Ruijian Pharmaceuticals Secures Over RMB 100 Million in Series B Financing to Accelerate Global Expansion and Advance Clinical Pipeline

Recently, iRegene, a company dedicated to becoming a global leader in universal chemically induced cell therapy drugs, announced the completion of an over RMB 100 million Series B financing round. This round was jointly led by ORINNO CAPITAL and Guosheng Capital, with participation from well-known industry investment institutions and Wuhan Optics Valley Industrial Investment.

CEC CAPITAL served as the exclusive financial advisor to iRegene in this round of financing.

At the same time, the company'sSeries B+ FinancingIt is also about to enter the final stage and will be completed soon, indicating that the company's products continue to gain favor in the capital market. CEC CAPITAL will continue to serve as the exclusive financial advisor for subsequent rounds.

Dr. Wei Jun, Founder and CEO of iRegene"It is a great honor to receive strong support from new shareholders, and we are deeply grateful for the continued encouragement from our existing shareholders. Special thanks also go to CEC CAPITAL and the iRegene team for their close collaboration. iRegene has always adhered to the principle of addressing genuine clinical needs by starting from the patients' demands, using original innovation to develop groundbreaking therapies that can truly reverse disease progression. This round of financing will further solidify the foundation for iRegene to accelerate its clinical progress, and the team will continue to work hard to bring entirely new therapies to a wide range of patients. Additionally, the completion of this financing will also provide momentum for the company's further expansion into international markets."

Dr. Yang Fang, Executive Director of CEC CAPITALSaid: "iRegene, with its globally leading small molecule chemical transcriptional regulation iPSC technology platform, is developing a new generation of chemically induced cell therapies. In the past few years, it has demonstrated impressive growth and progress, gradually growing into one of the top companies in the iPSC field worldwide. iRegene's solid R&D and clinical advancement have established its leading position in product development, industrial implementation, and other aspects. We look forward to iRegene further accelerating the industrialization and commercialization of its pipeline through this round of financing, continuing to drive biopharmaceutical innovation, and bringing revolutionary changes to the global healthcare field."

The funds from this round of financing will be used to accelerate the advancement of the company's Parkinson's disease treatment product, NouvNeu001.NouvNeu003, and the China-U.S. clinical advancement of ophthalmic treatment product NouvSight001, strengthen the R&D advancement of multiple innovative pipelines and the establishment of clinical capabilities, as well as intensify the company's industrialization efforts.

NouvNeu001 Injection, fully independently developed by iRegene, is a chemically induced functional human dopaminergic neuron precursor cell.The World's FirstThe universal cell therapy product based on chemical induction that has entered the clinical stage was approved by the National Medical Products Administration (NMPA) in August 2023 to conduct a combined Phase I-II clinical study. To date, the safety of the subjects has been favorable, with significant improvements generally observed in motor function and quality of life. iRegene has now become the company with the largest accumulation of patient data in the registrational clinical stage globally in the field of iPSC-derived cell therapy for Parkinson's disease.

On June 20, 2024, the U.S. Food and Drug Administration (FDA) officially approved the IND application for iRegene's Parkinson's pipeline NouvNeu001. As the world's first chemically induced, off-the-shelf cell therapy product in the Parkinson’s field to enter the clinical stage, it has achievedIND in China and the United States"Double Submission and Double Approval"

It is worth mentioning that in March this year, iRegene also obtainedSpecial Exemption Granted by the FDA(Exemption), represents the FDA's recognition of the company's pioneering platform and the innovative production and quality systems established on this platform.

Recently, iRegene presented significant findings from the low-dose group of the first Phase I clinical trial of NouvNeu001, a Parkinson's cell therapy product, at the MDS Annual Meeting in Philadelphia, USA. The results preliminarily confirmed the positive therapeutic effects of chemically induced functional dopamine precursor cell products on mid-to-late stage Parkinson's disease. The Phase I clinical trial of the early-onset Parkinson’s project, NouvNeu003, is also nearing completion of its dose expansion phase, marking an important step for iRegene in covering the entire course of Parkinson’s disease.

iRegene is also continuously exploring in the field of ophthalmic diseases. The company's breakthrough ophthalmic product, NouvSight001, received approval in the United States in March this year.FDA Grants Orphan Drug Designation(Orphan Drug Designation, ODD). Targeting the treatment of "a series of retinitis pigmentosa indications," this product is the first universal ophthalmic cell therapy product derived from induced pluripotent stem cells (iPSC) developed by the iRegene team based on the company's unique "AI + chemical induction" platform.

iRegene was founded in 2017 as an international innovative biopharmaceutical company focused on the field of regenerative medicine. By leveraging a unique technology platform, the company concentrates on small-molecule chemical transcriptional regulation of iPSC. Its core team originates from the University of Cambridge and the Roslin Institute in the UK. Meanwhile, the company is deeply rooted in China, collaborating extensively with top-tier Chinese research institutions to establish the world's first one-stop cell drug R&D platform based on "Artificial Intelligence (AI) + Chemical Induction." iRegene boasts a pipeline of First-in-Class (FIC) products covering neurodegenerative diseases, ophthalmology, and more.