Ruijian Medicine Leads iPSC Field with Rapid Clinical Progress and RMB 200M Raised in Six Months

In recent years, induced pluripotent stem cells（iPSC）It has shown great potential in medical research and clinical treatment, with market attention continuously increasing. Only in 2024, the total global financing for iPSC-related companies has exceeded 8 billion US dollars, increasing by nearly 60% compared to the previous year, with the financing amount"Capital Winter"iRegene Rises Against the Trend."

On April 11, focusing on the iPSC chemical induction platformiRegeneNewly announced completionNearly 100 Million B+ Round Financing. This round of financing was led by Fengchuan Capital, followed by Hetang Ventures, with Easy Capital serving as the exclusive financial advisor. Combined with the company's completion of an over 100-million-yuan Series B round of financing last October, iRegene has achieved this in less than half a year.Total financing exceeds 200 million RMB`, 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 technological research and development as well as clinical progress," said the lead investor of this round of financing.Founder of Fengchuan Capital, Duan XiangiRegene, with its globally leading small-molecule chemical transcriptional 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 by BCC Research, the global iPSC therapeutics 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 treatment drug for Parkinson's disease, an irreversible condition, NouvNeu001 achieves high-purity neuronal subtype differentiation through compound regulation, forms connections with the body's original neurons, and enhances cellular secretion functions. This further strengthens the improvement of the original lesion by the transplanted cells, achieving a comprehensive therapeutic effect."Reversal"Parkinson's disease treatment, with the potential to revolutionize current clinical therapies."

As early as August 2023, NouvNeu001 was approved by the National Medical Products Administration (NMPA).（NMPA）Approval for Conducting Combined Phase I-II Clinical Trials, BecomingThe World's First Chemically-Induced Universal Cell Drug in the Parkinson's Field to Enter Clinical Stage。

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. Especially 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 steadily continuing.

"Some patients were already in a very severe condition and required family care at the time of enrollment. After four weeks of treatment, they could move independently, and after six months of treatment...""The ability to walk has become very stable, greatly improving the quality of life."Dr. Wei Jun, Founder and CEO of iRegeneThis may indicate that universal cell transplantation for the treatment of Parkinson's disease is highly feasible, and the transplanted cells can function effectively in patients over the long term.

Guo Kai, Managing Director of Hetang VenturesIt was 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 delaying disease progression. ——iRegeneCore Product NouvNeu001 is the world's first iPSC-derived dopamine precursor cell therapy product to enter the clinical stage., with significant advantages in clinical progress, clinical efficacy, and production costs.

It is reported that the Phase II clinical trial of NouvNeu001 will officially commence in the near future. Internationally, in June 2024, the U.S. Food and Drug Administration (FDA)China Food and Drug Administration（FDA）has also officially approved the IND application for NouvNeu001, formally achieving IND in both China and the U.S."Dual Filing and Dual Approval"". The related Phase I clinical trial in the U.S. is also planned to commence 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 this capital favor lies the broader potential demonstrated by iRegene's chemically induced iPSC cell therapies.

Similarly, in Parkinson'sIn the field of medicine, as the onset of such diseases is becoming increasingly younger, iRegene has launched its self-developed product NouvNeu003 for early-onset Parkinson's disease, providing a solution for Parkinson's."One Old One Early""Full lifecycle and full treatment cycle coverage for the two major patient populations."

As early as December 2023,NouvNeu003 has already received NMPA approval to officially enter Phase I clinical trials, adding another achievement for iRegene."First」——The World's First iPSC-Derived Universal Cell Therapy Product for Early-Onset Parkinson's Disease to Enter the Registration Clinical Stage。

Currently, NouvNeu003 has also completed the enrollment of all subjects in Phase I clinical trials, maintaining the same pace as NouvNeu001. The clinical trial has also shown that subjects tolerate NouvNeu003 well and preliminarily revealed specific cellular treatment patterns for early-onset Parkinson's disease, laying the foundation for subsequent confirmatory clinical studies.

In addition, in iPSC cell therapyIn other potential fields, iRegene's breakthrough ophthalmology product NouvSight001 was also granted Orphan Drug Designation by the U.S. FDA in March 2024.（Orphan Drug Designation, ODD）. The product is targeted at"Retinitis Pigmentosa Series Indications"iRegene's first induced pluripotent stem cell treatment"（iPSC）Source: Ophthalmology General Cell Therapy Product.

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

Overall, overall, iRegene has becomeThe 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, boasting unique..."Chemical Induction"The cell function modification platform has further demonstrated its unique 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 Phase I clinical trials for iPSC cell drugs. Meanwhile, the company plans to initiate Phase I clinical trials with the FDA this year. In terms of overall clinical progress, iRegene has significantly outpaced its competitors in the industry and is poised to become the first cell therapy company in China approved for 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 said that iRegene has always adhered toFocus"Starting from the needs of patients, solving real clinical needs""The purpose of""Source Innovation"To develop groundbreaking therapies that can truly reverse the course of diseases for patients. This round of financing has further solidified 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 has also provided support for iRegene to further expand into international markets."

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