On July 13, 2023, the proprietary VGM-R02b of Shanghai Vitalgen BioPharma Co., Ltd. was granted CTA approval for the treatment of glutaric acidemia type I from the National Medical Products Administration (NMPA). VGM-R02b is registered as a dedicated new drug for the treatment of rare pediatric diseases. VGM-R02b has been granted Rare Pediatric Disease Designation (RPDD) by the US Food and Drug Administration (FDA) for the treatment of glutaric acidemia type I (GA-I), which is the third gene therapy project with clinical trial approval since the establishment of Vitalgen.
