iRegene

Our Vision

Re-defining
Medicine for the Coming
Generation

Curing incurable diseases by re-programming cell fate or function.

Passionate

Reliable

Achievers

Committed

Team players

Innovative

Courageous

Engaged

Values in PRACTICE

iRegene's
mission

We are a passionate team committed
to developing first-in-class therapies
for patients suffering from major
incurable diseases. Making fast-acting
and disease-reversing therapies accessible
to patients in the greatest extent
possible is our priority.

Passionate

Achievers

Team players

Courageous

Reliable

Committed

Innovative

Engaged

Next Generation R&D Eco-system, Made by iRegene

iReMeta

Discovering Omics, Powered by AI

iReChem

Deep Learning Assisted Virtual Screening

iReXam

Compounds Validation

iReDita

Gene Editing & Reporter Cell Lines

iReCena

Designing Exosomes for Therapeutics Delivery

Pipelines

Project

Indication

IND Phase I Phase II Phase III

RIGHT

NouvNeu001

Parkinson′s Disease

China Phase II dosing completed Q1 2026;
U.S. Phase lla; FDA FTD & RMAT

NouvNeu003

Early-onset
Parkinson's Disease

NMPA IND approved Dec 11, 2023; Phase I dosing completed Mar 2025

NouvNeu004

Multiple System
Atrophy (MSA-P)

NMPA Phase I/IIl approved Oct 2025; FDA Phase I & specialexemption approved Nov 2023

NouvSight001

Retinal Degenerative
Diseases

FDA ODD approved Mar 2024；NMPA Phase I/IIl approved Sep 2026；
FDA Phase I/II & special exemption approved Sep 2026

NouvNeu002

Ischemic Stroke

IND filing targeted around Q4 2026

Contact

Wuhan Suzhou Denmark Singapore Australia Chengdu

News

iRegene Hits Dual Global Firsts: U.S. Patient Dosed in Phase IIa for NouvNeu001 in Parkinson’s and First Enrollment in China’s Randomized MSA Trial for NouvNeu004

2026-02-23

FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to iRegene’s NouvNeu001, Making It the World’s First iPSC Therapy with Both FTD and RMAT Recognitions

2026-01-19

FDA Grants RMAT Designation to iRegene’s NouvNeu001, Cementing its Lead as the World’s First iPSC Therapy with Both FTD and RMAT Recognitions

2026-01-19

Designing for scalability from day one: iRegene's foundational tech unlocks commercial cell therapies

2025-11-03

Designing for Scalability from Day One: iRegene's Foundational Tech Unlocks Commercial Cell Therapies

2025-10-27

iRegene Therapeutics announced promising NouvNeu001 Phase I clinical data

2025-10-14

iRegene Therapeutics Secures Series B+ Financing Following FDA Fast Track Designation for its Flagship Product NouvNeu001

2025-09-10

iRegene Secures Over RMB 300 Million in Landmark Series B+ Financing to Advance First-in-Class iPSC Cell Therapies

2025-09-10

Frost & Sullivan: iRegene Therapeutics Honored as

2025-06-09

iRegene Receives IND approval from U.S. FDA to Start Clinical Trial for Parkinson’s Disease

2024-06-24

NouvNeu001 Achieves Milestone with Successful Dosing of First Patient, Signaling Smooth Progress in iRegene Therapeutics’ Multicenter Clinical Trial for Innovative Novel Parkinson’s Disease Therapy

2024-02-05