- Fol­low­ing its Parkin­son’s dis­ease pro­gram, iRe­gene ad­vances an­oth­er off-the-shelf cell ther­a­py in­to clin­i­cal de­vel­op­ment in the U.S. and Chi­na.

Cheng­du, Chi­na, Sept. 7, 2026 — iRe­gene Ther­a­peu­tics Co., Ltd. (“iRe­gene” or the “Com­pa­ny”), a biotech­nol­o­gy com­pa­ny pi­o­neer­ing chem­i­cal­ly in­duced al­lo­gene­ic cell ther­a­py, to­day an­nounced that its in­ves­ti­ga­tion­al cell ther­a­py Nou­vSight001 has re­ceived clear­ance from Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA) for a Phase I/III clin­i­cal tri­al in pa­tients with re­tini­tis pig­men­tosa (RP) to eval­u­ate its safe­ty, tol­er­a­bil­i­ty and pre­lim­i­nary ef­fi­ca­cy.

The U.S. Food and Drug Ad­min­is­tra­tion (FDA) has al­so cleared Nou­vSight001 for a Phase I/II clin­i­cal tri­al for the same in­di­ca­tion and grant­ed a spe­cial ex­emp­tion.

Nou­vSight001 is an al­lo­gene­ic, off-the-shelf pho­tore­cep­tor cell ther­a­py de­vel­oped us­ing iRe­gene’s pro­pri­etary “AI + Chem­i­cal In­duc­tion” (“AI + Chem”) plat­form. As a cell re­place­ment ther­a­py, Nou­vSight001 is not lim­it­ed to pa­tients with a spe­cif­ic dis­ease-caus­ing geno­type. The reg­u­la­to­ry clear­ances in the U.S. and Chi­na mark an­oth­er mile­stone in iRe­gene’s glob­al prod­uct de­vel­op­ment.

The com­pa­ny has built a re­gen­er­a­tive med­i­cine pipeline fo­cused on ma­jor dis­eases as­so­ci­at­ed with the struc­tur­al bur­den of an ag­ing glob­al pop­u­la­tion, in­clud­ing Parkin­son’s dis­ease (PD), mul­ti­ple sys­tem at­ro­phy (MSA), reti­nal de­gen­er­a­tive dis­eases and is­chemic stroke. Its pipeline now spans the cen­tral ner­vous sys­tem, vi­su­al sys­tem and neu­rovas­cu­lar sys­tem.

iRe­gene’s “AI + Chem” plat­form is de­signed to iden­ti­fy and char­ac­ter­ize key bi­o­log­i­cal net­works that de­ter­mine cell fate and func­tion, and to pre­cise­ly reg­u­late these net­works us­ing small mol­e­cules.

Through this ap­proach, iRe­gene aims to make com­plex cell dif­fer­en­ti­a­tion process­es more pre­dictable, con­trol­lable, re­pro­ducible and scal­able for ther­a­peu­tic man­u­fac­tur­ing.

As mul­ti­ple pro­grams gen­er­at­ed from the same plat­form move in­to in­ter­na­tion­al clin­i­cal de­vel­op­ment, iRe­gene is be­gin­ning to show the plat­form’s ap­plic­a­bil­i­ty across dif­fer­ent cell types and dis­ease ar­eas.

Nou­vSight001 ex­pands iRe­gene’s pipeline in­to reti­nal re­gen­er­a­tive med­i­cine, an area with sig­nif­i­cant un­met med­ical need. The pro­gram has now been cleared for clin­i­cal de­vel­op­ment in both the U.S. and Chi­na. This marks an­oth­er step to­ward iRe­gene’s “one plat­form, mul­ti­ple prod­ucts, glob­al de­vel­op­ment” mod­el, a key ca­pa­bil­i­ty for a glob­al plat­form biotech.

Fol­low­ing FDA Or­phan Drug Des­ig­na­tion in 2024, Nou­vSight001 has now re­ceived clin­i­cal tri­al clear­ances from both the NM­PA and FDA, as well as a spe­cial ex­emp­tion from the FDA. This fur­ther demon­strates iRe­gene’s abil­i­ty to ad­vance in­ter­nal­ly de­vel­oped ther­a­pies in­to U.S. clin­i­cal de­vel­op­ment un­der glob­al reg­u­la­to­ry and de­vel­op­ment stan­dards.

Al­though iRe­gene’s pro­grams ad­dress dif­fer­ent dis­eases, tar­get tis­sues and clin­i­cal set­tings, they share a com­mon set of un­der­ly­ing ca­pa­bil­i­ties: glob­al reg­u­la­to­ry strat­e­gy; CMC and qual­i­ty sys­tems es­tab­lished to meet FDA and NM­PA re­quire­ments; man­u­fac­tur­ing ca­pa­bil­i­ties for al­lo­gene­ic, off-the-shelf cell ther­a­pies; cross-bor­der cold-chain and sup­ply-chain ca­pa­bil­i­ties; clin­i­cal de­vel­op­ment ca­pa­bil­i­ties in the U.S. and Chi­na; and an R&D plat­form de­signed to con­tin­u­ous­ly gen­er­ate new ther­a­peu­tic can­di­dates.

For iRe­gene, glob­al­iza­tion is there­fore mov­ing be­yond reg­u­la­to­ry clear­ance in­to what it calls “glob­al clin­i­cal ex­e­cu­tion.” This re­quires co­or­di­na­tion across R&D, man­u­fac­tur­ing, qual­i­ty, reg­u­la­to­ry af­fairs, sup­ply chain and clin­i­cal op­er­a­tions.

As pop­u­la­tions age world­wide and health­care needs evolve, iRe­gene is fo­cused on the fun­da­men­tal chal­lenge of restor­ing cells and tis­sue func­tions lost to dis­ease and ag­ing.

Rather than de­vel­op­ing a sin­gle cell ther­a­py, iRe­gene aims to build a tech­nol­o­gy plat­form ca­pa­ble of con­tin­u­ous­ly gen­er­at­ing new re­gen­er­a­tive med­i­cine prod­ucts. The com­pa­ny has built a pipeline across sev­er­al ma­jor dis­ease ar­eas. Its pro­grams seek to re­store func­tions lost to dis­ease, in­clud­ing neur­al cir­cuits and vi­sion, and to re­pair dam­aged neur­al tis­sue.

Through these pro­grams, iRe­gene is build­ing a re­gen­er­a­tive med­i­cine port­fo­lio around key func­tions lost to ag­ing and dis­ease. The com­pa­ny aims to move more of these ther­a­pies in­to glob­al de­vel­op­ment while build­ing to­ward com­mer­cial scal­a­bil­i­ty.

“Glob­al­iza­tion has been em­bed­ded in our R&D sys­tem since the com­pa­ny was found­ed,” said Tian­shi Ru­an, Chief Fi­nan­cial Of­fi­cer of iRe­gene Ther­a­peu­tics. “Nou­vNeu001 has giv­en us hands-on ex­pe­ri­ence ad­vanc­ing an iP­SC-de­rived cell ther­a­py across both the NM­PA and FDA reg­u­la­to­ry frame­works. Nou­vSight001 al­lows us to ap­ply that ex­pe­ri­ence to oph­thal­mol­o­gy, a very dif­fer­ent dis­ease and tis­sue set­ting.”

“The same un­der­ly­ing tech­nol­o­gy plat­form al­lows us to ad­vance our pipeline glob­al­ly and more ef­fi­cient­ly. Go­ing for­ward, we will con­tin­ue to ad­vance our core pro­grams in clin­i­cal de­vel­op­ment in the U.S. and Chi­na, while ac­tive­ly ex­plor­ing glob­al mul­ti­cen­ter stud­ies and in­ter­na­tion­al com­mer­cial part­ner­ships.” Ru­an added.

About Re­tini­tis Pig­men­tosa

Re­tini­tis pig­men­tosa (RP) is a group of in­her­it­ed reti­nal de­gen­er­a­tive dis­eases af­fect­ing ap­prox­i­mate­ly 1.5 mil­lion peo­ple world­wide. It typ­i­cal­ly be­gins with night blind­ness and pro­gress­es to pe­riph­er­al vi­sion loss and, in some cas­es, blind­ness. The on­ly ap­proved ther­a­py is lim­it­ed to pa­tients with bial­lel­ic RPE65 mu­ta­tions, who rep­re­sent a small frac­tion of the RP pop­u­la­tion. Most pa­tients still have no dis­ease-mod­i­fy­ing treat­ment op­tions.

About iRe­gene Ther­a­peu­tics

iRe­gene Ther­a­peu­tics is a plat­form biotech­nol­o­gy com­pa­ny de­vel­op­ing re­gen­er­a­tive med­i­cines for ma­jor ag­ing-re­lat­ed dis­eases world­wide. At the core of the com­pa­ny is its pro­pri­etary “AI + Chem” plat­form, com­bin­ing ar­ti­fi­cial in­tel­li­gence, sys­tems bi­ol­o­gy and chem­i­cal bi­ol­o­gy to iden­ti­fy and con­trol key bi­o­log­i­cal net­works that de­ter­mine cell fate and func­tion. iRe­gene us­es this ap­proach to de­vel­op al­lo­gene­ic, off-the-shelf cell ther­a­pies de­signed for stan­dard­ized, scal­able man­u­fac­tur­ing.

Me­dia Con­tact: PR@ire­gene.com

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