iRegene completes over RMB 300 million in series B financing against the trend
Recently, iRegene, a company dedicated to becoming a globally leading universal chemically induced cell therapy drug enterprise, announced the completion of its B+ round of financing. This round of financing was jointly completed by Northern Light Venture Capital, Qingdao Chuangjing Private Equity Fund Management Co., Ltd., and Yuanxi Haihe (Tianjin) Biomedical Industry Fund Partnership (Limited Partnership).
CEC Capital served as the exclusive financial advisor to iRegene in this round of financing.
The company rapidly completed multiple rounds of large-scale financing within just a few months, securing a total of over RMB 300 million. This represents the largest financing in China’s iPSC field in recent years and fully reflects investors’ strong recognition and confidence in iRegene as a leading enterprise in the industry.
The funds raised in this round will be used to accelerate the domestic and international clinical development of the company’s Parkinson’s disease therapy products NouvNeu001/NouvNeu003 and ophthalmology therapy product NouvSight001, while strengthening the company’s early-stage R&D and clinical teams and accelerating its industrialization capabilities.
iRegene's self-developed NouvNeu001 injection, as the world’s first iPSC-derived universal-type dopamine progenitor cell therapy product to enter clinical trials, officially launched its multi-center Phase II clinical trial in April 2025. Data from the earlier Phase I clinical trial indicated that patients exhibited good safety and tolerability 15 months post-transplantation. PET imaging analysis also confirmed the long-term survival of the cells in vivo without immunosuppressants as the transplantation time increased. Behavioral and non-behavioral efficacy indicators have demonstrated significant competitive advantages globally. Marked improvements were observed in UPDRS III motor function scores, including substantial enhancement in mobility and extended "on" periods, among other positive outcomes.
On August 15, 2025, NouvNeu001 injection received the Fast Track Designation (FTD) from the FDA and was approved to expand its scope of application. This marks the first FTD designation for a universal iPSC-derived Parkinson's cell therapy product globally. Additionally, this comes after the product received Special Exemption from the FDA in March 2024, further obtaining support through the FDA’s FTD accelerated pathway. This significant milestone signifies that NouvNeu001 has officially entered the international accelerated track, reflecting the FDA’s strong recognition of iRegene’s clinical data for NouvNeu001. After receiving FTD status, the FDA will engage more frequently with iRegene, providing targeted one-on-one guidance on aspects like clinical trial design and data requirements. iRegene has also gained the qualification for rolling communication with the FDA without time restrictions. More importantly, the granting of FTD also allows NouvNeu001 to expand its scope of application to include other compassionate use cases, greatly enhancing the clinical application value and commercial scenarios of NouvNeu001. What is particularly noteworthy is that FTD can be pursued in parallel with Breakthrough Therapy Designation (BTD), Priority Review, and Accelerated Approval, speeding up the market launch of iRegne Pharma’s NouvNeu001 and bringing this clinically significant therapy to patients as quickly as possible.
Globally, iRegene's iPSC-derived universal cell therapy project NouvNeu001 has received multiple designations from the FDA. In March 2024, it first obtained special FDA exemption, and in June 2024, the FDA approved its IND to initiate an international multicenter Phase I clinical trial overseas. On the international competitive front, BlueRock Therapeutics was fully acquired by Bayer in August 2019 at a valuation of $1 billion. Its core pipeline product, Bemdaneprocel (BRT-DA01), is an embryonic stem cell-derived cell therapy that received RMAT (Regenerative Medicine Advanced Therapy) designation in August 2023. In January 2025, the FDA granted BlueRock Therapeutics' BRT-DA01 direct exemption from Phase II clinical trials for the treatment of Parkinson’s disease, allowing it to advance directly to confirmatory Phase III clinical trials.
In addition, iRegene's self-developed product NouvNeu003 for early-onset Parkinson's disease was officially approved for Phase I clinical trials in December 2023, becoming the world’s first iPSC-derived universal cell therapy product to enter the registered clinical stage for early-onset Parkinson’s disease. This product addresses the increasingly younger onset of Parkinson’s disease. With this, iRegene has achieved full lifecycle and full treatment cycle coverage for Parkinson’s patients. Currently, NouvNeu003 has completed Phase I clinical trials, with preliminary verification of safety and efficacy, successfully reaching the study endpoint. This marks an important step for iRegene in covering the entire course of Parkinson’s disease.
At the same time, iRegene continues to explore in the field of ophthalmic diseases. The company's breakthrough ophthalmic product NouvSight001 received Orphan Drug Designation (ODD) from the U.S. FDA in March 2024. This product targets the treatment of a series of retinitis pigmentosa indications and is the first universal iPSC-derived ophthalmic cell therapy product developed by iRegene.
Currently, iRegene has become one of the leading enterprises in the international pluripotent stem cell field. The completion of this round of financing will further solidify its strategic layout, deepen technological innovation and industrial transformation, and accelerate the realization of its global strategic goals.
Dr. Wei Jun, founder and CEO of iRegene, stated, we would like to express our heartfelt gratitude to both new and existing investors for their trust and continuous support in iRegene, as well as to CEC Capital and the iRegene team for their close collaboration. iRegene has always adhered to the mindset of a pioneer, aspiring to make breakthroughs in major international disease areas from 0 to 1. The iRegene team has always focused on genuine clinical needs and patient demands, meticulously developing entirely new therapies that can truly reverse disease progression. This round of financing will significantly accelerate iRegene's international development and industrialization efforts, carrying the company through cycles and expediting product launches.
Song Gaoguang, partner of Northern Light Venture Capital, shared that they are honored to co-lead this round of financing for iRegene. iRegene focuses on iPSC Drug Development, with its leading chemical induction technology platform and professional execution team, has made remarkable progress in the field of regenerative medicine. In particular, its first pipeline for treating Parkinson’s disease has successfully advanced to Phase II clinical trials, showing excellent safety and efficacy in previous trials. This also marks that China has gained the ability to compete on the same stage as the United States and Japan in the iPSC field. Parkinson’s disease, as a common neurodegenerative disorder, imposes a heavy burden on patients and their families, and currently lacks an effective cure. The emergence of iPSC drug therapy is expected to change this situation, offering patients safer, more effective, and affordable treatments. We continue to be optimistic about and fully support iRegene, facilitating the development of more regenerative cell products to make a positive contribution to human health.
According to Song Longtao, Managing Partner of Qingdao Chuangjing Private Equity Fund Management Co., Ltd., Qingdao Chuangjing Private Equity Fund Management Co., Ltd. is honored to co-lead the current round of financing for iRegene. iRegene NouvNeu001, as the world's first iPSC-derived universal Parkinson’s cell therapy product to enter Phase II clinical trials, has already demonstrated global Best-in-Class (BIC) potential with its Phase I clinical data. It is currently advancing rapidly through clinical trials and is expected to become the world’s first approved iPSC-based cell therapy. We are optimistic about the founding team's long-term expertise and deep commitment to chemically induced cell drug development. Through a small molecule induction approach, the company aims to achieve the industrial goal of low-cost, high-quality production. Based on a fully self-developed foundational technology platform and process methodology, the company has established multiple pipelines, including early-onset Parkinson’s disease, multiple system atrophy, and retinal degeneration. We look forward to the company continuing to lead the development of iPSC cell therapy and addressing unmet clinical needs.
A representative of Yuanxi Haihe (Tianjin) Biomedical Industry Fund Partnership (Limited Partnership) said, it is a great honor to participate in the financing of iRegene. The iRegene team has deep expertise in the iPSC drug field. Through differentiated technology deployment and efficient clinical development strategies, its first pipeline, NouvNeu001, has entered Phase II clinical trials and has already demonstrated superior efficacy and safety. Meanwhile, iRegene’s universal drug design enables low-cost, high-efficiency production, making the drug more accessible to a broad population of Parkinson's disease patients. We look forward to iRegene’s further clinical progress and the application of its iPSC technology platform across more indications to benefit more patients.
Fang Yang, Executive Director of CEC Capital, mentioned that CEC is glad to assist iRegene in successfully completing this round of financing. The company completed multiple rounds of financing exceeding RMB 100 million each in a short period, not only highlighting the sustained strong interest of the capital market in the iPSC field but also further confirming iRegene’s leading position in technology platforms and product development. We look forward to iRegene bringing more disruptive innovations and breakthroughs to the global healthcare sector in the future.
iRegene NouvNeu001 Project Milestone Timeline
August 3, 2023: NouvNeu001 received approval from China’s NMPA to conduct combined Phase I/II clinical trials for moderate-to-severe Parkinson’s disease in China.
December 2023: NouvNeu001 officially initiated Phase I clinical trials at the National Center for Geriatrics, Peking Hospital, Ministry of Health, China.
March 2024: The U.S. FDA granted NouvNeu001 a special exemption, recognizing iRegene’s breakthrough innovation platform and comprehensive quality system, and waived certain U.S. Pharmacopeia requirements for NouvNeu001.
June 2024: The U.S. FDA approved the IND for NouvNeu001 to initiate international multicenter Phase I clinical trials in the U.S. and other countries.
November 2024: NouvNeu001 completed patient enrollment for Phase I clinical trials in China.
April 2025: NouvNeu001 officially initiated Phase II clinical trials in China.
April–June 2025: NouvNeu001 initiated overseas multicenter Phase I clinical trials in multiple countries.
July 2025: The first patients received dosing in the Phase II clinical trial of NouvNeu001.
August 15, 2025: NouvNeu001 further received Fast Track Designation (FTD) from the FDA.