Ruijian Medicine Secures Over RMB 300 Million in Series B+ Financing; iPSC-Derived Parkinson’s Therapy Receives FDA Fast Track Designation

36Kr learned that recently, iRegene (Chengdu) Pharmaceutical Technology Co., Ltd. ("iRegene") has completed a new round of B+ financing. This round of financing was jointly invested by Northern Light Venture Capital, Cowin Capital, Yuanxi Haihe and other institutions, with CEC Capital serving as the exclusive financial advisor.

The proceeds of this fundraising will be used to accelerate the clinical development of iRegene's Parkinson's disease treatment products NouvNeu001/NouvNeu003 and ophthalmic treatment product NouvSight001, as well as team building and industrialization capabilities.

iRegene was founded in 2017, focusing on the development of small molecule chemical transcriptional regulation-induced pluripotent stem cell (iPSC) products. In April this year,iRegene Announces Over 100 Million Yuan in Series B+ FinancingThe company's Series B financing has accumulated to exceed 300 million yuan.

iRegene's core product, NouvNeu001, is a chemically induced functional human-derived dopaminergic neuronal precursor cell. At the time of completing its B+ round of financing, Wei Jun, founder and CEO of iRegene, introduced to 36Kr that the product had initiated a multi-center Phase II clinical trial. In the previous Phase I clinical trial, NouvNeu001 "demonstrated good safety and tolerability" in patients 15 months post-transplantation; meanwhile, PET imaging analysis also showed that as transplantation time increased, the cells achieved long-term survival in patients without the use of immunosuppressants.

Recently, the international progress of NouvNeu001 has accelerated once again. In mid-August, the product received Fast Track Designation (FTD) from the U.S. FDA and was approved to expand its scope of application. This also means that the clinical application range and commercial scenarios of NouvNeu001 may be further expanded.

According to the company, after obtaining the FTD designation this time, the FDA will provide "targeted one-on-one guidance to the company in areas such as clinical trial design and data requirements." In addition, this designation can be used in parallel with the FDA's Breakthrough Therapy Designation (BTD), Priority Review, and Accelerated Approval, which may help expedite the market launch of NouvNeu001.

In addition, iRegene's self-developed product NouvNeu003 for early-onset Parkinson's disease is also under simultaneous development. This is a cell therapy product targeting early-onset Parkinson's patients under the age of 50, and it has completed Phase I clinical trials. The company stated that the trial successfully reached its endpoints, with the safety and efficacy of the product preliminarily validated.

In the field of ophthalmic diseases, iRegene's NouvSight001 received Orphan Drug Designation (ODD) from the U.S. FDA in March 2024. This product is primarily used to treat a series of indications related to retinitis pigmentosa.

Founders and Investors' Perspectives:

iRegene Founder and CEO Wei Jun expressed gratitude to both new and existing investors for their trust and continued support, as well as to CEC Capital and the iRegene team for their close collaboration. iRegene has always adhered to the mindset of a pioneer, aiming to achieve groundbreaking progress from 0 to 1 in major international disease areas. This round of financing will greatly accelerate iRegene's international development and industrialization efforts, enabling the company to navigate through cycles and expedite product launches.

Song Gaoguang, partner of Northern Light Venture Capital, stated that iRegene focuses on iPSC drug development. With its leading chemical induction technology platform and professional execution team, it 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, demonstrating excellent safety and efficacy in previous clinical trials. This also marks that China now has the capability to compete with the United States and Japan in the iPSC field.

Song Longtao, Managing Partner of Chuangjing Capital, stated that 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 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 involvement in chemically induced cell drug development. Through chemical small molecule induction, the company is poised to achieve the industrial goal of low-cost, high-quality production in the future.

Yuan Xihaihe Investment’s person in charge stated that the iRegene team has deep expertise in the iPSC drug field. Through differentiated technical layouts and highly efficient clinical development strategies, their 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 wide population of Parkinson's disease patients.

Fang Yang, Executive Director of CEC Capital, stated that CEC Capital is honored to assist iRegene in successfully completing this round of financing. The company has consecutively completed multiple rounds of financing exceeding 100 million yuan in a short period, not only demonstrating the continued high attention from the capital market to the iPSC sector 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 field in the future.