 September 10, 2025

The investigational new drug (IND) application for RGL-2102, an mRNA-based gene therapy independently developed by Shanghai Ruihongdi Pharmaceutical, a subsidiary of Hengrui Pharmaceuticals, has been officially approved by the U.S. Food and Drug Administration (FDA). The Phase II clinical trial will evaluate the efficacy and safety of the therapy in patients with lower limb ischemic diseases.