Ruijian Pharmaceuticals Secures Nearly RMB 100 Million in Series A+ Financing to Advance Clinical Development of Chemically Induced Cell Therapies

Biopharmaceutical companies at the forefront of innovation often attract more attention from capital and institutions.

On January 20, 2022, Wuhan iRegene Therapeutics Co., Ltd. ("iRegene"), which is committed to the development of chemically induced adult cell therapies, announced the completion of a nearly RMB 100 million Series A+ financing round. This round of financing was led by Changjiang Securities Innovation Investment (Hubei) Co., Ltd.

Public information shows that iRegene is the world's first high-tech pharmaceutical company focusing on efficient chemical small-molecule-induced functional cell regeneration. Currently, around the research and transformation of cell fate regulation mechanisms, iRegene has built a cell drug R&D technology platform based on small-molecule chemical induction, and has carried out comprehensive and systematic patent layouts. The company focuses on developing off-the-shelf cell drugs with independent intellectual property rights for specific degenerative, injury-related diseases, tumors, and metabolic system diseases.

The proceeds from this financing will be mainly used to advance the clinical Phase I study of iRegene's pipeline candidate NouvNeu001 for Parkinson’s disease, while also supporting the subsequent pipeline candidate NS001 in its dual Investigational New Drug (IND) applications in both China and the U.S.

While "joining hands" with market capital, iRegene has recently signed a strategic cooperation agreement with Danaher Life Sciences China. The two parties will jointly build the "iRegene-Danaher China Life Sciences Joint Laboratory" to jointly promote the research and clinical application of globally innovative AI platform-based chemical induction cell therapy.

With the aging population, the incidence of neurodegenerative diseases such as Parkinson's disease is rapidly increasing, becoming a major threat to human health in China and globally. These related diseases also severely impact the quality of life for patients and their families, placing a burden on society.

"Traditional drug and surgical therapies have significant limitations for many diseases, while cell therapy, with its unique treatment approach, is a beneficial complement to conventional methods," noted Dr. Yan Xuan, partner of Changjiang Securities Innovation Investment (Hubei) Co., Ltd., who participated in iRegene's recent Series A+ financing. He pointed out that after decades of exploration and development, the stem cell industry has seen increasingly mature theories and industrialization-related technologies. The founder of iRegene has deep expertise in the field, with extensive experience in the directed differentiation of various types of cells and is a domestic leader in the area of Parkinson's disease. The company’s platform-based technology, combined with low-cost and standardized production methods, is expected to bring a series of new drugs with proven efficacy and affordability to more patients.

It is reported that the so-called induced pluripotent stem cell (iPSC) drug, in essence, dedifferentiates mature human cells back into induced pluripotent stem cells (iPSCs) that are similar to embryonic stem cells. Based on this, through biotechnological or chemical methods, these cells are then transformed into mature functional cells for therapeutic use. Compared with neural cell transplantation derived from embryos or human tissues, induced neural cell drugs have no ethical issues, avoid the risks associated with allogeneic cell use, and also ensure an adequate supply of neural cells.

Currently, iRegene has not only achieved the dedifferentiation reprogramming of various human cells—including blood cells, skin cells, urinary exfoliated epithelial cells, and liver cells—into pluripotent stem cells, but also established a pure chemical differentiation system to transform pluripotent stem cells into nerve cells, liver cells, and other types of cells. In this context, the human body itself becomes a "walking medicine cabinet," where specific cells from targeted locations are reconstructed and reused to replenish damaged or degenerated functional cells.

Although the mechanism of action is clear, the complex drug form of cellular drugs makes their research and development extremely difficult.

To this end, iRegene has independently developed a multifunctional stem cell product development platform based on artificial intelligence (AI) screening of small molecule compounds as inducers and culture medium, to achieve the efficient transformation of induced pluripotent stem cells. Using AI technology for extensive sequencing, iRegene can analyze the differences between induced pluripotent stem cells and target transformed cells, determining which genes dictate the direction of cell differentiation and maturation—a key issue often overlooked in the industry.

After identifying the driver genes of cell transformation, iRegene seeks small molecule drugs that can bind to these genes and induce cell transformation through target screening. Ultimately, with just a simple combination of a few suitable chemical small molecules and a pure chemically-based culture medium, iRegene can efficiently transform induced pluripotent stem cells into target cells. Additionally, iRegene has further advanced this platform by using chemical small molecules to inhibit the development of the MHC pathway, thereby establishing a world-class universal cell induction platform.

Since the cell transformation is entirely driven by intrinsic genetic factors, iRegene's cell therapy achieves an extremely high conversion rate. For instance, NouvNeu001, the company’s investigational pipeline for Parkinson’s disease, demonstrates a purity of over 99% in converting induced pluripotent stem cells into dopaminergic neurons, perfectly replicating the function and characteristics of the target cells.

Dr. Wang Xiaoyan, partner of Runpu Medical Fund of GSR United Capital, who participated in iRegene's Series A financing round, also stated that in the field of cell therapy, transdifferentiation has broad application prospects. "iRegene has developed transdifferentiation solutions from the ground up and established a unique chemical induction system. Moreover, it has pioneered a method based on developmental biology MHC inhibition, showcasing iRegene’s originality and forward-thinking strategy."

It is worth mentioning that iRegene's innovative cell drug R&D model has caught the attention of international scientific instrumentation giant Danaher.

Just before the completion of this A+ round of financing, iRegene signed a strategic cooperation agreement with Danaher Life Sciences China to closely collaborate in the field of globally groundbreaking cell drug research and development and production. According to the agreement, the two parties will jointly establish the "iRegene-Danaher China Life Sciences Joint Laboratory" to jointly promote the research, development, and clinical application of globally innovative AI platform-based chemical induction cell therapies.

"During the new drug development process, iRegene utilized many pieces of equipment that other cell therapy companies typically do not use, which aroused the curiosity of our upstream equipment supplier, Danaher. After an on-site visit, Danaher discovered that we had applied some of the equipment in entirely new usage scenarios with excellent outcomes, leading to this collaboration," said Dr. Wei Jun, co-founder of iRegene.

The entry of international scientific instrument giants will undoubtedly enhance the quality and efficiency of iRegene's new drug research and development.

According to Ms. Zhou Weihua, Director of Strategy and Strategic Marketing at Danaher Life Sciences China, in this strategic cooperation, Danaher will actively participate in the construction of iRegene's future multi-directional platforms. It will provide advanced detection instruments and technical reserves including but not limited to life science research, efficacy compound development and screening, multi-omics cellular mechanism research, and multi-substance screening. Danaher will assist Wuhan iRegene in improving the efficiency of platform construction and the capability to deliver practical application solutions, support iRegene in building a distinctive innovative pipeline for drug research and development and production base, and fully back iRegene’s future planning and development. The aim is to jointly promote the innovative development of life science research in China.

"In the future, the efficiency of chemical induction and high-throughput screening of small molecules in iRegene's cell drug development process is expected to improve with the arrival of new testing instruments," said Wei Jun. She added that both parties will serve as a model for globally pioneering life science applications, jointly promoting the application and development of breakthrough technologies in life sciences for innovative drug discovery.

According to reports, iRegene has just submitted an Investigator Initiated Trial (IIT) filing for NouvNeu001, which is applicable to Parkinson's disease, to China's National Health Commission. It is expected that the dual IND application in both China and the U.S. will be initiated in the first quarter of 2022. Other cell-based drugs applicable to conditions such as spinal cord injury and stroke have all completed foundational research and obtained relevant patent authorization.

However, the applications of cell drugs independently developed by iRegene are not limited to this. According to information on the company’s official website, in just over four years since its establishment, iRegene has rapidly completed the layout of nine R&D pipelines. In addition to the aforementioned cell drugs targeting neurodegenerative diseases, the company is also exploring the potential of cell drug treatments in areas such as optic nerve disorders, diabetic retinopathy, and amyotrophic lateral sclerosis. One of the future directions for the nearly 100-million-yuan Series A+ financing round is to support the company's subsequent R&D pipeline—NS001—in initiating dual IND filings in both China and the U.S.

It is precisely based on the relentless research into the application of cellular drugs and innovative new drug development methods that iRegene has recently been recognized as a "National High-tech Enterprise" by the Leading Group for the Identification and Management of National High-tech Enterprises.

"Over the past 20 years, a variety of targeted drugs and immunotherapy medications for tumors have emerged one after another, but few pharmaceutical companies have shown interest in neurodegenerative diseases such as Alzheimer's and Parkinson's that occur with aging. iRegene hopes to leverage its proprietary technology to develop affordable clinical-grade cell therapy products for neurological indications, and to expand the application of cellular drugs to other unmet clinical needs," said Wei Jun.