TusPark 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 been supported by preliminary clinical efficacy data. It is expected to become the first therapy capable of significantly slowing disease progression. The core product of iRegene, NouvNeu001, is the world’s first iPSC-derived dopamine precursor cell therapy 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 will also 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 the "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.

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

In the same vein within the Parkinson's field, in response to the increasingly younger onset of such diseases, iRegene has launched its self-developed product NouvNeu003 for early-onset Parkinson's, achieving full lifecycle and full treatment cycle coverage for the two major patient populations of Parkinson’s: "the elderly and the early-onset."

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 shown that subjects tolerated NouvNeu003 well, and preliminary findings have revealed unique cell therapy 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 ophthalmic product NouvSight001 was granted Orphan Drug Designation (ODD) by the U.S. FDA in March 2024. Targeting the treatment of "retinitis pigmentosa-related indications," this product is the first off-the-shelf, iPSC-derived ophthalmic cell therapy developed by iRegene.

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

Overall, iRegene has become the leading enterprise 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 CEC 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 Phase I clinical trials for iPSC cell drugs. At the same time, the company plans to initiate Phase I clinical trials with the FDA this year. In terms of overall clinical progress, it has significantly outpaced its competitors in the industry and is expected to become the first cell therapy company in China approved in the Parkinson's disease field. We look forward to iRegene further accelerating the industrialization and commercialization of its pipeline through this round of financing, continuing to drive biopharmaceutical innovation, 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 real 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 continue to work hard 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 international markets."