HUIDAGENE ANNOUNCES IND APPROVAL OF THE FIRST CHINA MULTI-REGIONAL, MULTI-NATIONAL MASTER PROTOCOL OF HG004 BY NMPA
SHANGHAI and CLINTON, N.J., April 3, 2023 /PRNewswire/ -- HuidaGene Therapeutics (????; HuidaGene), a global clinical-stage biotechnology company focusing on developing genomic medicine, announces that the US. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for HG004, HuidaGene's lead gene replacement therapy for the treatment of inherited retinal disease caused by RPE65 mutations. Patients who are suffering from RPE65 mutation-associated inherited retinal diseases (IRDs), a group of rare blinding conditions caused by biallelic RPE65 mutations, affect the retina and pass on to children.