YolTech Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation to YOLT-203 for the Treatment of Primary Hyperoxaluria Type 1

February 2nd, 2026 – Shanghai, China —YolTech Therapeutics, a clinical-stage biotechnology company developing next-generation in vivo gene-editing therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to YOLT-203, the company’s investigational in vivo gene-editing therapy for the treatment of Primary Hyperoxaluria Type 1 (PH1).

Established under the 21st Century Cures Act，RMAT designation is intended to facilitate the development and expedite the review of regenerative medicine therapies for serious or life-threatening diseases with the potential to address unmet medical needs. The designation enables enhanced interactions with the FDA, including early and frequent regulatory engagement and the potential for priority review and accelerated approval pathways.

“RMAT designation underscores the FDA’s recognition of the potential of in vivo gene editing to fundamentally change how PH1 is treated,” said Yuxuan Wu, CEO of YolTech Therapeutics. “We believe YOLT-203 has the potential to deliver a one-time, durable intervention for a disease with profound unmet need.”

YOLT-203 is currently being evaluated in a global multicenter, randomized, double-blind, placebo-controlled study, the first pivotal trial of an in vivo gene-editing therapy for PH1. aiming to evaluate the safety and efficacy of YOLT-203 in reducing urinary oxalate levels and improving long-term renal outcomes.

YOLT-203 has previously received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the U.S. FDA, as well as Orphan Drug Designation from the European Medicines Agency (EMA).

About YOLT-203

YOLT-203 is an investigational in vivo gene-editing therapy designed to be a once-and-done treatment for PH1, a rare genetic disorder that leads to recurrent kidney stone formation and progress to kidney failure. The therapy aims to reduce the oxalate overproduction in PH1 patients by deactivating glycolate oxidase (GO), an enzyme encoded by HAO1 gene and suppressing the synthesis of oxalate precursors.

About YolTech

Built on next-generation CRISPR/Cas and LNP technologies, YolTech Therapeutics is pioneering in vivo gene-editing medicines with the potential for one-time, lifelong benefit. The company’s expanding clinical pipeline targets genetic, metabolic, cardiovascular, and autoimmune diseases, with initial results supporting the potential for durable and transformative therapeutic benefit.