Record-Breaking $420M Series B Funding and FDA Fast Track Designation: What Makes This Chinese Biotech Stand Out? | An Interview with Dr. Wei Jun

Recently, iRegene has announced significant progress: On September 4th, the company declaredCompleted Over 300 Million Yuan in Series B Financing Against the Trend, Setting a Record for the Largest Financing Amount in China's iPSC Field in Recent Years; On August 15, its first R&D product, NouvNeu001, was granted Fast Track designation by the U.S. FDA,Becoming the world's first iPSC-derived universal Parkinson's disease cell therapy product to receive Fast Track designation. A series of advancements have drawn industry attention to this iPSC Biotech.

iRegene was founded in August 2017.Focus on the Development of Universal Chemically Induced Cell Therapeutics, for the treatment of neurodegenerative diseases, ophthalmic diseases and other indications.

After years of accumulation, iRegene has entered the fast lane in 2024-2025. Not only have multiple milestone advancements been achieved in product development, but the company has also secured over 300 million yuan in financing from investors such as Northern Light Venture Capital, Chengjing Capital, Yuanxi Haihe Fund, Fengchuan Capital, Hotang Ventures, Ceyuan Capital, Chengdu Bio-City Industrial Fund, Tigermed, and Wuhan Optics Valley Industrial Investment. So far, more than a dozen investment institutions have invested in iRegene.

On this occasion, Dingxiangyuan Insight Database andDr. Wei Jun, Founder and CEO of iRegeneEngaged in an in-depth dialogue, exploring topics such as iRegene's R&D strategy and core advantages, the challenges of iPSC therapy, entrepreneurial experiences, and the current status and future development trends of China's innovative drug environment.

Dr. Jun Wei: I think what investors value most might be the following characteristics of iRegene:

First,UtilizeiThe Potential of PSC Universal Cell Therapy in Treating Parkinson's Disease. Since 2024, our firstiPSC Product NouvNeu001 Achieves Significant Progress, Including: Phase I and Phase II Clinical Trials Initiated in China; International Multicenter Phase I Clinical Trial Launched in the U.S. and Other Countries; Granted Special Exemption and Fast Track Designations by the U.S. FDA, Among Others. These Key Advancements Have Given Investors Confidence.iThe Drugability of PSC Universal Cell Therapy Products.

SecondlyiRegene's Unique "AI + Chemical Induction" Platform. Based on the "AI + Chemical Induction" platform, a universal type has been developed.iThe safety and efficacy of the PSC therapy NouvNeu001 have been preliminarily validated. Compared with other cell therapies, the production cost of chemically induced universal cell therapy is relatively lower, offering higher patient accessibility and greater commercial value.

ThirdlyiRegene Team iniPSC's rich and solid professional accumulation, the courage to continuously achieve "0-1" breakthroughs, and the team’s efficient collaboration and execution capabilities.。

DXY Insight：Parkinson's disease is one of the main research areas of iRegene. In your opinion, what are the main challenges currently faced in the treatment of Parkinson's disease? What is iRegene's solution?

Dr. Jun Wei: Although Parkinson's disease has been discovered for a long time, its treatment options are still very limited. Currently, the main clinical treatment methods are mainly divided into two categories: one is chemical drugs.(Oral dopamine, etc.)Representative drug treatments; the other category is deep brain stimulation（DBS）Representative physical therapy.Their positioning is for symptomatic treatment or "complication management," rather than "disease-modifying" therapies.。

Parkinson's disease is caused by the loss or shedding of dopaminergic neuron cells in certain areas of the patient's brain.Cell transplantation holds promise to fundamentally repair dopaminergic neuron loss and reverse the progression of Parkinson's disease.. Therefore, iRegene hopesTreating Parkinson's Disease through Stem Cell Transplantation。

However, cell therapy is not intended to replace other treatments. Parkinson's disease is a complex condition, and the ideal treatment model in the future will involve a combination of various therapies working on different levels to maximize symptom improvement for patients. Given the variability in symptoms among patients — often described as "a thousand patients, a thousand Parkinson's" — it will also be necessary to personalize the combination of different treatment methods such as cell therapy, chemical drugs, and medical devices based on individual patient conditions to create the most suitable treatment plan.

DXY Insight：In your opinion, what are the main challenges in developing iPSC therapies? How does iRegene overcome these difficulties?

Dr. Jun Wei: Commercialization of Cell Therapy ProductsThe core challenge lies in the dual constraints of efficacy and cost.iPSC therapy is no exception. Before iRegene, some universities, research institutions, and companies overseas had already been developingiPSC cell therapy, but these products have some shortcomings, such as slow onset and unstable effects after cell transplantation into animals, as well as potential risks of tumorigenicity and immune rejection.

In response to the aforementioned shortcomings, iRegene has optimized its previous products:First, compounds are innovatively introduced to modulate the biochemical functions of transplanted cells., accelerating its dopamine secretion rate, thereby potentially enabling the product to take effect more quickly and stably;Secondly, compounds are used to inhibit the expression of HLA series molecules on the cell surface., reduce the immunogenicity of the product itself, thereby decreasing the risk of rejection after transplantation. Through such improvements, we can further enhance the efficacy and safety of the product.

The second challenge is cost control. Cell therapy involves complex processes and high-standard quality control, with pricing far exceeding that of traditional chemical drugs, making payment a persistent issue. iRegene took into account scientific background, patient experience, methods of drug administration by doctors, affordability, and other factors from the outset of project initiation, while also evaluating existing therapies for Parkinson's disease.(Including cell therapy, chemical drugs, and medical devices)A comprehensive analysis was conducted, and finally confirmedDetermined to use a chemical induction platform to produce functionally enhanced universal cell drugs, thereby reducing production costs., to improve the accessibility of the product for patients.

DXY Insight：iRegene's First Product NouvNeu001 Recently Granted FDA Fast Track Designation: Can You Introduce the Advantages and Potential of This Product in Treating Parkinson’s Disease?

Dr. Jun Wei: NouvNeu001 is the company's first product, andThe World's First iPSC-Derived Universal Dopamine Progenitor Cell Therapy Product to Enter Clinical StageThe completed Phase I clinical trial data shows that in Parkinson's disease patients 15 months post-transplant, NouvNeu001 has demonstrated good safety and tolerability. Meanwhile, PET imaging analysis also confirms that with the increase in transplant duration, NouvNeu001 cells have achieved long-term survival in vivo without immunosuppressants. Behavioral and non-behavioral efficacy indicators already exhibit a significant competitive advantage in the global market. UPDRS III motor function scores show substantial improvement during the "on" period.（Symptom relief)Effects such as prolonged time。

Due to the advantages of the NouvNeu001 R&D platform and Phase I clinical data,The FDA granted it special exemption status in 2024 and recently awarded it Fast Track designation.，It is the world's first iPSC-derived universal Parkinson's disease cell therapy product to receive FDA Fast Track designation.In addition, the FDA has also approved NouvNeu001 for expanded use in other compassionate medication applications, which can greatly enhance the clinical application value and commercial scenarios of NouvNeu001. Currently, NouvNeu001 is undergoing Phase II clinical trials for the treatment of Parkinson's disease, and we will accelerate the progress to bring it to market as soon as possible.

DXY Insight：What is the overall development strategy for iRegene's pipeline? Besides NouvNeu001, what other products are currently under research by the company?

Dr. Wei Jun: The core strategy of iRegene is to select the most suitable direction for regenerative medicine, focus on the field of developmental biology where it excels, and target degenerative diseases that currently lack effective interventions. The company’s current pipeline primarily centers on the central nervous system.（CNS）And in the field of ophthalmology.

In the CNS field, the company's core product, NouvNeu001, is planned to complete dosing for all patients in the Phase II clinical trial by the end of this year. Based on the approval process for cell therapy products in China, if everything goes smoothly, NouvNeu001 is expected to be approved for marketing in 2028.

At the same time, another product of oursNouvNeu003, an iRegene-developed product for early-onset Parkinson's diseaseHave completed Phase I clinical trials. The onset of Parkinson's disease is becoming increasingly younger, and NouvNeu001 and NouvNeu003 can complement each other synergistically, covering the entire life cycle and full treatment period of Parkinson's patients. In addition, we have also developed aFor Multiple System Atrophy（MSA）Products, which has currently entered the IND application stage.

Beyond the CNS, iRegene has also ventured into the field of ophthalmic treatments. The rationale for choosing the ophthalmology track is consistent with that of Parkinson's disease: the degenerative or pathological damage associated with these conditions leads to irreversible harm to specific cells in the eye, and currently, there are no effective drug interventions available. Therefore, we similarly utilize our proprietary chemically-induced technology to obtain functional ocular cells, with the aim of providing an effective treatment option for such patients.

iRegeneThe First Ophthalmic Product NouvSight001It is a universal iPSC-derived ophthalmic cell therapy product, which was granted Orphan Drug Designation by the FDA in March 2024.

DXY Insight：Since the founding of iRegene in 2017, it has been more than 8 years. What is the biggest challenge and difficulty you have encountered since starting your business?

Dr. Jun Wei: Since starting the business, we have indeed encountered many difficulties, but I have always maintained a positive attitude towards these challenges. Whenever problems arise, I face them together with my team, tackling each issue as it comes, and focusing our greatest efforts on finding solutions and resources. In the end, all problems are solved smoothly, and through addressing these issues, both myself and the team have been tempered and grown. For iRegene, the road ahead is still long, and I think the biggest challenges and difficulties may always lie in the future, but we have full confidence in resolving these problems.

DXY Insight：What do you think are the main factors that determine the success of a company?

Dr. Wei Jun: There are many definitions and models for business success. Regardless of the model, the indispensable factors for success are timing, favorable conditions, and human harmony. For most innovative pharmaceutical companies, I believe a key factor in determining success is whether they possess differentiated products with competitive market advantages. If a company can develop a drug that combines efficacy and safety while addressing unmet clinical needs of patients, it will significantly increase the probability of success.

DXY Insight：Do you think the current火热的 license out phenomenon in China's innovative drug sector will become a常态? What is iRegene's perspective on external collaborations?

Dr. Wei Jun：Affected by the industry's overall environment in the past two years, the financing situation of Biotech companies is not optimistic overall. For many companies with limited funds, licensing out their products can generate a certain amount of cash flow to ensure the survival of the company.This火热的 license out trend may continue, but I believe it is a阶段性现象 and will not become the norm.。

For iRegene's NouvNeu001, our current focus is on advancing its registration and clinical progress. As for future development models, whether it’s licensing out or independent research and development, the team remains open-minded. The ultimate choice of model will depend on what is most beneficial for iRegene’s development at that time.

DXY Insight：What do you think Chinese pharmaceutical companies need to do in order to become MNCs?

Dr. Jun Wei: Over the past two decades, China's drug research and development sector has grown exceptionally fast, giving rise to many outstanding pharmaceutical companies. Becoming an MNC is a goal that today's Chinese pharmaceutical companies can aspire to and hopefully achieve in the future.

For Chinese pharmaceutical companies that have grown locally, to become a true MNC, I believe the first thing they need to address is their global capabilities, including cultural differences abroad, registration and submissions, clinical development, commercialization models, patient populations, payment systems, and more. Currently, some companies are already attempting to build their global operational capabilities in different overseas regions and have accumulated some experience. I believe it’s only a matter of time before Chinese pharmaceutical companies become MNCs.

DXY Insight：What is your view on the current innovative drug environment in China? Is it still in a寒冬期 (cold winter period)? What do you expect the landscape of China's innovative drug sector to look like ten years from now?

Dr. Jun Wei: I thinkIt is still in the cold winter period currently, but different from the cold winter two years ago.。The cold spell of the past two years stemmed from investors' lack of confidence in the entire industry, whereas their current caution may be more about how to choose the right investment targets and entry points. As some companies achieve product launches, commercialization, or IPOs, the market has established predictable development pathways, making investors behave more rationally. Overall, I believe the investment environment for innovative drugs is moving towards a more pragmatic direction.

Ten years later, the industry should be different from today in many aspects. First,At the technical level, I believe that the application of AI in the biopharmaceutical field will become increasingly widespread., Its application scenarios are no longer limited to specific aspects such as compound screening and design in the R&D process, but will comprehensively penetrate multiple dimensions of the biopharmaceutical industry. Companies need to actively adapt to the transformative trends brought by AI technology. It is expected that within the next decade, AI is likely to achieve significant breakthroughs in certain specific fields, potentially leading to the market launch of AI-designed drugs, which could change the treatment of certain diseases.

At the enterprise level, many companies are expected to undergo transformation. Some will evolve from Biotech to Biopharma, and we may even witness some Chinese pharmaceutical companies grow into MNCs.

In addition, the trend of Chinese drugs going overseas is expected to become more common, and their influence in overseas markets will also increase. Chinese pharmaceutical companies are very hopeful to establish the image of "Made in China" drugs in more countries and regions around the world.

Cover Source:Produced by DXY Insight Database

Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It also does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.

Editor：Xinyao

PR Article Coordination: WeChat insightxb

SubmissionWeChat: insightxb; Email: insight@dxy.cn

---