Chengdu, China – September 29, 2026 -- iRegene Therapeutics has secured clinical trial clearances in both China and the United States for NouvSight001, an off-the-shelf cell therapy targeting retinitis pigmentosa (RP), a retinal disease affecting roughly 1.5 million people worldwide.
China's NMPA clears Phase I/III trial while FDA grants Phase I/II clearance with special exemption
China's National Medical Products Administration authorized a Phase I/III trial to assess safety, tolerability and preliminary efficacy of NouvSight001 in RP patients. The U.S. FDA separately cleared a Phase I/II trial for the same indication and granted a special exemption, building on the Orphan Drug Designation the agency awarded the program in 2024.
Allogeneic photoreceptor therapy bypasses genotype restrictions limiting current treatment options
NouvSight001 is an allogeneic, off-the-shelf photoreceptor cell therapy built on iRegene's proprietary "AI + Chemical Induction" platform. Unlike the only currently approved RP therapy, which is restricted to patients with biallelic RPE65 mutations -- a small subset of the RP population -- NouvSight001 is designed as a cell replacement therapy not limited to a specific disease-causing genotype.
Second program advances under same platform following Parkinson's disease candidate NouvNeu001
NouvSight001 marks iRegene's second internally developed cell therapy to reach dual clinical clearance in the U.S. and China, following its Parkinson's disease program NouvNeu001. The company's pipeline now spans the central nervous system, visual system and neurovascular system, including programs for Parkinson's disease, multiple system atrophy, retinal degenerative diseases and ischemic stroke.
Company frames dual clearances as validation of repeatable, multi-indication R&D platform
Tianshi Ruan, Chief Financial Officer of iRegene Therapeutics, said NouvNeu001 provided the company hands-on experience navigating both NMPA and FDA regulatory frameworks for an iPSC-derived cell therapy, and that NouvSight001 applies that experience to ophthalmology. Ruan added that the company will continue advancing core programs in U.S. and China clinical development while exploring global multicenter studies and international commercial partnerships.
iRegene said its cross-border capabilities -- spanning CMC and quality systems meeting FDA and NMPA requirements, allogeneic manufacturing, cold-chain logistics, and clinical operations in both countries -- now support what it calls "global clinical execution" across its expanding pipeline.