
Cell Therapy Product Developer
▎WuXi AppTec Content Team Report

iRegene was founded in 2017 as an innovative biopharmaceutical company focused on the field of regenerative medicine. Through its unique technology platform,Focus on Small Molecule Chemical Transcriptional RegulationInduced Pluripotent Stem Cells (iPSC), thereby developing universal chemically induced cell therapy drugs.
NouvNeu001 Injection isiRegene has developed aChemically Induced Functional Human Dopaminergic Neuronal Precursor CellsIn August 2023, it received approval from China's NMPA to conduct Phase 1-2 combined clinical trials. To date, the NouvNeu001 study has completed dosing for all 10 enrolled patients, with the longest follow-up data exceeding one year. Overall, the patients have shown good safety and tolerability.Six months after transplantation, the patient showed significant improvement in UPDRS III motor function, prolonged "on" periods, and other positive effects. Meanwhile, PET imaging analysis also confirmed that with the increase of transplantation time, there was a significant enhancement in dopamine transporter activity in the transplanted area, verifying the healthy survival of the product in the patient’s body post-transplantation.Based on Phase 1 data, iRegene is expected to officially commence Phase 2 clinical trials in the near future.
Internationally, in June 2024, the U.S. FDA also officially approved the IND application for NouvNeu001. iRegene expects to formally initiate Phase 1 clinical enrollment in the U.S. in H1 of this year.
At the same time, iRegene is facingEarly-Onset Parkinson's DiseaseThe second product, NouvNeu003, also received NMPA approval to enter Phase 1 clinical trials in December 2023. Currently, the Phase 1 clinical trial has completed patient enrollment and dosing, demonstrating good safety and tolerability of the product, successfully achieving the primary objectives of the study.
iRegene is also continuously exploring in the field of ophthalmic diseases.iPSC-Derived Universal Ophthalmic Cell Therapy Product NouvSight001Granted Orphan Drug Designation by the FDA in March 2024, the product is intended for"Series of Indications for Retinitis Pigmentosa"To carry out development.
References:
[1]iRegene Completes Over 200 Million Yuan in Financing, with CEC Capital Serving as the Exclusive Financial Advisor.Retrieved Apr 11,2025, From https://mp.weixin.qq.com/s/snb0Ahp3oaKXHlAYe1hTaA
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