iRegene
iRegene Therapeutics is a clinical-stage Chinese biotechnology company developing first-in-class iPSC-derived cell therapies via a proprietary chemical induction platform, targeting Parkinson's disease, MSA, retinal degeneration, and ischemic stroke across U.S. and Chinese trials.
- Company typePrivate
- Founded2017
- HeadquartersWuhan, China
- Headcount51–100
- GTM typeB2B
- OfferingServices
What iRegene does
iRegene Therapeutics is a clinical-stage Chinese biotechnology company developing first-in-class iPSC-derived cell therapies for incurable neurodegenerative, ophthalmologic, and neurological diseases. Its core platform applies a proprietary chemical induction-based cell reprogramming approach, which avoids genetic modification and is positioned as safer and more scalable than conventional iPSC methodologies. The pipeline comprises five candidates: NouvNeu001 for Parkinson's disease, NouvNeu003 for early-onset Parkinson's, NouvNeu004 for Multiple System Atrophy-Parkinsonian type (MSA-P), NouvSight001 for retinal degenerative diseases, and NouvNeu002 for ischemic stroke. Supporting the pipeline is a five-module AI-augmented R&D ecosystem — iReMeta (AI-powered omics discovery), iReChem (deep learning virtual screening), iReXam (compound validation), iReDita (gene editing and reporter cell lines), and iReCena (exosome engineering) — applied to discovery, screening, and validation workflows rather than as standalone commercial products.
The company is pre-revenue and funded entirely through venture capital, with cumulative disclosed funding exceeding $58M across rounds in 2020, 2024, 2025, and 2026, including a Series B+ of over RMB 300 million (~$42M) in September 2025 and a further ~$31M round in June 2026. The lead program NouvNeu001 has secured three FDA designations — Orphan Drug (via NouvSight001), Fast Track, and Regenerative Medicine Advanced Therapy (RMAT), the latter making iRegene the world's first iPSC therapy developer to hold both FTD and RMAT recognitions. Active clinical operations include a Phase II trial in China (to be completed no later than Q4 2026) and a Phase IIa trial in the U.S. (first patient dosed February 2026), with parallel Phase I/III approvals in China and Phase I approval with special exemption in the U.S. for NouvNeu004.
iRegene is headquartered in Wuhan with offices in Suzhou, Chengdu, Singapore, Aarhus (Denmark), and Dundas (Australia), and operates 51–100 employees across these jurisdictions. The business model targets eventual commercialization of cell therapies directly and through pharmaceutical licensing, co-development, and royalty partnerships. The company is led by CEO Jun Wei and reaches customers through PR-driven earned media, scientific publications, milestone announcements, and a bilingual corporate website rather than traditional field sales, consistent with its clinical-stage status.
iRegene firmographics
Firmographics- Name
- iRegene
- Legal name
- iRegene Therapeutics
- Website
- https://iregene.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- iRegene Therapeutics is a clinical-stage Chinese biotechnology company developing first-in-class iPSC-derived cell therapies via a proprietary chemical induction platform, targeting Parkinson's disease, MSA, retinal degeneration, and ischemic stroke across U.S. and Chinese trials.
- Ownership category
- akta.pro rank
iRegene industry classification
Industry- Product category
- Regenerative Cell Therapy
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (3254), Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Neurology/CNS Gene Therapies (HLAAACAH)
- akta.pro secondary industries
- Target Identification & Validation Platforms (omics-driven, chemoproteomics, genetic validation) (HLAAAIAI), Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL), Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)
Keywords
Where iRegene is headquartered
LocationHeadquarters
- HQ city
- Wuhan
- HQ country
- China
- HQ region
- Asia
Offices6 records
Markets served
iRegene business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Infrastructure, Marketing or Sales
Revenue model
- Future cell therapy commercialization: iRegene is a clinical-stage biotech without current product revenue. Future revenue is expected to come from commercialization of first-in-class iPSC-derived cell therapies (NouvNeu001, NouvNeu003, NouvNeu004, NouvSight001, NouvNeu002) for Parkinson's disease, MSA, retinal degenerative diseases, and ischemic stroke, with potential upfront payments, milestones, and royalties from pharma partnerships.
- Equity financing: Pre-commercial biotech funded through venture capital and strategic investment rounds, including a Series B+ financing of over RMB 300 million secured in September 2025 following FDA Fast Track Designation.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | — | Therapy and partnership pricing not publicly disclosed |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels4 records
iRegene product offering
Product offeringCore offering
iRegene is a clinical-stage biotechnology company that develops first-in-class iPSC (induced pluripotent stem cell)-derived cell therapies for incurable diseases, using a proprietary chemical induction-based cell reprogramming platform supported by an AI-augmented discovery ecosystem. Its current pipeline includes NouvNeu001 for Parkinson's disease, NouvNeu003 for early-onset Parkinson's, NouvNeu004 for multiple system atrophy (MSA-P), NouvSight001 for retinal degenerative diseases, and NouvNeu002 for ischemic stroke. The company has secured FDA Fast Track Designation, RMAT Designation, and Orphan Drug Designation for its candidates and expects future commercialization through licensing and co-development with pharmaceutical partners.
Differentiator
Problem solved
Functional benefit
Brands
- iReMeta: Omics discovery platform powered by AI, part of iRegene's next-generation R&D ecosystem.
- iReChem
- iReXam
- iReDita
- iReCena
Products and services
- NouvNeu001 iPSC-derived cell therapy candidate for the treatment of Parkinson's Disease; lead asset in iRegene's pipeline, in Phase II trial in China (to be completed no later than Q4 2026) and Phase IIa trial in the United States; recipient of FDA Fast Track Designation, RMAT Designation, and Special Exemption.
- NouvNeu003 iPSC-derived cell therapy candidate for the treatment of early-onset Parkinson's Disease; Phase I trial has been completed.
- NouvNeu004 iPSC-derived cell therapy candidate for the treatment of Multiple System Atrophy (MSA-P); received Phase I/III trial approval from China's NMPA and Phase I trial approval with "special exemption" from the US FDA in late 2025.
- NouvSight001 iPSC-derived cell therapy candidate for the treatment of inherited and age-related retinal degenerative diseases; received FDA Orphan Drug Designation on March 20, 2024, with IND application planned around Q2 2026.
- NouvNeu002 iPSC-derived cell therapy candidate for the treatment of ischemic stroke; IND application planned for submission around Q4 2026.
Quantifiable outcome
- World's first iPSC therapy with both FDA Fast Track Designation and RMAT Designation
- +2 more outcomes
Companies that use iRegene
Customer profileSegments4 records
Ideal customer profiles2 records
iRegene technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability6 records
Feature6 records
iRegene partnerships and signals
Strategic signalScale indicators8 records
Recent moves7 records
Expansion highlights6 records
iRegene competitors and assessment
Company assessmentDirect peers
- BlueRock Therapeutics: Clinical-stage iPSC-derived cell therapy company (Bayer-owned) developing dopaminergic neuron therapies for Parkinson's disease — directly competing with iRegene's NouvNeu001 program and targeting the same patient population with similar iPSC-derived neural cell approach.
- Aspen Neuroscience: U.S. clinical-stage biotech developing autologous iPSC-derived dopaminergic neuron cell therapy for Parkinson's disease (ANPD001), making it the closest direct competitor to iRegene's NouvNeu001 in indication, modality, and patient segment.
- Century Therapeutics: Clinical-stage iPSC-derived allogeneic cell therapy company developing engineered NK and T-cell therapies for oncology; comparable to iRegene as a pure-play iPSC platform company leveraging genetic engineering and AI-driven discovery to build multi-asset pipelines.
- Fate Therapeutics: Clinical-stage cell therapy company developing iPSC-derived NK and T-cell product candidates for cancer and autoimmune diseases; shares iPSC-platform architecture and Phase I/II clinical-stage profile with iRegene, though focused on immuno-oncology rather than regenerative medicine.
- Sana Biotechnology: Clinical-stage cell therapy company developing engineered cell therapies (including hypoimmune iPSC-derived cells) for Parkinson's disease and oncology; directly comparable in modality, target indication overlap with NouvNeu001, and platform-driven multi-asset strategy.
Emerging players
- Cyto Therapeutics: Stem cell and iPSC-derived regenerative medicine company developing cell therapies for neurological and ophthalmologic indications; overlaps with iRegene's pipeline across retinal degeneration and neurodegenerative disease, though typically earlier-stage and U.S.-based.
- Semma Therapeutics (Vertex-owned legacy): Stem cell therapy developer (acquired by Vertex) that pioneered islet cell differentiation approaches; relevant as a comparator in the regenerative cell therapy category, particularly for understanding late-stage cell therapy commercialization economics.
Broad incumbents
- Sumitomo Pharma (Sumitomo Dainippon Pharma): Major Japanese pharmaceutical company developing allogeneic iPSC-derived cell therapies (e.g., Parkinson's program with Kyoto University / Ractigen partnership context) and other regenerative medicines — a broader incumbent that competes in the same Parkinson's cell therapy space with deeper capital and existing iPSC infrastructure.
- Vertex Pharmaceuticals: Large-cap pharmaceutical company with a late-stage cell therapy program (VX-880 / zimislecel) for type 1 diabetes and broader regenerative medicine ambitions through its subsidiary ViaCyte; representative of the Big Pharma end-game iRegene may partner with or compete against for cell therapy commercialization.
Regional players
- Cellular Biomedicine Group (CBMG): China- and U.S.-based clinical-stage cell therapy company developing CAR-T, MSC, and iPSC-related regenerative medicine products; comparable as a Chinese-headquartered cell therapy peer with cross-border clinical operations, though focused primarily on immuno-oncology rather than neurological indications.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
iRegene social profiles
Digital presenceiRegene financial estimates
Financial estimateRevenue estimate
Valuation estimate
iRegene leadership team
Management profileNumber of profiles
Profiles1 record
iRegene subsidiaries and ownership
Company hierarchySubsidiaries5 records
iRegene funding detail
Funding detailFunding overview
Funding rounds6 records
Investors20 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
iRegene M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about iRegene
What does iRegene do?
iRegene is a clinical-stage biotechnology company that develops first-in-class iPSC (induced pluripotent stem cell)-derived cell therapies for incurable diseases, using a proprietary chemical induction-based cell reprogramming platform supported by an AI-augmented discovery ecosystem. Its current pipeline includes NouvNeu001 for Parkinson's disease, NouvNeu003 for early-onset Parkinson's, NouvNeu004 for multiple system atrophy (MSA-P), NouvSight001 for retinal degenerative diseases, and NouvNeu002 for ischemic stroke. The company has secured FDA Fast Track Designation, RMAT Designation, and Orphan Drug Designation for its candidates and expects future commercialization through licensing and co-development with pharmaceutical partners.
Is iRegene a public or private company?
iRegene is a private company. It is classified as venture growth investor backed and is currently operating.
When was iRegene founded?
iRegene was founded in 2017. It employs 51 to 100 people.
Where is iRegene based?
iRegene is headquartered in Wuhan, China, in the Asia region.
How does iRegene make money?
Two revenue lines are on record. Future cell therapy commercialization is the primary driver. The others are equity financing.
Who are iRegene's main competitors?
Direct peers on record are BlueRock Therapeutics, Aspen Neuroscience, Century Therapeutics, Fate Therapeutics and Sana Biotechnology. Emerging players are Cyto Therapeutics and Semma Therapeutics (Vertex-owned legacy). Broad incumbents are Sumitomo Pharma (Sumitomo Dainippon Pharma) and Vertex Pharmaceuticals. Cellular Biomedicine Group (CBMG) is listed as a regional player.
Does iRegene have an API?
No public API is recorded for iRegene.
What industry is iRegene in?
iRegene's product category is Regenerative Cell Therapy. Its primary akta.pro industry code is HLAAACAH, Neurology/CNS Gene Therapies, with a secondary code of HLAAAIAI, Target Identification & Validation Platforms (omics-driven, chemoproteomics, genetic validation). Its NAICS code is 541714 and its SIC code is 2834.