U.S. Food and Drug Administration (FDA) approved the IND application for NouvNeu001, a cell therapy product from iRegene therapeutics targeting Parkinson's Disease. This marks a significant milestone as NouvNeu001 becomes the world's first chemically induced allogeneic cell therapy product to enter clinical stages for Parkinson's disease in the US. Previously, the "Combined Phase I/II Clinical Study" of NouvNeu001 had already received approval from China NMPA in August 2023 and demonstrated positive safety and efficacy data in its Phase I trials. On June 20, 2024, iRegene further announced IND approval of NouvNeu001 by the U.S. FDA for the treatment of mid-to-late stage of Parkinson's disease.

Notably, in March 2024, iRegene was granted the exemption from the FDA, highlighting the recognition of iRegene's pioneering platform and innovative production and quality systems.

Dr. Cai Meng, the CMO of iRegene, emphasized that obtaining the exemption from the FDA, followed by the IND approval for NouvNeu001, underscores iRegene's professionalism in developing innovative chemically induction platform. This milestone also paves the way for subsequent international operations of iRegene.

iRegene is among the early biotech companies globally to apply "AI + chemical induction" for the specific functional modification of cells. This platform offers significant advantages, including higher efficiency, safety, cost-effectiveness, and suitability for large-scale industrial production. Leveraging this unique platform, iRegene has developed a robust pipeline of universal iPSC derived cell products aimed at treating "incurable" diseases such as neurodegenerative disorders, including Parkinson's disease and blindness. Due to the originality of iRegene's technological platform and the strong advantages demonstrated in product development, the FDA granted a special exemption for iRegene's groundbreaking product in March 2024.

In early 2024, clinical trials for NouvNeu001 were successfully initiated at Beijing Hospital and Zhongnan Hospital of Wuhan University in China. By integrating the advantageous clinical resources of neurosurgery, neurology, and other departments, a systematic evaluation of the safety, tolerability, and efficacy of stereotactic bilateral intracerebral injections of NouvNeu001 for mid-to-late stage Parkinson's disease is being conducted. The clinical project is currently in its acceleration stage. Preliminary results from the ongoing multicenter clinical study have indicated that the patients received NouvNeu001 showed consistently significant improvements in MDS-UPDRS Part III (motor) scores, and good safety with no cell product related adverse effects.

Following the significant progress of the NouvNeu001 clinical trial and the preliminary positive efficacy and safety data, iRegene will soon commence patient recruitment for the clinical trial of its early-onset Parkinson's disease product, NouvNeu003, which was also approved by China NMPA in December 2023.

Beyond neurodegenerative diseases, iRegene continues to explore other "incurable" diseases. On March of this year, iRegene's breakthrough ophthalmic product, NouvSight001, was granted Orphan Drug Designation (ODD) by the FDA. This product targets retinal diseases and is a first of its kind induced pluripotent stem cell (iPSC)-derived ophthalmic allogeneic cell therapy developed by iRegene's team also from company's unique "AI+ chemical induction" platform.

Dr. Wei Jun, CEO of iRegene, highlighted that the team's efforts in maintaining rigorous standards of innovative products while ensuring steady progress in R&D. The project advancement plan previously set by iRegene is scheduled to the "week", laying an indispensable foundation for the timely clinical entry of core pipelines. "On the basis of cautious and robust R&D efforts, iRegene aims to leverage its innovative technologies to bring breakthroughs for a multitude of currently incurable diseases, bringing hope to patients and families deeply affected by these conditions. Dual approval of IND applications of NouvNeu001 by the U.S. FDA and China NMPA further boosts the confidence of iRegene's global team in building a world-class innovative platform," said Dr. Wei Jun.