Ruijian Medicine Secures Nearly RMB 100 Million Series A Funding to Advance IND Filing for Parkinson’s Cell Therapy NouvNeu001

The R&D of domestically produced cell therapy drugs has been accelerated once again following the closing of a financing round nearing 100 million RMB.

August 11,Exactly four years after its establishment, Wuhan iRegene Medical Technology Co., Ltd. (abbreviated as “iRegene”) announced the completion of nearly RMB 100 million in Series A financing.According to reports, this round of financing was led by Fortune Capital, with follow-on investment from Jiuyou Capital. The funds will be primarily used to complete the Phase I clinical trials for iRegene’s first investigational pipeline for Parkinson’s disease—NouvNeu001. Alongside securing nearly RMB 100 million in funding, iRegene has also relocated to a new R&D and manufacturing facility covering a total area of 4,000 square meters, completing the company’s site and hardware upgrades. Additionally, pilot-scale production for multiple new pipelines will be initiated in the newly constructed “Grade B+A” pilot facility.

Publicly available information indicates that iRegene is the world's first high-tech pharmaceutical company dedicated to researching highly potent chemical small molecule-induced functional cell regeneration. Currently, focusing on the research and translation of cell fate regulation mechanisms, iRegene has established a cell-based drug R&D technology platform based on small molecule chemical induction, and has built a comprehensive and systematic patent portfolio.

Liu Xi, Investment Director at Forchance Capital (lead investor in this financing round) and Executive Director of the Xinghai Healthcare Sub-fund, pointed out that backed by a cell therapy R&D technology platform featuring core patented technologies, iRegene can continuously develop off-the-shelf cell therapies with proprietary intellectual property, high safety, strong efficacy, and controllable manufacturing costs for specific degenerative and injury-related diseases, tumors, and metabolic disorders. Furthermore, the company has already achieved systematic and robust data validation in indications with significant unmet clinical needs, such as Parkinson's disease.

Cellular drugs represent the third generation of pharmaceuticals following small-molecule chemical drugs and macromolecular protein drugs, and are also known as "living drugs."

The essence of induced pluripotent stem cell (iPSC) therapeutics lies in reprogramming mature, differentiated human cells back into iPSCs, which closely resemble embryonic stem cells, and subsequently differentiating them into mature, functional cells for therapeutic use via biotechnological or chemical approaches. Compared with neural cell transplants derived from embryos or human tissues, iPSC-derived neural cell therapeutics circumvent ethical concerns, eliminate the risks associated with allogeneic cell use, and simultaneously ensure an ample supply of neural cells.

Currently, iRegene has not only achieved the dedifferentiation reprogramming of human blood cells, skin cells, urinary exfoliated epithelial cells, and liver cells into pluripotent stem cells, but has also established a purely chemical differentiation system capable of directing pluripotent stem cells into neural cells, hepatic cells, and other cell lineages. In this context, the human body itself serves as a "walking medicine cabinet," whereby the aforementioned specific cells can be reconstructed and repurposed to replenish damaged or degenerating functional cells.

Although the mechanism of action is clear, the complex drug modality of cell-based therapeutics makes their research and development extremely challenging.

To this end, iRegene independently developed an AI-driven platform for screening small-molecule compounds as induction factors and culture media for pluripotent stem cell product development, aiming to achieve the efficient conversion of induced pluripotent stem cells.Leveraging AI-powered large-scale sequencing, iRegene can conduct differential analysis between induced pluripotent stem cells (iPSCs) and target differentiated cells to identify the genes that govern the trajectory of cellular differentiation and maturation—a critical issue widely overlooked in the industry.

After identifying the driver genes responsible for cell conversion, iRegene screens for small-molecule drugs that can specifically bind to these targets and induce cellular conversion. Ultimately, by simply combining a few suitable chemical small molecules with a chemically defined basal medium, iRegene can achieve the highly efficient conversion of induced pluripotent stem cells (iPSCs) into target cell types. Furthermore, iRegene has further leveraged this platform by utilizing chemical small molecules to inhibit the MHC pathway, thereby establishing a world-leading universal cell induction platform.

Since cellular differentiation is entirely driven by intrinsic genetic programming, iRegene achieves an exceptionally high conversion efficiency for its cellular therapeutics. Taking NouvNeu001, the company’s investigational candidate for Parkinson’s disease, as an example, the dopaminergic neurons differentiated from induced pluripotent stem cells (iPSCs) achieve a purity of up to 99.99%, perfectly recapitulating the functions and characteristics of the target cells.

“When we first engaged with iRegene two years ago, we recognized that, with its AI-designed cell therapy development platform, the company’s technological capabilities and development progress had already comprehensively outpaced its international counterparts. This platform boasts remarkable extensibility, and the therapeutics it yields hold significant potential for broad applicability, giving it the capacity to reshape the competitive landscape of the cell therapy sector.” This was how Luo Wangqian, Partner at Huafang Capital—the lead investor in iRegene’s angel round—evaluated the company’s cell therapy development platform during an interview.

The cell therapy development platform equipped with core patented technologies also makes it possible to accelerate iRegene's R&D pipeline.

According to public records, iRegene was registered in August 2017, marking exactly four years since its establishment as of August 11. However, according to co-founder Dr. Jun Wei, the company's official operations actually commenced in April 2018. AndIn the three years since officially commencing operations, iRegene has rapidly established five R&D pipelines.Among them, the cellular therapeutics indicated for spinal cord injury, stroke, and optic neuropathy have all completed basic research and secured relevant patent grants. The fastest-advancing pipeline candidate for Parkinson’s disease, NouvNeu001, is expected to file an Investigational New Drug (IND) application in early 2022.

Wei Jun further disclosed that the tens of millions of RMB raised by the company in its Pre-A round have already been allocated to the safety evaluation of NouvNeu001 and its IND application. The nearly RMB 100 million secured in this Series A financing will be dedicated to advancing NouvNeu001 through the completion of its Phase I clinical trial.

Based on the results of completed pharmacological, efficacy, and safety trials, various experimental animals treated with NouvNeu001 demonstrated exceptional efficacy, exhibiting significant improvement in Parkinson's disease symptoms just four weeks post-administration. In contrast, comparable drugs globally for Parkinson's disease require a minimum of twelve weeks of administration to take effect, highlighting a marked difference in pharmacological efficacy.

Additionally, by transplanting a defined dose of neurons into lesioned brain regions, NouvNeu001 effectively promotes the recovery of motor and other functions in patients. For instance, in a rat Parkinson’s disease model, a single administration significantly improved motor deficits within 4 weeks. By 18 weeks, Parkinsonian behavioral symptoms had recovered by more than 50%.

Sun Yi, Managing Partner of Jiuyou Capital, which participated in iRegene's Series A financing round, pointed out that with the aging population, the incidence of neurodegenerative diseases such as Parkinson's disease is rising rapidly. These conditions have already become major diseases threatening public health in China and globally. Such diseases also severely impact the quality of life for patients and their families, placing a substantial burden on society.

“Currently, the clinical market lacks effective therapeutic options for Parkinson’s disease and related disorders,” said Sun Yi. “The induced pluripotent stem cell (iPSC) product development platform established by iRegene enables the development of various clinical-grade cell therapy products targeting neurological indications, paving a novel clinical treatment and R&D pathway for neurological diseases and bringing hope to patients.”

Concurrent with the closing of this Series A financing round, iRegene's new R&D and production facility will officially commence operations.

It is reported that the new R&D and production base covers a total area of nearly 4,000 square meters. It will facilitate pilot-scale production for the company's various pipelines under development, thereby accelerating their R&D progress. Additionally, once the production facilities are fully operational, the new base will be capable of producing 120,000 doses of NouvNeu001 within a 21-day cycle, fully meeting the needs of Parkinson's patients in China.

“Over the past two decades, a steady stream of targeted therapies and immunotherapies for cancer has emerged, yet few pharmaceutical companies have ventured into addressing age-related neurological diseases such as Alzheimer’s and Parkinson’s. Leveraging its proprietary technologies, iRegene aims to develop accessible, clinical-grade cell therapy products for neurological indications, bringing hope to patients and families profoundly affected by these disorders,” said Wei Jun.